National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 8) (PB 76 of 2016) (Cth)

Case

PB 76 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 8)

National Health Act 1953
___________________________________________________________________________

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated    29  August 2016

Julianne Quaine
Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits 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 2016 (No. 8).

(2)This instrument may also be cited as PB 76 of 2016.

2              Commencement

This instrument commences on 1 September 2016.

3              Amendment

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)

  1. Division 1, Section 4, definition for CAR drug

    Substitute:

    CAR drug (Complex Authority Required drug) means any of the following highly specialised drugs:

    a) abatacept

    b) adalimumab

    c) ambrisentan

    d) azacitidine

    e) bosentan

    f) eculizumab

    g) eltrombopag

    h) epoprostenol

    i) etanercept

    j) iloprost

    k) infliximab

    l) ivacaftor

    m) lenalidomide

    n) macitentan

    o) omalizumab

    p) pasireotide

    q) pomalidomide

    r) rituximab

    s) romiplostim

    t) sildenafil

    u) tadalafil

    v) tocilizumab

    w) vedolizumab

  1. Schedule 1, after entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin

    Insert:

Pasireotide Injection (modified release) 20 mg (as embonate), vial and diluent syringe Injection Signifor LAR NV EMP C6330 C6347 C6365 2 5 D
Injection (modified release) 40 mg (as embonate), vial and diluent syringe Injection Signifor LAR NV EMP C6330 C6347 C6365 2 5 D
Injection (modified release) 60 mg (as embonate), vial and diluent syringe Injection Signifor LAR NV EMP C6330 C6347 C6365 2 5 D

  1. Schedule 1, entry for Rifabutin

    Omit from the column headed ‘Circumstances’: C1299 C1435 C3317 C3415                   Insert in numerical order: C6349 C6350 C6356 C6361

  2. Schedule 3, after entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin

    Insert:

Pasireotide C6330

Where the patient is receiving treatment at/from a private or public hospital

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 modified Authority Required procedures
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

  1. Schedule 3, entry for Rifabutin

    Substitute:

Rifabutin C6349

Where the patient is receiving treatment at/from a private hospital

Mycobacterium avium complex infection

Patient must be human immunodeficiency virus (HIV) positive.

 Compliance with Authority Required procedures
C6350

Where the patient is receiving treatment at/from a public hospital

Mycobacterium avium complex infection

Patient must be human immunodeficiency virus (HIV) positive.

 Compliance with Authority Required procedures - Streamlined Authority Code 6350
C6356

Where the patient is receiving treatment at/from a public hospital

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures - Streamlined Authority Code 6356
C6361

Where the patient is receiving treatment at/from a private hospital

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures
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