Commonwealth legislation

National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Highly Specialised Drugs Program (No. PB 16 of 2007)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

8/10 complexity

These Arrangements update the Highly Specialised Drugs Program under the National Health Act 1953, commencing 1 March 2007 and repealing prior arrangements (para 1). They set which named specialised medicines can be supplied to eligible Medicare patients treated at private hospitals, the clinical circumstances and brands covered, how prescriptions are authorised and repeated, what patients may be charged, and how suppliers are paid. Mechanically, the instrument allocates administrative authority to Medicare Australia and defines pricing, repeat limits and recordkeeping that determine who pays and when treatment is subsidised.

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Current sections

Direct links to the current provisions in National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Highly Specialised Drugs Program (No. PB 16 of 2007).

Commencement

(a) These Arrangements commence on 1 March 2007.

(b) The Arrangements made on 7 November 2006 with effect from 1 December 2006 (No. PB 51 of 2006), as amended on 5 January 2007 with effect from 1 February 2007 (No. PB 10 of 2007), are repealed with effect from the commencement of these Arrangements.

Definitions

In these Arrangements:

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

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

(d) “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;

(e) “highly specialised drug” means a special pharmaceutical product in relation to which, by virtue of paragraphs 4, 7 and 9, these Arrangements apply;

(f) “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;

(g) “medication for the treatment of HIV or AIDS” means any of the following highly specialised drugs:

abacavir sulfate

abacavir sulfate with lamivudine

abacavir sulfate with lamivudine and zidovudine

amprenavir

atazanavir sulfate

azithromycin dihydrate

cidofovir

clarithromycin

delavirdine mesylate

didanosine

doxorubicin hydrochloride, pegylated liposomal

efavirenz

emtricitabine

enfuvirtide

fosamprenavir calcium

foscarnet sodium

ganciclovir

ganciclovir sodium

indinavir sulfate

lamivudine (tablet 150 mg, tablet 300 mg or oral solution 10 mg per mL, 240 mL)

lamivudine with zidovudine

lopinavir with ritonavir

nelfinavir mesylate

nevirapine

rifabutin

ritonavir

saquinavir mesylate

stavudine

stavudine with water - purified BP

tenofovir disoproxil fumarate

tenofovir disoproxil fumarate with emtricitabine

valaciclovir hydrochloride

valganciclovir hydrochloride

zidovudine

(h) “private hospital” has the same meaning as in subsection 3(1) of the Health Insurance Act 1973;

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

Entitlement to receive highly specialise

Entitlement to receive highly specialised drugs under these Arrangements

Subject to these Arrangements, a person who:

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

(b) is receiving medical treatment by a medical practitioner 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.
The name of the manufacturer or the names of the manufacturers denoted in accordance with the following table by letters specified in column 4 of Schedule 2 in relation to a special pharmaceutical product is or are the brand or brands under which the special pharmaceutical product may be supplied as a highly specialised drug, and these Arrangements do not apply to the special pharmaceutical product as marketed under any other brand:

<table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><tbody><tr><td style="width:30.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span style="font-style:italic">Letters</span></p></td><td style="width:159.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span style="font-style:italic">Manufacturer’s Name</span></p></td><td style="width:10.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span style="font-style:italic"></span></p></td><td style="width:31.75pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span style="font-style:italic">Letters</span></p></td><td style="width:173.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span style="font-style:italic">Manufacturer’s Name</span></p></td></tr><tr><td rowspan="8" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>AB</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>AN</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>AP</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>AT</span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p style="widows:0; orphans:0; font-size:10pt"><span>BQ</span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p style="widows:0; orphans:0; font-size:10pt"><span>BU</span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p style="widows:0; orphans:0; font-size:10pt"><span>BY</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>GI</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>GK</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>HX</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>IS</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>JC</span></p></td><td rowspan="8" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Abbott Australasia Pty Ltd</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Amgen Australasia Pty Ltd</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>AstraZeneca Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Actelion Pharmaceuticals </span><span>Australia</span><span></span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Bausch &amp; Lomb A Division of Bausch &amp; Lomb (</span><span>Australia</span><span>) Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Boehringer Ingelheim Pty Limited</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Gilead Sciences Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>GlaxoSmithKline Australia Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Hexal Australia Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Ipsen Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Janssen-Cilag Pty Ltd</span></p></td><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td><td rowspan="8" style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>MK</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>MX</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>NV</span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>OA</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>PF</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>PI</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>PU</span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>PS</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>RO</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>SC</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>SH</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>WY</span></p><p style="widows:0; orphans:0; font-size:10pt"><span></span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>ZT</span></p></td><td rowspan="8" style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Merck Sharp &amp; Dohme (</span><span>Australia</span><span>) Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Mayne Pharma Pty Ltd</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Novartis Pharmaceuticals Australia Pty Ltd</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Orphan Australia Pty Ltd</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Pfizer Pty Limited</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Pharmion Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Pharmacia Products Pharmacia &amp; Upjohn Pty Limited</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Pharmacia &amp; Upjohn Pty Limited</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Roche Products Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Schering Pty Ltd</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Schering-Plough Pty Ltd</span></p><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span>Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited</span></p><p style="widows:0; orphans:0; font-size:10pt"><span>Synthon AU Pty Ltd</span></p></td></tr><tr><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr><tr><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr><tr style="height:11.25pt"><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr><tr style="height:32.55pt"><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr><tr style="height:11.25pt"><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr><tr style="height:23.8pt"><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr><tr style="height:23.8pt"><td style="width:10.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="widows:0; orphans:0; font-size:10pt"><span></span></p></td></tr></tbody></table>

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 medical practitioner who wishes to prescribe a highly specialised drug must submit to the Medicare Australia CEO a prescription for the supply of the highly specialised drug:

(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 “epoprostenol sodium”, “etanercept”, “iloprost trometamol”, “infliximab” and “sildenafil citrate”, 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 monohydrate”:

(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).

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

Subject to paragraph 13, the authorisation of a prescription for a highly specialised drug may be made:

(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 and 15, up to 5 repeat supplies.

14A. The Medicare Australia CEO may authorise:

(a) in the case of the highly specialised drugs “bosentan monohydrate”, “clozapine”, “epoprostenol sodium”, “etanercept”, “iloprost trometamol” and “sildenafil citrate”, 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 or with severe active psoriatic 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 5 mg per kg.

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 “sildenafil citrate” 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 sildenafil citrate for less than 6 months prior to 1 March 2007, 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 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;

(f) 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 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;

(g) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with active ankylosing spondylitis, up to 3 repeat supplies of the highly specialised drug.

14C. The Medicare Australia CEO must not authorise the supply of the highly specialised drug “bosentan monohydrate” to be repeated except in the following situations:

(a) in the case of a prescription for the balance of a 6 month course of initial PBS-subsidised treatment of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma for patients who have been issued with an authority prescription for the first month of the 6 month course, up to 4 repeat supplies of the highly specialised drug 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, up to 5 repeat supplies of the highly specialised drug may be authorised.

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

Supplier of highly specialised drugs und

Supplier of highly specialised drugs under these Arrangements

Highly specialised drugs may be supplied:

(i) by 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.

Cost to patient of highly specialised dr

Cost to patient of highly specialised drugs under these Arrangements

An approved pharmacist or an approved hospital authority who supplies a highly specialised drug may charge the person to whom the highly specialised drug is supplied an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the person.

19A. In addition to the amount that may be charged by an approved pharmacist or an approved hospital authority under paragraph 19, an approved pharmacist or an approved hospital authority who supplies a highly specialised drug which is:

(i) named in column 1 of Schedule 4;

(ii) in the form specified in column 2 of Schedule 4 in relation to that highly specialised drug;

(iii) marketed under the brand specified in column 3 of Schedule 4 in relation to that highly specialised drug; and

(iv) in the quantity or number of units specified in column 4 of Schedule 4 in relation to that highly specialised drug;

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 in relation to that highly specialised drug from the amount specified in column 6 of Schedule 4 in relation to that highly specialised drug.

Payment to supplier of highly specialise

Payment to supplier of highly specialised drugs under these Arrangements

An approved pharmacist or an approved hospital authority who has supplied a highly specialised drug is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the highly specialised drug exceeds the amount that the approved pharmacist or approved hospital authority was entitled to charge under paragraph 19.
The dispensed price for the supply of a highly specialised drug will be ascertained in accordance with paragraphs 22 to 28.
The dispensed price for the supply of a highly specialised drug will be —

(a) where a quantity of a highly specialised drug that is 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 of the highly specialised drug; or

(b) where a quantity of a highly specialised drug that is 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

(c) where a quantity of a highly specialised drug that is 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.

The mark-up will be —

(a) 10 per cent, where the price ex manufacturer for the manufacturer’s pack is less than $40.00;

(b) $4.00, where the price ex manufacturer for the manufacturer’s pack is between $40.00 and $100.00 inclusive;

(c) 4 per cent, where the price ex manufacturer for the manufacturer’s pack is between $100.01 and $1000.00 inclusive; and

(d) $40.00 where the price ex-manufacturer for the manufacturer’s pack is greater than $1000.00.

Where a quantity of a highly specialised drug that is ordered and supplied is less than the quantity contained in the manufacturer’s pack (that is, a broken quantity), the amount referred to in subsubparagraph 22(b)(i) or 22(c)(ii) will be 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).

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.
Notwithstanding anything contained elsewhere in these Arrangements, 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.
Where a prescription specifies a quantity of one of the highly specialised drugs referred to in paragraph 10 as being a highly specialised drug 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.
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 or number of units of the highly specialised drug, not exceeding the total quantity or number of units that could be prescribed if the medical practitioner directed a repeated supply, the dispensed price for the supply of that highly specialised drug will include only one dispensing fee.
Where there are 2 or more brands specified in column 4 of Schedule 2 in relation to a highly specialised drug, the dispensed price will be based on the price ex manufacturer of the brand of the highly specialised drug for which the dispensed price for the supply of the highly specialised drug is lowest.

Dated this 14th day of February 2007.

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing

Atazanavir Sulfate

Fosamprenavir Calcium

(1) have a documented history of severe

(1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and

(4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and

(5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

- elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

- shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (3) develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 22 weeks of treatment;

if less than 22 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete 22 weeks of uninterrupted therapy may be submitted by telephone

Initial treatment, or recommencement of treatment, with infliximab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and

(3) have not failed treatment with infliximab during the current Treatment Cycle; and

where biological agent means adalimumab or etanercept or infliximab; and

where the following conditions apply:

patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with infliximab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with infliximab, to their most recent course of PBS-subsidised infliximab treatment; and

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 22 week initial treatment course; and

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 22 weeks of treatment;

Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of infliximab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

(2) were receiving treatment with infliximab prior to 16 March 2006; and

(3) have demonstrated a response to infliximab treatment as specified in the criteria for continuing PBS-subsidised treatment with infliximab; and

(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where the following conditions apply:

the course of treatment is limited to a maximum of 24 weeks of treatment;

if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete 24 weeks of uninterrupted therapy may be submitted by telephone;

patients are eligible for PBS-subsidised treatment under the above criteria once only

Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:

(1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and

(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with infliximab; and

(3) who, at the time of application, demonstrate an adequate response to treatment with infliximab; and

where biological agent means adalimumab or etanercept or infliximab; and

where the following conditions apply:

an adequate response to treatment with infliximab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

- elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with infliximab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of infliximab therapy was a 22 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment;

(2) have received prior PBS-subsidised t