Positive Recommendations made by the PBAC in March 2002

Pharmaceutical Benefits Advisory Committee (PBAC) Positive Recommendations made in March 2002

table containing PBAC Positive Recommendation made in March 2002

Drug and form	Drug use and type	Listing requested by Sponsor (or other applicant)	PBAC Recommendation and Comments
Amisulpride tablets 100 mg, 200 mg and 400 mg, Solian Sanofi-Synthelabo Australia Pty Limited New listing	Atypical antipsychotic for schizophrenia	Authority required listing for the treatment of schizophrenia	Recommended for listing as requested with 100 mg amisulpride being considered as being of similar safety and efficacy to 1 mg risperidone.
Bisoprolol fumarate tablets 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg, Bicor® Alphapharm Pty Ltd New listing	Cardiac failure	Restricted benefit listing for the treatment of heart failure in patients stabilised on conventional therapy	Recommended for listing with an authority required restriction for moderate to severe heart failure in patients stabilised on conventional therapy (including ACE-inhibitors as tolerated), on a cost-minimisation basis compared with carvedilol, with 7.4 mg of bisoprolol fumarate being considered equivalent to 37 mg of carvedilol.
Budesonide 200 µg with eformoterol fumarate dihydrate 6 µg per dose, 120 doses, Symbicort® AstraZeneca Pty Ltd New listing	Asthma	Restricted benefit listing for patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids and who are stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide.	Recommended for listing with the requested restriction, on a cost-minimisation basis.
Carmellose sodium eye drops, 10 mg per mL (1%), 15 mL, Refresh Liquigel® Allergan Australia Pty Ltd New listing	Severe dry eyes	Restricted benefit listing for severe dry eye syndrome, including Sjogren's syndrome.	Recommended for listing as requested on a cost-minimisation basis compared with 0.5% carmellose sodium eye drops.
Carvedilol tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg, Dilatrend® Roche Products Pty Limited Amend listing	Heart failure	Amend authority required listing to allow treatment of severe congestive heart failure in patients stabilised on conventional therapy	Recommended for listing for moderate to severe heart failure in patients stabilised on conventional therapy (including ACE-inhibitors as tolerated), on the basis of acceptable cost-effectiveness.
Letrozole tablet 2.5 mg, Femara® Novartis Pharmaceuticals Australia Pty Ltd New listing	Breast cancer	Restricted benefit listing for treatment of hormone-dependent advanced breast cancer in post-menopausal women (i.e. 1st line setting)	Recommended for listing as requested on the basis of acceptable cost-effectiveness.

 

table containing PBAC Positive Recommendation made in March 2002

Drug and form	Drug use and type	Listing requested by Sponsor (or other applicant)	PBAC Recommendation and Comments
Mesalazine granules, 500mg & 1g sachets, Salofalk® Orphan Australia Pty Ltd New listing	Colitis	Authority required listing for the treatment of colitis where hypersensitivity to sulfonamides or intolerance to sulfasalazine exists.	Recommended for listing as an authority required benefit for acute mild to moderate ulcerative colitis where hypersensitivity to sulfonamides or intolerance to sulfasalazine exists.
Metformin hydrochloride 1g, tablet, Diabex 1000® Alphapharm Pty Ltd New listing	Diabetes	Unrestricted listing	Recommended for listing as requested.
Peginterferon alfa-2b powder for injection 50 µg, 80 µg, 100 µg, 120 µg, 150 µg, Peg-Intron® Schering-Plough Pty Limited New listing	Hepatitis C	Section 100 listing for the treatment of chronic hepatitis C in patients who have received no prior interferon therapy and have a contra-indication to ribavirin. Patients must be 18 years of age or older and have compensated liver disease.	Recommended for listing as requested on the basis of acceptable cost-effectiveness.
Tiotropium capsules for inhalation 18 µg, Spiriva®Boehringer IngelheimPty Limited New listing	Chronic obstructive pulmonary disease	Restricted benefit listing for treatment of chronic obstructive pulmonary disease	Recommended for listing as a restricted benefit for the long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease, on the basis of acceptable cost-effectiveness.
Travaprost 0.004% eye drops, Travatan®Alcon Laboratories (Australia) Pty LtdNew listing	Glaucoma	(Presumably) unrestricted listing	Recommended for listing on a cost-minimisation basis compared with latanoprost eye drops.
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine, MSUD Gel®Vitaflo Australia Pty LtdNew listing	A food for an inborn error of metabolism	Restricted benefit listing for maple syrup urine disease	Recommended for listing on a cost-minimisation basis compared with MSUD Maxamaid on a gram for gram of protein basis.
Amino acid formula with vitamins and minerals without phenylalanine, PKU Express®Vitaflo Australia Pty LtdNew listing	A food for an inborn error of metabolism	Restricted benefit listing for phenylketonuria	Recommended for listing on a cost-minimisation basis compared with XP Maxamum on a gram for gram of protein basis.