Herceptin cancer drug wins final British go-ahead

Britain’s cost-effectiveness watchdog issued final guidance on Wednesday recommending that Herceptin should be used in early breast cancer and be paid for by the state health service.

The move by the National Institute of Health and Clinical Excellence (NICE) clears the way for the drug to be prescribed on the National Health Service for women with aggressive HER2 breast cancer following surgery.

NICE had given a preliminary green light to the Roche medicine in June but that decision was challenged by Newbury and Community Primary Care Trust, delaying final approval. In the event, the trust’s appeal was not upheld.

British authorities have been under intense pressure to back wider use of Herceptin after women with early-stage disease went to court to force local health authorities to pay for it.

Until now, Herceptin has been recommended for treating only metastatic cancer, a late-stage condition in which tumors have spread around the body. The new approval extends its use to a much large number of mainly younger patients.

NICE deliberations are watched closely by other governments, who increasingly have to weigh the benefits of modern medicines against their price. Herceptin costs around 20,000 pounds ($38,000) per patient a year.

Herceptin is not a wonder drug. It only works in just over one in five breast cancer cases, and it can cause cardiotoxicity, which means it is not suitable for patients with heart problems.

But the injectable drug has been shown to prolong survival chances for those women whose tumors contain a large amount of the HER2 protein and NICE Chief Executive Andrew Dillion said it was clearly “clinically and cost effective”.

The medicine, which was originally discovered by Roche’s U.S. biotech partner Genentech, is the Swiss group’s third-biggest product, with sales last year of 2.15 billion Swiss francs ($1.75 billion).

It was first approved in Europe in 2000 and in the United States in 1998 for advanced breast cancer.

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