This is the text extract for 2011-09 PTAC Minutes, browse documents here.

PTAC Email meeting held 12 to 26 September 2011 (minutes for web publishing)

PTAC minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees 2008. Note that this document is not necessarily a complete record of the PTAC meeting; only the relevant portions of the minutes relating to PTAC discussions about an Application or PHARMAC staff proposal that contain a recommendation are published. PTAC may: (a) recommend that a pharmaceutical be listed by PHARMAC on the Pharmaceutical Schedule and the priority it gives to such a listing; (b) defer a final recommendation, and give reasons for the deferral (such as the supply of further information) and what is required before further review; or (c) recommend that PHARMAC decline to list a pharmaceutical on the Pharmaceutical Schedule.

Contents

1 Valganciclovir for prophylaxis and treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients. .........................................................................................3

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Valganciclovir for prophylaxis and treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients.

Application 1.1 The Committee reviewed a PHARMAC staff proposal for the listing of valganciclovir on the Pharmaceutical Schedule for prophylaxis and treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients.

Recommendation 1.2 The Committee recommended that valganciclovir be listed on the Pharmaceutical Schedule under Special Authority for prophylaxis and treatment of CMV retinitis in immunocompromised patients a high priority. The Decision Criteria particularly relevant to this recommendation are: (i) The health needs of all eligible people within New Zealand; (iii) The availability and suitability of existing medicines, therapeutic medical devices and related products and related things; (iv) The clinical benefits and risks of pharmaceuticals; and (vi) The budgetary impact (in terms of the pharmaceutical budget and the Government’s overall health budget) of any changes to the Pharmaceutical Schedule. Discussion 1.3 The Committee noted that valganciclovir is currently available for up to 14 weeks supply for cytomegalovirus retinitis treatment in immunocompromised patients under Discretionary Community Supply from a District Health Board hospital. The Committee considered that it would be appropriate to include treatment for cytomegalovirus retinitis in any proposed listing for valganciclovir in the community. The Committee recommended the following Special Authority

Treatment of CMV retinitis in immunocompromised patients. Approvals valid for 90 days for applications meeting the following criteria: 1) Patient is immunocompromised 2) Patient has CMV retinitis

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