EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
HIGHLY SPECIALISED DRUGS PROGRAM
NO. PB 19 of 2006
Purpose and operation
- The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
5. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
6. Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
7. The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
8. The Highly Specialised Drugs Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge.
9. The Highly Specialised Drugs Program Arrangements made under subparagraph 100(b)(i) of the Act on 10 January 2006, with effect from 1 February 2006 (No. PB 6 of 2006), are repealed and substituted with these Arrangements.
10. These Arrangements were remade on 24 March 2006 to give effect, as from 1 April 2006, to the list of drugs and medicinal preparations available under the Highly Specialised Drugs Program under section 100, as recommended by the Pharmaceutical Benefits Advisory Committee. Schedules 1 and 4 have been amended to give effect to the changes detailed in the attached summary.
11. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
12. Details of the Arrangements are set out in the Attachment.
Consultations
13. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
14. PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
15. The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC). The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program. The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members. The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.
SUMMARY OF CHANGES
Alterations of Restriction — Schedule 1
Adefovir Dipivoxil
Peginterferon Alfa-2a
Peginterferon Alfa-2b
Ribavirin and Peginterferon Alfa-2a
Ribavirin and Peginterferon Alfa-2b
Brands with price changes but no change in brand premium — Schedule 4
Cyclosporin Capsule 25 mg (NV)
Capsule 100 mg (NV)
Brands with a decreased brand premium — Schedule 4
Cyclosporin Capsule 25 mg (HX)
Capsule 50 mg (HX, NV)
Capsule 100 mg (HX)
ATTACHMENT
Paragraph 1(a) provides that these Arrangements commence on 1 April 2006.
Paragraph 1(b) provides that the Arrangements made on 10 January 2006, with effect from 1 February 2006 (No. PB 6 of 2006), are repealed with effect from commencement of these Arrangements.
Paragraph 2 provides that a word or phrase used in these Arrangements will be taken to have the same meaning as in the National Health Act 1953 (the Act), the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations, unless the contrary intention appears. Paragraph 2 also defines certain terms used in these Arrangements.
Paragraph 3 provides that a person is entitled to receive highly specialised drugs under these Arrangements, without payment or other consideration, other than the charges specified in paragraphs 19 and 19A, if that person is an eligible person within the meaning of the Health Insurance Act 1973, and if that person is receiving treatment by medical practitioner as a non-admitted patient, a day admitted patient or a patient on discharge at a private hospital.
Paragraph 4 provides that the highly specialised drugs to which these Arrangements apply are listed in column 1 of Schedule 1.
Paragraph 5 provides that the supply of a highly specialised drug under these Arrangements is authorised only in the circumstances specified in column 2 of Schedule 1 for that highly specialised drug.
Paragraph 6 provides that:
(a) where a class of persons is specified in column 2 of Schedule 1, the highly specialised drug is to be supplied to 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 subparagraph (ii) does not apply, the highly specialised drug is to be supplied for the treatment of that disease or condition; or
(ii) if a disease or condition is specified in relation to a 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.
Paragraph 7 provides that where a form of a highly specialised drug is specified in column 2 of Schedule 2 or Schedule 3, each specified form is a highly specialised drug and these Arrangements do not apply to that highly specialised drug in any other form.
Paragraph 8 provides that a highly specialised drug may only be administered in the manner specified in column 3 of Schedule 2.
Paragraph 9 provides that a highly specialised drug may only be supplied as a brand specified in column 4 of Schedule 2 and that no other brand may be supplied under these Arrangements. Paragraph 12 also lists all of the manufacturers of brands listed in these Arrangements.
Paragraph 10 provides that where a prescription specifies a quantity of a highly specialised drug that is less than the quantity specified in column 2 of Schedule 3 for that highly specialised drug, then a complete pack shall be supplied.
Paragraph 11 provides that when prescribing a highly specialised drug the medical practitioner must submit the prescription to the Medicare Australia CEO (for authorisation) by:
(a) preparing and signing the prescription:
(i) in a form approved by the Secretary, and completed in ink in the medical practitioner’s handwriting; or
(ii) in a computer-prepared form that is accordance with the form approved by the Secretary under subsubparagraph (i); or
(iii) in a computer-prepared form approved in writing for the purpose by the Secretary and in a format approved in writing by the Secretary; or
(iv) by a method approved by the Secretary in writing; or
(b) subject to paragraph 11AA, by submitting the prescription:
(i) by telephone, giving the Medicare Australia CEO the details of that prescription which has been prepared and signed in accordance with subparagraph (a); or
(ii) where the medical practitioner is seeking authorisation by telephone, and is unable to obtain authorisation due to unavailability of telephone systems, submitting the prescription according to the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
Paragraph 11AA provides that a medical practitioner may not submit a prescription for authorisation in accordance with subparagraph 11(b):
(a) for “etanercept” or “iloprost trometamol”, unless a previous prescription, which has been submitted in accordance with subparagraph 11(a) for an amount less than the maximum number of repeats allowable for a particular purpose, was authorised. Thereafter, the prescription may be submitted by telephone [in accordance with subsubparagraph 11(b)(i)] for the balance of the allowable repeats for that purpose; or
(b) for “infliximab”:
(i) unless a previous prescription has been submitted in accordance with subparagraph 11(a) and an amount less than the maximum number of repeats allowable for a particular purpose was authorised. Thereafter, the prescription may be submitted by telephone [in accordance with subsubparagraph 11(b)(i)] for the balance of the allowable repeats for that purpose; or
(ii) unless the prescription is the first prescription for continuing PBS-subsidised treatment of an adult patient with active ankylosing spondylitis immediately following a course of therapy initiating, or recommencing, PBS-subsidised treatment with infliximab, and is safe for a single dose only. In this case the prescription may be submitted by telephone [in accordance with subsubparagraph 11(b)(i)]; or
(c) for “bosentan monohyrate”:
(i) unless a previous prescription has been submitted in accordance with subparagraph 11(a) and an amount less than the maximum number of repeats allowable for a particular purpose was authorised. Thereafter, the prescription may be submitted by telephone [in accordance with subsubparagraph 11(b)(i)] for the balance of the allowable repeats for that purpose; or
(ii) unless the prescription is for the final PBS-subsidised supply. In this case the prescription may be submitted by telephone in accordance with subsubparagraph 11(b)(i).
Paragraph 11A provides that a prescription that is prepared and signed by a medical practitioner may be submitted by an employee of that medical practitioner.
Paragraph 12 provides that the Medicare Australia CEO may authorise a prescription:
(a) by signing that prescription if it was submitted in accordance with subparagraph 11(a) and:
(i) if an alteration is required by Medicare Australia, returning the prescription to the medical practitioner for alteration before it is given to the patient; or
(ii) in any other case by returning it to the medical practitioner, or sending it to the patient.
(b) orally if the prescription was submitted by telephone in accordance with subparagraph 11(b).
Paragraph 12A provides that 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 that authorised prescription; and
(b) the medical practitioner must mark the authorisation number on the prescription and retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
Paragraph 13 provides that if the prescription was submitted in accordance with subsubparagraph 11(b)(ii), the authorisation shall be deemed to be granted when the medical practitioner has completed the prescription according to instructions specified in the emergency telephone message provided by the Medicare Australia CEO.
Paragraph 14 provides that the Medicare Australia CEO may authorise a prescription for a highly specialised drug for:
(a) the supply of a quantity sufficient for up to 2 months of treatment, subject to paragraph 14A; and
(b) up to 5 repeat supplies, subject to paragraphs 14B, 14C, 14D and 15.
Paragraph 14A provides that the Medicare Australia CEO may authorise:
(a) for “bosentan monohydrate”, “clozapine”, “etanercept” and “iloprost trometamol”, a sufficient supply for one month of treatment;
(b) for “infliximab”, sufficient to provide a single dose of 3 mg per kg, based on the patient’s weight, for the treatment of adults with severe active rheumatoid arthritis;
(c) for “infliximab”, sufficient to provide 2 doses of 5 mg per kg, based the patient’s weight, for the initial treatment of adults with active ankylosing spondylitis, who have not received PBS-subsidised treatment with either etanercept or infliximab within at least the previous 5 years and have not received non-PBS subsidised treatment with infliximab prior to 1 March 2004;
(d) for “infliximab”, sufficient to provide 2 doses of 5 mg per kg, based on the patient’s weight, for initial or recommencing PBS-subsidised treatment with infliximab of adults with active ankylosing spondylitis who have received PBS-subsidised treatment with either etanercept or infliximab and who have not failed PBS-subsidised treatment with infliximab more than once;
(e) for “infliximab”, sufficient to provide a single dose of 5 mg per kg, based on the patient’s weight, for the initial PBS-subsidised treatment of adults with active ankylosing spondylitis who, at the time of application, are receiving treatment with infliximab, who were receiving treatment with infliximab prior to 1 March 2004 and who have not received prior PBS-subsidised treatment with etanercept;
(f) for “infliximab”, sufficient to provide a single dose of 5 mg per kg, based on the patient’s weight, for continuing treatment of adults with active ankylosing spondylitis who demonstrate a response to PBS-subsidised treatment with infliximab.
Paragraph 14B provides that the Medicare Australia CEO may authorise:
(a) for “etanercept”, up to 3 repeat supplies for the initial treatment of severe polyarticular course juvenile chronic arthritis;
(b) for “iloprost trometamol”, sufficient repeat supplies to allow the patient to complete 6 months duration in total of PBS-subsidised and non-PBS-subsidised treatment for primary pulmonary hypertension, pulmonary arterial hypertension secondary to connective tissue disease or drug-induced pulmonary arterial hypertension, in patients who were receiving non-PBS-subsidised treatment with iloprost trometamol for less than 6 months prior to 1 April 2005.
Paragraph 14C provides that the Medicare Australia CEO must not authorise the repeat supply of “bosentan monohydrate” except:
(a) in the case of a prescription for the balance of the 6 months of initial treatment of patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who have been issued with an authority prescription for 1 month of initial PBS-subsidised therapy, in which case up to 4 repeat supplies may be authorised;
(b) in the case of a prescription for continuing PBS-subsidised treatment of patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who have achieved a response to PBS-subsidised treatment, in which case up to 5 repeat supplies may be authorised.
Paragraph 14D provides that Medicare Australia CEO must not authorise the repeat supply of “infliximab” except:
(a) in the case of a prescription for the initial treatment of adults with severe active rheumatoid arthritis who have not received PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug for this condition within at least the previous 5 years, in which case up to 3 repeat supplies may be authorised;
(b) in the case of a prescription for the initial treatment, or recommencement of previously ceased infliximab treatment, of adults with severe active rheumatoid arthritis who have received PBS-subsidised treatment with either infliximab or another biological disease modifying anti-rheumatic drug for this condition and are eligible to receive further treatment, in which case up to 3 repeat supplies may be authorised;
(c) in the case of a prescription for the initial PBS-subsidised treatment of adults with severe active rheumatoid arthritis who were receiving treatment with infliximab prior to 1 March 2005 and who failed to qualify for PBS-subsidised treatment after 1 November 2003 due to testing negative for rheumatoid factor, in which case up to 2 repeat supplies may be authorised;
(d) in the case of a prescription for continuing treatment of adults with severe active rheumatoid arthritis who demonstrate an adequate response to PBS-subsidised treatment with infliximab, in which case up to 2 repeat supplies may be authorised;
(e) in the case of a prescription for the initial PBS-subsidised treatment of adults with active ankylosing spondylitis who, at the time of application, are receiving treatment with infliximab and who were receiving treatment with infliximab prior to 1 March 2004 and who have not received prior PBS-subsidised treatment with etanercept, in which case up to 3 repeat supplies may be authorised;
(f) in the case of a prescription (which is not a prescription for a single dose) for continuing treatment of adults with active ankylosing spondylitis who demonstrate a response to PBS-subsidised treatment with infliximab, in which case up to 3 repeat supplies may be authorised.
Paragraph 15 provides that the Medicare Australia CEO must not authorise the repeat supply of a highly specialised drug 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.
Paragraph 16 provides that regulation 24 of the Regulations applies to the supply of highly specialised drugs as if the quantity or number of units of the highly specialised drug authorised by the Medicare Australia CEO under paragraph 14 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.
Paragraph 17 provides that regulation 25 of the Regulations applies to the supply of highly specialised drugs as if highly specialised drugs were pharmaceutical benefits in relation to which the Minister determines, under paragraph 85A(2)(b) of the Act, that the maximum number of occasions on which the supply of the benefit may, in one prescription, be directed to be repeated is more than 4.
Paragraph 18 provides that highly specialised drugs may be supplied by:
(i) an approved pharmacist; or
(ii) by an approved hospital authority, to a patient receiving treatment at the hospital of which it is the governing body or proprietor;
but not by an approved medical practitioner
Paragraph 19 provides that an approved pharmacist or an approved hospital authority may charge the person to whom a highly specialised drug has been supplied an amount equal to that which may be charged under section 87 of the Act for the supply of a pharmaceutical benefit.
Paragraph 19A provides that, in addition to the amount charged under paragraph 19, an approved pharmacist or an approved hospital authority which supplies a highly specialised drug which is :
(i) specified in column 1 of Schedule 4; and
(ii) in the form specified in column 2 of Schedule 4; and
(iii) marketed under the brand specified in column 3 of Schedule 4; and
(iv) in the quantity specified in column 4 of Schedule 4;
may charge the person, to whom the highly specialised drug is supplied, the amount calculated by subtracting the amount specified in column 5 of Schedule 4 from the amount specified in column 6 of Schedule 4 for that highly specialised drug.
Paragraph 20 provides that an approved pharmacist or an approved hospital authority that has supplied a highly specialised drug is entitled to be paid by the Commonwealth the amount by which the dispensed price exceeds the amount that the approved hospital authority was entitled to charge under paragraph 19.
Paragraph 21 provides that the dispensed price of a highly specialised drug will be ascertained in accordance with paragraphs 22 to 28.
Paragraph 22 provides that the dispensed price for the supply of a highly specialised drug will be:
(a) where a quantity ordered and supplied is equal to the quantity contained in the manufacturer’s pack, the sum of:
(i) the price ex manufacturer of the manufacturer’s pack, plus mark-up as specified in paragraph 23, taken to the nearest cent, one half cent being counted as one cent; and
(ii) a dispensing fee equal to the dispensing fee for the supply of a ready-prepared pharmaceutical benefit, specified in the determination under paragraph 98B(1)(a) of the Act that is in force at the time of supply; or
(b) where a quantity ordered and supplied is less than the quantity contained in the manufacturer’s pack, the sum of:
(i) the amount calculated in accordance with paragraph 24; and
(ii) a dispensing fee equal to the dispensing fee for the supply of a ready-prepared pharmaceutical benefit, specified in the determination under paragraph 98B(1)(a) of the Act that is in force at the time of supply of the highly specialised drug; or
(c) where a quantity ordered and supplied is more than the quantity contained in the manufacturer’s pack, the sum of:
(i) the price ex manufacturer, plus mark-up as specified in paragraph 23, taken to the nearest cent, one half cent being counted as one cent, for each complete manufacturer’s pack contained in the quantity supplied; and
(ii) the amount calculated in accordance with paragraph 24 in respect of that remainder, if any, of the quantity supplied that is less than the quantity contained in the manufacturer’s pack, as applicable; and
(iii) a dispensing fee equal to the dispensing fee for the supply of a ready-prepared pharmaceutical benefit, specified in the determination under paragraph 98B(1)(a) of the Act that is in force at the time of supply of the highly specialised drug.
Paragraph 23 provides that the mark-up for a highly specialised drug will be:
(a) 10 per cent, where the price ex manufacturer for the manufacturer’s pack is not more than $40.00; or
(b) $4.00, where the price ex manufacturer for the manufacturer’s pack is more than $40.00 but not more than $100.00; or
(c) 4 per cent, where the price ex manufacturer for the manufacturer’s pack is more than $100.00.
Paragraph 24 provides that if a quantity of a highly specialised drug that is ordered and supplied is less than that contained in the manufacturer’s pack, the amount referred to in subsubparagraph 22(b)(i) or 22(c)(ii) is calculated by:
(a) adding the mark-up as specified in paragraph 23 to the price ex manufacturer for the manufacturer’s pack and taking the result to the nearest cent, one half cent being counted as one cent; and
(b) 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
(c) taking that percentage, ascertained in accordance with subparagraph (b), of the amount worked out in accordance with subparagraph (a).
Paragraph 25 provides that the dispensed price for the supply of a highly specialised drug will in each case be taken to the nearest cent, one half cent being counted as one cent.
Paragraph 26 provides that the dispensed price for the supply of a quantity of a highly specialised drug will not exceed the dispensed price for a greater quantity of that highly specialised drug.
Paragraph 27 provides that where a prescription specifies a quantity of one of the highly specialised drugs referred to in paragraph 10 (the complete pack of which will be supplied regardless of any lesser quantity ordered), the dispensed price will be calculated on the basis that the complete pack was supplied.
Paragraph 28 provides that where, in accordance with paragraph 27, a medical practitioner, instead of directing a repeated supply of a highly specialised drug, directs the supply on one occasion of a quantity not exceeding the total quantity that could be prescribed if the medical practitioner directed a repeated supply, the dispensed price for that supply will include only one dispensing fee.
Paragraph 29 provides that where 2 or more brands are specified in column 4 of Schedule 2 for a particular highly specialised drug, the dispensed price will be based on the price ex manufacturer of the brand which has the lowest dispensed price.
Schedule 1 to the Arrangements lists those drugs and medicinal preparations that are highly specialised drugs when prescribed by a medical practitioner for the circumstances specified.
Schedule 2 to the Arrangements lists the forms (strength, type, size etc), the manner of administration and the brands of those drugs and medicinal preparations that are highly specialised drugs when prescribed by a medical practitioner for the circumstances specified in Schedule 1.
Schedule 3 to the Arrangements lists those highly specialised drugs the complete pack of which shall be supplied regardless of any lesser quantity ordered in the prescription.
Schedule 4 to the Arrangements lists those highly specialised drugs to which paragraph 19A of these Arrangements applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay (Commonwealth price) and the price to pharmacist that the manufacturer requires.