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Herceptin status unchanged

October 16, 2006

Herceptin status unchanged following further PTAC advice

Herceptin is to remain unfunded for early stage breast cancer for the present time, PHARMAC said today.

PHARMAC’s clinical advisory committee (“PTAC”), has examined further evidence, and recommended 12 months treatment of Herceptin not be funded. PTAC identified continuing uncertainties raised by clinical trials as a key reason for its recommendation.

PTAC (the Pharmacology and Therapeutics Advisory Committee) reviewed further data following a PHARMAC decision to not fund Herceptin in July. The new information included:

provisional (not peer reviewed) two-year data from the one year treatment arm of the large-scale HERA trial;

an independent analysis of Herceptin by the University of Sheffield; and

a Finland-based trial for a 9-week treatment option (the FinHer trial).

Despite some new information, PTAC’s view is that funding is still not justified, says PHARMAC’s Deputy Medical Director Dr Dilky Rasiah.

“PTAC’s view is that the uncertainty still surrounding Herceptin means it is not possible to justify a positive funding recommendation for 12 months treatment,” Dr Rasiah says.

“This is a difficult, but responsible recommendation. When funding medicines, we need to be confident that the evidence supports that investment over other medicines PHARMAC is evaluating. This is particularly important when investments are very large, such as with Herceptin (around $20-25 million per year). At the moment, the evidence does not provide us with that confidence.”

DHBs CEO spokesman David Meates says DHBs are in agreement with PHARMAC’s assessment to date.

“DHBs contine to strongly endorse the work being undertaken by PHARMAC on behalf of District Health Boards and are fully supportive of the position that has been reached” says David Meates. “New Zealand is not the same as other countries, we have a different decision framework, different funding structures and have to make our decisions accordingly. PHARMAC has very clear and robust processes for ensuring that any new DHB spending on pharmaceuticals is justified.”

PTAC has, however, asked for further advice from its cancer treatments sub-committee on the feasibility of using nine weeks of treatment with Herceptin (as tested in the FinHer trial).

“Any decision such as this needs to be taken carefully and in light of all the available evidence. We will be interested in the cancer sub-committee’s view on nine week treatment,” says David Meates.

The cancer treatments subcommittee examined Herceptin in April and gave it a low to medium priority for funding.

“We will ask the cancer subcommittee for further advice to ensure all possible avenues for funding Herceptin are thoroughly investigated,” says Dr Rasiah.

Dr Rasiah acknowledges that PTAC has arrived at a different view to clinical committees in other countries. The key reasons for this difference are a stronger emphasis by PTAC and PHARMAC on the uncertainty in clinical evidence given the cost; the drug’s cost effectiveness compared to other drugs; and taking into account the practical implications for health services of administering this medicine.

Dr Rasiah says PHARMAC remains committed to an ongoing review of new evidence in relation to Herceptin.

[ENDS]

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