'Preliminary results on the use of Herceptin for early stage breast cancer are encouraging and it is important that the NHS receives timely advice on the clinical use and cost effectiveness of these treatments.'

The move should allow thousands of women to benefit from using Herceptin next year up to three years earlier than originally scheduled.

Impressive results from three major clinical trials in May showed the drug halves the risk of cancer recurring in women with a particularly aggressive form of the disease.

The decision came within hours of a decision announced yesterday by the medical insurer BUPA to pay for the use of Herceptin in early stage breast cancer.

Early Stage Breast Cancer

Dr. Natalie-Jane Macdonald, medical director of BUPA Insurance, said: "Breast cancer is a terrible disease which causes women great anxiety. We think it is important to bring new and innovative treatments backed by clinical evidence to our members.

"We have calculated that around 400 women with BUPA cover and early stage breast cancer could directly benefit from the use of Herceptin by slowing or even eliminating the progression of the disease, if trial results are replicated."

Other private medical insurers that have agreed to reimburse the treatforment for early stage breast cancer are Norwich Union, Western Provident Association and Standard Life.

Around one in four of 40,000 newly diagnosed women each year has the HER2 form of the disease which Herceptin is designed to treat.

It is already licensed for use in advanced stages of breast cancer, although surveys show only half of eligible women are getting it.

Manufacturer Roche is expected to apply for an extended license shortly, enabling the drug to be marketed for early stage cancers in May 2006.

A Clear Signal

Mrs. Hewitt said she was concerned that there could be a significant delay before the National Institute Health and Clinical Excellence approved its use on the NHS.

Under the current system of appraisal Herceptin would be unlikely to win approval before 2009, three years after licensing.

Her announcement of an early referral is a clear signal that she expects it to be approved and funded by NHS trusts as quickly as possible. She made a similar referral for the drug Velcade, which showed promising results in the treatment of multiple myeloma.

Mrs. Hewitt said: "I have the deepest sympathy for the pain and suffering that cancer patients and their families experience and completely understand why they want to see any drug that can help made more widely available.

"I have decided that an early referral of Herceptin is necessary to allow the National Institute to begin the preliminary work on the development of advice to the NHS on the clinical and cost effectiveness of these treatments and react as soon as possible after the drug is licensed."

Mike Richards, national cancer director at the Department of Health, welcomed the move, saying: "Preliminary results on the use of Herceptin for early stage breast cancer are encouraging and it is important that the NHS receives timely advice on the clinical use and cost effectiveness of these treatments."

Bureaucratic Delays?

CancerBACUP, a leading cancer charity, has attacked past delays, claiming some patients are dying while they wait for new treatments to be approved.

It called for a fast-tracking system to be introduced, despite claims by the National Institute that it was not holding up treatments with " bureaucratic delays."

The National Institute for Health and Clinical Excellence has already been condemned this week for postponing a decision on Alzheimer's drugs which sufferers claim would buy them months of improved life if made available on the NHS.