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News for week ending 5 July 2002


New Zealand haematologists are describing Pharmac's proposal to restrict funding of the new leukaemia drug Glivec to patients with advanced leukaemia as deplorable.

In its submission to Pharmac this week, the New Zealand of the Haematology Society of Australia and New Zealand says it is "probably unethical" not to offer imatinib mesylate (Glivec) to patients with chronic myeloid leukaemia in the chronic (early) phase who have failed other therapy.

Society president Dr Peter Browett says imatinib mesylate is less effective in advanced disease.

"In the phase II and III studies presented to date, the greatest benefit has been in patients treated in the chronic phase of their disease, and this has been the recommendation of haematologists worldwide," he said.

The Society wants imatinib mesylate funded for all three phases of chronic myeloid leukaemia i.e. chronic phase, accelerated phase (advanced disease) and blast crisis (end stage disease). Pharmac has proposed that it funds the new treatment for patients in the two advanced stages of the disease only.

"In the US and parts of Europe imatinib mesylate has now become the standard of care for patients with chronic myeloid leukaemia. New Zealand haematologists are now faced with the dilemma as to whether it would be unethical not to offer patients treatment with this agent in chronic phase when they have failed other therapy," said Dr Browett.

The Society also says that Pharmac, in recommending funding for imatinib mesylate for patients in accelerated phase and blast crisis only, is ignoring the recommendation of its own specialist committee.

Dr Browett says it is a matter of concern to New Zealand haematologists that their colleagues had been asked to provide specialist advice that was subsequently misrepresented by Pharmac's Pharmacological and Therapeutic Advisory Committee (PTAC)

"Contrary to what PTAC reported, the specialist advisory committee did not suggest prioritisation of funding of imatinib mesylate when it first reviewed the therapy. Subsequently, however, the advisory committee did recommend funding of accelerated phase patients as a priority, if prioritisation was required. It then said that funding should be given to chronic phase patients over blast crisis patients."

Christchurch haematologist Dr Ruth Spearing says even within advanced disease Pharmac's proposed criteria for funding are too rigid. Those criteria dictate that to remain on the therapy, a patient must have a complete haematologic response (i.e. normalised white blood cell count) within three months of starting therapy and a major cytogenetic response (i.e. major disappearance of cancer cells) within six months.

"There are an estimated 90 people with this disease in New Zealand who are eligible for treatment with this therapy. There are only six to eight patients in accelerated phase or blast crisis and if you adopted Pharmac's proposed selection criteria, only one or two of them would be able to remain on Glivec after six months. Yet, given the opportunity to remain on imatinib mesylate, patients can achieve the required response up to and, in some cases, beyond 12 months after starting therapy. "

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