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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This instrument establishes the Highly Specialised Drugs (HSD) Program within Australia’s PBS, setting the framework for how certain high-cost, clinically sensitive medicines are prescribed, authorised, dispensed, and paid for when supplied to non-admitted or day patients (including discharged patients) at private hospitals.
It affects eligible Medicare patients, prescribing medical practitioners, approved pharmacists and hospital suppliers, and Services Australia — ensuring access to subsidised, tightly controlled treatment for conditions like HIV/AIDS and serious autoimmune and rare diseases.
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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 35 of 2005).
(b) The Arrangements made on 26 July 2005 with effect from 1 August 2005 (No. PB 21 of 2005) are repealed with effect from the commencement of these Arrangements.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;
(c) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
(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
saquinavir mesylate
stavudine
stavudine with water - purified BP
tenofovir disoproxil fumarate
valaciclovir hydrochloride
valganciclovir hydrochloride
zalcitabine
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.
(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="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 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></td><td 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></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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>JC</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Janssen-Cilag Pty Ltd</span></p></td></tr><tr><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AN</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Amgen Australasia 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 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></td><td 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 & Dohme (</span><span>Australia</span><span>) Pty Ltd</span></p></td></tr><tr><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AP</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AstraZeneca 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>MX</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Mayne Pharma Pty Ltd</span></p></td></tr><tr style="height:12pt"><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>AT</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Actelion Pharmaceuticals Australia Pty Ltd</span></p></td><td rowspan="2" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>NV</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Novartis Pharmaceuticals Australia Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>OA</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Orphan Australia Pty Ltd</span></p></td></tr><tr style="height:12.75pt"><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BQ</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd</span></p></td><td rowspan="2" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>PF</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Pfizer Pty Limited</span></p></td></tr><tr style="height:9.75pt"><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>PU</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Pharmacia Products Pharmacia & Upjohn Pty Limited</span></p></td></tr><tr><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BU</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Bausch & Lomb A Division of Bausch & Lomb (</span><span>Australia</span><span>) Pty Ltd</span></p></td><td rowspan="3" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>PS</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Pharmacia & Upjohn Pty Limited</span></p></td></tr><tr><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>RO</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Roche Products Pty Ltd</span></p></td></tr><tr><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BY</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Boehringer Ingelheim Pty Limited</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>SC</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Schering Pty Ltd</span></p></td></tr><tr style="height:9.75pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>GI</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Gilead Sciences Pty Ltd</span></p></td><td rowspan="2" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>SH</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Schering-Plough Pty Ltd</span></p></td></tr><tr style="height:13.5pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>GK</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>GlaxoSmithKline Australia Pty Ltd</span></p></td><td rowspan="3" style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><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="3" style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><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 style="height:11.65pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>HX</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Hexal Australia Pty Ltd</span></p></td><td rowspan="2" 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:11.6pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>IS</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Ipsen Pty Limited</span></p></td></tr></tbody></table>
Prescriptions for highly specialised drugs
(a) by preparing and signing a prescription for the highly specialised drug:
(i) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
(ii) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubparagraph (i); or
(iii) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(iv) by a method approved in writing by the Secretary; or
(b) subject to paragraph 11AA, by submitting the prescription:
(i) by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subparagraph (a); or
(ii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (i) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
11AA. A medical practitioner may not submit a prescription to the Medicare Australia CEO in accordance with subparagraph 11(b):
(a) in the case of the highly specialised drugs “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
(a) if the prescription was submitted in accordance with subparagraph 11(a) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
(ii) in any other case:
(A) by returning it to the medical practitioner; or
(B) by sending it to the person in respect of whom it was prepared; or
(b) if the prescription was submitted in accordance with subparagraph 11(b) — orally, at the time the Medicare Australia CEO is given details of the prescription.
12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(b):
(a) the Medicare Australia CEO must tell the medical practitioner the number that has been allotted to the authorised prescription; and
(b) the medical practitioner must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(b)(ii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
In authorising a prescription for a highly specialised drug under paragraph 12, the Medicare Australia CEO may authorise:
(a) subject to paragraph 14A, the supply of a quantity of number of units of the highly specialised drug sufficient for up to 2 months’ treatment with the highly specialised drug; and
(b) subject to paragraphs 14B, 14C, 14D 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”, “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, 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 initial treatment of adults with active ankylosing spondylitis who have not received treatment with either etanercept or infliximab for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS) within at least the previous 5 years and have not received non-PBS-subsidised treatment with infliximab prior to 1 March 2004, 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;
(d) in the case of a prescription for the highly specialised drug “infliximab” for initial, or recommencement of, PBS-subsidised treatment with infliximab of adults with active ankylosing spondylitis who have received PBS-subsidised treatment with either etanercept or infliximab for this condition and have not failed PBS-subsidised treatment with infliximab more than once, 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 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, 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;
(f) in the case of a prescription for the highly specialised drug “infliximab” for continuing treatment of adults with active ankylosing spondylitis who demonstrate a response to PBS-subsidised treatment with infliximab, 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 “iloprost trometamol” for the initial PBS-subsidised treatment of patients with primary pulmonary hypertension, pulmonary arterial hypertension secondary to connective tissue disease or drug-induced pulmonary arterial hypertension who were receiving non-PBS-subsidised treatment with iloprost trometamol for less than 6 months prior to 1 April 2005, 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 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, 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 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, up to 3 repeat supplies of the highly specialised drug 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, up to 3 repeat supplies of the highly specialised drug 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, up to 2 repeat supplies of the highly specialised drug 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, up to 2 repeat supplies of the highly specialised drug 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, up to 3 repeat supplies of the highly specialised drug may be authorised;
(f) in the case of a prescription for continuing treatment of adults with active ankylosing spondylitis who demonstrate a response to PBS-subsidised treatment with infliximab (and which is not a prescription for a single dose), up to 3 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.
(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.
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.
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
(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 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.
(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.
(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 twenty third day of November 2005.
JOAN CORBETT
Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
Form (strength, type, size, etc.)
Relevant quantity or number of units
Commonwealth Price
Price claimed by manufacturer
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(b) The Arrangements made on 26 July 2005 with effect from 1 August 2005 (No. PB 21 of 2005) are repealed with effect from the commencement of 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;
(c) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
(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
saquinavir mesylate
stavudine
stavudine with water - purified BP
tenofovir disoproxil fumarate
valaciclovir hydrochloride
valganciclovir hydrochloride
zalcitabine
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.
(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="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 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></td><td 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></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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>JC</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Janssen-Cilag Pty Ltd</span></p></td></tr><tr><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AN</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Amgen Australasia 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 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></td><td 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 & Dohme (</span><span>Australia</span><span>) Pty Ltd</span></p></td></tr><tr><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AP</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>AstraZeneca 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>MX</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Mayne Pharma Pty Ltd</span></p></td></tr><tr style="height:12pt"><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>AT</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Actelion Pharmaceuticals Australia Pty Ltd</span></p></td><td rowspan="2" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>NV</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Novartis Pharmaceuticals Australia Pty Ltd</span></p></td></tr><tr style="height:11.25pt"><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>OA</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Orphan Australia Pty Ltd</span></p></td></tr><tr style="height:12.75pt"><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BQ</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd</span></p></td><td rowspan="2" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>PF</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Pfizer Pty Limited</span></p></td></tr><tr style="height:9.75pt"><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>PU</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Pharmacia Products Pharmacia & Upjohn Pty Limited</span></p></td></tr><tr><td rowspan="2" style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BU</span></p></td><td rowspan="2" style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Bausch & Lomb A Division of Bausch & Lomb (</span><span>Australia</span><span>) Pty Ltd</span></p></td><td rowspan="3" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>PS</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Pharmacia & Upjohn Pty Limited</span></p></td></tr><tr><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>RO</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tNormal" style="font-size:10pt"><span>Roche Products Pty Ltd</span></p></td></tr><tr><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>BY</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Boehringer Ingelheim Pty Limited</span></p></td><td style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>SC</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Schering Pty Ltd</span></p></td></tr><tr style="height:9.75pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>GI</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Gilead Sciences Pty Ltd</span></p></td><td rowspan="2" 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 style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>SH</span></p></td><td style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>Schering-Plough Pty Ltd</span></p></td></tr><tr style="height:13.5pt"><td style="width:30.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>GK</span></p></td><td style="width:159.3pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="font-size:10pt"><span>GlaxoSmithKline Australia Pty Ltd</span></p></td><td rowspan="3" style="width:31.75pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><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="3" style="width:173.45pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><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 style="height:11.65pt"><td style="width:3
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