This is the text extract for Proposal to subsidise aripiprazole (Abilify), browse documents here.

27 May 2008

Proposal to subsidise aripiprazole (Abilify)

Proposal summary PHARMAC and Bristol-Myers Squibb have reached a provisional agreement for funding of a new treatment for schizophrenia, aripiprazole (Abilify), from 1 August 2008. Aripiprazole (Abilify) would be fully subsidised for patients who have previously tried risperidone or quetiapine but had to stop therapy with these medicines because of unacceptable side effects or inadequate response, and the prescriber would need to annotate this on the prescription. Aripiprazole (Abilify) would have protection from delisting and subsidy reduction until 1 August 2011. Under the provisional agreement with Bristol-Myers Squibb the terms of listing of the antipsychotic fluphenazine decanoate depot injection (Modecate) and the oral antifungal treatment amphoteracin B lozenges (Fungilin), both of which are currently supplied by Bristol-Myers Squibb, would be amended to extend the period of protection from subsidy reduction and delisting until July 2011. The price and subsidy for these medicines would remain the same and both treatments would remain fully funded as they are now. Further details of the proposal can be found on the following pages. Feedback sought We welcome your feedback on this proposal. To provide feedback please submit an email, fax or letter by 4 pm, Friday 13 June 2008 to: Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington 6143 Email: geraldine.macgibbon@pharmac.govt.nz Fax: (04) 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

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The details of the proposal Aripiprazole We have entered into a provisional agreement with Bristol-Myers Squibb (NZ) Ltd to list aripiprazole (Abilify) in the General Antipsychotics section of Section B, and in Part II of Section H, of the Pharmaceutical Schedule from 1 August 2008, at the following prices and subsidies (ex-manufacturer, excluding GST): Pharmaceutical Brand Name Form and Strength

10 mg tablet 15 mg tablet 20 mg tablet 30 mg tablet

Pack Size

Proposed Price and Subsidy

$123.54 $175.28 $213.42 $260.07

Aripiprazole Aripiprazole Aripiprazole Aripiprazole

Abilify Abilify Abilify Abilify

30 30 30 30

Abilify would be listed subject to a requirement for the following prescription endorsement for subsidy: “Aripiprazole is subsidised for patients suffering from schizophrenia or related psychoses after a trial of an effective dose of risperidone or quetiapine that has been discontinued, or is in the process of being discontinued, because of unacceptable side effects or inadequate response, and the prescription is endorsed accordingly.” Abilify would have protection from delisting and subsidy reduction until 1 August 2011.

Fluphenazine decanoate and amphoteracin B Bristol-Myers Squibb would continue to supply fluphenazine decanoate depot injection 20 mg per ml and 100 mg per ml (Modecate), at the same price and subsidy as currently listed in Section B and in Part II of Section H of the Pharmaceutical Schedule, and would have protection from subsidy reduction and delisting until July 2011. Bristol-Myers Squibb would continue to supply amphoteracin B 10 mg lozenges (Fungilin) at the same price and subsidy as currently listed in Section B of the Pharmaceutical Schedule, and would have protection from subsidy reduction and delisting until July 2011. Background to the proposal PHARMAC received an application to fund the atypical antipsychotic aripiprazole in September 2007. This application was considered by the Mental Health Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) at its meeting in October 2007, and by PTAC in November 2007. Both PTAC and the Subcommittee considered that key benefits of aripiprazole were its reduced propensity to cause weight gain versus some of the other funded atypical

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antipsychotics, reduced risk of raised prolactin and reduced risk of prolongation of the QTc interval. PTAC considered that it would be beneficial to have another funded treatment option for schizophrenia; however, it noted that the place of aripiprazole in therapy was uncertain but was likely to be similar to ziprasidone. Therefore, the Committee recommended that aripiprazole be listed on the Pharmaceutical Schedule only if it was cost-neutral compared with ziprasidone. If the Board approves this proposal there would be no further funding applications under consideration by PHARMAC with regard to aripiprazole; however, we would always remain open to receiving new applications for changes to the access criteria.

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