New Listings & Changes to PBS 1 September 2009

 

ADDITIONS
 

1017M Clotrimazole, Cream 10 mg per g (1%), 20 g (Clonea)

The PBAC recommended listing of clotrimazole cream for the treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person. This is listed as a streamlined authority under the 2004-05 Budget Measure “Improving the capacity of the PBS to meet the needs of Indigenous Australians”. 

This product is an alternative for clotrimazole lotion.

 

9477T Lansoprazole, Tablet 30 mg (orally disintegrating) (Zoton FasTabs)

9478W Lansoprazole, Tablet 30 mg (orally disintegrating) (Zoton FasTabs) (Diff. Max. Rpts)

The PBAC recommended the listing of this dispersible tablet formulation of lansoprazole. Item 9477T is for the initial treatment of peptic ulcer and item 9478W is for the treatment of gastro-oesophageal reflux disease or scleroderma oesophagus.

 

9476R Poly-l-lactic acid, Powder for injection 150 mg (Sculptra)

9475Q Poly-l-lactic acid, Powder for injection 150 mg (Sculptra) (Diff. Max. Rpts)

The PBAC recommended listing of poly-l-lactic acid for the treatment of facial lipoatrophy caused by antiretroviral therapy in HIV positive patients. It was recommended on the basis of acceptable cost-effectiveness.

Facial lipoatrophy is one of the adverse effects of highly active antiretroviral therapy (HAART) that is of concern to patients with HIV. Treatment with poly-l-lactic acid reverses the visible effects of facial lipoatrophy and improves the quality of life for HIV patients. (Extract from PBAC outcomes and public summary document at: http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-poly-l-lactic-march09)

 

9479X Silver sulfadiazine, Cream 10 mg per g (1%), 50 g (Flamazine)

The PBAC recommended the listing of a new formulation of silver sulfadiazine cream on the basis of cost minimisation with the currently listed silver sulphadiazine with chlorhexidine (Silvazine) cream.

This product is a replacement for silver sulphadiazine with chlorhexidine cream.

 

9470K Sodium bicarbonate, Capsule 840 mg (Sodibic)

The PBAC recommended listing of sodium bicarbonate for the treatment of metabolic acidosis associated with chronic renal impairment. Metabolic acidosis is a condition commonly encountered in both chronic renal failure (CRF) and end-stage renal disease (ESRD).  Acidosis in renal insufficiency is a result of decreased net acid excretion.

 

ALTERATIONS
 

The following listings have been changed to Authority required (Streamlined):
 

8800E Cladribine, Injection 10 mg in 5 mL (Litak)

1811H Cladribine, Solution for I.V. infusion 10 mg in 10 mL (Leustatin)

            For Hairy cell leukaemia.

 

8786K Fotemustine, Powder for injection 208 mg with solvent (Muphoran)

            For metastatic malignant melanoma.

 

8414W Irinotecan hydrochloride trihydrate, I.V. injection 40 mg in 2 mL (Camptosar, Irinotecan Actavis, Irinotecan Sandoz, Omegapharm Irinotecan, HH)
8415X Irinotecan hydrochloride trihydrate, I.V. injection 100 mg in 5 mL (Camptosar, Irinotecan Actavis, Irinotecan Sandoz, Omegapharm Irinotecan, HH)
9410G Irinotecan hydrochloride trihydrate, I.V. injection 300 mg in 15 mL (Camptosar)
9119Y Irinotecan hydrochloride trihydrate, I.V. injection 500 mg in 25 mL (HH)

            For metastatic colorectal cancer in patients with a WHO performance status of 2 or less.

 

8284B Raltitrexed, Powder for I.V. infusion 2 mg (Tomudex)

            For use as a single agent in the treatment of advanced colorectal cancer.

 

8199M Topotecan hydrochloride, Powder for I.V. infusion 4 mg (base) (Hycamtin)

            For advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound.

These items are now streamlined authority and therefore do not require prior telephone authorisation by Medicare Australia.

 

Section 100 - Highly Specialised Drugs Program

 

Thalidomide, Capsule 50 mg (Thalidomide Pharmion)

The PBAC recommended an extension to the section 100 listing for thalidomide. The drug will now be available for people who are newly diagnosed with multiple myeloma. Previously, thalidomide was available for people who had relapsed or refractory multiple myeloma who had failed at least one other treatment.