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PHARMAC QUESTIONING HERCEPTIN TREATMENT DURATION

February 20, 2007

New Zealand's Pharmaceutical Management Agency (PHARMAC) has announced its financial support for an international trial that will examine whether nine weeks or 12 months is the better treatment duration for Herceptin, a breast cancer drug marketed by Roche. In addition, PHARMAC is continuing to assess funding options, including for the nine-week treatment option.

International trials have raised questions about the optimum duration and sequencing of Herceptin (trastuzumab) treatment. The HERA trial demonstrated the benefit of a 12-month treatment regimen, while study N9831 did not. The sequential arm of the N9831 trial was missing from the study report, according to PHARMAC. This arm showed that Herceptin had no significant benefits over chemotherapy alone. Roche has told PHARMAC it is unable to supply the full data, PHARMAC said.

Many countries are not able to consider funding a treatment duration other than 12 months, given the drug's registered indication. But PHARMAC does not want to commit to a long-term treatment regimen, as promoted by Roche, without sufficient evidence, Deputy Medical Director Dilky Rasiahsaid said. "There is no problem with such lock-in, or long-term treatments, in principle if the evidence strongly supports that, but that is not currently the case with Herceptin," he said.

Longer-term treatment regimens may expose patients to prolonged treatment effects and toxicity without any proven added benefit, according to PHARMAC.