National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 31 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 31 of 2009

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 2nd April 2009

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 May 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, item dealing with Hydromorphone

insert in “Column 3” below the text “Severe disabling pain not responding to non-narcotic analgesics”:

In respect of the tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg:

Chronic severe disabling pain not responding to non-narcotic analgesics

1. Schedule 1, after item dealing with Lansoprazole

insert in the columns in the order indicated:

Lanthanum	In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy, following initiation and stabilisation of treatment with lanthanum carbonate, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy
Maintenance therapy, following initiation and stabilisation of treatment with lanthanum carbonate, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy

1. Schedule 1, after item dealing with Paclitaxel

insert in the columns in the order indicated:

Paclitaxel, nanoparticle albumin-bound

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic breast cancer after failure of prior therapy which includes an anthracycline

1. Schedule 1, item dealing with Sevelamer

omit from “Column 3” (twice occurring):

other products

and substitute:

calcium

1. Schedule 1, after item dealing with Sumatriptan

insert in the columns in the order indicated:

Sunitinib	In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who meets the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group and has a World Health Organisation performance status of 2 or less
Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria
Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009

1. Schedule 1, after item dealing with Terbutaline

insert in the columns in the order indicated:

Teriparatide

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, as the sole PBS-subsidised agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who:

 (a) has a bone mineral density (BMD) T-score of -3.0 or less; and

 (b) has had 2 or more fractures due to minimal trauma; and

 (c) has experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; and

 where:

 a vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body;

 anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly, raloxifene hydrochloride 60 mg per day (women only), disodium etidronate 200 mg with calcium carbonate 1.25 g per day, strontium ranelate 2 g per day and zoledronic acid 5 mg per annum;

 if treatment with anti-resorptive therapy is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, details of the contraindication are included in the authority application;

 if an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of 1 anti-resorptive agent, alternate anti-resorptive agents are trialled so that the patient achieves the minimum requirement of 12 months continuous therapy, and details of toxicities including severity are included in the authority application;

 the authority application is made in writing and includes details of prior anti-resorptive therapy, fracture history including the date(s) and site(s), the symptoms associated with the fracture(s) which developed during the course of anti-resorptive therapy, and the score of the qualifying BMD measurement

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, as the sole PBS-subsidised agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who was receiving treatment with teriparatide prior to 1 May 2009, and where:

 the authority application is made in writing and the commencement date of teriparatide treatment and the number of doses the patient has received are provided with the application;

 the patient is eligible to receive a maximum of 18 months of combined PBS-subsidised and non-PBS-subsidised therapy in their lifetime;

 the patient is eligible for PBS-subsidised treatment under this restriction once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment for severe, established osteoporosis where the patient has previously been issued with an authority prescription for teriparatide;

 teriparatide must only be used for a lifetime maximum of 18 months therapy;

 PBS-subsidised treatment is limited to a maximum of 18 months therapy in the patient's lifetime

1. Schedule 1, omit item dealing with Zonisamide

1. Schedule 2, item dealing with Hydromorphone

insert in “Column 2” below the text “Severe disabling pain not responding to non-narcotic analgesics”:

In respect of the tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg:

Chronic severe disabling pain not responding to non-narcotic analgesics