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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This instrument creates the Highly Specialised Drugs (HSD) Program under the National Health Act, adding a subsidised PBS pathway for very expensive, specialised medicines used in rare or severe conditions. It affects patients, hospital specialists, pharmacists and suppliers by requiring prior approval, strict clinical eligibility and ongoing response monitoring while setting payment formulas to control costs.
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Direct links to the current provisions in National Health Act 1953 - Special Arrangements under section 100(1) - Highly Specialised Drugs Program (No. PB 92 of 2007).
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
Special Arrangements — highly specialised drugs program (PB 92 of 2007)
as amended
made under subsection 100(1) of the
National Health Act 1953
This compilation was prepared on 31 July 2008
taking into account amendments up to PB 72 of 2008
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Special Arrangements – highly specialised drugs program (PB 92 of 2007)
Commencement [see Note 1]
(b) Instrument No. PB 53 of 2007 is repealed.
Definitions
(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) “brand” means the brand of a pharmaceutical item determined under subsection 85(6) of the Act; or where the highly specialised drug does not have a pharmaceutical item, the trade name under which it is supplied, or if there is no trade name, the name of the manufacturer of the highly specialised drug;
(d) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
(e) “details of the prescription”, for the purpose of subparagraph 11(b), means:
(i) all matters included in the prescription completed by the medical practitioner in accordance with subparagraph 11(a); and
(ii) the proposed duration of treatment for which authority is sought by the medical practitioner; and
(iii) the provider number of the hospital with which the medical practitioner is affiliated;
(f) “highly specialised drug” means a special pharmaceutical product in relation to which, by virtue of paragraphs 4, 7 and 9, these Arrangements apply;
(g) “medical practitioner” means a medical practitioner, within the meaning of the Health Insurance Act 1973, who is affiliated with the hospital in or at which the patient is receiving treatment and is:
(i) a staff hospital specialist; or
(ii) a visiting or consulting specialist of the hospital; or
(iii) providing maintenance therapy in a situation where it is impractical to obtain a prescription from, and with the agreement of, a medical practitioner referred to in subsubparagraph (i) or (ii); or
(iv) accredited, in the State or Territory in which the medical practitioner practises, to prescribe medication for the treatment of HIV or AIDS; or
(v) the subject of a specific arrangement between the Commonwealth and the relevant State or Territory Government;
(h) “medication for the treatment of HIV or AIDS” means any of the following highly specialised drugs
abacavir
abacavir with lamivudine
abacavir with lamivudine and zidovudine
atazanavir
azithromycin
cidofovir
clarithromycin
darunavir
delavirdine
didanosine
doxorubicin, pegylated liposomal
efavirenz
emtricitabine
enfuvirtide
fosamprenavir
foscarnet
ganciclovir
indinavir
lamivudine
lamivudine with zidovudine
lopinavir with ritonavir
nelfinavir
nevirapine
raltegravir
rifabutin
ritonavir
saquinavir
stavudine
tenofovir
tenofovir with emtricitabine
valaciclovir
valganciclovir
zidovudine
(i) “private hospital” has the same meaning as in subsection 3(1) of the Health Insurance Act 1973;
(j) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
Entitlement to receive highly specialised drugs under these Arrangements
(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 at a private hospital as a non-admitted patient, day admitted patient or patient on discharge;
is entitled to receive highly specialised drugs under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraphs 19 and 19A.
The special pharmaceutical products to which these Arrangements apply are the highly specialised drugs specified in column 1 of Schedule 1.
The supply of a highly specialised drug under these Arrangements is authorised only in the circumstances specified in column 2 of Schedule 1 in relation to the highly specialised drug.
The following circumstances are specified in relation to each highly specialised drug:
(a) where a class of persons is specified in column 2 of Schedule 1 — the highly specialised drug is to be supplied for the treatment of a person included in that class of persons; or
(b) where a disease or condition is specified in column 2 of Schedule 1 —
(i) if subsubparagraph (ii) does not apply — the highly specialised drug is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — the highly specialised drug is to be supplied for the treatment of that disease or condition in a person included in that class of persons; or
(c) where a purpose is specified in column 2 of Schedule 1 — the highly specialised drug is to be supplied for that purpose.
Where strength, type of unit, size of unit or other particulars of form are specified in column 2 of Schedule 2 or column 2 of Schedule 3 in relation to a special pharmaceutical product, each specified form of the product is a highly specialised drug, and these Arrangements do not apply in relation to the special pharmaceutical product in any other form.
The manner of administration specified in column 3 of Schedule 2 in relation to a highly specialised drug is the only manner of administration that may be directed to be used in relation to the highly specialised drug.
These Arrangements only apply to the supply of a highly specialised drug having a brand mentioned in column 4 of Schedule 2 for the form and manner of administration mentioned of the highly specialised drug.
Where a prescription specifies a quantity of a highly specialised drug listed in Schedule 3 that is less than the quantity contained in the size of unit included in the particulars specified in column 2 of that Schedule in relation to that highly specialised drug, the complete pack shall be supplied.
Prescriptions for highly specialised drugs
(a) by preparing and signing a prescription for the highly specialised drug:
(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 subsubparagraph (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) subject to paragraph 11AA, by submitting the prescription:
(i) 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 (a); or
(ii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (i) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
11AA.A medical practitioner may not submit a prescription to the Medicare Australia CEO in accordance with subparagraph 11(b):
(a) in the case of the highly specialised drugs “abatacept”, “epoprostenol”, “etanercept”, “iloprost”, “infliximab”, “sildenafil” and “sitaxentan”, unless the medical practitioner has previously submitted a prescription to the Medicare Australia CEO in accordance with subparagraph 11(a) for a particular patient and for a specified circumstance, and the number of repeats that was authorised by the Medicare Australia CEO was less than the maximum number of repeats allowable for that purpose. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i) for the balance of the allowable repeats for that patient for that circumstance; or
(b) in the case of the highly specialised drug “bosentan”:
(i) unless the medical practitioner has previously submitted a prescription to the Medicare Australia CEO in accordance with subparagraph 11(a) for a particular patient and for a specified circumstance, and the number of repeats that was authorised by the Medicare Australia CEO was less than the maximum number of repeats allowable for that purpose. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i) for the balance of the allowable repeats for that patient for that circumstance; or
(ii) unless the prescription is for the final PBS-subsidised supply for the patient. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i); or
(c) in the case of the highly specialised drug “rituximab”.
11A. For the purposes of subparagraph 11(a), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.
Authorisation of prescriptions for highly specialised drugs
(a) if the prescription was submitted in accordance with subparagraph 11(a) — 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 subparagraph 11(b) — orally, at the time the Medicare Australia CEO is given details of the prescription.
12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(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.
Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(b)(ii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
In authorising a prescription for a highly specialised drug under paragraph 12, the Medicare Australia CEO may authorise:
(a) subject to paragraph 14A, the supply of a quantity of number of units of the highly specialised drug sufficient for up to 2 months treatment with the highly specialised drug; and
(b) subject to paragraphs 14B, 14C, 14D, 14E and 15, up to 5 repeat supplies.
14A. The Medicare Australia CEO may authorise:
(a) in the case of a prescription for one of the highly specialised drugs “bosentan”, “clozapine”, “epoprostenol”, “etanercept”, “iloprost”, “sildenafil” and “sitaxentan”, the supply of a quantity of number of units of the highly specialised drug sufficient for up to 1 month’s treatment with the highly specialised drug;
(b) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with severe active rheumatoid arthritis, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 3 mg per kg;
(c) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with active ankylosing spondylitis, severe active psoriatic arthritis or severe chronic plaque psoriasis, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 5 mg per kg;
(d) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of patients with refractory Crohn’s disease, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 5 mg per kg;
(e) in the case of a prescription for the highly specialised drug “rituximab”, the supply of a quantity of number of units of the highly specialised drug sufficient to provide for either 1 or 2 doses;
(f) in the case of a prescription for the highly specialised drug “abatacept”, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose;
(g) in the case of a prescription for the highly specialised drug “cinacalcet”, the supply of a quantity of number of units of the highly specialised drug sufficient to provide for 4 weeks treatment at a dose of 30 to 180 mg per day;
(h) in the case of a prescription for the highly specialised drug “natalizumab”, the supply of a single infusion.
14B. The Medicare Australia CEO may authorise:
(a) in the case of a prescription for the highly specialised drug “etanercept” for the initial treatment of severe polyarticular course juvenile chronic arthritis, up to 3 repeat supplies of the highly specialised drug;
(b) in the case of a prescription for the highly specialised drug “sitaxentan” for the initial PBS-subsidised treatment of patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease who were receiving non-PBS-subsidised treatment with sitaxentan for less than 6 months prior to 1 April 2008, sufficient repeat supplies of the highly specialised drug to allow the patient to complete a period of combined PBS-subsidised and non-PBS-subsidised therapy of 6 months duration in total;
(c) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with severe active rheumatoid arthritis in accordance with the circumstances specified in Schedule 1 which permit a course of up to a maximum of 22 weeks of treatment to be authorised, up to 3 repeat supplies of the highly specialised drug;
(d) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with severe active rheumatoid arthritis in accordance with the circumstances specified in Schedule 1 which permit a course of up to a maximum of 24 weeks of treatment to be authorised, up to 2 repeat supplies of the highly specialised drug;
(e) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with severe active psoriatic arthritis in accordance with the
This is an opening excerpt, not the complete document.