November 2005 PBAC Outcomes - 1st time decisions not to recommend

Recommendations made by the PBAC (Pharmaceutical Benefits Advisory Committee) in November 2005 relating to the listing of drugs on the PBS (Pharmaceutical Benefits Scheme)

Drug and Sponsor	Drug use and type	Request of Sponsor	PBAC recommendation and comments
BOTULINUM TOXIN type A Botox® Allergan Australia Pty Ltd Major submission	Treatment of spasticity	Section 100 listing for the treatment of focal spasticity in adults.	The PBAC rejected the submission because of uncertainty with interpreting the extent of clinically relevant benefits, uncertainty associated with the modelled cost off-sets and the resulting unacceptable and uncertain cost-effectiveness.
		Sponsor’s comments:	The sponsor did not wish to comment
CINACALCET HYDROCHLORIDE 30 mg, 60 mg and 90 mg tablets, Sensipar® Amgen Australia Pty Ltd Major submission	Treatment of hyperparathyroidism in patients with end stage renal disease.	Section 100 listing for the treatment of patients with end stage renal disease receiving dialysis who have uncontrolled secondary hyperparathyroidism who meet certain criteria.	The PBAC rejected the submission because of uncertain extent of clinical benefit and the resultant uncertain cost-effectiveness.
		Sponsor’s comments:	The sponsor intends to work collaboratively with clinicians and the PBAC to find a way to move forward with reimbursement of Cinacalcet.
ETANERCEPT 25 mg powder for injection, Enbrel® Wyeth Australia Pty Ltd Major submission	Treatment of rheumatoid arthritis	Authority required for treatment in combination with methotrexate for patients with severe active rheumatoid arthritis at high risk of erosive disease who meet certain criteria.	The PBAC rejected the submission on the grounds that the requested restriction fails to adequately identify and restrict usage to the intended PBS population and the choice of comparator is inappropriate.
		Sponsor’s comments:	The sponsor will be making a re-submission in due course and looks forward to working with the PBAC.
IMIQUIMOD 5% cream sachets, Aldara® 3M Health Care Pty Ltd Major submission	Treatment of skin cancer	Authority required for the primary treatment of biopsy confirmed superficial basal cell carcinoma (sBCC) where surgery is considered inappropriate (consistent with the TGA-approved indication).	Although there is a clinical place for imiquimod, which was demonstrated to be an effective treatment for sBCC, the PBAC rejected the submission because of the inappropriate restriction, because the trials were not representative of those for whom PBS listing was sought and because of uncertain and inadequately demonstrated cost-effectiveness.
		Sponsor’s comments:	3M looks forward to continuing to work with the PBAC.
LETROZOLE 2.5 mg tablet, Femara® Novartis Pharmaceuticals Australia Pty Ltd Major submission	Treatment of breast cancer	Restricted benefit for the treatment of early-stage hormone-dependent breast cancer in post-menopausal women who have completed no less than 4.5 years of standard adjuvant tamoxifen therapy.	The PBAC rejected the submission because of unacceptable and uncertain cost-effectiveness.
		Sponsor’s comments:	Novartis disagrees with the decision and will be considering its position regarding any future course of action, and refers you to its website for further information: www.novartis.com.au
MACROGOL 3350 with electrolytes, Movicol® and Movicol Half® Norgine Pty Limited Major submission	Laxative	Extend current listing to include treatment of faecal impaction, where conventional therapies have failed, and the alternative treatments may require hospital admission.	The PBAC rejected the submission because clinical and economic uncertainties and inadequately demonstrated cost-effectiveness.
		Sponsor’s comments:	The sponsor disagrees with the decision and needs to clarify the decision with the PBAC.
METHYL AMINOLEVULINATE 160 mg per g cream, Metvix® Galderma Australia Pty Ltd Major submission	Treatment of skin cancer	Authority required listing for treatment of patients aged 18 years or older with primary superficial or nodular basal cell carcinoma (BCC) where surgery is inappropriate due to the risk of post-surgical morbidities or disfigurement. The lesions must be confirmed as superficial BCC or nodular BCC either histologically by biopsy or by specialist opinion.	The PBAC rejected the submission because of issues with the restriction, because the trials were not representative of those for whom PBS listing was sought, ie those not suitable for surgery; and because of uncertain cost-effectiveness.
		Sponsor’s comments:	The sponsor disagrees with the decision but needs to clarify the decision with the PBAC and refers you to its website www.treatskincancer.com for further information.
TRANDOLAPRIL with VERAPAMIL HYDROCHLORIDE tablets, 2 mg-180 mg and 4 mg-240 mg, Ziaxel® Abbott Australasia Pty Ltd Major submission	Treatment of hypertension.	Restricted benefit for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.	The PBAC rejected the submission because of a lack of clinical need in patients with hypertension for the combination and uncertainty about the evidence of superiority over the individual components in the requested doses.
		Sponsor’s comments:	The sponsor disagrees with the decision and is working to address the PBAC’s concerns.
TRAVOPROST with TIMOLOL eye drops 40 µg - - 5 mg (base) (0.004%- 0.5%), Extravan® Alcon Laboratories (Australia) Pty Ltd Major submission	Treatment of glaucoma	Restricted benefit listing for reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension for whom a single agent therapy provides insufficient intraocular pressure reduction. Extravan should not be used to initiate therapy.	The PBAC rejected the submission because of uncertainty over the clinical claim.
		Sponsor’s comments:	The sponsor is considering the Committee’s concerns.