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Monday, 2 December 2002
Page: 6951


Senator Lees asked the Minister for Health and Ageing, upon notice, on 26 September 2002:

(1) What was the percentage increase in Commonwealth spending on the Pharmaceutical Benefits Scheme (PBS) for each month from January to July 2002.

(2) What was the total percentage increase for the period January to July 2002.

(3) What new drugs have been listed on the PBS in the 12 months from September 2001.

(4) What is the estimated cost to the PBS of the new drugs listed in the 12 months from September 2001.

(5) What is the estimated cost of each of these newly-listed drugs.

(6) What drugs approved by the Therapeutic Goods Administration (TGA) in the past 12 months have not been listed on the PBS.

(7) Given that the diabetes drug Avandia has been approved by the TGA but has not been listed on the PBS, what impediments are preventing the listing of this particular drug.

(8) Why have the rheumatoid arthritis drugs Enbrel and Remicade which have been approved by the TGA, not been listed.

(9) For each of the past five years (1997 to 2001 inclusive) can the following details be provided:

(a) the average number of drugs listed on the PBS each year; and

(b) the average number of submissions made to the Pharmaceutical Benefits Advisory Committee.

(10) What is the estimated annual cost to the PBS of the drugs approved by the TGA but still awaiting listing.


Senator Patterson (Minister for Health and Ageing) —The answer to the honourable senator's question is as follows:

(1)&(2) Monthly changes in Commonwealth spending on the PBS from January 2001 to June 2002 are as set out in the following table. The table represents cash figures for Concessional and General PBS prescriptions and does not include payments made under the Section 100 arrangements:

2001

2002

Change

$

$

$

%

Jan

375,413,640

426,065,760

50,652,120

13.49

Feb

250,642,182

286,177,816

35,535,634

14.18

Mar

335,073,495

310,484,450

-24,589,046

-7.34

Apr

308,275,114

335,104,906

26,829,793

8.70

May

339,266,314

371,762,986

32,496,672

9.58

Jun

307,719,907

334,996,902

27,276,996

8.86

Jan-Jun

1,916,390,652

2,064,592,821

148,202,169

7.73

(3)-(5) The estimated annual expenditure on new PBS listings and extensions to existing listings during the period from September 2001 to October 2002 is set out below. The figures represent first full year costs (for example for a drug listed from 1 February 2002, the estimated cost is for the financial year 2002-03). The estimates are net costs, that is the cost of listing each drug less, where relevant, the reduction in expenditure on other PBS drugs for which it is substituting. The estimates exclude a number of listings where expenditure on the drug concerned is expected to be fully offset by reductions in expenditure on other PBS drugs.

Name of Drug

Estimated Annual Cost ($million)

Abacavir Sulfate with Lamivudine and Zidovudine

0.082

Imatinib Mesylate (brand name Glivec)

28.949

Dorzolamide Hydrochloride with Timolol Maleate

1.425

Lopinavir with Ritonavir

3.78

Soy Protein and Fat Formula with Vitamins and Minerals Carbohydrate Free

0.100

Zoledronic Acid

0.272

Bisoprolol Fumarate

5.990

Peginterferon alfa-2b

0.209

Tenofovir Disoproxil Fumarate

8.100

Kindergen

0.150

Oxaliplatin

1.800

Valganciclovir HCl

0.170

Carvedilol

1.700

Letrozole

2.700

Risedronate

1.800

Cyclosporin

1.600

Pegylated Doxorubicin

0.885

Lenograstim/Filgrastim

0.815

TOTAL

$60.527

(6) The following new drug approvals and extensions to existing approvals provided by the Therapeutic Goods Administration (TGA) in the twelve months to the end of September 2002 are not listed on the PBS:

Agalsidase alfa

Pegfilgrastim

Agalsidase beta

Rasburicase

Artemether

Riluzole

Bimatoprost

Sibutramine hydrochloride monohydrate

Drotrecogin alfa (activated)

Sulesomab

Eflornithine hydrochloride

Tegaserod maleate

Ertapenem sodium

Tiotropium bromide monohydrate

Fondaparinux sodium

Unoprostone isopropyl

Inactivated influenza vaccine (surface antigen)

Yaldecoxib

Modafinil

Yoriconazole

Olapatadine hydrochloride

Zaleplon

Olizumab

Ziprasidone hydrochloride

Parecoxib sodium

(7) Rosiglitazone (brand name Avandia) has been recommended for listing on the PBS by the Pharmaceutical Benefits Advisory Committee (PBAC). There have been delays in finding an acceptable pricing outcome for this product with the company concerned. Because the estimated cost to the PBS of listing Avandia exceeds $10 million per annum, Cabinet consideration is also necessary.

(8) Before a drug can be included on the PBS it must be assessed by the PBAC. The Committee is required to take into account a drug's medical effectiveness, cost-effectiveness and safety compared with other treatments.

The Committee has not to date been provided with adequate evidence to support the listing of new rheumatoid arthritis treatments like etanercept (brand name Enbrel) and infliximab (brand name Remicade). The Government is unable to subsidise a medicine under the PBS without a positive recommendation from the PBAC.

The Committee is continuing to work with clinicians and the companies concerned to try to develop a suitable basis for listing of these products.

(9) (a) The number of new drug listings and extensions to existing listings on the PBS in recent years is as follows:

Year

Number

1997

38

1998

45

1999

37

2000

34

2001

34

2002

31

(9) (b) On average, the PBAC receives around 90 submissions each year for new drug listings and extensions to existing listings.

(10) It is not possible to provide this figure. PBS listing has not yet been sought for some of the drugs and the listing arrangements for some others have not yet been resolved.