PB 48 of 2019
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 27 June 2019
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
1 Name of Instrument
(1) This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 6).
(2) This Instrument may also be cited as PB 48 of 2019.
2 Commencement
This Instrument commences on 1 July 2019.
3 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
[1] Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)
omit:
| | | | Bosentan APOTEX | TX | EMP | C4628 C6089 C6710 C6734 C6748 C6764 C6776 | | See Note 1 | See Note 2 | D |
[2] Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)
omit:
| | | | Bosentan APOTEX | TX | EMP | C6089 C6710 C6734 C6748 C6764 C6776 | | See Note 1 | See Note 2 | D |
[3] 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”: C6330
(b) omit from the column headed “Circumstances”: C7027
(c) insert in numerical order in the column headed “Circumstances”: C9043
[4] 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
(a) omit from the column headed “Circumstances”: C7068 C7070
(b) insert in numerical order in the column headed “Circumstances”: C9041
[5] 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”: C7068 substitute: C9041
[6] Schedule 1, entry for Pegvisomant in the form Injection set containing powder for injection 20 mg, 30 and diluent, 30
(a) omit from the column headed “Circumstances”: C7068 C7070
(b) insert in numerical order in the column headed “Circumstances”: C9041
[7] Schedule 1, entry for Ritonavir
omit:
| | Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL | Oral | Norvir | VE | EMP | C4454 C4512 | | 10 | 5 | D |
[8] Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | DEZTRON | DZ | EMP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | | 1 | 11 | PB |
[9] Schedule 3, entry for Pasireotide
(a) omit:
| | C6330 | | Acromegaly
Grandfathering treatment
Patient must have received non PBS treatment with this drug for this condition prior to 1 September 2016.
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)
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 previously been 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. | Compliance with Written Authority Required procedures |
(b) omit:
| | 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 |
(c) insert in numerical order after existing text:
| | C9043 | | 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 1 micrograms per litre or 3 mIU/L; AND
Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than 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 after completion of a prior therapy with either octreotide or lanreotide is defined as:
1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR
2) IGF-1 level is greater than 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) 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
d) a recent copy of GH and IGF-1 levels must be provided. | Compliance with Written Authority Required procedures |
[10] Schedule 3, entry for Pegvisomant
(a) omit:
| | 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 |
(b) insert in numerical order after existing text:
| | C9041 | | 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 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 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 1 mcg/L or 3 mIU/L; OR
2) IGF-1 level is greater than 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 |