July 2005 PBAC Outcomes - "1st time" Decisions not to recommend

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

Table containing PBAC Outcomes of 1st time decisions not to recommend for July 2005

Drug and form	Listing requested by Sponsor	Listing requested by Sponsor	PBAC outcome and comments
DOCETAXEL 20 mg and 80 mg Injection, Taxotere® Sanofi Aventis Group Major submission	Anti-cancer drug used to treat prostate cancer, breast cancer, ovarian cancer and lung cancer	Authority Required listing for the treatment of androgen independent (hormone refractory) prostate cancer.	The PBAC rejected the submission because of uncertain and unacceptable cost-effectiveness.
		Sponsor’s comments	The sponsor disagrees with the decision but needs to clarify the decision with the PBAC.
ETANERCEPT vial powder for injection, 25 mg, Enbrel® Wyeth Australia Pty Ltd Major submission	Used to treat inflammatory diseases such as chronic plaque psoriasis	Authority required listing for the treatment of certain patients with severe chronic plaque psoriasis.	Despite good evidence of clinical effectiveness and a demonstrated clinical need for a drug to treat this group of patients, the PBAC rejected the submission because of uncertain and unacceptable cost-effectiveness.
		Sponsor’s comments	The sponsor will be making a re-submission and looks forward to continuing to work with the PBAC. The sponsor refers you to its website for further information. www.wyeth.com.au
RISPERIDONE injection (long acting), 25 mg, 37.5 mg and 50 mg, Risperdal Consta ® Janssen-Cilag Pty Ltd Minor submission	Used to treat schizophrenia	Add to Section 100 for the treatment of schizophrenia in patients whose illness requires supervision and treatment at hospital outpatient clinics	The PBAC rejected the submission because of advice that the problem that had been experienced with access by a limited number of patients to risperidone injection has been resolved.
		Sponsor’s comments	Janssen-Cilag intends to work collaboratively with the Highly Specialised Drugs Working Party and clinicians to monitor patient access to Risperdal Consta under the current listing.