RespiteMatch.com Health Blog

By Sam Lister
A licence to extend the use of the breast cancer drug may be granted within months

WOMEN with early-stage breast cancer should be able to get the drug Herceptin on the NHS by the end of the year after a licensing application was made by its manufacturer.
Roche, the pharmaceutical company, announced yesterday that it had submitted an application to the European Medicines Agency for the use of Herceptin to treat women in the early stages of the disease.

If, as expected, a licence is granted within a few months, the drug will be eligible for use in early-stage breast cancer treatment throughout the European Union, with guidance issued by the National Institute for Health and Clinical Excellence (NICE) soon afterwards. NICE, which advises on best practice for the NHS in England and Wales, has already begun a fast-track assessment of the drug, which will ensure that its appraisal is under way before a licence is granted.

However, breast cancer sufferers said yesterday that moves to extend the use of Herceptin had come too late for many women. Access to the drug around the country has been described as a “postcode lottery”. A course of treatment, which costs £21,000, is far more expensive than other medications, and there are also concerns about prescribing it before the full checks have been completed.

This week, Ann Marie Rogers lost her legal challenge over her local NHS trust’s refusal to fund treatment with Herceptin, which is not yet licensed for use in the early stages of breast cancer. Yesterday Ms Rogers’ solicitor welcomed Roche’s announcement, but said that it would be too late for many women.

Dave Standard, of Irwin Mitchell Solicitors, said: “This does not help the women who are currently living under a death sentence from being denied this potentially lifesaving drug on account of where they live.”

Herceptin is already licensed for use in women with advanced cancer whose tumours are classed as HER2 positive. But research has found that using Herceptin in the earlier stages of the disease can reduce the chances of cancer returning by 50 per cent after surgery.

About a fifth of breast cancer sufferers have tumours that are suited to treatment with Herceptin.

Elisabeth Cooke, 59, of Bristol, who had the aggressive HER2 form of the disease diagnosed in March last year, welcomed the news. She began a legal battle against Bristol North Primary Care Trust after it refused her Herceptin application.

This month the High Court ruled that the trust would have to fund the treatment on an interim basis.

Mrs Cooke said that she was “absolutely delighted” about Roche’s application to extend the licence. “I think all the recent media publicity over Ann Marie Rogers fuelled the fire a bit and made them get on with it. But I’m still concerned about when it is actually going to get licensed,” she said.

Ed Holdener, the head of Roche’s Global Pharma Development, said that “outstanding benefits” from Herceptin use in post-surgical therapy for early-stage breast cancer supported the company’s drive to improve access to it.

Anna Wood, of the charity Breast Cancer Care, said that the application was “extremely positive news”. She added: “Breast Cancer Care has been hearing daily from people with real fears over whether they will be able to access Herceptin. The lack of a licence for its use in the early stages of breast cancer has created a postcode lottery, with people’s access varying throughout the country. Today’s submission of this licence application is the start of the process to end the inequalities that exist for patients trying to access the drug.”