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23 May 2008

Pfizer agreement for varenicline, quinapril and medroxyprogesterone acetate not approved

Summary The PHARMAC Board has not approved a provisional agreement with Pfizer New Zealand Limited, which was the subject of a consultation letter dated 30 November 2007. This means that the funding of the smoking cessation treatment Champix (varenicline) and the proposed changes to the Accupril (quinapril), Accuretic (quinapril with hydrochlorothiazide), and Depo-Provera (medroxyprogesterone acetate) terms of listing will not proceed. The funding of varenicline will be reviewed upon consideration of new data regarding its risk/benefit profile. The proposal that was consulted upon The provisional agreement with Pfizer that was consulted upon included the listing of varenicline under Special Authority. It also included amending the terms of listing of quinapril, quinapril with hydrochlorothiazide, and medroxyprogesterone acetate. Why the proposal was not approved The PHARMAC Board did not approve the agreement with Pfizer following advice provided by the Pharmacology and Therapeutics Advisory Committee (PTAC) on new information that came to light during the consultation period. We sought further advice from PTAC on varenicline after new information became available which drew international attention. This information focused on post-marketing data that indicated an increased risk of serious side effects such as depressed mood, suicidal ideation, aggression, convulsions, and cardiovascular events. In addition to this the first head-to-head study comparing varenicline with Nicotine Replacement Therapy (NRT) was also published on 8 February 2008 (Aubin, et. al., Thorax 2008 Feb 8 [Epub ahead of print] http://thorax.bmj.com/cgi/rapidpdf/thx.2007.090647v1. PTAC considered the new information and recommended that varenicline not be funded at present due to un-favourable evidence regarding its risk/benefit profile, particularly in relation to other funded options. It also recommended that before its funding is reconsidered the most upto-date information regarding its risk/benefit profile should be reviewed. Feedback received during consultation We appreciate the feedback we received as a result of our 30 November 2007 consultation letter and acknowledge the time people took to respond. We considered all the responses and presented them to the PHARMAC Board for consideration when it made its decision. Information contained in the consultation responses could generally be categorised as: 1. Support for the proposal. 2. Suggestions regarding the proposed restrictions. 3. Safety concerns. A196610 - T07-112

Support for the proposal – a number of responses were received supporting the listing of varenicline based on: · · · · · · · Evidence from indirect short-term studies showing the superiority of varenicline over NRT (although it was noted long-term studies are not currently available). Varenicline being more effective than bupropion and even though no direct comparison with nicotine replacement therapy (NRT) are available it is expected that varenicline will be at least as effective as NRT. Varenicline’s Numbers Needed to Treat (NNT) is possibly better than other smoking cessation therapies or methods. It being important that smoking cessation therapies are available and accessible as cost is a significant barrier to lower socio-economic groups. Varenicline’s subsidization would increase the availability and choice of products. An increase in cost effective choices. Smoking being a significant factor in a number of patients’ initial hospitalisation.

Suggestions regarding the proposed restrictions – the following comments/suggested changes to the proposed Special Authority restriction for varenicline were made: · · The restriction of six months authorisation in a two year period is too long due to the chronic relapsing nature of addition (it was recognised in some responses that this would increase cost and that there are other cessation supports available). Limiting the period of varenicline access to three months for any one attempt and permitting a further prescription after one year should be considered, instead of allowing up to 6 months treatment, as overall the opportunity for another quit attempt after one year would result in an effect similar to the first attempt while the second 12 week period would result in only a small additional benefit. The UK National Institute for Health and Clinical Excellence recommended that varenicline should normally be prescribed only as part of a programme of behavioural support.

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Safety concerns - Some responses discussed safety concerns with the following points being made: · Adverse reactions/emerging safety issues have become evident during post-marketing use in other countries including suicidal ideation, aggressive and erratic behaviour, confusion, drowsiness, impaired driving ability, myocardial infarction, and cardiovascular safety. Certain characteristics of the product increase the possibility that a number of previously unreported adverse reactions may become evident and that this would only occur after its use became widespread. While a causative association has not been established between the post marketing adverse reactions and although the situation is being closely monitored in the USA and the UK, the tolerability of varenicline should be reviewed closer to its anticipated funding date in order to check that funding is still appropriate. Monitoring of varenicline has been occurring since July 2007 following a recommendation by the Medicines Assessment Advisory Committee (MAAC)

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More information If you have any further questions about PHARMAC’s decision, you can call our toll-free number on 0800 66 00 50 (9am to 5pm, Monday to Friday).

A196610 - T07-112