National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 5) (PB 45 of 2016) (Cth)

PB 45 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 5)

National Health Act 1953
___________________________________________________________________________

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

Dated 31 May 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. 5).

(2)This instrument may also be cited as PB 45 of 2016.

2              Commencement

This instrument commences on 1 June 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]      Schedule 1, after entry for Atazanavir with cobicistat

Omit:

Atazanavir with cobicistat Tablet containing 300 mg atazanavir and 150 mg cobicistat Oral Evotaz BQ EMP C4454 C4512 60 5

[2]      Schedule 1, entry for Azacitidine

Substitute:

Azacitidine	Powder for injection 100 mg	Injection	Azadine	RZ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	P6132 P6143 P6177	See Note 1	See Note 2	D
			Vidaza	CJ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	P6132 P6143 P6177	See Note 1	See Note 2	D
			Azadine	RZ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	P6144 P6186 P6199	See Note 1	See Note 2	D
			Vidaza	CJ	EMP	C6132 C6143 C6144 C6177 C6186 C6199	P6144 P6186 P6199	See Note 1	See Note 2	D

[3]        Schedule 1, entry for Levodopa with carbidopa

Omit from the column headed ‘Circumstances’: C3704 C3705  Insert in numerical order: C6154 C6179

[4]        Schedule 1, entry for Omalizumab

Omit from the column headed ‘Circumstances’: C4886        Insert in numerical order: C6142

[5]        Schedule 3, entry for Azacitidine

Substitute:

Azacitidine	C6132	P6132	Where the patient is receiving treatment at/from a private or public hospital Chronic Myelomonocytic Leukaemia Initial treatment The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder. The first authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Azacitidine PBS Authority Application - Supporting Information Form; and (c) a copy of the bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia ; and (d) a copy of the full blood examination report; and (e) a signed patient acknowledgement. No more than 3 cycles will be authorised.	Compliance with modified Authority Required procedures
	C6143	P6143	Where the patient is receiving treatment at/from a private or public hospital Acute Myeloid Leukaemia Initial treatment The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification. The first authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Azacitidine PBS Authority Application - Supporting Information Form; and (c) a copy of the bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and (d) a copy of the full blood examination report; and (e) a signed patient acknowledgement. No more than 3 cycles will be authorised.	Compliance with modified Authority Required procedures
	C6144	P6144	Where the patient is receiving treatment at/from a private or public hospital Chronic Myelomonocytic Leukaemia Continuing treatment The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Applications for continuing therapy may be made by telephone. Up to 6 cycles will be authorised.	Compliance with modified Authority Required procedures
	C6177	P6177	Where the patient is receiving treatment at/from a private or public hospital Myelodysplastic syndrome Initial treatment The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); OR The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS). Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations: a. 11% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR c. 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR f. Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias. Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations: a. 21% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR d. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias. The first authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Azacitidine PBS Authority Application - Supporting Information Form; and (c) a copy of the bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and (d) a copy of the full blood examination report; and (e) a copy of the pathology report detailing the cytogenetics demonstrating intermediate-2 or high risk disease according to the International Prognostic Scoring System (IPSS); and (f) a signed patient acknowledgment form. No more than 3 cycles will be authorised.	Compliance with modified Authority Required procedures
	C6186	P6186	Where the patient is receiving treatment at/from a private or public hospital Acute Myeloid Leukaemia Continuing treatment The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Applications for continuing therapy may be made by telephone. Up to 6 cycles will be authorised.	Compliance with modified Authority Required procedures
	C6199	P6199	Where the patient is receiving treatment at/from a private or public hospital Myelodysplastic syndrome Continuing treatment The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); OR The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Applications for continuing therapy may be made by telephone. Up to 6 cycles will be authorised.	Compliance with modified Authority Required procedures

[6]        Schedule 3, entry for Levodopa with carbidopa

Substitute: 

Levodopa with carbidopa	C6154	P6154	Where the patient is receiving treatment at/from a private hospital Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic.	Compliance with Authority Required procedures
	C6179	P6179	Where the patient is receiving treatment at/from a public hospital Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic.	Compliance with Authority Required procedures - Streamlined Authority Code 6179

[7]Schedule 3, entry for Omalizumab

Omit entry for C4886

Insert :

C6142 P6142 Where the patient is receiving treatment at/from a private or public hospital Uncontrolled severe allergic asthma
Initial treatment
Patient must be under the care of the same physician for at least 12 months; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have forced expiratory volume (FEV1) less than or equal to 80% predicted, documented on 3 or more occasions in the previous 12 months; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or RAST; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND
Patient must have 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
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 12 years or older.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Optimised asthma therapy includes:
(i) adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (budesonide 1600 micrograms per day or fluticasone propionate 1000 micrograms per day or equivalent), plus long-acting beta-2 agonist therapy (at least salmeterol 50 micrograms bd or eformoterol 12 micrograms bd) for at least 12 months, unless contraindicated or not tolerated, AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy 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.
The initial IgE assessment must be no more than 12 months old at the time of application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, must be made at around 22 to 26 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.
A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Allergic Asthma PBS Authority Application - Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) the signed patient acknowledgement; and
(c) the IgE pathology report; and
(d) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms. Compliance with modified Authority Required procedures