National Health Act 1953 Special Arrangements under section 100(1) Special Authority Program Trastuzumab (No. PB 56 of 2009) (Cth)

Special Arrangements: Special Authority Program — Trastuzumab (PB 56 of 2009)

as amended

made under subsection 100(1) of the

National Health Act 1953

This compilation was prepared on 1 January 2010
taking into account amendments up to PB 127 of 2009

Prepared by the Office of Legislative Drafting and Publishing,

Attorney-General’s Department, Canberra

Special Arrangements: Special Authority Program — Trastuzumab

(PB 56 of 2009)

Commencement [see Note 1]

1.       (a)     This instrument commences on the day it is registered.

(b)     Instrument No. PB 123 of 2008 is repealed.

Definitions

2.       In these Arrangements:

(a)     unless the contrary intention appears, a word or phrase will be taken to have the same meaning as in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations;

(b)     “Act” means the National Health Act 1953;

(c) “approved private hospital authority” means the proprietor of a private hospital approved under s 94 of the Act;

(d) “approved public hospital authority” means the governing body of a public hospital approved under s 94 of the Act that is participating in the Pharmaceutical Reform Arrangements within the meaning of the National Healthcare Agreement;

(e)     “approved public hospital” means a public hospital that is:

(i)      not participating in the Pharmaceutical Reform Arrangements within the meaning of the National Healthcare Agreement; and

(ii) is a public hospital authority in respect of which, in accordance with section 84BA of the Act, account may be taken of payments made by a person to it for supplies of out-patient medication when it is being ascertained, for the purposes of Part VII of the Act, whether the person is eligible to be issued with a concession card or an entitlement card;

(f)      “approved supplier” means a person or body mentioned in paragraph 15 that may supply Trastuzumab under this Arrangement;

(g)     “I.V.” means intravenous;

(h)     “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;

(i)      “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.

Part VII of the Act and Regulations

3.       Except where otherwise specified in these Arrangements, the provisions of the Act, the Regulations and the declarations, determinations and other instruments made under Part VII of the Act and under the Regulations will apply to the prescribing and supply of trastuzumab.

Entitlement to receive trastuzumab under these Arrangements

4.       Subject to these Arrangements, a person who:

(a)     is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and

(b)     is receiving medical treatment by a medical practitioner;

is entitled to receive trastuzumab under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraph 16 or 17.

Prescriptions for trastuzumab

5.       The writing of a prescription for the supply of trastuzumab as a special pharmaceutical product under these Arrangements is authorised only in the circumstances specified in Schedule 1.

6.       These Arrangements apply to trastuzumab for intravenous administration in the forms, marketed under the tradename, and supplied by the manufacturer specified below. 

Form (strength, type, size, etc.)	Proprietary name	Manufacturer
Powder for I.V. infusion 150 mg	Herceptin	Roche Products Pty Ltd

7.       The maximum quantity that may be prescribed on a prescription for trastuzumab is:

(a)     in respect of a three-weekly treatment regimen, a sufficient number of vials to provide for a single infusion based on the weight of the patient and the dosage recommendations contained in the Product Information for trastuzumab approved by the Therapeutic Goods Administration;

(b)     in respect of a weekly treatment regimen, a sufficient number of vials to provide for three infusions based on the weight of the patient and the dosage recommendations contained in the Product Information for trastuzumab approved by the Therapeutic Goods Administration.

8.       Subject to paragraph 13, the maximum number of repeats that may be prescribed in a prescription for trastuzumab is:

(a)     none, in the case of a prescription for initial treatment in a patient not previously treated with trastuzumab for HER2 positive early breast cancer; or

(b)     3, in the case of a prescription for continuing treatment; or

(c)     none, in the case of a prescription for a new loading dose in a patient previously treated with trastuzumab for HER2 positive early breast cancer.

9.       A prescription for the supply of trastuzumab must be approved in accordance with paragraphs 10 and 11 prior to the prescription being given to the patient or the drug being dispensed.

10.     (1)     Subject to subparagraph (2), a medical practitioner who wishes to prescribe trastuzumab under these Arrangements must:

(a)     prepare and sign a prescription for trastuzumab:

(i)      in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or

(ii)      in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subparagraph (i); or

(iii)     in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

(iv)     by a method approved in writing by the Secretary; and

(b)     subject to paragraph (c), submit the prescription and, where appropriate, the material specified in Schedule 1 to the Medicare Australia CEO;

(c)     in the case of continuing treatment, submit the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subparagraph 10(1)(b).

(2)     Where the appropriate Early Breast Cancer – PBS Supporting Information Form approved by the Medicare Australia CEO is completed by the medical practitioner, it will not be necessary for the medical practitioner to complete the medical indication section of the prescription referred to in subparagraph (10)(1)(a).

Authorisation of prescriptions for trastuzumab

11.     The authorisation of a prescription submitted under paragraph 10 may be made:

(a)     if the prescription was submitted in accordance with subparagraph 10(1)(b) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:

(i)      if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or

(ii)     in any other case:

(A)    by returning it to the medical practitioner; or

(B)     by sending it to the person in respect of whom it was prepared; or

(b)     if the prescription was submitted in accordance with subsubparagraph 10(1)(c) — verbally, at the time the Medicare Australia CEO is given details of the prescription.

12.     If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 11(b):

(a)     the Medicare Australia CEO must tell the medical practitioner the number that has been allotted to the authorised prescription; and

(b)     the medical practitioner must:

(i)      mark that number on the prescription; and

(ii)     retain a copy of the prescription for 1 year from the date on which the prescription was authorised.

13.     The Medicare Australia CEO must not authorise the supply of trastuzumab powder for I.V. infusion to be repeated in respect of a prescription for a foreign person who is entitled to be treated as an eligible person within the meaning of the Health Insurance Act 1973 under section 7 of that Act.

14.     Regulation 24 of the Regulations applies to the supply of trastuzumab as if the quantity or number of units of trastuzumab powder for I.V. infusion authorised by the Medicare Australia CEO under paragraph 11 or 12 were the maximum quantity or number of units applicable in relation to a pharmaceutical benefit in accordance with a determination of the Minister under paragraph 85A(2)(a) of the Act.

Supplier of trastuzumab under these Arrangements

15.     Trastuzumab may be supplied:

(a)     by an approved pharmacist; or

(b)     by an approved medical practitioner; or

(c) by an approved public hospital authority within the limits of its approval under section 94 of the Act, to a patient receiving treatment at, or from, the hospital as a non-admitted patient, day admitted patient or patient on discharge; or

(d) by an approved private hospital authority within the limits of its approval under section 94 of the Act; or

(e)     by an approved public hospital to a patient receiving treatment at, or from, the hospital as a non-admitted patient, day admitted patient or patient on discharge.

Cost to patient of trastuzumab under these Arrangements

16. An approved private hospital authority, approved pharmacist or approved medical practitioner that supplies trastuzumab may charge the person to whom the drug is supplied an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the person.

17. An approved public hospital authority or an approved public hospital that supplies trastuzumab may charge the person to whom the drug is supplied the applicable amount specified as the maximum value of a supply of out-patient medication in the determination made under s 84BA(2) of the Act as in force on the date of the supply.

Payment to supplier of trastuzumab under these Arrangements

Payments to approved private hospital authorities

18.     An approved private hospital authority, approved pharmacist or approved medical practitioner that has supplied trastuzumab in accordance with these arrangements, is entitled to be paid by the Commonwealth as if paragraphs 20 to 23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in No. PB 54 of 2009 as in force from time to time apply to trastuzumab.

Payments to approved public hospitals

19.     Where an approved public hospital has supplied trastuzumab in accordance with these arrangements, the Government of the State or Territory in which the public hospital is located is entitled to be paid by the Commonwealth 99.2% of the dispensed price for the supply of the drug.

20.     For the purposes of 19, the dispensed price is to be ascertained in accordance with paragraphs 33 to 35 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in No. PB 125 of 2009 as in force from time to time as if those arrangements applied to trastuzumab.

Payments to approved public hospital authorities

21.     An approved public hospital authority that has supplied trastuzumab in accordance with these arrangements is entitled to be paid by the Commonwealth the amount ascertained in accordance with paragraphs 22 to 25.

22.     Where a quantity of trastuzumab that is ordered and supplied by an approved public hospital authority is equal to the quantity contained in the manufacturer’s pack, the approved public hospital authority is entitled to be paid by the Commonwealth the sum of:

(a)     the price ex manufacturer of the manufacturer’s pack; and

(b)     a mark-up of 11.1%.

23.     Where a quantity of trastuzumab that is ordered and supplied by an approved public hospital authority is less than the quantity contained in the manufacturer’s pack, the approved public hospital authority is entitled to be paid by the Commonwealth the amount calculated by:

(a)     ascertaining the percentage that the quantity or number of units in the broken quantity bears to the quantity or number of units in the manufacturer’s pack; and

(b)     applying that percentage to the price for a complete manufacturer’s pack ascertained in accordance with paragraph 22.

24.     Where a quantity of a highly specialised drug that is ordered and supplied by an approved public hospital authority is more than the quantity contained in the manufacturer’s pack, the sum of:

(a)     the amount calculated in accordance with paragraph 22; and

(b)     the amount calculated in accordance with paragraph 23

25.     Prices calculated for the purposes of paragraphs 22 to 24 shall be taken to the nearest cent, with one half cent being counted as 1 cent.

Payment arrangements for the supply of trastuzumab by approved public hospitals

26.     Where an approved public hospital supplies trastuzumab, the State or Territory Government in which the public hospital is located must make a claim for payment in accordance with the following procedures:

(a)     one claim for payment per State or Territory must be submitted to Medicare Australia in respect of all trastuzumab dispensed by all public hospitals within each State and Territory in a calendar month in arrears;

(b)     a claim in respect of a calendar month must be submitted within three months of the end of that month;

(c)     for each supply of trastuzumab, the claim must include the following information:

(i)      the State or Territory;

(ii)     the hospital provider number;

(iii)     the Medicare Australia Authority Prescription Number;

(iv)    the original supply or repeat number;

(v)     the supply date; and

(vi)    the number of manufacturer’s packs supplied.

Note: Claims by other approved suppliers must be made in accordance with the Act.

SCHEDULE 1

Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery.

The total duration of PBS-subsidised treatment (initial plus continuing) that will be authorised is 52 weeks.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.  Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

Authority applications for initial treatment must be made in writing and must include:

a.       a completed authority prescription form; and

b.       a completed Early Breast Cancer – PBS Supporting Information Form which includes:

(i)      a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and

(ii)      a copy of the signed patient acknowledgement form.

The medical practitioner should request sufficient quantity based on the weight of the patient to provide for a maximum of 3 weeks’ treatment (equivalent to the loading dose for the 3-weekly regimen, and the loading dose and 2 weekly doses for the once-weekly regimen).

Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS-subsidised trastuzumab.

The patient is eligible to receive sufficient trastuzumab to complete 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.

Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by a suitable method including for example, ECHO or MUGA, at 3 monthly intervals during treatment.

Authority applications for continuing treatment may be made by telephone.

The medical practitioner should request sufficient quantity based on the weight of the patient for 3 weeks’ supply (equivalent to 1 dose for the 3-weekly dosing regimen, or 3 doses for the once-weekly dosing regimen). Up to a maximum of 3 repeats may be authorised.

Breaks in therapy.

Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. Authority applications for new loading doses may be made by telephone.

Notes to the Special Arrangements: Special Authority Program — Trastuzumab (PB 56 of 2009)

Note 1

The Special Arrangements: Special Authority Program — Trastuzumab (PB 56 of 2009) (in force under subsection 100(1) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title	Date of FRLI Registration	Date of commencement	Application, saving or transitional provisions
PB 56 of 2009	28 June 2009 (see F2009L02597)	28 June 2009
PB 127 of 2009	16 Dec 2009 (see F2009L04639)	1 Jan 2010	—

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted
Provision affected	How affected
S. 20.......................................................	rs. PB 127 of 2009
S. 22.......................................................	am. PB 127 of 2009