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Tuesday, 13 May 2003
Page: 14229


Mr Jenkins asked the Minister representing the Minister for Health and Ageing, upon notice, on 6 February 2003:

(1) What was the average time in (a) 1995, (b) 1996, (c) 1997, (e) 1998, (f) 1999, (g) 2000, (h) 2001 and (i) 2002 between the Pharmaceutical Benefits Advisory Committee (PBAC) making a recommendation that a drug be listed on the Pharmaceutical Benefits Scheme (PBS) and the drug being listed.

(2) Of the drugs that the PBAC has recommended be on the PBS but have yet to be listed, (a) what are their names, (b) when was the original recommendation made by the PBAC, (c) what are the reasons for the delay in the drug being listed on the PBS and (d) when does the Minister expect the drugs will be on the PBS.


Mr Andrews (Minister for Ageing) —The Minister for Health and Ageing has provided the following answer to the honourable member's question:

(1) The average time between the Pharmaceutical Benefits Advisory Committee (PBAC) making a recommendation that a drug be listed on the Pharmaceutical Benefits Scheme (PBS) and the drug being listed for each of the requested years is as follows:

Year of PBAC Recommendation

Average Number Months to PBS Listing

1995

9.5 months

1996

8 months

1997

6.5 months

1998

5.5 months

1999

6.5 months

2000

7 months

2001

5.5 months

2002

5 months

(2) Details of items recommended by the PBAC for listing on the PBS which have not been finalised are as follows:

Item Name (Generic Name)

PBAC meeting

Reason for Delay

Expected PBS Listing Date

Buspirone Hydrochloride Tablet 5mg

June 1998

Unable to negotiate a price acceptable for listing

*PBAC expected to rescind recommendation

Buspirone Hydrochloride Tablet 10mg

June 1998

Unable to negotiate a price acceptable for listing

*PBAC expected to rescind recommendation

Itraconazole Oral solution 10mg per mL,. 150mL

June 1998

Unable to negotiate a price acceptable for listing

*PBAC expected to rescind recommendation

Cyproterone Acetate with Ethinyloestradiol, pack containing 21 tablets 2mg - 35 mcg and 7 inert tablets

December1998

Company did not proceed

*PBAC expected to rescind recommendation.

Gestodene with Ethinyloestradiol, pack containing 6 tablets 50 mcg -30 mcg, 5 tablets 70 mcg - 40 mcg, 10 tablets 100 mcg - 30 mcg and 7 inert tablets

December 1998

Company did not proceed

*PBAC expected to rescind recommendation

Gestodene with Ethinyloestradiol, pack containing 6 tablets 50 mcg -30 mcg, 5 tablets 70 mcg - 40 mcg, 10 tablets 100 mcg - 30 mcg and 7 inert tablets

December 1998

Company did not proceed

*PBAC expected to rescind recommendation

Levonorgestrel with Ethinyloestradiol, pack containing 21 tablets 100 mcg - 20 mcg and 7 inert tablets

December 1998

Company did not proceed

*PBAC expected to rescind recommendation

Pramipexole Hydrochloride Tablet 125 micrograms

March 1999

Unable to negotiate a price acceptable for listing.

Unknown

Pramipexole Hydrochloride Tablet 250 micrograms

March 1999

Unable to negotiate a price acceptable for listing.

Unknown

Pramipexole Hydrochloride Tablet 1mg

March 1999

Unable to negotiate a price acceptable for listing.

Unknown

Epoetin Alfa Injection 500 units in 0.25mL

December 1999

Company did not proceed

Unknown

Nevirapine Oral suspension 50mg per 5mL, 240mL

June 2000

Unable to negotiate a price acceptable for listing.

Unknown

Somatropin Injection 0.2mg with diluent in single use syringe (without preservative)

June 2000

Company did not proceed

Unknown

Somatropin Injection 0.4mg with diluent in single use syringe (without preservative)

June 2000

Company did not proceed

Unknown

Somatropin Injection 0.6mg with diluent in single use syringe (without preservative)

June 2000

Company did not proceed

Unknown

Etoposide Phosphate Powder for IV infusion 568mg (equivalent to 500mg etoposide)

December2000

Company did not proceed

Unknown

Insulin Lispro with Insulin Lispro Protamine Injections (human analogue) 100 units (50 units - 50 units) per mL, 3mL, 5

December 2000

Company did not proceed

Unknown

Oestradiol with Dydrogesterone Tablet 1mg-5mg

March 2001

Company did not proceed

Unknown

Rosiglitazone Maleate Tablet 4mg (base)

March 2001

Protracted considerations of cost effectiveness and pricing issues.

Unclear at this time.

Rosiglitazone Maleate Tablet 8mg (base)

March 2001

Protracted considerations of cost effectiveness and pricing issues.

Unclear at this time.

Interferon Alfa-2b Injection set containing one vial powder for injection 10 million IU and one ampoule water for injections 2mL

June 2001

Unable to negotiate a price acceptable for listing.

Unknown

Levetiracetam Tablet 250mg

June 2001

Unable to negotiate a price acceptable for listing.

Unknown

Levetiracetam Tablet 500mg

June 2001

Unable to negotiate a price acceptable for listing.

Unknown

Levetiracetam Tablet 1g

June 2001

Unable to negotiate a price acceptable for listing.

Unknown

Pioglitazone Hydrochloride Tablet 15mg (base)

September 2001

Protracted considerations of cost effectiveness and pricing issues.

Unclear at this time.

Pioglitazone Hydrochloride Tablet 30mg (base)

September 2001

Protracted considerations of cost effectiveness and pricing issues.

Unclear at this time.

Pioglitazone Hydrochloride Tablet 45mg (base)

September 2001

Protracted considerations of cost effectiveness and pricing issues.

Unclear at this time.

Galantamine Hydrobromide Oral solution 4mg (base) per mL, 100mL

September 2001

Unable to negotiate a price acceptable for listing.

Unknown

Eptifibatide Solution for IV injection 20mg in 10mL

December 2001

Company did not proceed

Unknown

Eptifibatide Solution for IV injection 75mg in 100mL

December 2001

Company did not proceed

Unknown

Oestrogens-Conjugated with Medroxyprogesterone Acetate Tablets 300 micrograms - 1.5mg, 28

June 2002

Company did not proceed

Company anticipates listing will proceed late 2003

Oestrogens-Conjugated with Medroxyprogesterone Acetate Tablets 450 micrograms - 1.5mg, 28

June 2002

Company did not proceed

Company anticipates listing will proceed late 2003

Fluvastatin Tablet 80mg (prolonged release)

June 2002

Company did not proceed

Company anticipates listing will proceed late 2003

Mometasone Furoate powder for oral inhalation in breath actuated device 200 micrograms per dose (120 doses)

June 2002

Company did not proceed

Unknown

Mometasone Furoate powder for oral inhalation in breath actuated device 400 micrograms per dose (60 doses)

June 2002

Company did not proceed

Unknown

Oxycodone Hydrochloride Oral liquid 1mg per mL, 250mL

June 2002

Unable to negotiate a price acceptable for listing

Unknown

Oxycodone Hydrochloride Oral liquid 10mg per mL, 120mL

June 2002

Unable to negotiate a price acceptable for listing.

Unknown

Gatifloxacin Sesquihydrate Tablet 400mg (anhydrous)

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Gatifloxacin Sequihydrate Injection concentrate 400mg in 40mL

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Gatifloxacin Sesquihydrate IV infusion 400mg in 200mL

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Linezolid Tablet 600mg

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Linezolid Powder for suspension 20mg per mL, 150mL

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Linezolid Solution for IV injection 600mg in 300mL

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Oestradiol Hemihydrate Nasal spray 150 micrograms per dose (60 doses)

September 2002

Pricing issues which are now resolved

Earliest possible listing 1 August 2003

Efavirenz Oral solution 30mg per mL, 180mL

September 2002

Unable to negotiate a price acceptable for listing.

Unknown

Choriogonadotrophin Alfa Powder for injection 250mcg

December2002

Unable to negotiate a price acceptable for listing.

Unknown

Erythromycin Lactobionate IV. Infusion 1g (base)

December 2002

Lack of stock

Possible 1 August 2003 listing

Etanercept Powder for injection 25mg

December 2002

Consideration costs and development of restricted listing and risk management strategies needed.

Unclear at this time.

Naproxen Suspension 125mg per 5mL, 500mL

December 2002

Company still attempting to source product/pricing matters still to be resolved

Unknown

Progesterone Vaginal gel 90mg (prolonged release), single dose pre-filled applicator, 15

December 2002

Will be listed 1 May 2003

*When a recommendation to list has not been implemented within 2 years, the PBAC Secretariat will write and ask the applicant whether they wish the recommendation to stay active. If the recommendation has not been implemented within 5 years, the PBAC automatically rescinds it. This is the process agreed with the peak industry body, the Australian Pharmaceutical Manufacturers' Association (now Medicines Australia).