Entitlement to receive highly specialiseEntitlement to receive highly specialised drugs under these Arrangements

Entitlement to receive highly specialised drugs under these Arrangements

3. 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.

4. The special pharmaceutical products to which these Arrangements apply are the highly specialised drugs specified in column 1 of Schedule 1.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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="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="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="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="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="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="font-size:10pt"><span>AB</span></p><p class="tNormal" style="font-size:10pt"><span>AN</span></p><p class="tNormal" style="font-size:10pt"><span>AP</span></p><p style="font-size:10pt"><span>AT</span></p><p style="font-size:10pt"><span></span></p><p style="font-size:10pt"><span>BQ</span></p><p style="font-size:10pt"><span></span></p><p style="font-size:10pt"><span></span></p><p style="font-size:10pt"><span>BU</span></p><p style="font-size:10pt"><span></span></p><p style="font-size:10pt"><span>BY</span></p><p style="font-size:10pt"><span>GI</span></p><p style="font-size:10pt"><span>GK</span></p><p style="font-size:10pt"><span>HX</span></p><p style="font-size:10pt"><span>IS</span></p><p style="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="font-size:10pt"><span>Abbott Australasia Pty Ltd</span></p><p class="tNormal" style="font-size:10pt"><span>Amgen Australasia Pty Ltd</span></p><p class="tNormal" style="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="font-size:10pt"><span>Bausch &amp; Lomb A Division of Bausch &amp; Lomb (</span><span>Australia</span><span>) Pty Ltd</span></p><p style="font-size:10pt"><span>Boehringer Ingelheim Pty Limited</span></p><p style="font-size:10pt"><span>Gilead Sciences Pty Ltd</span></p><p style="font-size:10pt"><span>GlaxoSmithKline Australia Pty Ltd</span></p><p style="font-size:10pt"><span>Hexal Australia Pty Ltd</span></p><p style="font-size:10pt"><span>Ipsen Pty Ltd</span></p><p style="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="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="font-size:10pt"><span>MK</span></p><p style="font-size:10pt"><span>MX</span></p><p class="tNormal" style="font-size:10pt"><span>NV</span></p><p style="font-size:10pt"><span></span></p><p class="tNormal" style="font-size:10pt"><span>OA</span></p><p class="tNormal" style="font-size:10pt"><span>PF</span></p><p style="font-size:10pt"><span>PI</span></p><p style="font-size:10pt"><span>PU</span></p><p style="font-size:10pt"><span></span></p><p class="tNormal" style="font-size:10pt"><span>PS</span></p><p class="tNormal" style="font-size:10pt"><span>RO</span></p><p style="font-size:10pt"><span>SC</span></p><p style="font-size:10pt"><span>SH</span></p><p class="tNormal" style="font-size:10pt"><span>WY</span></p><p style="font-size:10pt"><span></span></p><p class="tNormal" style="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="font-size:10pt"><span>Merck Sharp &amp; Dohme (</span><span>Australia</span><span>) Pty Ltd</span></p><p style="font-size:10pt"><span>Mayne Pharma Pty Ltd</span></p><p class="tNormal" style="font-size:10pt"><span>Novartis Pharmaceuticals Australia Pty Ltd</span></p><p class="tNormal" style="font-size:10pt"><span>Orphan Australia Pty Ltd</span></p><p class="tNormal" style="font-size:10pt"><span>Pfizer Pty Limited</span></p><p style="font-size:10pt"><span>Pharmion Pty Ltd</span></p><p style="font-size:10pt"><span>Pharmacia Products Pharmacia &amp; Upjohn Pty Limited</span></p><p class="tNormal" style="font-size:10pt"><span>Pharmacia &amp; Upjohn Pty Limited</span></p><p class="tNormal" style="font-size:10pt"><span>Roche Products Pty Ltd</span></p><p style="font-size:10pt"><span>Schering Pty Ltd</span></p><p style="font-size:10pt"><span>Schering-Plough Pty Ltd</span></p><p class="tNormal" style="font-size:10pt"><span>Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited</span></p><p style="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="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="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="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="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="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="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="font-size:10pt"><span></span></p></td></tr></tbody></table>

10. 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

11. 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” and “iloprost trometamol”, 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 “infliximab”:

(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 the first prescription for continuing PBS-subsidised treatment for an adult patient with active ankylosing spondylitis immediately following a course of therapy initiating, or recommencing, PBS-subsidised treatment with infliximab, and is for a single dose only. 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 “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

12. 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.

13. 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.

14. 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 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” and “iloprost trometamol”, 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 in accordance with the circumstances specified in Schedule 1, 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 severe active psoriatic arthritis in accordance with the circumstances specified in Schedule 1, 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 adults with active ankylosing spondylitis in accordance with the circumstances specified in Schedule 1 which permit a course of up to a maximum of 6 weeks of treatment to be authorised, 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 2 doses of 5 mg per kg;

(e) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with active ankylosing spondylitis 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, 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 “epoprostenol sodium” for the initial PBS-subsidised treatment of patients with primary pulmonary hypertension who were receiving non-PBS-subsidised treatment with epoprostenol sodium for less than 6 months prior to 1 August 2006, 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.

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.

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

(a) in the case of a prescription 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;

(b) in the case of a prescription 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;

(c) in the case of a prescription 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;

(d) in the case of a prescription 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;

(e) in the case of a prescription for the treatment of adults with active ankylosing spondylitis 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 3 repeat supplies of the highly specialised drug.

15. 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.

16. 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.

17. 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.