NICE rejects new use of Novartis, GSK meds

Britain's cost-effectiveness watchdog has rejected two cancer-treatment approaches: GlaxoSmithKline's Arzerra for resistant leukemia, and Novartis' Glivec in high doses for gastrointestinal tumors. The National Institute for Health and Clinical Excellence said the data on benefits and cost-effectiveness weren't enough to support these uses for the drugs.

Glivec is approved for use by the National Health Service at a 400-mg dose in patients with gastrointestinal stromal tumors that can't be surgically removed. Novartis wanted clearance for 600- and 800-mg doses for use in patients who don't respond to the lower dose. But NICE said the application lacked "good quality clinical and cost effectiveness data" for the new doses.

On Arzerra, NICE objected to the cost of using the drug to treat leukemia patients who don't respond to both first-line drugs--£18,449 on average, compared with supportive care for £4,885. The agency said the extra cost wasn't justified, despite GSK data showing that patients could live an extra seven months, on average. The agency had wanted GSK to test Arzerra comparatively with supportive care, but the company submitted a study in which all patients were given Arzerra, NICE said.

The use--or rejection--of costly cancer drugs has become a big issue in the U.K., as NICE continues to turn away expensive meds that, in its estimation, don't provide enough benefits to justify the cost. The coalition government earlier this year established a special fund for cancer drugs that NICE hasn't approved.

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