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9 June 2008 Media release Herceptin consultation ends Consultation on PHARMAC’s proposal to decline funding for 12 months treatment with the breast cancer drug Herceptin ends today, with more than 300 submissions received. CEO Matthew Brougham says that given the need to analyse all consultation responses carefully, and seek further input from advisory committees, the earliest PHARMAC could make a decision would be July 2008. In its letter seeking consultation responses, PHARMAC had indicated a decision might be made in June. “We need to consider all the information we have received very thoroughly and where appropriate seek further input from our advisory committees,” says Matthew Brougham. “We know this will mean a slightly longer time-frame for our decision but we think it’s better to make a good decision than a quick decision, so this is the right way to go.” “We appreciate the time and effort that people have put into their submissions, the response has been considerable.” Matthew Brougham says the next step will be to seek input from a committee of cancer specialists, the cancer treatments sub-committee of PTAC. That committee will provide its advice to PHARMAC’s main clinical committee, the Pharmacology and Therapeutics Advisory Committee (PTAC). Overall, Matthew Brougham says PHARMAC aims to take a very thorough approach to all its decision–making. “Herceptin is no exception and the steps we are taking will ensure that when the PHARMAC Board is asked to make its decision, it does so with all necessary information to enable it to make the best decision possible.” Indicative forward timeline: · · · · · ENDS More information: Simon England 021 863 342. 9 June – consultation ends 13 June – Cancer Treatments sub-committee (Catsop) meets June/July – PTAC meets to consider outcome of Catsop meeting 4 July – Consumer Advisory Committee meeting Earliest date for PHARMAC Board decision - end July

Background Why did PHARMAC again consult on Herceptin? A High Court judicial review decision directed PHARMAC to consult on its decision not to fund Herceptin for HER 2 positive early breast cancer in July 2006. PHARMAC decided not to fund Herceptin in July 2006 and, after a thorough consideration of the evidence, economic analysis and with advice from its clinical advisory committees, decided in April 2007 to fund 9 weeks treatment with Herceptin from 1 June 2007. The previous consultation that PHARMAC conducted in March/April 2007 was on a proposal to fund 9 weeks’ treatment with Herceptin for HER 2 positive early breast cancer. What did PHARMAC consult on this time? Consultation was on a proposal to decline funding for 12 months’ Herceptin. Who was consulted with? PHARMAC sought the views of anyone with an interest in Herceptin. This included clinicians, public groups and individuals. The consultation document was sent to over 200 individuals and organisations and posted on the PHARMAC website. Meetings were also held with some groups as part of consultation. What happens now? All the feedback we received will be taken into consideration before a recommendation is taken to the PHARMAC Board. In addition, further input will be sought from the cancer treatments sub-committee of PTAC (Catsop), and PHARMAC’s Consumer Advisory Committee. We anticipate that a decision on this proposal would be made by the Board in late July 2008. What is the nature of PHARMAC’s consultation? PHARMAC wants to make its decisions after assessing all relevant information. Part of this information gathering is asking the wider public for its input, particularly on the impact of a particular funding proposal should it proceed. Consultation is not about counting votes but rather ensuring that the decision maker – in this case the PHARMAC Board – has all relevant information before it when it makes a decision. The purpose of consultation is to ensure that decision makers make a robust and well-informed decision.

Is Herceptin still funded? Yes. At present New Zealand women continue to have fully funded access to an effective and full course of Herceptin treatment – 9 weeks’ concurrent treatment with a taxane drug. Currently about 350 women each year are eligible for treatment with Herceptin for early breast cancer. If, having considered consultation responses, the Board approves the proposal to decline funding for a 12 months Herceptin treatment, the 9 week funded treatment would remain available. With respect to 12 months treatment, even if the Board decides not to fund such a treatment following this consultation, PHARMAC could still reconsider that decision in future if new information shows that funding could be justified under our decision criteria. What would be the cost of funding a 12 month treatment regimen? A nine-week regimen of Herceptin is currently funded and this is estimated to cost DHBs about $6 million per year. Funding 12 months’ Herceptin at the current contracted price would cost about $25 million per year. Why is NZ currently funding a different treatment regimen to other countries? Concurrent 9 week Herceptin is available as a treatment choice in other countries, and international debate about whether longer duration treatment is necessary continues. PHARMAC is helping to fund an international clinical trial (SOLD), to help answer the question of whether it is worth adding longer-duration treatment to a concurrent 9 week regimen. The trial has ethics committee approval to proceed in NZ.