Positive Recommendations made by the PBAC in June 2002

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

Table containing PBAC Positive recommendations made in June 2002
Drug and form	Drug use and type	Listing requested by Sponsor (or other applicant)	PBAC Recommendation and comments
Capecitabine 150 mg and 500 mg tablets, Xeloda® Roche Products Pty Ltd Change to listing	Treatment for breast cancer	Extend current authority required indication to include use in combination with docetaxel for the treatment of patients with advanced breast cancer after failure of prior anthracycline-containing chemotherapy.	Recommended for locally advanced and metastatic breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy, on the basis of acceptable cost-effectiveness. Use in combination with docetaxel is consistent with TGA-approved indication.
Cephazolin injections, 500 mg David Bull Laboratories and 1g, David Bull Laboratories, Kefzol®, Eli Lilly Australia Pty Ltd Change to listing	Antibiotic	Increase maximum quantity from 5 to 10.	Recommended as requested.
Conjugated oestrogens with medroxyprogesterone acetate, tablet, 300m g - 1.5mg and 450m g - 1.5mg Premia LD Continuous® Wyeth Australia Pty Limited New listing	Hormone replacement therapy	Unrestricted listing	Recommended for listing on a cost-minimisation basis compared with all other listed combination oral hormone replacement therapy products.
Desmopressin acetate, nasal spray, 10 m g per actuation, 5 mL Minirin® Ferring Pharmaceuticals Change to listing	Nocturnal enuresis	To amend the wording of the current Authority required listing to "Primary nocturnal enuresis in patients over 6 years of age who are refractory to enuresis alarms or in whom enuresis alarms are contraindicated or inappropriate"	Recommended for primary nocturnal enuresis in patients over 6 years of age who are refractory to enuresis alarms or in whom enuresis alarms are contraindicated. The restriction is consistent with the TGA-approved indication, but excludes patients for whom enuresis alarms are "inappropriate" to prevent wider than intended use.
Drotrecogin Alfa (Activated) vial 5mg and 20 mg Xigris® Eli Lilly Australia Pty Ltd New listing	Severe sepsis	Authority required listing for 9 the reduction of mortality in adult patients with severe sepsis who have a high risk of death (sepsis associated with acute organ dysfunction)	Recommended for listing for "Adult patients with severe sepsis who have a high risk of death as determined by acute organ dysfunction in at least two organs or modified Apache II score of at least 25" on the basis of acceptable cost-effectiveness. Restricted to patients with 2 or more failed organs to prevent use in less severely ill patients where the risks may outweigh the benefits.
Eprosartan mesylate tablet and hydrochlorothiazide 600mg-12.5 mg Teveten® Plus Solvay Pharmacueticals New listing	Heart failure	Restricted benefit listing for the treatment of hypertension in patients who are not adequately controlled with either hydrochlorothiazide or eprosartan mesylate monotherapy.	Recommended for listing as requested on a cost-minimisation basis at a price to pharmacist no greater than the sum of the individual components.

Table containing PBAC Positive recommendations made in June 2002
Drug and form	Drug use and type	Listing requested by Sponsor (or other applicant)	PBAC Recommendation and comments
Fluvastatin prolonged release tablet 80mg Lescol XL® Novartis Pharmaceuticals Australia Pty Ltd New listing	Treatment of high cholesterol	Restricted benefit listing for use in patients that meet the criteria set out in the General Statement for Lipid-lowering Drugs.	Recommended for listing as requested on the basis of the price being acceptable (in accord with the usual Pricing Authority criteria) relative to the PBS listed strengths of immediate release fluvastatin sodium.
Macrogol 3350 with electrolytes powder in sachets Movicol® Norgine Pty Ltd New listing	Treatment of constipation	Restricted benefit listing for 9malignant neoplasia'	Recommended for listing for constipation in patients with malignant neoplasia on the basis of acceptable cost-effectiveness.
Mesalazine enemas 2g in 60mL and 4g in 60mL, Salofalk® Orphan Australia Pty Ltd New listing	Treatment of ulcerative colitis	Authority required listing for the treatment and prophylaxis of acute episodes of ulcerative colitis.	Recommended for listing with an authority required restriction for acute episodes of mild to moderately severe ulcerative colitis, on the basis of acceptable cost-effectiveness. Restriction is consistent with TGA-approved indication
Methylprednisolone aceponate, lotion, 1mg in g (0.1%), 20g Advantan® CSL Limited New listing	Topical corticosteroid	Restricted benefit listing for eczema	Recommended for listing as requested on a cost-minimisation basis compared with mometasone furoate lotion 1 mg per g. Restriction is consistent with TGA-approved indication.
Mometasone 200 ?g per dose and 400 ?g per dose dry powder inhaler Asmanax® Twisthaler® Schering Plough Pty Ltd New listing	Treatment for asthma	Unrestricted listing	Recommended for listing as requested on a cost-minimisation basis compared with fluticasone, with 200 ?g mometasone furoate daily being considered to be equivalent to 250 ?g fluticasone propionate daily and 400 ?g mometasone furoate daily being considered to be equivalent to 500 ?g fluticasone propionate daily.
Phenelzine sulfate tablet 15 mg Nardil® Link Medical Products Pty Ltd Re-list under new sponsorship	Antidepressant	Request to re-list by the Royal Australian and New Zealand College of Psychiatrists for treatment resistant patients.	Recommended as a restricted benefit for depression where all other anti-depressant therapy has failed or is inappropriate.

Table containing June 2002 PBAC Positive Recommendations
Drug and form	Drug use and type	Listing requested by Sponsor (or other applicant)	PBAC Recommendation and comments
Rivastigmine hydrogen tartrate, oral solution, 2 mg (base) per mL, 120 mL, Exelon® Novartis Pharmaceuticals Australia Pty Limited Change to listing	Alzheimer's drug	Increase number of repeats from 1 to 5.	Recommended as requested.
Tenofovir tablet 300 mg Viread® Gilead Sciences Pty Ltd New listing	HIV/AIDS drug	Section 100 listing for treatment of HIV infection in patients who have failed or experienced treatment limiting toxicity with their current antiretroviral regimen and for whom a viable regimen cannot be constructed from other classes of antiretroviral agents.	The PBAC made two recommendations. The preferred option was a cost-minimisation listing compared with amprenavir for treatment, in combination with other anti-retroviral drugs, of HIV infection in patients who have failed or experienced treatment-limiting toxicity with their current antiretroviral regimen and for whom an effective regimen cannot otherwise be constructed. The second option was on a cost-effectiveness basis compared with amprenavir for treatment , in combination with other anti-retroviral drugs, of HIV infection in patients who have failed or experienced treatment-limiting toxicity with their current antiretroviral regimen and for whom an effective regimen, including a regimen containing amprenavir, cannot otherwise be constructed.
Tramadol capsule 50 mg Tramal® CSL Limited Change to listing	Analgesic	Change the current restriction for pain where aspirin and/or paracetamol alone are inappropriate or have failed and either of the following apply: acute pain For dose titration in chronic pain NOTE: Authorities for increased quantities and/or repeats up to a maximum of 3 packs will be granted only for dose titration.	Recommended with an additional restriction for dosage titration in chronic pain where aspirin and/or paracetamol alone are inappropriate or have failed, to accommodate dosage titration, with a maximum quantity of 20 and 2 repeats. Listing should also include a 'NOTE' stating that no applications for increased quantities and/or repeats will be authorised. The listing for acute pain should remain as current (with no repeats).
Valganciclovir tablet 450 mg Valcyte® Roche Products Pty Limited New listing	An anti-viral product	Section 100 listing for sight-threatening cytomegalovirus retinitis in severely immunocompromised patients.	Recommended for cytomegalovirus retinitis in AIDS patients on a cost-minimisation basis compared with ganciclovir intravenously followed by ganciclovir oral treatment. Restriction is consistent with TGA-approved indication.
Amino acid formula with Vitamins and minerals without phenylalanine powder Minaphlex® SHS Australia Products New 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 Maxamaid on a gram for gram of protein basis.