PB 115 of 2010
National Health (Trastuzumab) Special Arrangement 20101
National Health Act 1953
I, DAVID LEARMONTH, Deputy Secretary, Department of Health and Ageing, make this Special Arrangement under subsections 100 (1) and (2) of the National Health Act 1953.
Dated 28 November 2010
Signed by D Learmonth
Deputy Secretary,
Department of Health and Ageing
Contents
Part 1 Preliminary
Division 1 General
1 Name of Special Arrangement 5
2 Commencement 5
3 Revocation 5
4 Definitions 5
Division 2 Trastuzumab pharmaceutical benefit
5 Pharmaceutical benefits covered by this Special Arrangement 6
6 Application of Part VII of Act 6
7 Responsible person 7
8 Authorised prescriber 7
9 Prescription circumstances 7
10 Section 100 only supply 7
Division 3 Trastuzumab modified Authority Required procedures
11 Trastuzumab Authority Required procedures 8
12 Authority required procedures — submission of prescription 8
13 Authority required procedures — authorisation 9
Division 4 Maximum quantity and maximum repeats
14 Maximum quantity 10
15 Maximum number of repeats 11
16 No repeats for visitors 11
Part 2 Supply of trastuzumab pharmaceutical benefits
17 Entitlement to trastuzumab pharmaceutical benefit 12
18 Supply of trastuzumab pharmaceutical benefit under this Special Arrangement 12
Part 3 Claiming procedures and payment amounts
Division 1 Payments to suppliers of trastuzumab pharmaceutical benefit that are approved pharmacists, approved medical practitioners or approved hospital authorities for private hospitals
19 Application 13
20 Payments to approved pharmacists, approved medical practitioners and approved hospital authorities for private hospitals 13
Division 2 Claims and payments — hospital authorities for public hospitals using off‑line system
21 Application 14
22 How off-line claims are made 14
23 Payment for supply of trasztuzumab pharmaceutical benefit where off‑line claim is made 14
Division 3 Claims and payments — approved hospital authorities for public hospitals
24 Application 15
25 Claim for payment by approved hospital authority for a public hospital 15
26 Payment for supply of trastuzumab pharmaceutical benefit to approved hospital authority for public hospital 16
27 Limit on number of prescriptions in one claim 16
Part 4 Patient contributions
28 Patient contributions for claims by approved pharmacists and approved medical practitioners 17
29 Patient contributions if off-line claim is made 17
30 Patient contribution in relation to approved hospital authorities 17
Part 5 Miscellaneous
31 PBS Safety Net 18
Schedule 1 Pharmaceutical benefits to which this Special Arrangement applies and related information 19
Schedule 2 Responsible Person Codes 20
Schedule 3 Circumstances 21
Part 1 Preliminary
Division 1 General
1 Name of Special Arrangement
(1) This Special Arrangement is the National Health (Trastuzumab) Special Arrangement 2010.
(2) This Special Arrangement may also be cited as PB 115 of 2010.
2 Commencement
This Special Arrangement commences on 1 December 2010.
3 Revocation
Instrument PB 62 of 2010 is revoked.
4 Definitions
In this Special Arrangement:
ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.
Act means the National Health Act 1953.
authorised prescriber, for the trastuzumab pharmaceutical benefit, means a person who is a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised prescriber’ for the pharmaceutical benefit.
Note Section 5 sets out the trastuzumab pharmaceutical benefit to which this Special Arrangement applies and section 8 sets out the prescriber code for that pharmaceutical benefit.
approved hospital authority, for a hospital, means the hospital authority for the hospital that:
(a) is approved:
(i) by the Minister under section 94 of the Act; or
(ii) by the Medicare Australia CEO under section 52 of PB 116 of 2010; or
(b) was approved under section 52 of PB 63 of 2010 and the approval:
(i) is not suspended; or
(ii) has not been revoked.
eligible patient means 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.
hospital authority, for a hospital, means the governing body of a public hospital or the proprietor of a private hospital.
PB 63 of 2010 means the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010.
PB 116 of 2010 means the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.
prescriber code has the meaning given by paragraph 8 (2) (b).
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
trastuzumab means the listed drug mentioned in Schedule 1 in the column headed Listed Drug.
trastuzumab pharmaceutical benefit means the pharmaceutical benefit mentioned in Schedule 1.
Note Terms used in this Special Arrangement have the same meaning as in the Act — see section 13 of the Legislative Instruments Act 2003. These terms include:
· pharmaceutical benefit
· pharmaceutical item.
Division 2 Trastuzumab pharmaceutical benefit
5 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to the trastuzumab pharmaceutical benefit mentioned in Schedule 1.
(2) The trastuzumab pharmaceutical benefit to which this Special Arrangement applies is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note The listed drug mentioned in Schedule 1 is trastuzumab — see definition of trastuzumab in section 4. The listed drug has been declared by the Minister under subsection 85 (2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85 (3), (5) and (6) of the Act respectively.
6 Application of Part VII of Act
(1) The trastuzumab pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note See subsection 100 (3) of the Act.
7 Responsible person
(1) If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2) (a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Schedule 1:
(i) in the form mentioned in Schedule 1 for the listed drug; and
(ii) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note 1 The trastuzumab pharmaceutical benefit mentioned in Schedule 1 is a brand of a pharmaceutical item. Each listed drug mentioned in Schedule 1 has been declared under subsection 85 (2) of the Act and the form of the listed drug, the manner of administration for the form, and the brand have been determined under subsections 85 (3), 85 (5) and 85 (6) of the Act respectively.
8 Authorised prescriber
(1) Only an authorised prescriber may write a prescription for the trastuzumab pharmaceutical benefit under this Special Arrangement.
(2) For this Special Arrangement:
(a) only a medial practitioner is an authorised prescriber; and
(b) the prescriber code for the authorised prescriber is the letters ‘MP’.
(3) A reference in this Special Arrangement to a medical practitioner is a reference to an authorised prescriber.
9 Prescription circumstances
(1) The circumstances mentioned in Schedule 3 are the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written.
(2) For subsection (1), the trastuzumab pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
10 Section 100 only supply
(1) If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for the listed drug, the pharmaceutical benefits with the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
(2) The trastuzumab pharmaceutical benefit is not available for general supply on the Pharmaceutical Benefits Scheme.
Note The Minister has declared, under subsection 85 (2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
Division 3 Trastuzumab modified Authority Required procedures
11 Trastuzumab modified Authority Required procedures
(1) This section applies to the trastuzumab pharmaceutical benefit if the circumstances mentioned in Schedule 3 for the pharmaceutical benefit include any of the following:
(a) Compliance with modified Written Authority Required procedures;
(b) Compliance with Telephone Authority Required procedures;
(2) A prescription for the supply of the trastuzumab pharmaceutical benefit must be:
(a) submitted by the medical practitioner to the Medicare Australia CEO in accordance with section 12; and
(b) authorised by the Medicare Australia CEO in accordance with section 13.
12 Trastuzumab modified Authority required procedures — submission of prescription
(1) The medical practitioner must:
(a) deliver or post to the Medicare Australia CEO a prescription for the supply of the trastuzumab pharmaceutical benefit, prepared and signed by the medical practitioner:
(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; or
(b) submit to the Medicare Australia CEO, by telephone, details of a prescription for the supply of the pharmaceutical benefit prepared and signed by the medical practitioner in accordance with subparagraph (a) (i), (ii), (iii) or (iv); or
(c) if medical practitioner has attempted give details of the prescription to the Medicare Australia CEO in accordance with paragraph (b) but has been unable to do so because the telephone system established by the Medicare Australia CEO for the provision of such authorisations was unavailable — submit the prescription in accordance with the instructions in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
(2) If a circumstance mentioned in Schedule 3 includes Compliance with modified Written Authority Required procedures, the medical practitioner:
(a) must submit a prescription for the supply of the trastuzumab pharmaceutical benefit to the Medicare Australia CEO in accordance with paragraph (1) (a); and
(b) must submit with the prescription:
(i) the completed Early Breast Cancer — PBS Supporting Information Form; and
(ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(iii) a copy of the signed patient acknowledgement form; and
(c) is not required to complete the medical indication section of the prescription.
(3) If a circumstance mentioned in Schedule 3 includes Compliance with Telephone Authority Required procedures, the medical practitioner must submit a prescription for the supply of the trastuzumab pharmaceutical benefit to the Medicare Australia CEO in accordance with paragraph (1) (b) or (c).
(4) For paragraph (1) (a), a prescription prepared and signed by the medical practitioner in accordance with subsection (1) is taken to have been submitted by the medical practitioner if it is submitted by his or her employee.
Note This section modifies the ordinary Authority Required procedures set out in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 by inserting additional requirements in subsection 12(2) and removing the option to submit a prescription electronically.
13 Trastuzumab modified Authority required procedures — authorisation
(1) A prescription submitted in accordance with paragraph 12 (1) (a) may be authorised by the Medicare Australia CEO:
(a) signing his or her authorisation on the prescription; and
(b) either:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — 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) returning the authorised prescription to the medical practitioner; or
(B) sending it to the person in respect of whom it was prepared.
(2) A prescription submitted in accordance with paragraph 12 (1) (b) may be authorised by the Medicare Australia CEO telling the medical practitioner by telephone, at the time the Medicare Australia CEO is given details of the prescription, that the prescription is authorised.
(3) If the Medicare Australia CEO authorises a prescription under subsection (2):
(a) the Medicare Australia CEO must tell the medical practitioner the number given by the CEO to the 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 the prescription was authorised.
(4) For paragraph (3) (a), the Medicare Australia CEO must tell the medical practitioner the number by telephone or by electronic communication.
(6) A prescription submitted in accordance with paragraph 12 (1) (c) is taken to have been authorised by the Medicare Australia CEO if the medical practitioner completes the prescription in accordance with the instructions given in the emergency telephone message.
Division 4 Maximum quantity and maximum repeats
14 Maximum quantity
The maximum quantity of the trastuzumab pharmaceutical benefit that may, in 1 prescription, be directed to be supplied on 1 occasion under this Special Arrangement 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 the trastuzumab pharmaceutical benefit 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 the trastuzumab pharmaceutical benefit approved by the Therapeutic Goods Administration.
15 Maximum number of repeats
Subject to section 16, the maximum number of repeats of the trastuzumab pharmaceutical benefit that may be prescribed under this Special Arrangement is:
(a) for a prescription for the initial treatment in a patient not previously treated with the trastuzumab pharmaceutical benefit for HER2 positive early breast cancer — no repeats; or
(b) for a prescription for the continuing treatment in a patient previously treated with the trastuzumab pharmaceutical benefit for HER2 positive early breast cancer — 3 repeats; or
(c) for a prescription for a new loading dose in a patient previously treated with the trastuzumab pharmaceutical benefit for HER2 positive early breast cancer — no repeats.
16 No repeats for visitors
A medical practitioner must not write a repeat prescription for the trastuzumab pharmaceutical benefit 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.
Part 2 Supply of trastuzumab pharmaceutical benefits
17 Entitlement to trastuzumab pharmaceutical benefit
Subject to this Special Arrangement, an eligible patient is entitled to receive the trastuzumab pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 4.
18 Supply of trastuzumab pharmaceutical benefit under this Special Arrangement
The trastuzumab pharmaceutical benefit may be supplied under this Special Arrangement by any of the following:
(a) an approved pharmacist;
(b) an approved medical practitioner;
(c) an approved hospital authority for a hospital to an eligible patient receiving treatment at, or from, the hospital as a non‑admitted patient, day admitted patient or patient on discharge;
(d) 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.
Part 3 Claiming procedures and payment amounts
Division 1 Payments to suppliers of trastuzumab pharmaceutical benefit that are approved pharmacists, approved medical practitioners or approved hospital authorities for private hospitals
19 Application
This Division applies if an approved pharmacist, approved medical practitioner or approved hospital authority for a private hospital supplies the trastuzumab pharmaceutical benefit to an eligible patient under this Special Arrangement and makes a claim for payment.
20 Payments to approved pharmacists, approved medical practitioners and approved hospital authorities for private hospitals
(1) Subject to subsection (2), the approved pharmacist, approved medical practitioner or approved hospital authority is entitled to be paid by the Commonwealth in accordance with section 36, paragraph 39 (1) (a) and section 40 of PB 116 of 2010.
(2) For subsection (1), section 36, paragraph 39 (1) (a) and section 40 of PB 116 of 2010 apply to the supply of the trastuzumab pharmaceutical benefit under this Special Arrangement as if:
(a) a reference in those provisions to an HSD pharmaceutical benefit were a reference to the trastuzumab pharmaceutical benefit; and
(b) a reference in those provisions to subsections 46 (2) and 47 (2) were a reference to Part 4 of this Special Arrangement; and
(c) a reference in those provisions to an approved pharmacist included a reference to an approved pharmacist and an approved medical practitioner.
Note An approved hospital authority for a private hospital or an approved pharmacist may make claims for payment in accordance with rules made by the Minister under subsection 99AAA (8) of the Act — see section 99AAA (2) of the Act.
Division 2 Claims and payments — hospital authorities for public hospitals using off‑line system
21 Application
This Division applies if:
(a) a hospital authority for a public hospital supplies the trastuzumab pharmaceutical benefit under this Special Arrangement; and
(b) the relevant State or Territory agency responsible for the hospital makes an off‑line claim for payment.
22 How off-line claims are made
Subject to Division 3, the State or Territory agency responsible for the hospital must make the off‑line claim for payment by:
(a) lodging with Medicare Australia 1 claim per calendar month for payment for all trastuzumab pharmaceutical benefits dispensed by all public hospitals making an off‑line claim within the State and Territory; and
(b) submitting the claim within 3 months (or such longer period as Medicare Australia allows) after the end of the month in which the trastuzumab pharmaceutical benefit was dispensed; and
(c) include in the claim the following information for each supply of the trastuzumab pharmaceutical benefit:
(i) the State or Territory in which the trastuzumab pharmaceutical benefit was dispensed;
(ii) the hospital provider number of the hospital that dispensed the trastuzumab pharmaceutical benefit;
(iii) the authority approval number allotted to the prescription by Medicare Australia;
(iv) whether the supply is the original or repeated supply;
(v) the date on which the trastuzumab pharmaceutical benefit was supplied;
(vi) the number of manufacturer’s packs of trastuzumab pharmaceutical benefit supplied.
23 Payment for supply of trasztuzumab pharmaceutical benefit where off‑line claim is made
(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 the trastuzumab pharmaceutical benefit for which a claim is made under this Division.
(2) For subsection (1), the dispensed price of the trastuzumab pharmaceutical benefit is to be worked out in accordance with paragraph 37 (a) of PB 116 of 2010 as if a reference in that paragraph to an HSD pharmaceutical benefit were a reference to the trastuzumab pharmaceutical benefit under this Special Arrangement.
Division 3 Claims and payments — approved hospital authorities for public hospitals
24 Application
This Division applies if an approved hospital authority for a public hospital:
(a) supplies the trastuzumab pharmaceutical benefit under this Special Arrangement to an eligible patient; and
(b) makes a claim for payment under this Division.
25 Claim for payment by approved hospital authority for a public hospital
(1) An approved hospital authority may, subject to subsection (2) and section 27, make the claim for payment in accordance with the rules made by the Minister under subsection 99AAA (8) of the Act.
(2) In the application of those rules to a claim under this Subdivision:
(a) a reference in the rules to an approved supplier or an approved hospital authority includes a reference to a hospital authority that:
(i) is approved under subsection 52 (2) of PB 116 of 2010; or
(ii) was approved under section 52 of PB 63 of 2010 and the approval is not suspended and has not been revoked; 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 116 of 2010 or 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 for the trastuzumab pharmaceutical benefit under this Special Arrangement.
Note The rules made by the Minister under subsection 99AAA(8) allow on-line claims for payment for the supply of a pharmaceutical benefit in certain circumstances"
26 Payment for supply of trastuzumab pharmaceutical benefit to approved hospital authority for public hospital
The approved hospital authority for a public hospital is entitled to be paid the amount worked out in accordance with section 35 and paragraph 37 (a) of PB 116 of 2010 as if a reference in that paragraph to an HSD pharmaceutical benefit were a reference to the trastuzumab pharmaceutical benefit under this Special Arrangement.
27 Limit on number of prescriptions in one claim
The claim for payment must not contain more than 3 500 prescriptions.
Part 4 Patient contributions
28 Patient contributions for claims by approved pharmacists and approved medical practitioners
(1) This section applies if an approved pharmacist or an approved medical practitioner supplies the trastuzumab pharmaceutical benefit to an eligible patient under this Special Arrangement.
(2) The approved pharmacist or approved medical practitioner may charge the patient 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 patient.
29 Patient contributions if off-line claim is made
(1) This section applies if a hospital authority for a public hospital supplies the trastuzumab pharmaceutical benefit to an eligible patient and the State or Territory agency responsible for the hospital makes an off-line claim under this Special Arrangement.
(2) The hospital authority for the hospital may charge the patient the relevant amount 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 pharmaceutical benefit.
30 Patient contribution in relation to approved hospital authorities
(1) This section applies if:
(a) an approved hospital authority for a public hospital:
(i) supplies the trastuzumab pharmaceutical benefit under this Special Arrangement to an eligible patient; and
(ii) makes a claim for payment under Part 3, Division 3 of this Special Arrangement; and
(b) an approved hospital authority for a private hospital:
(i) supplies the trastuzumab pharmaceutical benefit under this Special Arrangement to an eligible patient; and
(ii) makes a claim for payment under this Special Arrangement.
(2) The approved hospital authority may charge the person 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 patient.
Part 5 Miscellaneous
31 PBS Safety Net
Any payment an eligible patient makes for the supply of the trastuzumab pharmaceutical benefit under this Special Arrangement counts towards the patient’s PBS Safety Net.
Note Division 1A of Part VII of the Act contains provisions about safety net concession cards.
Schedule 1 Pharmaceutical benefits to which this Special Arrangement applies and related information
(section 5 and subsection 7 (1))
Listed Drug
Form
Manner of Administration
Brand
Responsible Person
Authorised prescriber
Section 100 only
Trastuzumab
Powder for I.V. infusion 150mg
Injection
Herceptin
RO
MP
D
Schedule 2 Responsible Person Codes
(subsection 7 (2))
Code
Responsible Person
Australian Business Number
RO
Roche Products Pty Ltd
70 000 132 865
Schedule 3 Circumstances
(subsection 9 (1) and 11 (1))
Circumstances number
Circumstances
Authority Requirements — Part of Circumstances
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.
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).
Compliance with modified Written Authority Required procedures
2
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.
The medical practitioner should request sufficient quantity based on the weight of the patient for 3 weeks' supply.
Compliance with Telephone Authority Required procedures
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.
