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Drug maker appeals over NICE ruling

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A decision by the medicines watchdog to deny NHS funding for a breast cancer treatment is being appealed by the drug’s maker.

The National Institute for Health and Clinical Excellence (NICE) ruled that patients with advanced ErbB2-positive breast cancer should not be given access to Tyverb (lapatinib).

Initially, pharmaceutical giant GlaxoSmithKline (GSK) had offered to fund patients through a 12-week programme. The health service would then have the option to pay after the 12-week period only if it was proven patients were benefiting from the treatment.

But its final appraisal determination, NICE rejected the plan, explaining it was not a cost effective use of NHS resources.

A four-week course of Tyverb, which is not a cure but can delay progression of the disease, costs £1,608.

The NICE recommendation suggested the cost per QALY (quality-adjusted life year) using the GSK patient access scheme would be around £70,000 versus chemotherapy drug capecitabine.

But the manufacturer’s own analysis produced a figure of £16,000 and pointed out that it helped control the disease in women after standard chemotherapy and trastuzumab (Herceptin) had failed to stop it returning.

An independent panel will assess GSK’s submission to determine if there are grounds for an appeal against the Nice recommendation. A spokesman for Nice said it was unable to comment while the appeal was pending.

Copyright Press Association 2009

NICE






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