National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7) (PB 66 of 2017) (Cth)
PB 66 of 2017
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Pharmacy and Insurance 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 29 Aug 2017
JULIANNE QUAINE
Assistant Secretary
Pharmacy and Insurance Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Part 1 Preliminary
1 Name of Instrument
(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 7).
(2)This instrument may also be cited as PB 66 of 2017.
2 Commencement
This instrument commences on 1 September 2017.
3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule – Amendments
Schedule
National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Part 1, Division 1, Section 4, definition for CAR drug
(a)insert in alphabetical order: qa) pegvisomant
(b)insert in alphabetical order: xa) ustekinumab
Part 2, Division 4, Section 24(2)
(a)insert in alphabetical order:
(da) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of a patient with moderate to severe ulcerative colitis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram.
(b)insert in alphabetical order:
(ra) for HSD pharmaceutical benefits that have the drug omalizumab, for the treatment of severe chronic spontaneous urticaria:
(i) for initial treatment—a quantity of units that are sufficient to provide for 12 weeks treatment;
(ii) for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with omalizumab (grandfathered patients)—a quantity of units that are sufficient to provide for 24 weeks treatment;
(iii) for continuing treatment—a quantity of units that are sufficient to provide for 24 weeks treatment.
(c)insert in alphabetical order:
(za) for HSD pharmaceutical benefits that have the drug pasireotide, for the treatment of acromegaly:
(i)with the form Injection (modified release) 20 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes;
(ii)with the form Injection (modified release) 40 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes;
(iii)with the form Injection (modified release) 60 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes.
(d)insert in alphabetical order:
(zb) for HSD pharmaceutical benefits that have the drug pegvisomant, for the treatment of acromegaly:
(i)for initial treatment, for the 80 mg loading dose—4 x injection set containing powder for injection 20 mg, 1 and diluent, 1;
(ii)for intitial treatment (subsequent doses)—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30;
(iii)for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with pegvisomant—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30;
(iv)for continuing treatment—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30.
(e)insert in alphabetical order:
(zc) for HSD pharmaceutical benefits that have the drug ustekinumab, for the treatment of severe Crohn disease
(i)for initial treatment, for a weight-based loading dose—up to 4 vials of Solution for I.V. infusion 130 mg in 26 mL;
(ii)for a change or re-commencement of treatment, for a weight-based loading dose—up to 4 vials of Solution for I.V. infusion 130 mg in 26mL.
Part 2, Division 4, Section 25(2)
(a)insert in alphabetical order:
(ga) for infliximab, for the treatment of a patient with moderate to severe ulcerative colitis
(new patient or recommencement of treatment after more than 5 years break in —up to 2 repeat supplies;
—up to 2 repeat supplies;
(ii) for continuing treatment—up to 2 repeat supplies.
(b)insert in alphabetical order:
(va) for omalizumab, for the treatment of severe chronic spontaneous urticaria:
(i) for initial treatment—where the patient has received a quantity of units that are sufficient to provide for 12 weeks treatment—0 repeat supplies;
(ii) for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with omalizumab (grandfathered patients)—where the patient has received a quantity of units that are sufficient to provide for 24 weeks treatment—0 repeat supplies;
(iii) for continuing treatment—where the patient has received a quantity of units that are sufficient to provide for 24 weeks treatment—0repeat supplies;
(c)insert in alphabetical order:
(zd) for pasireotide—up to 5 repeat supplies.
(d)insert in alphabetical order:
(ze) for pegvisomant:
(i) for initial treatment, for the 80 mg loading dose—0 repeat supplies;
(i)for initial treatment (subsequent doses)—up to 5 repeat supplies;
(ii)for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with pegvisomant—up to 5 repeat supplies;
(iii)for continuing treatment—up to 5 repeat supplies.
(e)insert in alphabetical order:
(zf) for ustekinumab:
(i)for initial treatment, for a weight-based loading dose—0 repeat supplies;
(ii)for a change or re-commencement of treatment, for a weight-based loading dose——0 repeat supplies.
Schedule 1, entry for Infliximab
omit from the column headed ‘Circumstances’ for all brands: C3691 C3693 C3819 C3820
omit from the column headed ‘Circumstances’ for all brands: C6928
insert in numerical order in the column headed ‘Circumstances’ for all brands: C7008 C7009 C7010 C7011 C7037
Schedule 1, entry for Lamivudine in the form Tablet 150 mg
omit:
Lamivudine RBX RA EMP C4454 C4512 120 5 D
Schedule 1, entry for Lamivudine in the form Tablet 300 mg
omit:
Lamivudine RBX RA EMP C4454 C4512 60 5 D
Schedule 1, entry for Lanreotide in the form Powder for suspension for injection 30 mg (as acetate) with diluent
omit from the column headed ‘Circumstances’: C4559 C4567 substitute: C7042 C7063
Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre‑filled syringe; Injection 90 mg (as acetate) in single dose pre‑filled syringe; and Injection 120 mg (as acetate) in single dose pre‑filled syringe
omit from the column headed ‘Circumstances’: C4570 C4574
insert in numerical order in the column headed ‘Circumstances’: C7025 C7041
Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit:
Nevirapine RBX RA EMP C4454 C4512 120 5 D
Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Nevirapine XR APOTEX TX EMP C4454 C4526 60 5 D
Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
omit from the column headed ‘Circumstances’ for all brands: C6389
omit from the column headed ‘Circumstances’ for all brands: C6476
insert in numerical order in the column headed ‘Circumstances’ for all brands: C7028 C7043
Schedule 1, entry for Octreotide in the form Injection 500 micrograms (as acetate) in 1 mL
remove italics from text in column headed ‘Circumstances’
Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe
omit from the column headed ‘Circumstances’: C5896
omit from the column headed ‘Circumstances’: C5900
insert in numerical order in the column headed ‘Circumstances’: C7029 C7057
Schedule 1, entry for Omalizumab in the form Injection 150 mg in 1 mL single dose pre‑filled syringe
insert in numerical order in the column headed ‘Circumstances’: C7046 C7054 C7055
Schedule 1, entry for Pasireotide in each of the forms: Injection (modified release) 20 mg (as embonate), vial and diluent syringe; Injection (modified release) 40 mg (as embonate), vial and diluent syringe; and Injection (modified release) 60 mg (as embonate), vial and diluent syringe
(a)omit from the column headed ‘Circumstances: C6347 C6365
insert in numerical order in the column headed ‘Circumstances’: C7026 C7027
(b)omit from the column headed ‘Maximum Quantity’: 2
insert in the column headed ‘Maximum Quantity’: See Note 1
(c)omit from the column headed ‘Number of Repeats’: 5
insert in the column headed ‘Number of Repeats’: See Note 2
Schedule 1, after entry for Peginterferon alfa‑2a in the form Injection 180 micrograms in 0.5 mL single use pre‑filled syringe [Maximum Quantity: 8; Number of Repeats: 5]
insert in the columns in the order indicated:
Pegvisomant Injection set containing powder for injection 10 mg, 30 and diluent, 30 Injection Somavert PF EMP C7030 C7031 C7045 See Note 1 See Note 2 D Injection set containing powder for injection 15 mg, 30 and diluent, 30 Injection Somavert PF EMP C7030 C7031 C7045 See Note 1 See Note 2 D Injection set containing powder for injection 20 mg, 1 and diluent, 1 Injection Somavert PF EMP C7030 See Note 1 See Note 2 D Injection set containing powder for injection 20 mg, 30 and diluent, 30 Injection Somavert PF EMP C7030 C7031 C7045 See Note 1 See Note 2 D
Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL
omit from the column headed ‘Circumstances’: C5821 C5864 C5872 C5895 substitute: C7020 C7021 C7022 C7023
Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
omit from the column headed ‘Circumstances’: C5821 C5864 C5872 C5895
insert in numerical order in the column headed ‘Circumstances’: C7020 C7021 C7022 C7023
Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL
insert in the columns in the order indicated:
Ustekinumab Solution for I.V. infusion 130 mg in 26 mL Injection Stelara JC EMP C7048 C7059 See Note 1 See Note 2 PB
Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Valganciclovir Juno JU EMP C4980 C4989 C5031 120 5 D
Schedule 3, entry for Infliximab
(a)omit:
C3691 P3691 Where the patient is receiving treatment at/from a private or public hospital
Fistulising Crohn disease — initial treatment 1
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has 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 as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate 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 is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephoneCompliance with modified Authority Required procedures C3693 P3693 Where the patient is receiving treatment at/from a private or public hospital
Fistulising Crohn disease — initial treatment 3
(previous infliximab treatment non‑PBS‑subsidised)
Commencement of a treatment cycle with an initial PBS‑subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with infliximab prior to 1 March 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with infliximab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with infliximab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to infliximab treatment 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 application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with infliximab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;
a patient is eligible for PBS‑subsidised treatment under this restriction once onlyCompliance with modified Authority Required procedures C3819 P3819 Where the patient is receiving treatment at/from a private or public hospital
Fistulising Crohn disease — initial treatment 2
(change or recommencement of PBS‑subsidised treatment)
Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS‑subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS‑subsidised therapy with infliximab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF‑alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate 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 TNF‑alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF‑alfa antagonist therapy;
the assessment of response to the most recent course of TNF‑alfa antagonist therapy must:
(a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16‑week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF‑alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF‑alfa antagonist;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephoneCompliance with modified Authority Required procedures C3820 P3820 Where the patient is receiving treatment at/from a private or public hospital
Fistulising Crohn disease — continuing treatment
Continuing PBS‑subsidised treatment with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 authority application is made in writing and includes a completed copy of the appropriate 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 fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (up to 6 weeks following the third dose);
where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the responseCompliance with modified Authority Required procedures
(b)omit from the column headed ‘Purposes Code’ for Circumstances Code C4524:
P4524
omit from the column headed ‘Purposes Code’ for Circumstances Code C4535:
P4535
omit from the column headed ‘Purposes Code’ for Circumstances Code C4626:
P4626
omit from the column headed ‘Purposes Code’ for Circumstances Code C4627:
P4627
omit from the column headed ‘Purposes Code’ for Circumstances Code C4705:
P4705
omit from the column headed ‘Purposes Code’ for Circumstances Code C4718:
P4718
omit from the column headed ‘Purposes Code’ for Circumstances Code C4846:
P4846
omit from the column headed ‘Purposes Code’ for Circumstances Code C4854:
P4854
omit from the column headed ‘Purposes Code’ for Circumstances Code C5077:
P5077
omit from the column headed ‘Purposes Code’ for Circumstances Code C5078:
P5078
omit from the column headed ‘Purposes Code’ for Circumstances Code C5084:
P5084
omit from the column headed ‘Purposes Code’ for Circumstances Code C5097:
P5097
omit from the column headed ‘Purposes Code’ for Circumstances Code C5103:
P5103
omit from the column headed ‘Purposes Code’ for Circumstances Code C5109:
P5109
omit from the column headed ‘Purposes Code’ for Circumstances Code C5110:
P5110
omit from the column headed ‘Purposes Code’ for Circumstances Code C5118:
P5118
omit from the column headed ‘Purposes Code’ for Circumstances Code C5440:
P5440
omit from the column headed ‘Purposes Code’ for Circumstances Code C5484:
P5484
omit from the column headed ‘Purposes Code’ for Circumstances Code C5485:
P5485
omit from the column headed ‘Purposes Code’ for Circumstances Code C6379:
P6379
omit from the column headed ‘Purposes Code’ for Circumstances Code C6400:
P6400
omit from the column headed ‘Purposes Code’ for Circumstances Code C6414:
P6414
omit from the column headed ‘Purposes Code’ for Circumstances Code C6441:
P6441
omit from the column headed ‘Purposes Code’ for Circumstances Code C6446:
P6446
omit from the column headed ‘Purposes Code’ for Circumstances Code C6461:
P6461
(c)omit from the column headed ‘Purposes Code’ for Circumstances Code C6901:
P6901
omit from the column headed ‘Purposes Code’ for Circumstances Code C6909:
P6909
(d)omit:
C6928 P6928 Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously been issued with an authority prescription for 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.
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.
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 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, 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.Compliance with Authority Required procedures
(e)omit from the column headed ‘Purposes Code’ for Circumstances Code C6943:
P6943
(f)insert in numerical order after existing text [Circumstances Code: C6943]:
C7008 Fistulising Crohn disease — initial treatment 1
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has 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 as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate 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 is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone
The authority application must be made in writing
Compliance with Written Authority Required procedures C7009 Fistulising Crohn disease — initial treatment 3
(previous infliximab treatment non-PBS-subsidised)
Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with infliximab prior to 1 March 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with infliximab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with infliximab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to infliximab treatment 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 application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with infliximab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;
a patient is eligible for PBS-subsidised treatment under this restriction once only
The authority application must be made in writing
Compliance with Written Authority Required procedures C7010 Fistulising Crohn disease — initial treatment 2
(change or recommencement of PBS-subsidised treatment)
Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS-subsidised therapy with infliximab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF-alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate 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 TNF-alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy;
the assessment of response to the most recent course of TNF-alfa antagonist therapy must:
(a) be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone
The authority application must be made in writing
Compliance with Written Authority Required procedures C7011 Fistulising Crohn disease — continuing treatment
Continuing PBS-subsidised treatment with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 authority application is made in writing and includes a completed copy of the appropriate 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 fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (up to 6 weeks following the third dose);
where an assessment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response
The authority application must be made in writing
Compliance with Written Authority Required procedures C7037 Where the patient is receiving treatment at/from a private or public hospital
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 been issued with an authority prescription for 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.
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 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, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
The authority application must be made in writing
Up to a maximum of 2 repeats will be authorised.
Compliance with Written Authority Required procedures
Schedule 3, entry for Lanreotide
(a)omit
C4559 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures C4567 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4567
(b)omit
C4570 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatmentIn a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4570
C4574 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures
(c)insert in numerical order after existing text [Circumstances Code: C4575]:
C7025 Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Compliance with Authority Required procedures - Streamlined Authority Code 7025 C7041 Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Compliance with Authority Required procedures C7042 Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Compliance with Authority Required procedures - Streamlined Authority Code 7042 C7063 Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
Compliance with Authority Required procedures
Schedule 3, entry for Octreotide
(a)omit:
C5896 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections, AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose), AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures
(b)omit:
C5900 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections, AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose), AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 5900
(c)omit:
C6389 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Authority Required procedures ‑ Streamlined Authority Code 6389
(d)omit:
C6476 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Authority Required procedures
(e)insert in numerical order after existing text [Circumstances Code: C6477]:
C7028 Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Authority Required procedures - Streamlined Authority Code 7028 C7029 Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Authority Required procedures - Streamlined Authority Code 7029 C7043 Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Authority Required procedures C7057 Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Authority Required procedures
Schedule 3, entry for Omalizumab
insert in numerical order after existing text [Circumstances Code: C6788]:
C7046 Severe chronic spontaneous urticaria
Continuing treatment
Must be treated by a clinical immunologist; OR
Must be treated by an allergist; OR
Must be treated by a dermatologist; OR
Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).
Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.
Compliance with Authority Required procedures C7054 Severe chronic spontaneous urticaria
Grandfathering treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2017; AND
Patient must have documented history of itch and hives that persisted on a daily basis for at least 6 weeks despite treatment with H1 antihistamines prior to commencing non-PBS subsidised treatment with this drug for this condition; AND
Patient must have documented history of failure to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy prior to commencing non-PBS subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a clinical immunologist; OR
Must be treated by an allergist; OR
Must be treated by a dermatologist; OR
Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).
A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:
1) a H2 receptor antagonist (150 mg twice per day); or
2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or
3) doxepin (up to 25 mg three times a day)
If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.
A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial Grandfather PBS Authority Application - Supporting Information Form which must include:
(i) demonstration of failure to achieve an adequate response to standard therapy; and
(ii) drug names and doses of standard therapies that the patient has failed; and
(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.
Compliance with Written Authority Required procedures C7055 Severe chronic spontaneous urticaria
Initial treatment
Must be treated by a clinical immunologist; OR
Must be treated by an allergist; OR
Must be treated by a dermatologist; OR
Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).
The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND
Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND
Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND
Patient must not receive more than 12 weeks of treatment under this restriction.
A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:
1) a H2 receptor antagonist (150 mg twice per day); or
2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or
3) doxepin (up to 25 mg three times a day)
If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.
A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application - Supporting Information Form which must include:
(i) demonstration of failure to achieve an adequate response to standard therapy; and
(ii) drug names and doses of standard therapies that the patient has failed; and
(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.
Compliance with Written Authority Required procedures
Schedule 3, entry for Pasireotide
(a)omit:
C6347 Where the patient is receiving treatment at/from a private or public hospital
Acromegaly
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
Patient must be aged 18 years or older.
In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as:
1) Growth hormone (GH) levels of less than 2.5 mcg/L; and
2) normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1)
In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.Compliance with Authority Required procedures C6365 Where the patient is receiving treatment at/from a private or public hospital
Acromegaly
Initial treatment
Patient must not have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have a mean growth hormone (GH) level greater than 2.5 micrograms per litre; AND
Patient must have an age‑ and sex‑adjusted insulin‑like growth factor 1 (IGF‑1) level greater than 1.3 times the upper limit of normal (ULN); AND
The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information.
Patient must be aged 18 years or older.
If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of contraindication.
If intolerance to either octreotide or lanreotide treatment develops during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
Failure to achieve biochemical control is defined as:
1) Growth hormone level is greater than 2.5 mcg/L; and
2) IGF‑1 level is greater than 1.3 times the age‑ and sex‑adjusted ULN
In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as:
1) Growth hormone (GH) levels of less than 2.5 mcg/L; and
2) normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1)
The authority application must be made in writing and must include:
a) a completed authority prescription form; and
b) a completed Acromegaly PBS Authority Application ‑ Supporting Information Form; and
c) a signed patient acknowledgment; and
d) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of GH and IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and
e) a recent copy of GH and IGF‑1 levels must be provided.Compliance with modified Authority Required procedures
(b)insert in numerical order after existing text [Circumstances Code: C6330]:
C7026 Acromegaly
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
Patient must be aged 18 years or older.
In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as:
1) Growth hormone (GH) levels of less than 2.5 mcg/L; and
2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)
In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.
Compliance with Authority Required procedures C7027 Acromegaly
Initial treatment
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a mean growth hormone (GH) level greater than 2.5 micrograms per litre; AND
Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) level greater than 1.3 times the upper limit of normal (ULN); AND
The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
Patient must be aged 18 years or older.
If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.
If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
Failure to achieve biochemical control is defined as:
1) Growth hormone level is greater than 2.5 mcg/L; and
2) IGF-1 level is greater than 1.3 times the age- and sex-adjusted ULN
In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as:
1) Growth hormone (GH) levels of less than 2.5 mcg/L; and
2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)
The authority application must be made in writing and must include:
a) a completed authority prescription form; and
b) a completed Acromegaly PBS Authority Application - Supporting Information Form; and
c) a signed patient acknowledgment; and
d) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and
e) a recent copy of GH and IGF-1 levels must be provided.
Compliance with Written Authority Required procedures
Schedule 3, after entry for Peginterferon alfa‑2a [Circumstances Code: C6745]
insert:
Pegvisomant C7030 Acromegaly
Initial treatment
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than 1.3 times upper limit of normal (ULN); AND
The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND
The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue.
Somatostatin analogues include octreotide, lanreotide and pasireotide
Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:
1) Growth hormone level greater than 2.5 mcg/L; and
2) IGF-1 level is greater than 1.3 times the age- and sex-adjusted ULN
If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.
If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).
Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF-1 levels measured every 4 to 6 weeks in order to maintain the serum IGF-1 level within the age-adjusted normal range based on the dosage recommendations in the TGA-approved Product Information.
The authority application must be made in writing and must include:
a) two completed authority prescription forms ; and
b) a completed Acromegaly Pegvisomant initial PBS Authority Application - Supporting Information Form; and
c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and
d) a recent result of the IGF-1 level and the date of assessment ; and
e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide
Compliance with Written Authority Required procedures C7031 Acromegaly
Grandfathering
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2017; AND
The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue; AND
Patient must have had a documented age- and sex- adjusted insulin- like factor 1 (IGF-1) concentration greater than 1.3 times upper limit of normal (ULN) prior to commencing non- PBS- subsidised treatment with this drug.
Somatostatin analogues include octreotide, lanreotide and pasireotide
In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).
Treatment must be ceased if IGF-1 level is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be made in writing and must include:
a) a completed authority prescription form; and
b) a completed Acromegaly Pegvisomant Grandfather PBS Authority Application - Supporting Information Form; and
c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and
d) a recent result of the IGF-1 level and the date of assessment.
Compliance with Written Authority Required procedures C7045 Acromegaly
Continuing treatment
Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND
The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue; AND
The treatment must cease if IGF-1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.
Somatostatin analogues include octreotide, lanreotide and pasireotide
In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).
In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of IGF-1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application.
Compliance with Authority Required procedures
Schedule 3, entry for Rituximab
(a)omit:
C5821 P5821 Where the patient is receiving treatment at/from a private or public hospital
Severe active microscopic polyangiitis
Induction of remission
The treatment must be for the induction of remission; AND
Patient must not have previously received this drug for this condition; OR
Patient must have received this drug for this condition prior to 1 January 2016; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end‑organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti‑neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS‑subsidised for maintenance therapy.Compliance with modified Authority Required procedures C5864 P5864 Where the patient is receiving treatment at/from a private or public hospital
Severe active granulomatosis with polyangiitis (Wegeners granulomatosis)
Re‑induction of remission
The treatment must be for the re‑induction of remission; AND
Patient must have previously received and responded to this drug for this condition; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end‑organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti‑neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS‑subsidised for maintenance of remissionCompliance with modified Authority Required procedures C5872 P5872 Where the patient is receiving treatment at/from a private or public hospital
Severe active microscopic polyangiitis
Re‑induction of remission
The treatment must be for the re‑induction of remission; AND
Patient must have previously received and responded to this drug for this condition; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end‑organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti‑neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS‑subsidised for maintenance therapy.Compliance with modified Authority Required procedures C5895 P5895 Where the patient is receiving treatment at/from a private or public hospital
Severe active granulomatosis with polyangiitis (Wegeners granulomatosis)
Induction of remission
The treatment must be for the induction of remission; AND
Patient must not have previously received this drug for this condition; OR
Patient must have received this drug for this condition prior to 1 January 2016; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end‑organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti‑neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS‑subsidised for maintenance of remissionCompliance with modified Authority Required procedures
(b)insert in numerical order after existing text [Circumstances Code: C6049]:
C7020 Severe active microscopic polyangiitis
Induction of remission
The treatment must be for the induction of remission; AND
Patient must not have previously received this drug for this condition; OR
Patient must have received this drug for this condition prior to 1 January 2016; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end-organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS-subsidised for maintenance therapy.
The authority application must be made in writing
Compliance with Written Authority Required procedures C7021 Severe active granulomatosis with polyangiitis (Wegeners granulomatosis)
Re-induction of remission
The treatment must be for the re-induction of remission; AND
Patient must have previously received and responded to this drug for this condition; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end-organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS-subsidised for maintenance of remission
The authority application must be made in writing
Compliance with Written Authority Required procedures C7022 Severe active microscopic polyangiitis
Re-induction of remission
The treatment must be for the re-induction of remission; AND
Patient must have previously received and responded to this drug for this condition; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end-organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS-subsidised for maintenance therapy.
The authority application must be made in writing
Compliance with Written Authority Required procedures C7023 Severe active granulomatosis with polyangiitis (Wegeners granulomatosis)
Induction of remission
The treatment must be for the induction of remission; AND
Patient must not have previously received this drug for this condition; OR
Patient must have received this drug for this condition prior to 1 January 2016; AND
The treatment must in combination with glucocorticoids; AND
Patient must be at risk of end-organ damage or mortality; AND
Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide.
Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology.
This drug is not PBS-subsidised for maintenance of remission
The authority application must be made in writing
Compliance with Written Authority Required procedures
Schedule 3, after entry for Tocilizumab [Circumstances Code: C6053]
insert:
Ustekinumab C7048 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; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to steroids; 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 have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; 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 have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; 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 or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; AND
Patient must have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 if affected by extensive small intestine disease; OR
Patient must have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 if not affected by extensive small intestine disease, short gut syndrome or is an ostomy patient; AND
Patient must have evidence 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 radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; OR
Patient must (a) have evidence of intestinal inflammation, including: (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; or (b) be assessed clinically as being in a high faecal output state; or (c) 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.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; 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
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 2 vials of 45 mg and no repeats.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application.
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.
Compliance with Written Authority Required procedures C7059 Severe Crohn disease
Change or Re-commencement of treatment (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 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.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; 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.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
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 of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy 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
Schedule 3, Part 1, Section 3, Treatment regimen
omit the table and substitute:
Item Kind of patient Regimen 1 Patient:
(a) with Genotype 1; and
(b) who is treatment naïve; and
(c) who is non‑cirrhotic
Either:
(a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or
(b) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or
(c) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(d) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or
(f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(g) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(h) SOFOSBUVIR with VELPATASVIR for 12 weeks.
2 Patient:
(a) with Genotype 1; and
(b) who is treatment experienced; and
(c) who is non‑cirrhotic
Either:
(a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or
(b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(d) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or
(f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(g) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(h) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or
(i) SOFOSBUVIR with VELPATASVIR for 12 weeks.
3 Patient:
(a) with Genotype 2; and
(b) who is treatment naïve; and
(c) who is non‑cirrhotic
Either:
(a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
4 Patient:
(a) with Genotype 2; and
(b) who is treatment experienced; and
(c) who is non‑cirrhotic
Either:
(a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
5 Patient:
(a) with Genotype 3; and
(b) who is treatment naïve; and
(c) who is non‑cirrhotic
Either:
(a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(c) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(d) SOFOSBUVIR with VELPATASVIR for 12 weeks.
6 Patient:
(a) with Genotype 3; and
(b) who is treatment experienced; and
(c) who is non‑cirrhotic
Either:
(a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(c) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(d) SOFOSBUVIR with VELPATASVIR for 12 weeks.
7 Patient:
(a) with Genotype 4; and
(b) who is treatment naïve; and
(c) who is non‑cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(c) SOFOSBUVIR with VELPATASVIR for 12 weeks.
8 Patient:
(a) with Genotype 4; and
(b) who is treatment experienced; and
(c) who is non‑cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(c) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or
(d) SOFOSBUVIR with VELPATASVIR for 12 weeks.
9 Patient:
(a) with:
(i) Genotype 5; or
(ii) Genotype 6; and
(b) who is treatment naïve; and
(c) who is non‑cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
10 Patient:
(a) with:
(i) Genotype 5; or
(ii) Genotype 6; and
(b) who is treatment experienced; and
(c) who is non‑cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
11 Patient:
(a) with Genotype 1; and
(b) who is treatment naïve; and
(c) who is cirrhotic
Either:
(a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or
(b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(d) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(f) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(g) SOFOSBUVIR with VELPATASVIR for 12 weeks.
12 Patient:
(a) with Genotype 1; and
(b) who is treatment experienced; and
(c) who is cirrhotic
Either:
(a) LEDIPASVIR with SOFOSBUVIR for 24 weeks; or
(b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(d) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks; or
(g) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(h) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or
(i) SOFOSBUVIR with VELPATASVIR for 12 weeks.
13 Patient:
(a) with Genotype 2; and
(b) who is treatment naïve; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
14 Patient:
(a) with Genotype 2; and
(b) who is treatment experienced; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
15 Patient:
(a) with Genotype 3; and
(b) who is treatment naïve; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(c) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(e) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(f) SOFOSBUVIR with VELPATASVIR for 12 weeks.
16 Patient:
(a) with Genotype 3; and
(b) who is treatment experienced; and
(c) who is cirrhotic
Either:
(a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(c) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(e) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(f) SOFOSBUVIR with VELPATASVIR for 12 weeks.
17 Patient:
(a) with Genotype 4; and
(b) who is treatment naïve; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(c) SOFOSBUVIR with VELPATASVIR for 12 weeks.
18 Patient:
(a) with Genotype 4; and
(b) who is treatment experienced; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(c) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or
(d) SOFOSBUVIR with VELPATASVIR for 12 weeks.
19 Patient:
(a) with:
(i) Genotype 5; or
(ii) Genotype 6; and
(b) who is treatment naïve; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
20 Patient:
(a) with:
(i) Genotype 5; or
(ii) Genotype 6; and
(b) who is treatment experienced; and
(c) who is cirrhotic
Either:
(a) SOFOSBUVIR and PEGINTERFERON ALFA‑2A and RIBAVIRIN for 12 weeks; or
SOFOSBUVIR with VELPATASVIR for 12 weeks.
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0
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