National Health (Trastuzumab) Special Arrangements Instrument 2010 (Cth)
PB 62 of 2010
National Health (Trastuzumab) Special Arrangements Instrument 20101
National Health Act 1953
I, Linda Jackson, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under subsections 100 (1) and (2) of the National Health Act 1953.
Dated 25 June 2010
LINDA JACKSON
Assistant Secretary, Access and Systems Branch, Department of Health and Ageing
Contents
Division 1Preliminary
1Name of Instrument 3
2Commencement 3
3Definitions 3
4Part VII of Act and Regulations 4
5Entitlement to receive trastuzumab under this Instrument 4
Division 2Prescriptions for trastuzumab
6Prescriptions for trastuzumab 4
7Intravenous administration of trastuzumab 4
8Maximum quantity 4
9Maximum number of repeats 5
10Requirements for prescription 5
11How prescription is prepared 5
12How prescription is authorised by Medicare Australia CEO 6
13No repeats for visitors 6
Division 3Supplying trastuzumab
14Who may supply trastuzumab 7
Division 4Claims and payments
Subdivision 1 Claims and payments — approved pharmacists, medical practitioners and private hospital authorities
15Application 7
16Payments to approved pharmacists, medical practitioners and private hospital authorities 7
Subdivision 2 Claims and payments — hospital authorities for public hospitals using off‑line system
17Application 8
18Amount of payment to hospital authority using off‑line system 8
19Payment arrangements for the supply of trastuzumab by hospital authority 9
Subdivision 3 Claims and payments — approved public hospital authorities using on‑line system
20Application 9
21Amount of payment and co‑payment to approved public hospital authority using on‑line system 9
22Payment arrangements using on‑line claiming 10
23Limit on number of prescriptions in one claim 10
24Certain requirements to be satisfied before claim is lodged 10
25No mark‑ups 10
Division 5Miscellaneous
26Patient refund 11
27PBS Safety Net 11
28Revocation 11
Schedule 1Circumstances in which prescriptions for trastuzumab may be authorised 12
Part 1Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery 12
Part 2Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS‑subsidised trastuzumab 13
Division 1 Preliminary
Name of Instrument
(1) This Instrument is the National Health (Trastuzumab) Special Arrangements Instrument 2010.
(2) This Instrument may also be cited as PB 62 of 2010.
Commencement
This Instrument commences on 1 July 2010.
Definitions
(1) In this Instrument:
Act means the National Health Act 1953.
approved private hospital authority, for a private hospital, means the hospital authority for the hospital, that is approved under section 94 of the Act.
approved public hospital authority, for a public hospital, means the hospital authority for the hospital that is approved under:
(a) section 94 of the Act; or
(b) section 52 of PB 63 of 2010.
eligible patient means a person mentioned in section 5.
hospital authority, for a hospital, means the governing body of a public hospital or the proprietor of a private hospital.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
(2) A word or expression used in this Instrument and in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act has the same meaning in this Instrument as it has in the Act, the Regulations, declaration, determination or instrument.
Note Some terms used in this Instrument, including medical practitioner, Medicare Australia CEO and public hospital, are defined in the Act, or in the Health Insurance Act 1973. Definitions in the Health Insurance Act 1973 apply in the Act, unless the contrary intention appears (see subsection 4 (1A) of the Act).
Part VII of Act and Regulations
Subject to this Instrument, the provisions of the Act, the Regulations and any declarations, determinations or other instruments made under Part VII of the Act or the Regulations, apply to the prescribing and supply of trastuzumab under this Instrument.
Entitlement to receive trastuzumab under this Instrument
Subject to this Instrument, a person is entitled to receive trastuzumab under this Instrument without payment or other consideration, other than a charge made under subsection 16 (3), 18 (3) or 21 (3), if the person:
(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.
Division 2 Prescriptions for trastuzumab
Prescriptions for trastuzumab
A prescription for the supply of trastuzumab as a special pharmaceutical product under this Instrument is authorised:
(a) only in the circumstances mentioned in Schedule 1; and
(b) subject to the requirements in this Instrument.
Intravenous administration of trastuzumab
This Instrument applies to trastuzumab for intravenous administration only if the trastuzumab is:
(a) in the form; and
(b) has the proprietary name; and
(c) is supplied by the manufacturer;
mentioned in the following table.
Form (strength, type, size, etc)
Proprietary name
Manufacturer
Powder for intravenous infusion 150 mg Herceptin Roche Products Pty Ltd
Maximum quantity
The maximum quantity of trastuzumab that may be prescribed for an eligible patient is:
(a) for a 3‑weekly course of treatment — a sufficient number of vials to provide for a single infusion based on the weight of the patient and the dosage recommendations in the Product Information for trastuzumab approved by the Therapeutic Goods Administration; or
(b) for a weekly course of treatment — a sufficient number of vials to provide for 3 infusions based on the weight of the patient and the dosage recommendations in the Product Information for trastuzumab approved by the Therapeutic Goods Administration.
Maximum number of repeats
Subject to section 13, the maximum number of repeats of trastuzumab that may be prescribed for an eligible patient is:
(a) for a prescription for the initial treatment in a patient not previously treated with trastuzumab for HER2 positive early breast cancer — no repeats; or
(b) for a prescription for the continuing treatment in a patient previously treated with trastuzumab for HER2 positive early breast cancer — 3 repeats; or
(c) for a prescription for a new loading dose in a patient previously treated with trastuzumab for HER2 positive early breast cancer — no repeats.
Requirements for prescription
A prescription for the supply of trastuzumab must be prepared and authorised in accordance with sections 11 and 12 before the prescription is given to the patient or the trastuzumab is dispensed.
How prescription is prepared
(1) Subject to subsection (2), a medical practitioner who proposes to prescribe trastuzumab under this Instrument must:
(a) prepare and sign a prescription:
(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, in accordance with the form approved by the Secretary under subparagraph (i); or
(iii) that is 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 to the Medicare Australia CEO the prescription and, if appropriate, the material mentioned in item 4 in Schedule 1; and
(c) for continuing treatment of an eligible patient — submit the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription that has been prepared and signed by the medical practitioner in accordance with paragraph (a).
(2) The medical practitioner does not have to complete the medical indication section of a prescription mentioned in paragraph (1) (a) if he or she completes the appropriate Early Breast Cancer — PBS Supporting Information Form approved by the Medicare Australia CEO.
How prescription is authorised by Medicare Australia CEO
(1) For this Instrument, a prescription for trastuzumab is authorised by the Medicare Australia CEO as set out in this section.
(2) If the prescription is submitted in accordance with paragraph 11 (1) (b), the prescription is authorised by:
(a) the Medicare Australia CEO writing his or her authorisation of the prescription on it; and
(b) either:
(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 for 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 for whom it was prepared.
(3) If the prescription is submitted in accordance with paragraph 11 (1) (c), the prescription is authorised when:
(a) the details of the prescription are given to the Medicare Australia CEO over the telephone; and
(b) the following actions are completed:
(i) the Medicare Australia CEO tells the medical practitioner the number that has been allotted to the prescription;
(ii) the medical practitioner writes that number on the prescription.
(4) The medical practitioner must keep a copy of the prescription for 1 year commencing on the day the prescription is authorised.
No repeats for visitors
The Medicare Australia CEO must not authorise the supply of trastuzumab powder for intravenous infusion for a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.
Division 3 Supplying trastuzumab
Who may supply trastuzumab
Trastuzumab may be supplied by any of the following:
(a) an approved pharmacist;
(b) an approved medical practitioner;
(c) an approved public hospital authority, within the limits of its approval, to an eligible patient receiving treatment at, or from, the hospital as a non‑admitted patient, day admitted patient or patient on discharge;
(d) an approved private hospital authority within the limits of its approval under section 94 of the Act;
(e) a hospital authority for a public hospital to an eligible patient receiving treatment at, or from, the hospital as a non‑admitted patient, day admitted patient or patient on discharge.
Division 4 Claims and payments
Subdivision 1 Claims and payments — approved pharmacists, medical practitioners and private hospital authorities
Application
This Subdivision applies if an approved pharmacist, approved medical practitioner or approved private hospital authority supplies trastuzumab to an eligible patient under this Instrument.
Payments to approved pharmacists, medical practitioners and private hospital authorities
(1) Subject to subsection (2), the approved pharmacist, approved medical practitioner or approved private hospital authority is entitled to be paid by the Commonwealth in accordance with section 28, paragraph 30 (a) and section 31 of PB 64 of 2010.
(2) For subsection (1), section 28, paragraph 30 (a) and section 31 of PB 64 of 2010 apply to the supply of trastuzumab as if:
(a) a reference in those provisions to a highly specialised drug were a reference to trastuzumab; and
(b) a reference in those provisions to section 26 were a reference to subsection (3) of this section; and
(c) a reference in those provisions to an approved hospital authority included a reference to an approved private hospital authority, an approved pharmacist and an approved medical practitioner; and
(d) section 31 of PB 64 of 2010 were omitted and the following section inserted:
“31 The mark‑up is as follows:
(a) if the price ex‑manufacturer for the manufacturer’s pack of trastuzumab is less than $40.00 — 10% of that price;
(b) if the price ex‑manufacturer for the manufacturer’s pack of trastuzumab is $40.00 or more but not more than $100.00 — $4.00;
(c) if the price ex‑manufacturer for the manufacturer’s pack of trastuzumab is more than $100.00 but not more than $1 000.00 — 4% of that price;
(d) if the price ex‑manufacturer for the manufacturer’s pack of trastuzumab is more than $1 000.00 — $40.00.”.
Co‑payments
(3) The pharmacist, practitioner or authority may also charge the person, as a co‑payment, the relevant amount under section 87 of the Act.
Subdivision 2 Claims and payments — hospital authorities for public hospitals using off‑line system
Application
This Subdivision applies if:
(a) a hospital authority for a public hospital supplies trastuzumab under this Instrument; and
(b) the relevant State or Territory agency responsible for the hospital makes an off‑line claim for payment.
Amount of payment to hospital authority using off‑line system
(1) The government of the State or Territory in which the hospital is located is entitled to be paid 99.2% of the dispensed price for the supply of trastuzumab.
(2) For subsection (1), the dispensed price of trastuzumab is to be worked out in accordance with paragraph 42 (a) of PB 63 of 2010 as if a reference in that paragraph to a highly specialised drug were a reference to trastuzumab.
Co‑payments
(3) The authority may also charge the person, as a co‑payment, the relevant amount that is specified as the maximum value of a supply of out‑patient medication in the determination made under subsection 84BA (2) of the Act as in force on the date of the supply of the trastuzumab.
Payment arrangements for the supply of trastuzumab by hospital authority
A claim for payment under this Subdivision must comply with the following procedures:
(a) the government of the State or Territory must lodge 1 claim per calendar month for payment to Medicare Australia for all trastuzumab dispensed by all public hospitals making an off‑line claim within the State and Territory for the previous calendar month;
(b) the claim must be submitted within 3 months (or such longer period as Medicare Australia allows) after the end of the month in which the trastuzumab was dispensed;
(c) for each supply of trastuzumab, the claim must include the following information:
(i) the State or Territory in which the trastuzumab was dispensed;
(ii) the hospital provider number of the hospital that dispensed the trastuzumab;
(iii) the Medicare Australia authority prescription number on the prescription under which the trastuzumab was supplied;
(iv) the original supply, or repeat, number of the prescription under which the trastuzumab was supplied;
(v) the date on which the trastuzumab was supplied;
(vi) the number of manufacturer’s packs of trastuzumab supplied.
Note Claims by other approved suppliers must be made in accordance with the Act.
Subdivision 3 Claims and payments — approved public hospital authorities using on‑line system
Application
This Subdivision applies if an approved public hospital authority:
(a) supplies trastuzumab to an eligible patient; and
(b) makes an on‑line claims payment.
Amount of payment and co‑payment to approved public hospital authority using on‑line system
(1) The approved public hospital authority is entitled to be paid the amount worked out in accordance with paragraph 42 (a) of PB 63 of 2010 as if a reference in that paragraph to a highly specialised drug were a reference to trastuzumab.
(2) The amount worked out under subsection (1) is to be reduced by the co‑payment amount charged by the authority under subsection (3).
Co‑payments
(3) The authority may also charge the person, as a co‑payment, the relevant amount under section 87 of the Act.
Payment arrangements using on‑line claiming
(1) An on‑line claim for payment for the supply of trastuzumab under this Subdivision may be made only by an approved public hospital authority for a public hospital.
(2) The approved public hospital authority may, subject to subsection (3) and sections 23, 24 and 25, make the claim for payment in accordance with the rules made by the Minister under paragraph 99AAA (8) (a) of the Act.
(3) In the application of those rules to a claim under this Subdivision:
(a) a reference in the rules to an approved hospital authority or an approved supplier includes a reference to a hospital authority approved under section 52 of PB 63 of 2010; and
(b) a reference in the rules to a number allotted to an approval under regulation 8A includes a reference to a number allotted to an approval under section 52 of PB 63 of 2010; and
(c) a reference in the rules to an authority prescription includes a reference to a prescription under this Instrument for trastuzumab.
Limit on number of prescriptions in one claim
The claim for payment must not contain more than 3 500 prescriptions.
Certain requirements to be satisfied before claim is lodged
Before the approved public hospital authority lodges the claim, the pharmacist, or medical practitioner, at the public hospital must ensure that each supply of trastuzumab:
(a) was supplied to an eligible patient; and
(b) was prescribed in accordance with this Instrument; and
(c) was prescribed only for the therapeutic uses approved by the Therapeutic Goods Administration for the drug.
No mark‑ups
No mark‑ups may be added to the cost of trastuzumab for which payment is claimed under this Subdivision.
Division 5 Miscellaneous
Patient refund
(1) Subsection (2) applies if an approved public hospital authority for a public hospital makes a claim under this Instrument using the on‑line system.
(2) An eligible patient who has been supplied trastuzumab by the public hospital is entitled to be refunded either of the following amounts by Medicare Australia:
(a) if Medicare Australia is satisfied that the patient is entitled to receive trastuzumab at a concessional price and, at the time trastuzumab was supplied to the patient, the patient was unable to establish his or her concessional status — the amount above the co‑payment rate paid by the patient;
(b) if Medicare Australia is satisfied that the patient is entitled to receive trastuzumab at a concessional price and, at the time trastuzumab was supplied to the patient, the patient was eligible for, but had not been issued with, a Safety Net entitlement card or a concession card — the amount above the patient’s Safety Net threshold limit paid by the patient.
PBS Safety Net
Any payment an eligible patient makes for the supply of trastuzumab supplied under this Instrument counts towards the patient’s PBS Safety Net.
Note Division 1A of Part VII of the Act contains provisions about safety net concession cards.
Revocation
Instrument PB 56 of 2009 is revoked.
Schedule 1 Circumstances in which prescriptions for trastuzumab may be authorised
(section 6 and paragraph 11 (1) (b))
Part 1 Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery
1. The total duration of PBS‑subsidised treatment (initial plus continuing) that will be authorised is 52 weeks.
2. HER2 positivity must be demonstrated by in situ hybridisation (ISH).
3. Trastuzumab must not be used in a patient 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, before to seeking the initial authority approval and then at 3‑monthly intervals during treatment.
4. 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.
5. 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 course of treatment, and the loading dose and 2‑weekly doses for the weekly course of treatment).
Part 2 Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS‑subsidised trastuzumab
6. The patient is eligible to receive sufficient trastuzumab to complete 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy.
7. Trastuzumab must not be used in a patient 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.
8. Authority applications for continuing treatment may be made by telephone.
9. 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 course of treatment, or 3 doses for the weekly course of treatment). Up to a maximum of 3 repeats may be authorised.
10. If 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.
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See
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