National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 11) (PB 104 of 2015) (Cth)
PB 104 of 2015
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 11)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated 27 October 2015
Julianne Quaine
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 11).
(2)This Instrument may also be cited as PB 104 of 2015.
2 Commencement
This Instrument commences on 1 November 2015.
3 Amendment
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1, entry for Anakinra in the form Injection 100 mg in 0.67 mL single use pre-filled syringe and brand Kineret
omit from the column headed ‘Maximum Quantity’ : 1 insert: 28
Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesylate 500 mg
substitute:
Powder for injection containing desferrioxamine mesylate 500 mg Injection Hospira Pty Limited HH EMP C1085 C3340 400 5 D
Schedule 1, entry for Eculizumab
substitute:
Eculizumab Solution concentrate for I.V. infusion 300 mg in 30 mL Injection Soliris XI EMP C4668 C4713 C4732 C4733 C4760 C4761 C5546 C5547 C5548 C5558 C5582 C5583 C5603 C5604 P4733 P4760 1 0 D C4668 C4713 C4732 C4733 C4760 C4761 C5546 C5547 C5548 C5558 C5582 C5583 C5603 C5604 P4732 P4761 1 4 D C4668 C4713 C4732 C4733 C4760 C4761 C5546 C5547 C5548 C5558 C5582 C5583 C5603 C5604 P4668 P4713
P5548 P5582
P5583 P56041 5 D C4668 C4713 C4732 C4733 C4760 C4761 C5546 C5547 C5548 C5558 C5582 C5583 C5603 C5604 P5546 P5547 P5558 P5603 1 6 D
Schedule 1, entry for Everolimus in each of the forms Tablet 0.25 mg, Tablet 0.5 mg, Tablet 0.75 mg, Tablet 1 mg
omit from the column headed ‘Circumstances’ : C1650 C1651 C3355 C3356 insert: C5554 C5555 C5567 C5599
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg
a) omit from the column headed ‘Circumstances’ (all instances) : C5093 insert in the column headed ‘Circumstances’ (all instances): C5570
b) omit from the column headed ‘Purposes’ (all instances) : P5093 insert in the column headed ‘Purposes’ (all instances): P5570
Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg
substitute:
Capsule containing mycophenolate mofetil 250 mg Oral APO-Mycophenolate TX MP C5580 C5588 C5600 C5601 600 5 D CellCept RO MP C5580 C5588 C5600 C5601 600 5 D Ceptolate AF MP C5580 C5588 C5600 C5601 600 5 D Mycophenolate Sandoz SZ MP C5580 C5588 C5600 C5601 600 5 D Pharmacor Mycophenolate 250 CR MP C5580 C5588 C5600 C5601 600 5 D
Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg
substitute:
| Tablet containing mycophenolate mofetil 500 mg | Oral | APO-Mycophenolate | TX | MP | C5554 C5555 C5567 C5599 | 300 | 5 | D |
| CellCept | RO | MP | C5554 C5555 C5567 C5599 | 300 | 5 | D | ||
| Ceptolate | AF | MP | C5554 C5555 C5567 C5599 | 300 | 5 | D | ||
| Mycophenolate AN | EA | MP | C5554 C5555 C5567 C5599 | 300 | 5 | D | ||
| Mycophenolate Sandoz | SZ | MP | C5554 C5555 C5567 C5599 | 300 | 5 | D | ||
| Pharmacor Mycophenolate 500 | CR | MP | C5554 C5555 C5567 C5599 | 300 | 5 | D |
Schedule 1, entry for Mycophenolic acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL
omit from the column headed ‘Circumstances’ : C1650 C1651 C3355 C3356 insert : C5554 C5555 C5567 C5599
Schedule 1, entry for Peginterferon Alfa-2a in each of the forms Injection 135 micrograms in 0.5mL single use pre-filled syringe and Injection 180 micrograms in 0.5mL single use pre-filled syringe
omit from the column headed ‘Circumstances’ : C5020 insert: C5067
Schedule 1, entry for Sirolimus in each of the forms Tablet 0.5 mg, Tablet 1 mg, Tablet 2 mg, Oral solution 1 mg per mL, 60 mL
omit from the column headed ‘Circumstances’ : C1650 C3355 insert: C5567 C5599
Schedule 1, entry for Tacrolimus
substitute:
Tacrolimus Capsule 0.5 mg Oral Pharmacor Tacrolimus 0.5 CR MP C5569 C5602 200 5 D Prograf LL MP C5569 C5602 200 5 D TACROLIMUS APOTEX TX MP C5569 C5602 200 5 D Tacrolimus Sandoz SZ MP C5569 C5602 200 5 D Capsule 1 mg Oral Pharmacor Tacrolimus 1 CR MP C5569 C5602 200 5 D Prograf LL MP C5569 C5602 200 5 D TACROLIMUS APOTEX TX MP C5569 C5602 200 5 D Tacrolimus Sandoz SZ MP C5569 C5602 200 5 D Capsule 5 mg Oral Pharmacor Tacrolimus 5 CR MP C5569 C5602 100 5 D Prograf LL MP C5569 C5602 100 5 D TACROLIMUS APOTEX TX MP C5569 C5602 100 5 D Tacrolimus Sandoz SZ MP C5569 C5602 100 5 D Capsule 0.5 mg (once daily prolonged release) Oral Prograf XL LL MP C5569 C5602 60 5 D Capsule 1 mg (once daily prolonged release) Oral Prograf XL LL MP C5569 C5602 120 5 D Capsule 5 mg (once daily prolonged release)
Oral
Prograf XL
LL
MP
C5569 C5602
60
5
D
Schedule 1, entry for Tocilizumab in each of the forms Concentrate for injection 80 mg in 4 mL; Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL;
a)omit from the column headed ‘Circumstances’ (all instances) : C4025 C4026 C4027 C4028
b)insert in the column headed ‘Circumstances’ (all instances): C5545 C5556 C5557 C5568 C5581
Schedule 1, entry for Vedolizumab in the form Powder for injection 300 mg
omit from the column headed ‘Circumstances’ : C5124 insert: C5591
Schedule 2, after entry for SZ
insert:
TK Takeda Pharmaceuticals Australia Pty Ltd 71 095 610 870
Schedule 3, entry for Eculizumab
a) omit:
| C4667 | P4667 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Continuing treatment – beyond initial 48 weeks of treatment Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment The authority application must be in writing and must include: | Compliance with modified Authority Required procedures |
b) omit:
| C4691 | P4691 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Continuing treatment – beyond initial 48 weeks of treatment Patient must have received 48 weeks of treatment under Initial treatment-New patient, Initial treatment-Balance of supply and Continuing treatment-New patient with PBS-subsidised eculizumab for this condition; AND Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40%; OR Patient must have severe TMA-related neurological impairment; OR Patient must have severe TMA-related gastrointestinal impairment; OR Patient must have severe TMA-related pulmonary impairment; OR Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 ml/min); AND Patient must not receive more than 24 weeks of treatment under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment The authority application must be in writing and must include: (1) A completed authority prescription form; and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and (3) A copy of a current Certificate of vaccination; and (4) A measurement of body weight at the time of application; and (5) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment; and (6) Evidence that the patient has had a treatment response including haematological results of no more than 1 month old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 month old at the time of application; and (7) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (8) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
| C4692 | P4692 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Initial treatment 2 – Recommencement of treatment after an initial 48-week period Patient must have demonstrated treatment response to previous 48 weeks of treatment with PBS-subsidised eculizumab for this condition; AND Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L);OR(iii) TMA-related organ impairment including on recent biopsy; AND Patient must not receive more than 24 weeks of treatment under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment The authority application must be in writing and must include: (1) A completed authority prescription form(s); and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Initial treatment 2- Recommencement of treatment after an initial 48-week period; and (3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and (4) A copy of a current Certificate of vaccination; and (5) A measurement of body weight at the time of application, and (6) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy; (7) Evidence that the patient has had a treatment response to their previous treatment with eculizumab ; and (8) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (9) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
| C4708 | P4708 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Continuing treatment – following recommencement of treatment after an initial 48-week period Patient must have received Initial treatment 2-recommencement of treatment after an initial 48-week period with PBS-subsidised eculizumab for this condition; AND Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS-subsidised eculizumab for this condition; AND Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment The authority application must be in writing and must include: (1) A completed authority prescription form; and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and (3) A copy of a current Certificate of vaccination; and (4) A measurement of body weight at the time of application; and (5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and (6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
| C4712 | P4712 | Where the patient is receiving treatment at/from a private or public hospital Continuing treatment – New patient Patient must have received 24 weeks therapy under the initial restriction with PBS subsidised eculizumab for this condition; AND Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition; AND Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided The authority application must be in writing and must include: (1) A completed authority prescription form; and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and (3) A copy of a current Certificate of vaccination; and (4) A measurement of body weight at the time of application; and (5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and (6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
c) omit:
| C4725 | P4725 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Initial treatment 2 – Recommencement of treatment after an initial 48-week period Patient must have demonstrated treatment response to previous 48 weeks of treatment with PBS-subsidised eculizumab for this condition; AND Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L);OR(iii) TMA-related organ impairment including on recent biopsy; AND Patient must not receive more than 24 weeks of treatment under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment The authority application must be in writing and must include: (1) A completed authority prescription form(s); and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Initial treatment 2- Recommencement of treatment after an initial 48-week period; and (3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and (4) A copy of a current Certificate of vaccination; and (5) A measurement of body weight at the time of application, and (6) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy; (7) Evidence that the patient has had a treatment response to their previous treatment with eculizumab ; and (8) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (9) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
d) omit:
| C4750 | P4750 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Continuing treatment – New patient Patient must have received 24 weeks therapy under the initial restriction with PBS subsidised eculizumab for this condition; AND Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition; AND Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided The authority application must be in writing and must include: (1) A completed authority prescription form; and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and (3) A copy of a current Certificate of vaccination; and (4) A measurement of body weight at the time of application; and (5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and (6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
e) omit:
| C4767 | P4767 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) Continuing treatment – following recommencement of treatment after an initial 48-week period Patient must have received Initial treatment 2-recommencement of treatment after an initial 48-week period with PBS-subsidised eculizumab for this condition; AND Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS-subsidised eculizumab for this condition; AND Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist A treatment response is defined as: (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND (2) One of the following: a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or b) an eGFR within +/- 25% from baseline; or c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is: (1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or (2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment The authority application must be in writing and must include: (1) A completed authority prescription form; and (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and (3) A copy of a current Certificate of vaccination; and (4) A measurement of body weight at the time of application; and (5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and (6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and (7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required | Compliance with modified Authority Required procedures |
f) insert in numerical order after C4761:
| C5546 | P5546 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) A treatment response is defined as: | Compliance with modified Authority Required procedures |
| C5547 | P5547 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
| C5548 | P5548 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
| C5558 | P5558 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
| C5582 | P5582 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
| C5583 | P5583 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
| C5603 | P5603 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
| C5604 | P5604 | Where the patient is receiving treatment at/from a private or public hospital Atypical haemolytic uraemic syndrome (aHUS) | Compliance with modified Authority Required procedures |
Schedule 3, entry for Everolimus
substitute:
Everolimus C5554 P5554 Where the patient is receiving treatment at/from a public hospital
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 Written or Telephone Authority Required procedures - Streamlined Authority Code 5554 C5555 P5555 Where the patient is receiving treatment at/from a private hospital
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 Written or Telephone Authority Required procedures C5567 P5567 Where the patient is receiving treatment at/from a private hospital
Management of renal 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 Written or Telephone Authority Required procedures C5599 P5599 Where the patient is receiving treatment at/from a public hospital
Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5599
Schedule 3, entry for Infliximab
a)omit:
C5093 P5093 Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy (Initial 2)
Patient must have previously been issued with an authority prescription for infliximab or vedolizumab for moderate to severe ulcerative colitis, AND
Patient must have previously demonstrated an adequate response to the most recent treatment course with this drug by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 during treatment with this drug; OR
Patient must have previously demonstrated an adequate response to the most recent treatment course with this drugby 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; OR
Patient must have previously received treatment with vedolizumab for moderate to severe ulcerative colitis but failed to achieve or maintain an adequate response to 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.
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.
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 sufficient for a single infusion at a dose of 5 mg per kg.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with modified Authority Required procedures
b)insert in numerical order after C5485:
C5570 P5570 Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Treatment Phase: Change or Re-commencement of treatment after a break in therapy (Initial 2)
Patient must have previously been issued with an authority prescription for infliximab or vedolizumab for this condition in this treatment cycle, AND
Patient must not have failed PBS-subsidised therapy with infliximab for this condition more than once in the current treatment cycle.
Patient must be treated by a gastroenterologist (code 87); OR
Patient must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Patient must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Patient must be treated by a paediatrician; OR
Patient must be treated by a specialist paediatric gastroenterologist.
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.
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 sufficient for a single infusion at a dose of 5 mg per kg.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with modified Authority Required procedures
Schedule 3, entry for Mycophenolic acid
a) omit:
C1650 Where the patient is receiving treatment at/from a private hospital
Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as requiredCompliance with Written or Telephone Authority Required procedures C1651 Where the patient is receiving treatment at/from a private hospital
Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as requiredCompliance with Written or Telephone Authority Required procedures C3355 Where the patient is receiving treatment at/from a public hospital
Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as requiredCompliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3355 C3356 Where the patient is receiving treatment at/from a public hospital
Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as requiredCompliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3356 b) insert in numerical order after C4146:
C5554 P5554 Where the patient is receiving treatment at/from a public hospital
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 Written or Telephone Authority Required procedures - Streamlined Authority Code 5554 C5555 P5555 Where the patient is receiving treatment at/from a private hospital
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, ANDThe treatment must be under the supervision and direction of a transplant unit.
Compliance with Written or Telephone Authority Required procedures C5567 P5567 Where the patient is receiving treatment at/from a private hospital
Management of renal 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 Written or Telephone Authority Required procedures C5580 P5580 Where the patient is receiving treatment at/from a public hospital
Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5580 C5588 P5588 Where the patient is receiving treatment at/from a private hospital
Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures C5599 P5599 Where the patient is receiving treatment at/from a public hospital
Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5599 C5600 P5600 Where the patient is receiving treatment at/from a public hospital
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 Written or Telephone Authority Required procedures - Streamlined Authority Code 5600 C5601 P5601 Where the patient is receiving treatment at/from a private hospital
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 Written or Telephone Authority Required procedures
Schedule 3, entry Peginterferon Alfa-2a
a)omit:
C5020 Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Chronic hepatitis B infection
The treatment must be limited to a maximum duration of 48 weeks, AND
Patient must have cirrhosis, AND
Patient must have detectable HBV DNA, AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5020 b)insert in numerical order after C5016:
C5067 P5067 Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B infection
Patient must have cirrhosis, AND
Patient must have detectable HBV DNA, AND
The treatment must be the sole PBS-subsidised therapy for this condition, AND
The treatment must be limited to 1 course of treatment for a maximum duration of 48 weeks.
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5067
Schedule 3, entry for Sirolimus
substitute:
Sirolimus C5567 P5567 Where the patient is receiving treatment at/from a private hospital
Management of renal 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 Written or Telephone Authority Required procedures C5599 P5599 Where the patient is receiving treatment at/from a public hospital
Management of renal allograft rejection
Treatment Phase: Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5599
Schedule 3, entry for Tacrolimus
substitute:
Tacrolimus
C5569
P5569
Where the patient is receiving treatment at/from a public hospital
Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5569
C5602 P5602 Where the patient is receiving treatment at/from a private hospital
Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required.Compliance with Written or Telephone Authority Required procedures
Schedule 3, entry for Tocilizumab
a)omit:
C4025 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis — initial treatment 1
(new and recommencing patients after a break of more than 12 months)
Initial treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:
(a) has been diagnosed with systemic juvenile idiopathic arthritis; AND
(b) has polyarticular course disease and either:
(i) failure to achieve an adequate response to the following treatment regimen (see (1) below for definition of failure to achieve an adequate response):
— oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral
or intra‑articular corticosteroids for a minimum of 3 months; or
(ii) severe intolerance of, or toxicity due to, methotrexate (see (2) below for definition of severe intolerance and toxicity); OR
(c) has refractory systemic symptoms, demonstrated by:
— an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
(d) has not received PBS‑subsidised treatment with tocilizumab for this condition in the previous 12 months.
(1) The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy and must be demonstrated in all patients at the time of the initial application:
(a) in a patient with polyarticular course disease:
(i) an active joint count of at least 20 active (swollen and tender) joints; OR
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as swollen and tender); AND/OR
— shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement,
where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) an active joint count of at least 2 active joints; AND
(ii) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; AND/OR
(iii) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
(2) Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonia, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the
relevant Therapeutic Goods Administration (TGA)‑approved Product Information, please provide details at time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of this toxicity at the time of application.
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be provided for all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(ii) details of prior treatment including dose and duration of treatment;
(iii) pathology reports detailing CRP and platelet count where appropriate; and
(3) a signed patient or authorised guardian acknowledgement form.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment will be authorised under this restriction.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
Where fewer than 3 repeats are requested at the time of initial application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment may be requested by telephone.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment 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 Chief Executive Medicare no later than 4 weeks from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to respond to 2 courses of treatment in a treatment cycle they will not be eligible to receive further PBS‑subsidised tocilizumab therapy in that treatment cycle. A patient may re‑trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS‑subsidised treatment was stopped and the date of the first application under a new treatment cycleCompliance with modified Authority Required procedures C4026 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis — initial treatment 2
(retrial or recommencement of treatment after a break of less than 12 months)
Initial PBS‑subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of a patient who:
(a) has a documented history of systemic juvenile idiopathic arthritis; AND
(b) has received PBS‑subsidised treatment with tocilizumab for this condition in the previous 12 months; AND
(c) has not failed PBS‑subsidised therapy with tocilizumab for this condition more than once in the current treatment cycle.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) pathology reports detailing C‑reactive protein (CRP) and platelet count where appropriate.
Applications for a patient who has received PBS‑subsidised treatment with tocilizumab in this treatment cycle and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised tocilizumab treatment, within the timeframes specified below.
A maximum of 16 weeks of treatment will be authorised under this restriction.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
Where fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with tocilizumab may be requested by telephone.
An 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 Chief Executive Medicare 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 criteria. Where an assessment is not submitted to the Chief Executive Medicare within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with tocilizumab.
Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to that course of tocilizumab.
If a patient fails to respond to 2 courses of treatment they will not be eligible to receive further PBS‑subsidised tocilizumab therapy in this treatment cycle. A patient may re‑trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS‑subsidised treatment was stopped and the date of the first application under a new treatment cycleCompliance with modified Authority Required procedures C4027 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis — initial treatment 3
Initial treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of a patient who:
(a) has a documented history of systemic juvenile idiopathic arthritis; and
(b) was receiving treatment with tocilizumab prior 1 November 2011; and
(c) has demonstrated a response as specified in the criteria for continuing PBS‑subsidised treatment with tocilizumab; and
(d) is receiving treatment with tocilizumab at the time of application.
To ensure consistency in determining response, the same indices of disease severity used to establish the baseline must be provided for all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) pathology reports detailing C‑reactive protein (CRP) and platelet count where appropriate; and
(3) a signed patient or authorised guardian acknowledgement form.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application.
The baseline systemic juvenile idiopathic arthritis assessment must be provided and must be from immediately prior to commencing treatment with tocilizumab.
Baseline measurements of the joint count, fever and/or CRP level and platelet count will be used to determine whether a response to treatment has been demonstrated.
An 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 Chief Executive Medicare 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 criteria.
Where an assessment is not submitted to the Chief Executive Medicare within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with tocilizumab.
Patients are eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks providing they continue to sustain the response.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one months supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone.
A patient may only qualify for PBS‑subsidised treatment under this restriction onceCompliance with modified Authority Required procedures C4028 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis — continuing treatment
Continuing treatment with tocilizumab, by a rheumatologist or under the supervision of a paediatric rheumatology
treatment centre, of a patient who:
(a) has a documented history of systemic juvenile idiopathic arthritis; AND
(b) has demonstrated an adequate response to treatment with tocilizumab.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement,
where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; AND/OR
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; AND/OR
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) baseline and current pathology reports detailing CRP and platelet count where appropriate.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application.
Where the most recent course of PBS‑subsidised tocilizumab treatment was approved under the Initial treatment restriction, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS‑subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased.
Patients are eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks providing they continue to sustain the response.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are requested at the time of initial application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by.
If a patient fails to respond to 2 courses of treatment they will not be eligible to receive further PBS‑subsidised tocilizumab therapy in this treatment cycle. A patient may re‑trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS‑subsidised treatment was stopped and the date of the first application under a new treatment cycleCompliance with modified Authority Required procedures
b)insert in numerical order after C5505:
C5545 P5545 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis
Treatment Phase: Continuing treatment - balance of supply
Patient must have received insufficient tocilizumab therapy under the Continuing Treatment restriction to complete 24 weeks treatment, AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Compliance with modified Authority Required procedures C5556 P5556 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis
Treatment Phase: Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 12 months)
Patient must have been diagnosed with systemic juvenile idiopathic arthritis, AND
Patient must have received no prior PBS-subsidised treatment with tocilizumab for this condition; OR
Patient must not have received PBS-subsidised treatment with tocilizumab for this condition in the previous 12 months, AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy, AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Patient must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments 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.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following:
(i) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(ii) details of prior treatment including dose and duration of treatment;
(iii) pathology reports detailing CRP and platelet count where appropriate; and
(3) an acknowledgement signed by a parent or authorised guardian.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one months supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
If a patient fails to respond to 2 courses of treatment in a treatment cycle they will not be eligible to receive further PBS-subsidised tocilizumab therapy in that treatment cycle. A patient may retrial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised treatment was stopped and the date of the first application under a new treatment cycle.Compliance with modified Authority Required procedures C5557 P5557 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis
Treatment Phase: Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)
Patient must have a documented history of systemic juvenile idiopathic arthritis, AND
Patient must have received PBS-subsidised treatment with tocilizumab for this condition in the previous 12 months,
AND
Patient must not have failed to demonstrate an adequate response to PBS-subsidised therapy with tocilizumab for this condition more than once in the current treatment cycle, AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes pathology reports detailing C-reactive protein (CRP) level and platelet count where appropriate.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one months supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with tocilizumab in this treatment cycle and 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 tocilizumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to that course of treatment with tocilizumab.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
If a patient fails to respond to 2 courses of treatment they will not be eligible to receive further PBS-subsidised tocilizumab therapy in this treatment cycle. A patient may retrial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised treatment was stopped and the date of the first application under a new treatment cycle.Compliance with modified Authority Required procedures C5568 P5568 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis
Treatment Phase: Continuing treatment
Patient must have a documented history of systemic juvenile idiopathic arthritis, AND
Patient must have demonstrated an adequate response to their most recent course of PBS-subsidised treatment with tocilizumab, AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes baseline and current pathology reports detailing CRP and platelet count where appropriate.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one months supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with tocilizumab must include a measurement of response to the most recent prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with tocilizumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with tocilizumab.
Patients are eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks providing they continue to sustain the response.
If a patient fails to respond to 2 courses of treatment they will not be eligible to receive further PBS-subsidised tocilizumab therapy in this treatment cycle. A patient may retrial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised treatment was stopped and the date of the first application under a new treatment cycle.Compliance with modified Authority Required procedures C5581 P5581 Where the patient is receiving treatment at/from a private or public hospital
Systemic juvenile idiopathic arthritis
Treatment Phase: Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 12 months) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) - balance of supply
Patient must have received insufficient therapy under the Initial 1 (new patient or patient recommencing treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment, AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Patient must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Compliance with modified Authority Required procedures
Schedule 3, entry for Vedolizumab
a) omit from the column headed ‘Authority Requirements – Part of Circumstances’(all instances) : Compliance with Written or Telephone Authority Required procedures
b) insert in the column headed ‘Authority Requirements – Part of Circumstances’(all instances):Compliance with modified Authority Required procedures
c) omit:
C5124 P5124 Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Change or Recommencement of treatment after a break in therapy (Initial 2)
Patient must have previously been issued with an authority prescription for infliximab or vedolizumab for moderate to severe ulcerative colitis, AND
Patient must have previously demonstrated an adequate response to the most recent treatment course with this drug by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 during treatment with this drug; OR
Patient must have previously received treatment with infliximab for moderate to severe ulcerative colitis but failed to achieve or maintain an adequate response to treatment, 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)].
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.
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 or Telephone Authority Required procedures d) insert in numerical order after C5127:
C5591 P5591 Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Treatment Phase: Change or Re-commencement of treatment after a break in therapy (Initial 2)
Patient must have previously been issued with an authority prescription for infliximab or vedolizumab for this condition in this treatment cycle, AND
Patient must not have failed PBS-subsidised therapy with vedolizumab for this condition more than once 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.
Patient must be treated by a gastroenterologist (code 87); OR
Patient must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Patient must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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.
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 modified Authority Required procedures
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