July 2009 PBAC Outcomes - 1st Time Decisions not to Recommend

DRUG AND FORM	DRUG USE AND TYPE	LISTING REQUESTED BY SPONSOR	PBAC OUTCOME AND COMMENTS
ARACHIDONIC ACID with DOCOSAHEXANOIC ACID, sachets 4 g, containing 200 mg arachidonic acid and 100 mg docosahexanoic acid, KeyOmega® Vitaflo Australia Pty Ltd Minor submission	Medicinal food	Restricted benefit listing for use in inborn errors of metabolism.	The PBAC rejected the submission on the basis of uncertain clinical need, high cost and uncertain cost-effectiveness.
		Sponsor’s comments:	The sponsor has no comments.
BOTULINUM TOXIN TYPE A PURIFIED NEUROTOXIN COMPLEX, lyophilised powder for I.M. injection, 100 units, Botox® Allergan Australia Pty Ltd Minor submission	Spasticity	Extend the Section 100 listing to include treatment of moderate-severe spasticity of the upper limbs in adults with multiple sclerosis, traumatic brain injury and spinal cord injury as an adjunct to physical therapy.	The PBAC rejected the submission on the basis of unknown cost-effectiveness in the requested population.
		Sponsor’s comments:	The sponsor did not provide any comments.
CARBOHYDRATE with BRANCHED CHAIN AMINO ACIDS, sachets, 50 g, Hepatamine®   Nutricia Australia Pty Ltd   Minor submission	Medicinal food	Restricted benefit listing for use in patients with cirrhosis of the liver, hepatic encephalopathy resistant to drug therapy, patients awaiting liver transplantation, and patients undergoing curative resection for hepatocellular carcinoma.	The PBAC rejected the submission on the basis of uncertain cost-effectiveness, highly uncertain utilisation and that the term ‘cirrhosis of the liver’ in the requested restriction was ill-defined.
		Sponsor’s comments:	The sponsor accepts the decision of the PBAC and will be considering its position regarding any future course of action.
CILOSTAZOL, tablets, 50 mg and 100 mg, Pletal®   PharmaLink Pty Ltd   Major submission	Intermittent claudication	Authority required listing for the symptomatic improvement of intermittent claudication.	The PBAC rejected the submission on the basis of uncertain clinical benefit, uncertain cost-effectiveness and uncertain utilisation estimates.
		Sponsor’s comments:	The sponsor did not provide any comments.
CINACALCET HYDROCHLORIDE, tablets, 30 mg, 60 mg and 90 mg (base), Sensipar® Amgen Australia Pty Ltd   Major submission	Hyperparathyroidism Hypercalcaemia	To extend the current Authority required listing to include: (i) treatment of primary hyperparathyroidism in patients for whom parathyroidectomy is not an option; and (ii) persistent or recurrent hypercalcaemia following resection of parathyroid carcinoma.	The PBAC rejected the submission on the basis of both clinical and economic uncertainties resulting in high and uncertain cost-effectiveness ratios.
		Sponsor’s comments:	Amgen looks forward to working collaboratively with the PBAC and clinical experts to find a way to make the product available to patients in Australia.
DOCOSAHEXANOIC ACID, sachets 4 g, containing 200 mg docosahexanoic acid, DocOmega® Vitaflo Australia Pty Ltd   Minor submission	Medicinal food	Restricted benefit listing for use in inborn errors of metabolism.	The PBAC rejected the submission on the basis of uncertain clinical need, high cost and uncertain cost-effectiveness.
		Sponsor’s comments:	The sponsor has no comments.
DUTASTERIDE, capsule, 0.5 mg, Avodart®   GlaxoSmithKline Australia Pty Ltd   Major submission	Benign prostatic hyperplasia	Authority required (Streamlined) listing for the treatment of benign prostatic hyperplasia in men over 50 years who meet certain criteria.	The PBAC rejected the submission on the basis of uncertain clinical benefit and highly uncertain cost effectiveness.
		Sponsor’s comments:	The sponsor needs to clarify the decision with the PBAC.
IMIQUIMOD, cream, 50 mg per g (5%), 250 mg single use sachets, Aldara®   iNova Pharmaceuticals (Australia) Pty Ltd  Minor submission	Skin cancers Genital warts	Requests an increase in the maximum quantity from 1 to 2 and a decrease in repeats from 1 to nil. Also requests an alteration to the NOTE to allow increased quantities of up to 30 sachets.	The PBAC did not consider that sufficient evidence was presented to support the claim that the requested change to the listing would result in improved compliance, and considered the requested change to the ‘Note’ to allow Authority approval of additional half boxes (six sachets) of imiquimod impractical, considering a box containing 12 sachets is listed with a pack size of one.
		Sponsor’s comments:	The sponsor has no comments.
RIBAVIRIN and PEGINTERFERON ALFA-2a, various forms and strengths, Pegasys RBV®   Roche Products Pty Ltd   Minor submission	Hepatitis C	Extend the current Section 100 (Highly Specialised Drugs Program) listing to include treatment of patients who have failed one prior attempt at interferon based therapy (non-pegylated or pegylated) who meet certain criteria.	The PBAC considered that both the clinical and economic data to support the request required evaluation, and determined that the request requires a major submission.
		Sponsor’s comments:	The sponsor needs to clarify the decision with the PBAC.
ROMIPLOSTIM (rbe), powder for injection, 165 mcg, 375 mcg and 625 mcg, Nplate®   Amgen Australia Pty Ltd   Major submission	Thrombocytopenia	Section 100 listing for the initial and continuing treatment of adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who meet certain criteria.	The PBAC rejected the submission because of the uncertain place in treatment for romiplostim, uncertain clinical benefit and uncertain and unacceptable cost-effectiveness.
		Sponsor’s comments:	Amgen looks forwards to working with the PBAC to ensure a successful listing for the benefit of patients in this population.
SEVELAMER HYDROCHLORIDE, tablet, 800 mg, Renagel®   Genzyme Australasia Pty Ltd  Minor submission	Hyperphosphataemia	Change the Section 85 listing from the current Authority required to an Authority required (Streamlined) listing.	The PBAC rejected the submission for a Streamlined authority as it does not meet the criteria for this category of listing.
		Sponsor’s comments:	Genzyme Australasia is disappointed with the outcome and hopes to work with the PBAC to seek a possible approach that benefits patients and physicians dealing with this disease area.