National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10) (PB 87 of 2019) (Cth)
Case
PB 87 of 2019
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10)
National Health Act 1953
___________________________________________________________________________
I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 30 October 2019
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10).
(2)This Instrument may also be cited as PB 87 of 2019.
Commencement
This Instrument commences on 1 November 2019.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Part 1, Division 2, Section 7
(a)omit: Note 1 substitute: Note
(b)omit: Note 2 substitute: Note
Part 1, Division 4, Section 14
(a)omit: Note 1 substitute: Note
(b)omit: Note 2 substitute: Note
Part 4, Division 2, Section 30
omit:Note 1 substitute: Note
Part 7, Section 51
(a)omit: Note 1 substitute: Note
(b)omit: Note 2 substitute: Note
Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)
omit from the column headed “Responsible Person” for the brand “Tracleer”: AT substitute: JC
Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)
omit from the column headed “Responsible Person” for the brand “Tracleer”: AT substitute: JC
Schedule 1, entry for Ciclosporin in the form Capsule 10 mg
(a)omit from the column headed “Circumstances”: C6629 C6630
(b)omit from the column headed “Circumstances”: C6659
(c)omit from the column headed “Circumstances”: C6670 C6671
(d)insert in numerical order in the column headed “Circumstances”: C9694 C9695 C9742 C9763 C9764
Schedule 1, entry for Ciclosporin in the form Capsule 25 mg
(a)omit from the column headed “Circumstances” (all instances): C6629 C6630
(b)omit from the column headed “Circumstances” (all instances): C6659
(c)omit from the column headed “Circumstances” (all instances): C6670 C6671
(d)insert in numerical order in the column headed “Circumstances” (all instances): C9694 C9695 C9742 C9763 C9764
Schedule 1, entry for Ciclosporin in the form Capsule 50 mg
(a)omit from the column headed “Circumstances” (all instances): C6629 C6630
(b)omit from the column headed “Circumstances” (all instances): C6659
(c)omit from the column headed “Circumstances” (all instances): C6670 C6671
(d)insert in numerical order in the column headed “Circumstances” (all instances): C9694 C9695 C9742 C9763 C9764
Schedule 1, entry for Ciclosporin in the form Capsule 100 mg
(a)omit from the column headed “Circumstances” (all instances): C6629 C6630
(b)omit from the column headed “Circumstances” (all instances): C6659
(c)omit from the column headed “Circumstances” (all instances): C6670 C6671
(d)insert in numerical order in the column headed “Circumstances” (all instances): C9694 C9695 C9742 C9763 C9764
Schedule 1, entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL
(a)omit from the column headed “Circumstances”: C6629 C6630
(b)omit from the column headed “Circumstances”: C6659
(c)omit from the column headed “Circumstances”: C6670 C6671
(d)insert in numerical order in the column headed “Circumstances”: C9694 C9695 C9742 C9763 C9764
Schedule 1, entry for Ciclosporin in the form Solution concentrate for I.V. infusion 50 mg in 1 mL
(a)omit from the column headed “Circumstances”: C6677
(b)insert in numerical order in the column headed “Circumstances”: C9831
Schedule 1, entry for Darbepoetin alfa in all forms
(a)omit from the column headed “Circumstances”: C6260
(b)insert in numerical order in the column headed “Circumstances”: C9688
Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesilate 500 mg
(a)omit from the column headed “Circumstances”: C6408
(b)insert in numerical order in the column headed “Circumstances”: C9696
Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesilate 2 g
(a)omit from the column headed “Circumstances”: C6408
(b)insert in numerical order in the column headed “Circumstances”: C9696
Schedule 1, entry for Epoetin alfa in all forms
(a)omit from the column headed “Circumstances”: C6260
(b)insert in numerical order in the column headed “Circumstances”: C9688
Schedule 1, entry for Epoetin beta in all forms
(a)omit from the column headed “Circumstances”: C6260
(b)insert in numerical order in the column headed “Circumstances”: C9688
Schedule 1, entry for Epoetin lambda in all forms
(a)omit from the column headed “Circumstances”: C6260
(b)insert in numerical order in the column headed “Circumstances”: C9688
Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)
omit from the column headed “Responsible Person”: AT substitute: JC
Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)
omit from the column headed “Responsible Person”: AT substitute: JC
Schedule 1, entry for Everolimus in the form Tablet 0.25 mg
(a)omit from the column headed “Circumstances”: C5555 C5794
(b)insert in numerical order in the column headed “Circumstances”: C9691 C9693
Schedule 1, entry for Everolimus in the form Tablet 0.5 mg
(a)omit from the column headed “Circumstances”: C5555 C5794
(b)insert in numerical order in the column headed “Circumstances”: C9691 C9693
Schedule 1, entry for Everolimus in the form Tablet 0.75 mg
(a)omit from the column headed “Circumstances”: C5555 C5794
(b)insert in numerical order in the column headed “Circumstances”: C9691 C9693
Schedule 1, entry for Everolimus in the form Tablet 1 mg
(a)omit from the column headed “Circumstances”: C5555 C5794
(b)insert in numerical order in the column headed “Circumstances”: C9691 C9693
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Inflectra]
(a)omit from the column headed “Circumstances”: C7709 C7720 C7723 C7738 C7763
(b)omit from the column headed “Circumstances”: C7778 C7810 C7811 C7847 C7886 C7910 C7922 C7923 C7931 C7942 C7989 C7994 C8009
(c)insert in numerical order in the column headed “Circumstances”: C8644
(d)insert in numerical order in the column headed “Circumstances”: C8881
(e)omit from the column headed “Circumstances”: C8931
(f)insert in numerical order in the column headed “Circumstances”: C8941
(g)insert in numerical order in the column headed “Circumstances”: C9065
(h)omit from the column headed “Circumstances”: C9397
(i)omit from the column headed “Circumstances”: C9499 C9552 C9557
(j)insert in numerical order in the column headed “Circumstances”: C9587
(k)insert in numerical order in the column headed “Circumstances”: C9668 C9669 C9675 C9676 C9677 C9719 C9721 C9731 C9732 C9733 C9751 C9752 C9754 C9756 C9759 C9775 C9776 C9778 C9779 C9781 C9782 C9783 C9785 C9787 C9788 C9799 C9800 C9803 C9806
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Remicade]
(a)omit from the column headed “Circumstances”: C7709 C7710 C7720 C7723 C7738
(b)omit from the column headed “Circumstances”: C7778 C7788 C7810 C7811 C7886 C7910 C7922 C7923 C7928 C7942 C7994 C8009
(c)omit from the column headed “Circumstances”: C8931
(d)insert in numerical order in the column headed “Circumstances”: C9669 C9675 C9676 C9677 C9719 C9721 C9751 C9752 C9754 C9756 C9759 C9776 C9778 C9779 C9781 C9782 C9783 C9788 C9799 C9800 C9803
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Renflexis]
(a)omit from the column headed “Circumstances”: C7709 C7720 C7723 C7738 C7763
(b)omit from the column headed “Circumstances”: C7778 C7810 C7811 C7847 C7886 C7910 C7922 C7923 C7931 C7942 C7989 C7994 C8009
(c)insert in numerical order in the column headed “Circumstances”: C8644
(d)insert in numerical order in the column headed “Circumstances”: C8881
(e)omit from the column headed “Circumstances”: C8931
(f)insert in numerical order in the column headed “Circumstances”: C8941
(g)insert in numerical order in the column headed “Circumstances”: C9065
(h)omit from the column headed “Circumstances”: C9397
(i)omit from the column headed “Circumstances”: C9499 C9552 C9557
(j)insert in numerical order in the column headed “Circumstances”: C9587
(k)insert in numerical order in the column headed “Circumstances”: C9668 C9669 C9675 C9676 C9677 C9719 C9721 C9731 C9732 C9733 C9751 C9752 C9754 C9756 C9759 C9775 C9776 C9778 C9779 C9781 C9782 C9783 C9785 C9787 C9788 C9799 C9800 C9803 C9806
Schedule 1, entry for Lanthanum in each of the forms: Tablet, chewable, 500 mg (as carbonate hydrate); Tablet, chewable, 750 mg (as carbonate hydrate); and Tablet, chewable, 1000 mg (as carbonate hydrate)
(a)omit from the column headed “Circumstances”: C5454
(b)insert in numerical order in the column headed “Circumstances”: C9762
Schedule 1, entry for Macitentan
omit from the column headed “Responsible Person”: AT substitute: JC
Schedule 1, entry for Methoxy polyethylene glycol-epoetin beta in all forms
(a)omit from the column headed “Circumstances”: C6260
(b)insert in numerical order in the column headed “Circumstances”: C9688
Schedule 1, entry for Mycophenolic acid in each of the forms: Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid; and Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
(a)omit from the column headed “Circumstances”: C4108 C4146
(b)insert in numerical order in the column headed “Circumstances”: C9692 C9809
Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg
(a)omit from the column headed “Circumstances” (all instances): C5601 C5626
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9689 C9690
Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg
(a)omit from the column headed “Circumstances” (all instances): C5555 C5794
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9691 C9693
Schedule 1, entry for Mycophenolic acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL
(a)omit from the column headed “Circumstances”: C5555 C5794
(b)insert in numerical order in the column headed “Circumstances”: C9691 C9693
Schedule 1, entry for Natalizumab
omit from the column headed “Circumstances”: C7697 C9406 substitute: C9744 C9818
Schedule 1, entry for Sevelamer
(a)omit from the column headed “Circumstances”: C5454
(b)insert in numerical order in the column headed “Circumstances”: C9762
Schedule 1, entry for Sirolimus in each of the forms: Tablet 0.5 mg; Tablet 1 mg; Tablet 2 mg; and Oral solution 1 mg per mL, 60 mL
(a)omit from the column headed “Circumstances”: C5794
(b)insert in numerical order in the column headed “Circumstances” : C9693
Schedule 1, entry for Sucroferric oxyhydroxide
(a)omit from the column headed “Circumstances”: C5454
(b)insert in numerical order in the column headed “Circumstances”: C9762
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg
(a)omit from the column headed “Circumstances” (all instances): C5602
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9697
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)
(a)omit from the column headed “Circumstances”: C5602
(b)insert in numerical order in the column headed “Circumstances”: C9697
Schedule 1, entry for Tacrolimus in the form Capsule 0.75 mg
(a)omit from the column headed “Circumstances”: C5602
(b)insert in numerical order in the column headed “Circumstances”: C9697
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg
(a)omit from the column headed “Circumstances” (all instances): C5602
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9697
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release)
(a)omit from the column headed “Circumstances”: C5602
(b)insert in numerical order in the column headed “Circumstances”: C9697
Schedule 1, entry for Tacrolimus in the form Capsule 2 mg
(a)omit from the column headed “Circumstances”: C5602
(b)insert in numerical order in the column headed “Circumstances”: C9697
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg
(a)omit from the column headed “Circumstances” (all instances): C5602
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9697
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release)
(a)omit from the column headed “Circumstances”: C5602
(b)insert in numerical order in the column headed “Circumstances”: C9697
Schedule 1, entry for Teduglutide
(a)omit from the column headed “Circumstances”: C9456 C9457 C9458
(b)omit from the column headed “Circumstances”: C9543
(c)insert in numerical order in the column headed “Circumstances”: C9687 C9740 C9793 C9829
Schedule 1, entry for Ustekinumab
omit from the column headed “Circumstances”: C7059 C7463 substitute: C9655 C9656 C9710
Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)
omit:
| Valganciclovir AN | JO | EMP | C4980 C4989 C9316 | 120 | 5 | D |
| Valganciclovir Juno | JU | EMP | C4980 C4989 C9316 | 120 | 5 | D |
Schedule 1, entry for Vedolizumab
(a)omit from the column headed “Circumstances”: C5104
(b)omit from the column headed “Circumstances”: C5127 C6612
(c)omit from the column headed “Circumstances”: C7158 C7426 C7668 C7672 C7683
(d)insert in numerical order in the column headed “Circumstances”: C9682 C9683 C9708 C9738 C9739 C9771 C9792 C9796 C9815 C9825
Schedule 2
omit:
AT Actelion Pharmaceuticals Australia Pty Ltd 32 097 278 512
Schedule 3, entry for Azithromycin
omit:
| C6361 | Mycobacterium avium complex infection The treatment must be for prophylaxis; AND Patient must be human immunodeficiency virus (HIV) positive; AND Patient must have CD4 cell counts of less than 75 per cubic millimetre. | Compliance with Authority Required procedures |
Schedule 3, entry for Ciclosporin
(a)omit:
| C6629 | Severe atopic dermatitis Management (initiation, stabilisation and review of therapy) Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies. | Compliance with Authority Required procedures |
| C6630 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a dermatologist. | Compliance with Authority Required procedures |
(b)omit:
| C6659 | Severe active rheumatoid arthritis Management (initiation, stabilisation and review of therapy) The condition must have been ineffective to prior treatment with classical slow‑acting anti‑rheumatic agents (including methotrexate); OR The condition must be considered inappropriate for treatment with slow‑acting anti‑rheumatic agents (including methotrexate). Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist. | Compliance with Authority Required procedures |
(c)omit:
| C6670 | Management of transplant rejection Management (initiation, stabilisation and review of therapy) Patient must have had an organ or tissue transplantation; AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures |
| C6671 | Nephrotic syndrome Management (initiation, stabilisation and review of therapy) Patient must have failed prior treatment with steroids and cytostatic drugs; OR Patient must be intolerant to treatment with steroids and cytostatic drugs; OR The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND Patient must not have renal impairment. Must be treated by a nephrologist. | Compliance with Authority Required procedures |
(d)omit:
| C6677 | Management of transplant rejection The treatment must be used by organ or tissue transplant recipients. | Compliance with Authority Required procedures |
(e)insert in numerical order after existing text:
| C9694 | Nephrotic syndrome Management (initiation, stabilisation and review of therapy) Patient must have failed prior treatment with steroids and cytostatic drugs; OR Patient must be intolerant to treatment with steroids and cytostatic drugs; OR The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND Patient must not have renal impairment. Must be treated by a nephrologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9694 |
| C9695 | Severe atopic dermatitis Management (initiation, stabilisation and review of therapy) Must be treated by a dermatologist; OR Must be treated by a clinical immunologists. The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies. | Compliance with Authority Required procedures - Streamlined Authority Code 9695 |
| C9742 | Severe active rheumatoid arthritis Management (initiation, stabilisation and review of therapy) The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate). Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9742 |
| C9763 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9763 |
| C9764 | Management of transplant rejection Management (initiation, stabilisation and review of therapy) Patient must have had an organ or tissue transplantation; AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures - Streamlined Authority Code 9764 |
| C9831 | Management of transplant rejection The treatment must be used by organ or tissue transplant recipients. | Compliance with Authority Required procedures - Streamlined Authority Code 9831 |
Schedule 3, entry for Darbepoetin alfa
(a)omit:
| C6260 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9688 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9688 |
Schedule 3, entry for Desferrioxamine
(a)omit:
| C6408 | Disorders of erythropoiesis The condition must be associated with treatment‑related chronic iron overload. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9696 | Disorders of erythropoiesis The condition must be associated with treatment-related chronic iron overload. | Compliance with Authority Required procedures - Streamlined Authority Code 9696 |
Schedule 3, entry for Epoetin alfa
(a)omit:
| C6260 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9688 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9688 |
Schedule 3, entry for Epoetin beta
(a)omit:
| C6260 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9688 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9688 |
Schedule 3, entry for Epoetin lambda
(a)omit:
| C6260 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9688 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9688 |
Schedule 3, entry for Everolimus
(a)omit:
| C5555 | Management of cardiac allograft rejection Treatment Phase: Management (initiation, stabilisation and review of therapy) Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures |
| C5794 | Management of renal allograft rejection Treatment Phase: Management (initiation, stabilisation and review of therapy) Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9691 | Management of renal allograft rejection Management (initiation, stabilisation and review of therapy) Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures - Streamlined Authority Code 9691 |
| C9693 | Management of cardiac allograft rejection Management (initiation, stabilisation and review of therapy) Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures - Streamlined Authority Code 9693 |
Schedule 3, entry for Infliximab
(a)omit:
| C7709 | Severe Crohn disease Balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment). Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
| C7710 | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of the most recent clinical assessment. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7720 | Severe Crohn disease Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment; and (v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment. Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application and preferably should be performed whilst still on treatment with the most recent course of prior therapies. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7723 | Severe Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. A maximum of 24 weeks of treatment with this drug will be authorised under this criterion. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7738 | Severe Crohn disease Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed PBS‑subsidised therapy with this drug for this condition in the current treatment cycle. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment; and (iv) the details of prior biological medicine treatment including the details of date and duration of treatment. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7763 | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. Patient must be aged 18 years or older. Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7763 |
(b)omit:
| C7778 | Complex refractory Fistulising Crohn disease Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) details of prior biological medicine treatment including details of date and duration of treatment. The most recent fistula assessment must be no more than 1 month old at the time of application. Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7788 | Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7810 | Complex refractory Fistulising Crohn disease Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have an externally draining enterocutaneous or rectovaginal fistula. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and (ii) a signed patient acknowledgement. The most recent fistula assessment must be no more than 1 month old at the time of application. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7811 | Complex refractory Fistulising Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. A maximum of 24 weeks of treatment with this drug will be authorised under this restriction. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7847 | Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have received this drug as their most recent course of PBS‑subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7847 |
| C7886 | Moderate to severe Crohn disease Balance of supply Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 treatment (New patient or Recommencement of treatment after more than 5 years break in therapy) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or Re‑commencement of treatment after a break in therapy of less than 5 years ) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment). | Compliance with Authority Required procedures |
| C7910 | Moderate to severe Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. The PCDAI assessment must be no more than 1 month old at the time of application. The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. A maximum of 24 weeks of treatment with this drug will be authorised under this restriction. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7922 | Moderate to severe Crohn disease Initial 1 ‑ New patient or recommencement of treatment after more than 5 years break in therapy Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra‑indication to each of prednisolone (or equivalent), azathioprine, 6‑mercaptopurine and methotrexate; AND Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and (ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition. The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7923 | Moderate to severe Crohn disease Initial 2 ‑ Change or Re‑commencement of treatment after a break in therapy of less than 5 years Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and (ii) details of prior biological medicine treatment including details of date and duration of treatment. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7928 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7931 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. The PCDAI assessment must be no more than 1 month old at the time of prescribing. The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy. Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7931 |
| C7942 | Moderate to severe ulcerative colitis Initial 2 ‑ Change or Re‑commencement of treatment after a break in therapy of less than 5 years Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; OR Patient must have previously received PBS‑subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND Patient must not have failed PBS‑subsidised treatment with this drug for this condition in the current treatment cycle; OR Patient must not have failed PBS‑subsidised treatment with this drug for this condition in the current treatment cycle more than once if aged 6 to 17 years. Patient must be 6 years of age or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and (ii) the number of total failures to courses of biological medicine therapy in the current treatment cycle. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. If the response assessment to the previous course of biological medicine therapy is not met, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C7989 | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7989 |
| C7994 | Moderate to severe ulcerative colitis Initial 1 ‑ New patient or recommencement of treatment after more than 5 years break in therapy Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years). Patient must be 6 years of age or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8‑weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment. The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application. Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis. Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. | Compliance with Written Authority Required procedures |
| C8009 | Moderate to severe ulcerative colitis Balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 treatment (New patient or Recommencement of treatment after more than 5 years break in therapy) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or Re‑commencement of treatment after a break in therapy of less than 5 years ) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment). Patient must be 6 years of age or older. | Compliance with Authority Required procedures |
(c)omit:
| C8931 | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Authority Required procedures |
(d)omit:
| C9397 | Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures - Streamlined Authority Code 9397 |
(e)omit:
| C9499 | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. | Compliance with Authority Required procedures - Streamlined Authority Code 9499 |
| C9552 | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be aged 18 years or older. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9552 |
| C9557 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. The PCDAI assessment must be no more than 1 month old at the time of prescribing. The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures - Streamlined Authority Code 9557 |
(f)insert in numerical order after existing text:
| C9668 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 6 to 17 years inclusive. The PCDAI assessment must be no more than 1 month old at the time of prescribing. The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures - Streamlined Authority Code 9668 |
| C9669 | Moderate to severe Crohn disease Balance of supply for paediatric patient Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment. | Compliance with Authority Required procedures |
| C9675 | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; OR Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; OR Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years. Patient must be 6 years of age or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9676 | Severe Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C9677 | Complex refractory Fistulising Crohn disease Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C9719 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 6 to 17 years inclusive. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. The PCDAI assessment must be no more than 1 month old at the time of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C9721 | Moderate to severe Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 6 to 17 years inclusive. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition. The PCDAI assessment must be no more than 1 month old at the time of application. The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C9731 | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9731 |
| C9732 | Complex refractory Fistulising Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated an adequate response to treatment with this drug. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures - Streamlined Authority Code 9732 |
| C9733 | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9733 |
| C9751 | Moderate to severe Crohn disease Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and (ii) details of prior biological medicine treatment including details of date and duration of treatment. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
| C9752 | Moderate to severe Crohn disease Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following: (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and (ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition. The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. |
(c)omit:
| C7158 | Severe Crohn disease Change or Re‑commencement of treatment (initial 2) Patient must have a documented history of severe Crohn disease; AND Patient must have received prior PBS‑subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND Patient must not have failed PBS‑subsidised therapy with this drug for this condition in the current treatment cycle; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment; and (iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction. Where the most recent course of PBS‑subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures |
| C7426 | Severe Crohn disease Initial treatment (new patient ‑ initial 1) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more months; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment; and (v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment. Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following: (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. | Compliance with Written Authority Required procedures |
| C7668 | Moderate to severe ulcerative colitis Balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction); AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
| C7672 | Moderate to severe ulcerative colitis Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the signed patient acknowledgement. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application. Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment. If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. | Compliance with Written Authority Required procedures |
| C7683 | Moderate to severe ulcerative colitis Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) Patient must have previously received PBS‑subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND Patient must not have failed PBS‑subsidised therapy with vedolizumab for this condition in the current treatment cycle; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must be aged 18 years or older. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug. Applications for authorisation of change or recommencement treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) Mayo clinical assessment (to demonstrate response to prior treatment). A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. Up to a maximum of 2 repeats will be authorised. Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services. | Compliance with Written Authority Required procedures |
(d)insert in numerical order after existing text:
| C9682 | Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. Details of the accepted toxicities including severity can be found on the Department of Human Services website. | Compliance with Written Authority Required procedures |
| C9683 | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. Up to a maximum of 2 repeats will be authorised. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C9708 | Severe Crohn disease Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must be aged 18 years or older. Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment. Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following: (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9738 | Moderate to severe ulcerative colitis Balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. | Compliance with Authority Required procedures |
| C9739 | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. Up to a maximum of 2 repeats will be authorised. Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9771 | Severe Crohn disease Balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. |
| C9792 | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Application for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. Details of the accepted toxicities including severity can be found on the Department of Human Services website. | Compliance with Written Authority Required procedures |
| C9796 | Severe Crohn disease Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must be aged 18 years or older. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion. Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C9815 | Severe Crohn disease Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment; and (iv) the details of prior biological medicine treatment including the details of date and duration of treatment. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9825 | Severe Crohn disease Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND Patient must have evidence of intestinal inflammation; OR Patient must be assessed clinically as being in a high faecal output state; OR Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iii) the date of the most recent clinical assessment. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Actions
Download as PDF
Download as Word Document
Cases Citing This Decision
0
Cases Cited
0
Statutory Material Cited
0