National Health Act 1953 Arrangements made under subparagraph 100(1)(b)(i) Highly Specialised Drugs Program (No. PB 25 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)

HIGHLY SPECIALISED DRUGS PROGRAM

No. PB 25 of 2007

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge:

Commencement

1. (a) These Arrangements commence on 1 April 2007.

(b) The Arrangements made on 14 February 2007 with effect from 1 March 2007 (No. PB 16 of 2007) are repealed with effect from the commencement of these Arrangements.

Definitions

2. 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;

(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

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.

Entititlement 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.

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:

Letters	Manufacturer's Name
AB	Abbott Australasia Pty Ltd
AN	Amgen Australasia Pty Ltd
AP	AstraZeneca Pty Ltd
AT	Actelion Pharmaceuticals Australia Pty Ltd
BQ	Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd
BU	Bausch & Lomb A Division of Bausch & Lomb (Australia) Pty Ltd
BY	Boehringer Ingelheim Pty Limited
GI	Gilead Sciences Pty Ltd
GK	GlaxoSmithKline Australia Pty Ltd
HX	Hexal Australia Pty Ltd
IS	Ipsen Pty Ltd
JC	Janssen-Cilag Pty Ltd
MK	Merck Sharp & Dohme (Australia) Pty Ltd
MX	Mayne Pharma Pty Ltd
NV	Novartis Pharmaceuticals Australia Pty Ltd
OA	Orphan Australia Pty Ltd
PF	Pfizer Pty Limited
PI	Pharmion Pty Ltd
PU	Pharmacia Products Pharmacia & Upjohn Pty Limited
PS	Pharmacia & Upjohn Pty Limited
RO	Roche Products Pty Ltd
SC	Schering Pty Ltd
SH	Schering-Plough Pty Ltd
WY	Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited
ZT	Synthon AU Pty Ltd

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", "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

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 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 arthiritis 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 arthiritis 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 arthiritis 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 arthiritis 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.

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.

Supplier of highly specialised drugs under these Arrangements

18. 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 drugs under these Arrangements

19. 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 specialised drugs under these Arrangements

20. 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.

21. The dispensed price for the supply of a highly specialised drug will be ascertained in accordance with paragraphs 22 to 28.

22. 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.

23. 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.

24. 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).

25. 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.

26. 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.

27. 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.

28. 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.

29. 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 12 day of March 2007.

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing

Abacavir Sulfate	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Abacavir Sulfate with Lamivudine	Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Abacavir Sulfate with Lamivudine and Zidovudine	Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Adefovir Dipivoxil	Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria: (1) Repeatedly elevated (greater than 1.2 times the upper limit of normal) serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or serum HBV DNA positive)
(2) Female patients of childbearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Patients receiving treatment with adefovir dipivoxil subsidised under the Pharmaceutical Benefits Scheme (PBS) must receive that treatment as monotherapy, except in the following circumstances:
(i) patients who are not immunocompromised may receive concomitant treatment with lamivudine for the initial 3 months of PBS-subsidised adefovir dipivoxil therapy
(ii) patients who are immunocompromised may receive concomitant treatment with lamivudine for the initial 12 months of PBS-subsidised adefovir dipivoxil therapy
Apomorphine Hydrochloride	Parkinson's disease in patients severely disabled by motor fluctuations which do not respond to other therapy
Atazanavir Sulfate	Treatment, in combination with 2 or more other antiretroviral drugs, of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Azithromycin Dihydrate	Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus-positive patients with CD4 cell counts of less than 75 per cubic millimetre
Baclofen	Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity: (1) of cerebral origin; or
(2) due to multiple sclerosis; or
(3) due to spinal cord injury; or
(4) due to spinal cord disease
Bosentan Monohydrate	Initial treatment, for up to six months, of adult patients who have not received prior treatment with iloprost trometamol, epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and:
(a) who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension, and a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or
(b) who have been assessed by a physician from a designated hospital to have WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma, and a mean right atrial pressure of 8 mmHg or less as measured by RHC unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient is being commenced on bosentan monohydrate treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the first supply authorised under this criterion is limited to the provision of a quantity of the
62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with iloprost trometamol, epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds; or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; or
(c) WHO Functional Class IV primary pulmonary hypertension; or
(d) WHO Functional Class IV pulmonary arterial hypertension secondary to scleroderma; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the first supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS), who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, normal right ventricular function as assessed by echocardiography (ECHO), and who have failed to respond to 6 or more weeks of appropriate prior vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient is being commenced on bosentan monohydrate treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the first supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either a mean right atrial pressure greater than 8 mmHg as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular dysfunction as assessed by echocardiography (ECHO); or
(b) WHO Functional Class IV primary pulmonary hypertension; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the first supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of adult patients:
(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, who wish to re-commence bosentan monohydrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or
(b) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with iloprost trometamol or sildenafil citrate; or
(c) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which the first authorisation for PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate, whichever was initiated first, was granted; and
(2) the date of the first application which resulted in approval for PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate, whichever was initiated first; and
(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate;
the first supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients aged less than 18 years:
(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence bosentan monohydrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or
(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium or sildenafil citrate; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which the first authorisation for PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first, was granted; and
(2) the date of the first application which resulted in approval for PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first; and
(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised bosentan monohydrate, epoprostenol sodium or sildenafil citrate;
the first supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Continuing PBS-subsidised treatment, for up to 6 months, of patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, who have received approval for initial PBS-subsidised treatment with bosentan monohydrate and have completed the initial treatment course, and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of bosentan monohydrate treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Final PBS-subsidised supply to allow for gradual cessation of treatment for patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, who have not responded to bosentan monohydrate therapy; and
where the following conditions apply:
the authority application is submitted by telephone;
the supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient to allow gradual dose reduction over a period of 1 month and no longer
For the purpose of PBS-subsidised supply of bosentan monohydrate for the circumstances specified above:
Primary pulmonary hypertension and pulmonary arterial hypertension secondary to scleroderma are defined as:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
Response to bosentan monohydrate or prior vasodilator treatment is defined:
(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iv) for patients aged less than 18 years – as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital
Cidofovir	Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome
Clarithromycin	Treatment of Mycobacterium avium complex infections
Clozapine	Schizophrenia in patients who are: (a) non-responsive to other neuroleptic agents; or
(b) intolerant of other neuroleptic agents
Cyclosporin	In respect of the solution concentrate for I.V. infusion 50 mg in 1 mL ampoule and solution concentrate for I.V. infusion 250 mg in 5 mL ampoule: For use by organ or tissue transplant recipients In respect of the capsule 10 mg, capsule 25 mg, capsule 50 mg, capsule 100 mg and oral liquid 100 mg per mL, 50 mL: Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit, where management includes initiation, stabilisation and review of therapy as required Management, which includes initiation, stabilisation and review of therapy, by: (1) dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate (2) dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life (3) nephrologists of nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired (4) rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate
Darbepoetin Alfa	Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia
Deferasirox	Chronic iron overload in adults, adolescents and children 6 years and older associated with disorders of erythropoiesis Chronic iron overload in paediatric patients aged 2 to 5 years, associated with disorders of erythropoiesis, who are intolerant to desferrioxamine mesylate or in whom desferrioxamine mesylate has proven ineffective
Deferiprone	Iron overload in patients with thalassaemia major who are unable to take desferrioxamine mesylate therapy Iron overload in patients with thalassaemia major in whom desferrioxamine mesylate therapy has proven ineffective
Delavirdine Mesylate	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Desferrioxamine Mesylate	Disorders of erythropoiesis associated with treatment-related chronic iron overload
Didanosine	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Disodium Pamidronate	In respect of the concentrated injection 15 mg in 5 mL, injection set containing 4 vials powder for I.V. infusion 15 mg and 4 ampoules solvent 5 mL, concentrated injection 30 mg in 10 mL, injection set containing 2 vials powder for I.V. infusion 30 mg and 2 ampoules solvent 10 mL, and concentrated injection 60 mg in 10 mL: Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy In respect of the concentrated injection 90 mg in 10 mL and injection set containing 1 vial powder for I.V. infusion 90 mg and 1 ampoule solvent 10 mL: Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy Multiple myeloma Bone metastases from breast cancer
Dornase Alfa	Use by cystic fibrosis patients who satisfy all of the following criteria: (1) are 5 years of age or older
(2) have a FVC greater than 40% predicted for age, gender and height
(3) have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease)

In order for patients to be eligible for participation in the highly specialised drug program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the highly specialised drug program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation
(3) Prior to dornase alfa therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease
(4) Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose of 2.5 mg daily
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) are eligible for continued subsidy under the HSD program at a dose of 2.5 mg daily
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 2.5 mg daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. (Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals
(8) Other aspects of treatment, such as physiotherapy, must be continued
(9) Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the highly specialised drug program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)
Doxorubicin Hydrochloride, Pegylated Liposomal	Treatment of acquired immunodeficiency syndrome-related Kaposi’s sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and: (a) extensive mucocutaneous involvement; or
(b) extensive visceral involvement
Efavirenz	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Emtricitabine	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Enfuvirtide	Treatment, in combination with other antiretroviral agents, of human immunodeficiency virus (HIV) infection in antiretroviral experienced patients with treatment failure characterised by evidence of HIV replication despite ongoing therapy; and where the patient has previously failed treatment with 3 different antiretroviral regimens; and where the patient's previous treatment has included at least 1 non-nucleoside reverse transcriptase inhibitor, at least 1 nucleoside reverse transcriptase inhibitor and at least 1 protease inhibitor Treatment, in combination with other antiretroviral agents, of HIV infection in antiretroviral experienced patients with treatment failure characterised by treatment-limiting toxicity to previous antiretroviral agents; and where the patient has previously failed treatment with 3 different antiretroviral regimens; and where the patient's previous treatment has included at least 1 non-nucleoside reverse transcriptase inhibitor, at least 1 nucleoside reverse transcriptase inhibitor and at least 1 protease inhibitor
Entecavir Monohydrate	In respect of the tablet 0.5 mg:
Patients aged 16 years or older with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy)
(2) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or HBV DNA positive)
(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Patients receiving treatment with entecavir monohydrate subsidised under the Pharmaceutical Benefits Scheme (PBS) must receive that treatment as monotherapy
In respect of the tablet 1 mg:
Patients aged 16 years or older with chronic hepatitis B who have failed lamivudine therapy and who satisfy all of the following criteria:
(1) Repeatedly elevated (greater than 1.2 times the upper limit of normal) serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or serum HBV DNA positive)
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Patients receiving treatment with entecavir monohydrate subsidised under the Pharmaceutical Benefits Scheme (PBS) must receive that treatment as monotherapy
Epoetin Alfa	Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia
Epoetin Beta	Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia
Epoprostenol Sodium	Initial treatment, for up to six months, of adult patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension, and a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient is being commenced on epoprostenol sodium treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds; or
(b) WHO Functional Class IV primary pulmonary hypertension; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with bosentan monohydrate or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, normal right ventricular function as assessed by echocardiography (ECHO), and who have failed to respond to 6 or more weeks of appropriate prior vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient is being commenced on epoprostenol sodium treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with bosentan monohydrate or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either a mean right atrial pressure greater than 8 mmHg as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular dysfunction as assessed by echocardiography (ECHO); or
(b) WHO Functional Class IV primary pulmonary hypertension; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of adult patients:
(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence epoprostenol sodium treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or
(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate, iloprost trometamol or sildenafil citrate; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which the first authorisation for PBS-subsidised treatment with epoprostenol sodium, iloprost trometamol, bosentan monohydrate or sildenafil citrate, whichever was initiated first, was granted; and
(2) the date of the first application which resulted in approval for PBS-subsidised treatment with epoprostenol sodium, iloprost trometamol, bosentan monohydrate or sildenafil citrate, whichever was initiated first; and
(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised epoprostenol sodium, iloprost trometamol, bosentan monohydrate or sildenafil citrate;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients aged less than 18 years:
(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence epoprostenol sodium treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or
(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate or sildenafil citrate; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which the first authorisation for PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate, whichever was initiated first, was granted; and
(2) the date of the first application which resulted in approval for PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate, whichever was initiated first; and
(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised epoprostenol sodium, bosentan monohydrate or sildenafil citrate;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Continuing PBS-subsidised treatment, for up to 6 months, of patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension who have received approval for initial PBS-subsidised treatment with epoprostenol sodium and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of epoprostenol sodium treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
For the purpose of PBS-subsidised supply of epoprostenol sodium for the circumstances specified above:
Primary pulmonary hypertension is defined as:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
Response to epoprostenol sodium or prior vasodilator treatment is defined:
(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iv) for patients aged less than 18 years – as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital
Etanercept	Initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have severe active polyarticular course juvenile chronic arthritis and whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment; and who have demonstrated either: (i) severe intolerance of, or toxicity due to, methotrexate; or
(ii) failure to achieve an adequate response to 1 or more of the following treatment regimens: - oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or - oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug, alone or in combination with corticosteroids, for a minimum of 3 months; unless treatment with methotrexate alone or in combination with another disease modifying anti-rheumatic drug is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance develops during the period of use such that permanent withdrawal is necessary and a suitably effective treatment regimen cannot be implemented, in which case the patient is exempted from demonstrating an inadequate response within the time period specified above; and where the following conditions apply: severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours; toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis; failure to achieve an adequate response to either of the above treatment regimens is demonstrated by:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list: (i) elbow, wrist, knee or ankle (assessed as swollen and tender); or (ii) shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); where the authority application includes the information used to determine the patient’s eligibility according to the above criteria and the date of joint assessment
Initial PBS-subsidised supply for continuing treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients receiving treatment with etanercept prior to 1 December 2002, whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment Continuing PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients who have demonstrated an adequate response to treatment with etanercept as manifested by:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee or ankle (assessed as swollen and tender); or (ii) shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient’s eligibility according to the above criteria and the date of joint assessment; and patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; and applications for re-treatment of patients who have previously ceased treatment with etanercept due to having achieved and sustained complete remission of disease for 12 or more months are subject to the conditions applying to initial treatment and will not be authorised until a period of 12 months has elapsed since cessation of the previous treatment; and authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
Everolimus	Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for: (a) prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required; or
(b) prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required
Filgrastim	For use in patients undergoing induction and consolidation therapy for acute myeloid leukaemia Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for autologous transplantation into patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy Mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation Patients receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation Patients with non-myeloid malignancies receiving marrow-ablative chemotherapy and subsequent autologous blood progenitor cell transplantation Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in: Acute lymphoblastic leukaemia
Ewing’s sarcoma
Germ cell tumours
Infants and children with CNS tumours
Neuroblastoma
Non-Hodgkin's lymphoma (intermediate or high grade)
Osteosarcoma
Relapsed Hodgkin's disease
Rhabdomyosarcoma
Patients with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned Patients receiving first-line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned Patients receiving chemotherapy for myeloma who have had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned Patients with severe congenital neutropenia (absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, and in whom a bone marrow examination has shown evidence of maturational arrest of the neutrophil lineage) Patients with severe chronic neutropenia (absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, or evidence of neutrophil dysfunction, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months)) Patients with chronic cyclic neutropenia (absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months))
Fosamprenavir Calcium	Treatment, in combination with 2 or more other antiretroviral drugs, of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Foscarnet Sodium	Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome Treatment of aciclovir-resistant herpes simplex virus infection in immunocompromised patients with human immunodeficiency virus infection
Ganciclovir	Cytomegalovirus retinitis in severely immunocompromised patients
Ganciclovir Sodium	Cytomegalovirus retinitis in severely immunocompromised patients Prophylaxis of cytomegalovirus disease in bone marrow transplant patients at risk of cytomegalovirus disease Prophylaxis of cytomegalovirus disease in solid organ transplant patients at risk of cytomegalovirus disease
Iloprost Trometamol	Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and:
(a) who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension, and a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or
(b) who have been assessed by a physician from a designated hospital to have WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease, and a mean right atrial pressure of 8 mmHg or less as measured by RHC unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or

where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient is being commenced on iloprost trometamol treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds; or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; or
(c) WHO Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; or
(d) WHO Functional Class IV primary pulmonary hypertension; or
(e) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; or
(f) WHO Functional Class IV drug-induced pulmonary arterial hypertension; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of adult patients:
(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, WHO Functional Class III or IV drug-induced pulmonary arterial hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence iloprost trometamol treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with iloprost trometamol; or
(b) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate; or
(c) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; or
(d) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with sildenafil citrate; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which the first authorisation for PBS-subsidised treatment with iloprost trometamol, bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first, was granted; and
(2) the date of the first application which resulted in approval for PBS-subsidised treatment with iloprost trometamol, bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first; and
(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised iloprost trometamol, bosentan monohydrate, epoprostenol sodium or sildenafil citrate;
the supply authorised under this criterion provides for up to a maximum of 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Continuing PBS-subsidised treatment, for up to 6 months, of adult patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, pulmonary arterial hypertension secondary to connective tissue disease or drug-induced pulmonary arterial hypertension, who have received approval for initial PBS-subsidised treatment with iloprost trometamol and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of iloprost trometamol treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
For the purpose of PBS-subsidised supply of iloprost trometamol for the circumstances specified above:
Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension and pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma are defined as:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
Response to iloprost trometamol or prior vasodilator treatment is defined:
(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital
Indinavir Sulfate	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Infliximab	Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
(d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis 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 a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the application for authorisation is made in writing and includes:
(a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 18 weeks of treatment;
if less than 18 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 a course of 18 weeks of therapy in total may be submitted by telephone
Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
the application is accompanied by the results of the patient’s most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
(b) (i) if the course of therapy is an 18 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 18 weeks of treatment;
if less than 18 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 a course of 18 weeks of therapy in total may be submitted by telephone
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with infliximab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with infliximab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
if the patient commenced treatment with infliximab prior to 1 March 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L;
all measurements provided are no more than 1 month old at the time of application;
the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
(b) (i) if the course of therapy is an 18 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
a course of continuing treatment within an ongoing treatment cycle 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 a course of 24 weeks of therapy in total may be submitted by telephone
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:
(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
(b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months’ treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:
(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or
(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
failure to achieve an adequate response to the treatment regimens specified at (b) 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 a total 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;
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Biological DMARD 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 treatment 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 within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient’s first bDMARD treatment cycle;
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly, unless the patient commenced PBS-subsidised treatment with infliximab prior to 1 December 2004 and received concomitant methotrexate at a dose of less than 7.5 mg weekly, in which case the patient may continue to receive PBS-subsidised treatment with infliximab in combination with methotrexate at this lower dose for the duration of their first bDMARD treatment cycle;
patients are eligible to commence therapy with infliximab within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of infliximab therapy specified below, if applicable;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with infliximab within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:
(i) they have demonstrated an adequate response 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 when the most recent course of PBS-subsidised treatment was an initial 22 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
an adequate response to treatment 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
- 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);
the authority application is made in writing and includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient’s response to their most recent course of infliximab therapy;
a course of treatment 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
Commencement of infliximab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with infliximab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 November 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to infliximab treatment as specified in the criteria for continuing PBS-subsidised treatment with infliximab detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDS, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
the authority application is made in writing and contains sufficient information to determine the patient’s eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:
(a) who have demonstrated an adequate response to treatment with infliximab; and
(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with infliximab; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient’s first bDMARD treatment cycle;

(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient is being commenced on sildenafil citrate treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol or epoprostenol sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg as measured by right heart catheterisation (RHC) unless RHC is contraindicated on clinical grounds; or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC is contraindicated on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial PBS-subsidised supply for continuing treatment, for up to 6 months, of patients who were receiving treatment with sildenafil citrate prior to 1 March 2007, who have not received prior PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol or epoprostenol sodium and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension; or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) (a) for patients who have received less than 6 months of sildenafil citrate treatment at the time of application - a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results, as measured at the time that the patient commenced treatment with sildenafil citrate, from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where results from all 3 of the tests are not available or it was not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; or
(b) for patients who have received 6 or more months of sildenafil citrate treatment at the time of application - a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results, as measured both at the time that the patient commenced treatment with sildenafil citrate and at the time of application, from a RHC composite assessment plus ECHO composite assessment plus 6MWT, or, where results as at commencement of treatment are not available for all 3 of the tests or where it is, or was at commencement of treatment, not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) the date of commencement of sildenafil citrate treatment; and
(3) a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment; and
(4) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;
for patients who have received less than 6 months of sildenafil citrate treatment at the time of application – the supply authorised under this criterion provides sufficient to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy;
for patients who have received 6 or more months of sildenafil citrate treatment at the time of application – the supply authorised under this criterion provides for up to 6 months of therapy;
if the supply initially authorised under this criterion is less than that to which the patient is entitled, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete the maximum allowable duration of treatment may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Initial treatment, for up to 6 months, of patients:
(a) who have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence sildenafil citrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with sildenafil citrate; or
(b) who have WHO Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with iloprost trometamol; or
(c) who have WHO Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate; or
(d) who have WHO Functional Class III primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which the first authorisation for PBS-subsidised treatment with sildenafil citrate, iloprost trometamol, bosentan monohydrate or epoprostenol sodium, whichever was initiated first, was granted; and
(2) the date of the first application which resulted in approval for PBS-subsidised treatment with sildenafil citrate, iloprost trometamol, bosentan monohydrate or epoprostenol sodium, whichever was initiated first; and
(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised sildenafil citrate, iloprost trometamol, bosentan monohydrate or epoprostenol sodium;
the supply authorised under this criterion provides for up to a maximum of 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Continuing PBS-subsidised treatment, for up to 6 months, of patients with World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who have received approval for initial PBS-subsidised treatment with sildenafil citrate and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of sildenafil citrate treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;
the supply authorised under this criterion provides for up to 6 months of treatment;
if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy may be submitted by telephone;
determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
For the purpose of PBS-subsidised supply of sildenafil citrate for the circumstances specified above:
Primary pulmonary hypertension and pulmonary arterial hypertension secondary to connective tissue disease, are defined as:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
Response to sildenafil citrate or prior vasodilator treatment is defined:
(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;
(iv) for patients aged less than 18 years – as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital
Sirolimus	Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required
Stavudine	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Stavudine with Water – Purified BP	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Tacrolimus	Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for: (a) prophylaxis and treatment of liver allograft rejection, where management includes initiation, stabilisation and review of therapy as required; or
(b) prophylaxis and treatment of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required
Tenofovir Disoproxil Fumarate	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Tenofovir Disoproxil Fumarate with Emtricitabine	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Thalidomide	Relapsed or refractory multiple myeloma in patients who have failed at least 1 other treatment
Valaciclovir Hydrochloride	Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease
Valganciclovir Hydrochloride	Cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome Prophylaxis of cytomegalovirus infection and disease in solid organ transplant patients at risk of cytomegalovirus disease
Zidovudine	Treatment of human immunodeficiency virus infection in patients with: (a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
Zoledronic Acid	Multiple myeloma Bone metastases from breast cancer Bone metastases from hormone-resistant prostate cancer, with demonstration of biochemical progession of disease despite maximal therapy with hormone treatments Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy

Abacavir Sulfate	Tablet equivalent to 300 mg abacavir	Oral	GK
Oral solution equivalent to 20 mg abacavir per mL, 240 mL	Oral	GK
Abacavir Sulfate with Lamivudine	Tablet equivalent to 600 mg abacavir-300 mg	Oral	GK
Abacavir Sulfate with Lamivudine and Zidovudine	Tablet equivalent to 300 mg abacavir-150 mg-300 mg	Oral	GK
Adefovir Dipivoxil	Tablet 10 mg	Oral	GI
Apomorphine Hydrochloride	Injection 10 mg in 1 mL	Injection	MX
Atazanavir Sulfate	Capsule equivalent to 150 mg atazanavir	Oral	BQ
Capsule equivalent to 200 mg atazanavir	Oral	BQ
Azithromycin Dihydrate	Tablet equivalent to 600 mg azithromycin	Oral	PF
Baclofen	Intrathecal injection 10 mg in 5 mL	Injection	NV
Intrathecal injection 10 mg in 20 mL	Injection	NV
Bosentan Monohydrate	Tablet equivalent to 62.5 mg bosentan	Oral	AT
Tablet equivalent to 125 mg bosentan	Oral	AT
Cidofovir	Solution for I.V. infusion 375 mg (anhydrous) in 5 mL single use vial	Injection	PU
Clarithromycin	Tablet 250 mg	Oral	AB
Tablet 500 mg	Oral	AB
Clozapine	Tablet 25 mg	Oral	MX, NV, ZT
Tablet 50 mg	Oral	MX
Tablet 100 mg	Oral	MX, NV, ZT
Tablet 200 mg	Oral	MX
Cyclosporin	Solution concentrate for I.V. infusion 50 mg in 1 mL ampoule	Injection	NV
Solution concentrate for I.V. infusion 250 mg in 5 mL ampoule	Injection	NV
Capsule 10 mg	Oral	NV
Capsule 25 mg	Oral	HX, NV
Capsule 50 mg	Oral	HX, NV
Capsule 100 mg	Oral	HX, NV
Oral liquid 100 mg per mL, 50 mL	Oral	NV
Darbepoetin Alfa	Injection 10 micrograms in 0.4 mL pre-filled syringe	Injection	AN
Injection 20 micrograms in 0.5 mL pre-filled syringe	Injection	AN
Injection 20 micrograms in 0.5 mL pre-filled injection pen	Injection	AN
Injection 30 micrograms in 0.3 mL pre-filled syringe	Injection	AN
Injection 40 micrograms in 0.4 mL pre-filled syringe	Injection	AN
Injection 40 micrograms in 0.4 mL pre-filled injection pen	Injection	AN
Injection 50 micrograms in 0.5 mL pre-filled syringe	Injection	AN
Injection 60 micrograms in 0.3 mL pre-filled syringe	Injection	AN
Injection 60 micrograms in 0.3 mL pre-filled injection pen	Injection	AN
Injection 80 micrograms in 0.4 mL pre-filled syringe	Injection	AN
Injection 80 micrograms in 0.4 mL pre-filled injection pen	Injection	AN
Injection 100 micrograms in 0.5 mL pre-filled syringe	Injection	AN
Injection 100 micrograms in 0.5 mL pre-filled injection pen	Injection	AN
Injection 150 micrograms in 0.3 mL pre-filled syringe	Injection	AN
Injection 150 micrograms in 0.3 mL pre-filled injection pen	Injection	AN
Deferasirox	Tablet, dispersible, 125 mg	Oral	NV
Tablet, dispersible, 250 mg	Oral	NV
Tablet, dispersible, 500 mg	Oral	NV
Deferiprone	Tablet 500 mg	Oral	OA
Delavirdine Mesylate	Tablet 100 mg	Oral	PF
Desferrioxamime Mesylate	Powder for injection 500 mg vial	Injection	MX, NV
Powder for injection 2 g vial	Injection	MX, NV
Didanosine	Capsule 125 mg (containing enteric coated beadlets)	Oral	BQ
Capsule 200 mg (containing enteric coated beadlets)	Oral	BQ
Capsule 250 mg (containing enteric coated beadlets)	Oral	BQ
Capsule 400 mg (containing enteric coated beadlets)	Oral	BQ
Disodium Pamidronate	Concentrated injection 15 mg in 5 mL	Injection	MX
Concentrated injection 30 mg in 10 mL	Injection	MX
Concentrated injection 60 mg in 10 mL	Injection	MX
Concentrated injection 90 mg in 10 mL	Injection	MX
Injection set containing 4 vials powder for I.V. infusion 15 mg and 4 ampoules solvent 5 mL	Injection	NV
Injection set containing 2 vials powder for I.V. infusion 30 mg and 2 ampoules solvent 10 mL	Injection	NV
Injection set containing 1 vial powder for I.V. infusion 90 mg and 1 ampoule solvent 10 mL	Injection	NV
Dornase Alfa	Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL ampoule	Inhalation	RO
Doxorubicin Hydrochloride, Pegylated Liposomal	Suspension for I.V. infusion 20 mg in 10 mL vial	Injection	SH
Efavirenz	Capsule 200 mg	Oral	MK
Tablet 600 mg	Oral	MK
Oral solution 30 mg per mL, 180 mL	Oral	MK
Emtricitabine	Capsule 200 mg	Oral	GI
Enfuvirtide	Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)	Injection	RO
Entecavir Monohydrate	Tablet 0.5 mg	Oral	BQ
Tablet 1 mg	Oral	BQ
Epoetin Alfa	Injection 1,000 units in 0.5 mL pre-filled syringe	Injection	JC
Injection 2,000 units in 0.5 mL pre-filled syringe	Injection	JC
Injection 3,000 units in 0.3 mL pre-filled syringe	Injection	JC
Injection 4,000 units in 0.4 mL pre-filled syringe	Injection	JC
Injection 5,000 units in 0.5 mL pre-filled syringe	Injection	JC
Injection 6,000 units in 0.6 mL pre-filled syringe	Injection	JC
Injection 8,000 units in 0.8 mL pre-filled syringe	Injection	JC
Injection 10,000 units in 1 mL pre-filled syringe	Injection	JC
Injection 20,000 units in 0.5 mL pre-filled syringe	Injection	JC
Injection 40,000 units in 1 mL pre-filled syringe	Injection	JC
Epoetin Beta	Injection 1,000 units in 0.3 mL pre-filled syringe	Injection	RO
Injection 2,000 units in 0.3 mL pre-filled syringe	Injection	RO
Injection 3,000 units in 0.3 mL pre-filled syringe	Injection	RO
Injection 4,000 units in 0.3 mL pre-filled syringe	Injection	RO
Injection 5,000 units in 0.3 mL pre-filled syringe	Injection	RO
Injection 6,000 units in 0.3 mL pre-filled syringe	Injection	RO
Injection 10,000 units in 0.6 mL pre-filled syringe	Injection	RO
Injection 20,000 units in 0.6 mL pre-filled syringe	Injection	RO
Injection 30,000 units in 0.6 mL pre-filled syringe	Injection	RO
Epoprostenol Sodium	Powder for I.V. infusion equivalent to 500 micrograms epoprostenol with 1 vial diluent 50 mL	Injection	GK
Powder for I.V. infusion equivalent to 1.5 mg epoprostenol with 2 vials diluent 50 mL	Injection	GK
Etanercept	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	Injection	WY
Everolimus	Tablet 0.25 mg	Oral	NV
Tablet 0.5 mg	Oral	NV
Tablet 0.75 mg	Oral	NV
Filgrastim	Injection 300 micrograms in 0.5 mL single use pre-filled syringe	Injection	AN
Injection 300 micrograms in 1 mL vial	Injection	AN
Injection 480 micrograms in 0.5 mL single use pre-filled syringe	Injection	AN
Injection 480 micrograms in 1.6 mL vial	Injection	AN
Fosamprenavir Calcium	Tablet equivalent to 700 mg fosamprenavir	Oral	GK
Oral liquid equivalent to 50 mg fosamprenavir per mL, 225 mL	Oral	GK
Foscarnet Sodium	I.V. infusion 24 mg per mL, 250 mL bottle	Injection	AP
Ganciclovir	Intravitreal implant 4.5 mg	Intravitreal implantation	BU
Ganciclovir Sodium	Powder for I.V. infusion equivalent to 500 mg ganciclovir, vial	Injection	RO
Iloprost Trometamol	Solution for inhalation equivalent to 20 micrograms iloprost in 2 mL ampoule	Inhalation	SC
Indinavir Sulfate	Capsule equivalent to 100 mg indinavir	Oral	MK
Capsule equivalent to 200 mg indinavir	Oral	MK
Capsule equivalent to 400 mg indinavir	Oral	MK
Infliximab	Powder for I.V. infusion 100 mg vial	Injection	SH
Interferon Alfa-2a	Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	RO
Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	RO
Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	RO
Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	RO
Interferon Alfa-2b	Solution for injection 10,000,000 I.U. in 1 mL single dose vial	Injection	SH
Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen	Injection	SH
Solution for injection 18,000,000 I.U. in 3 mL single dose vial	Injection	SH
Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial	Injection	SH
Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen	Injection	SH
Solution for injection 60,000,000 I.U. in 1.2 mL multi-dose injection pen	Injection	SH
Interferon Gamma-1b	Injection 2,000,000 I.U. in 0.5 mL vial	Injection	BY
Lamivudine	Tablet 100 mg	Oral	GK
Oral solution 5 mg per mL, 240 mL	Oral	GK
Tablet 150 mg	Oral	GK
Tablet 300 mg	Oral	GK
Oral solution 10 mg per mL, 240 mL	Oral	GK
Lamivudine with Zidovudine	Tablet 150 mg-300 mg	Oral	GK
Lanreotide Acetate	Powder for suspension for injection equivalent to 30 mg lanreotide with diluent ampoule	Injection	IS
Injection equivalent to 60 mg lanreotide in single dose pre-filled syringe	Injection	IS
Injection equivalent to 90 mg lanreotide in single dose pre-filled syringe	Injection	IS
Injection equivalent to 120 mg lanreotide in single dose pre-filled syringe	Injection	IS
Lenograstim	Powder for injection 13,400,000 I.U. (105 micrograms) vial	Injection	MX
Powder for injection 33,600,000 I.U. (263 micrograms) vial	Injection	MX
Lopinavir with Ritonavir	Capsule 133.3 mg-33.3 mg	Oral	AB
Tablet 200 mg-50 mg	Oral	AB
Oral liquid 400 mg-100 mg per 5 mL, 60 mL	Oral	AB
Mycophenolate Mofetil	Capsule 250 mg	Oral	RO
Tablet 500 mg	Oral	RO
Mycophenolate Mofetil with Water - Purified BP	Powder for oral suspension 1 g per 5 mL, 165 mL	Oral	RO
Mycophenolate Sodium	Tablet (enteric coated) equivalent to 180 mg mycophenolic acid	Oral	NV
Tablet (enteric coated) equivalent to 360 mg mycophenolic acid	Oral	NV
Nelfinavir Mesylate	Tablet equivalent to 250 mg nelfinavir	Oral	RO
Nevirapine	Tablet 200 mg	Oral	BY
Octreotide Acetate	Injection equivalent to 50 micrograms octreotide in 1 mL	Injection	NV
Injection equivalent to 100 micrograms octreotide in 1 mL	Injection	NV
Injection equivalent to 500 micrograms octreotide in 1 mL	Injection	NV
Injection (modified release) equivalent to 10 mg octreotide, vial and diluent syringe	Injection	NV
Injection (modified release) equivalent to 20 mg octreotide, vial and diluent syringe	Injection	NV
Injection (modified release) equivalent to 30 mg octreotide, vial and diluent syringe	Injection	NV
Pegfilgrastim	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	AN
Peginterferon Alfa-2a	Injection 135 micrograms in 0.5 mL single use pre-filled syringe	Injection	RO
Injection 180 micrograms in 0.5 mL single use pre-filled syringe	Injection	RO
Peginterferon Alfa-2b	Powder for injection 50 micrograms with diluent in single use injection pen	Injection	SH
Powder for injection 80 micrograms with diluent in single use injection pen	Injection	SH
Powder for injection 100 micrograms with diluent in single use injection pen	Injection	SH
Powder for injection 120 micrograms with diluent in single use injection pen	Injection	SH
Powder for injection 150 micrograms with diluent in single use injection pen	Injection	SH
Ribavirin and Peginterferon Alfa-2a	Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms	Oral (tablets) and injection (injections)	RO
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms	Oral (tablets) and injection (injections)	RO
Ribavirin and Peginterferon Alfa-2b	Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent	Oral (capsules) and injection (injections)	SH
Rifabutin	Capsule 150 mg	Oral	PS
Ritonavir	Capsule 100 mg	Oral	AB
Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL	Oral	AB
Saquinavir Mesylate	Capsule equivalent to 200 mg saquinavir	Oral	RO
Tablet equivalent to 500 mg saquinavir	Oral	RO
Sildenafil Citrate	Tablet equivalent to 20 mg sildenafil	Oral	PF
Sirolimus	Tablet 1 mg	Oral	WY
Tablet 2 mg	Oral	WY
Oral solution 1 mg per mL, 60 mL	Oral	WY
Stavudine	Capsule 20 mg	Oral	BQ
Capsule 30 mg	Oral	BQ
Capsule 40 mg	Oral	BQ
Stavudine with Water - Purified BP	Powder for oral solution 1 mg per mL, 200 mL	Oral	BQ
Tacrolimus	Capsule 500 micrograms	Oral	JC
Capsule 1 mg	Oral	JC
Capsule 5 mg	Oral	JC
Tenofovir Disoproxil Fumarate	Tablet 300 mg	Oral	GI
Tenofovir Disoproxil Fumarate with Emtricitabine	Tablet 300 mg-200 mg	Oral	GI
Thalidomide	Capsule 50 mg	Oral	PI
Valaciclovir Hydrochloride	Tablet equivalent to 500 mg valaciclovir	Oral	GK
Valganciclovir Hydrochloride	Tablet equivalent to 450 mg valganciclovir	Oral	RO
Zidovudine	Capsule 100 mg	Oral	GK
Syrup 10 mg per mL, 200 mL bottle	Oral	GK
Capsule 250 mg	Oral	GK
Zoledronic Acid	Injection concentrate for I.V. infusion 4 mg in 5 mL vial	Injection	NV

Enfuvirtide	Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)
Ribavirin and Peginterferon Alfa-2a	Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms
Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms
Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms
Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms
Ribavirin and Peginterferon Alfa-2b	Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent
Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Cyclosporin	Capsule 25 mg	NV	30	$41.63	$42.62
Capsule 50 mg	NV	30	$86.60	$87.67
Capsule 100 mg	NV	30	$176.45	$177.53
Desferrioxamine Mesylate	Powder for injection 500 mg vial	NV	10	$99.00	$107.19
Powder for injection 2 g vial	NV	1	$39.60	$40.00