National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 8) (PB 75 of 2017) (Cth)
PB 75 of 2017
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 8)
National Health Act 1953
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I, NATASHA PLOENGES, Assistant Secretary (Acting), 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 20 September 2017
NATASHA PLOENGES
Assistant Secretary (Acting)
Pharmacy and Insurance Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 8).
(2)This Instrument may also be cited as PB 75 of 2017.
Commencement
This Instrument commences on 1 October 2017.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Part 1, Division 1, Section 4, definition of ‘medication for the treatment of hepatitis B’
omit: (b) entecavir monohydratesubstitute: (b) entecavir
Part 1, Division 1, Section 4, definition of ‘medication for the treatment of HIV or AIDS’
(a)insert in alphabetical order: (da) atazanavir with cobicistat
(b)omit: (zj) enofovir with emtricitabine efavirenz
substitute: (zj) tenofovir with emtricitabine efavirenz
Part 2, Division 4, Section 24(2), paragraph (zc)
substitute:
(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 26 mL.
Part 2, Division 4, Section 25(2), paragraph (ga)
substitute:
(ga) for infliximab, for the treatment of a patient with moderate to severe ulcerative colitis:
(i) for initial treatment (new patient or re-commencement of treatment after more than 5 years break in therapy)—up to 2 repeat supplies;
(ii) for a change or re-commencement of treatment after a break in therapy—up to 2 repeat supplies;
(iii) for continuing treatment—up to 2 repeat supplies.
Part 2, Division 4, Section 25(2), paragraph (ze)
substitute:
(ze) for pegvisomant:
(i) for initial treatment, for the 80 mg loading dose—0 repeat supplies;
(ii) for intitial treatment (subsequent doses)—up to 5 repeat supplies;
(iii) for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with pegvisomant—up to 5 repeat supplies;
(iv) for continuing treatment—up to 5 repeat supplies.
Schedule 1, entry for Azacitidine
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
AZACITIDINE DR.REDDY’S RI EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D
Schedule 1, entry for Pegvisomant in each of the forms: Injection set containing powder for injection 10 mg, 30 and diluent, 30; and Injection set containing powder for injection 15 mg, 30 and diluent, 30
omit from the column headed ‘Circumstances’: C7030 C7031 C7045 substitute: C7068 C7070 C7087
Schedule 1, entry for Pegvisomant in the form Injection set containing powder for injection 20 mg, 1 and diluent, 1
omit from the column headed ‘Circumstances’: C7030 substitute: C7068
Schedule 1, entry for Pegvisomant in the form Injection set containing powder for injection 20 mg, 30 and diluent, 30
omit from the column headed ‘Circumstances’: C7030 C7031 C7045 substitute: C7068 C7070 C7087
Schedule 3, entry for Pegvisomant
substitute:
C7068 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
No increase in the maximum quantity or number of units may be authorised for the loading dose.
Compliance with Written Authority Required procedures C7070 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 C7087 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 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 Part 1, Section 3(2), entry for Item 20
omit from the column headed ‘Regimen’:
SOFOSBUVIR with VELPATASVIR for 12 weeks.
substitute:
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks.
Schedule 4, entry for Lamivudine
(a)omit from the column headed ‘Approved Ex-manufacturer Price or Proportional Ex-manufacturer Price’: $55.34 substitute: $34.70
(b)omit from the column headed ‘Claimed price’: $56.30 substitute: $35.30
Schedule 4, entry for Valaciclovir
(a)omit from the column headed ‘Approved Ex-manufacturer Price or Proportional Ex-manufacturer Price’: $52.40 substitute: $44.20
(b)omit from the column headed ‘Claimed price’: $52.92 substitute: $44.64
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