The UK National Health Service’s cost-effectiveness watchdog has ruled that Roche’s Herceptin should be made available to women with early-stage breast cancer, in a move that should bring to an end the controversy over access to the drug.

The National Institute of Health and Clinical Excellence delivered draft guidance on Herceptin (trastuzumab) this morning, supporting its use in women with HER2-positive breast cancer, including those with early-stage disease, and should finalise its recommendations in July.

Once adopted, health authorities will have a three-month period to comply with the recommendations, but thereafter will lay themselves open to legal action if they deny treatment with Herceptin to eligible women. Only women who have signs of heart disease will not stand to receive it, because of concerns that Herceptin may exacerbate the problem. Moreover, women will need to have their cardiac function monitored every three months while on the drug.

Around 20% to 30% of breast cancers are HER2-positive, and it is estimated that roughly a tenth of all patients will be excluded from treatment with the drug because of heart problems.

NICE had been expected to come out in favour of Herceptin, as there has been relentless pressure on the agency from all sides to expand access to the drug. Women have been taking to the courts to force their primary care trusts to pay for the drug, and Health Secretary Patricia Hewitt has also put her weight behind drive, asking NICE to fast-track the application.

One of the primary objections to the use of in early-stage patients was the lack of data showing that it could improve overall survival in these patients, but this situation was rectified last week when two-year results of the HERA study were presented at the American Society of Clinical Oncology meeting.

This showed that Herceptin taken for 12 months following standard chemotherapy significantly reduced the risk of death by 34% for women with early-stage HER2-positive breast cancer after two years follow-up.

NICE’s guidance comes just a couple of weeks after the European Medicines Agency (EMEA) gave a green light for the use of Herceptin in early-stage patients.

Breast cancer campaigners welcomed the guidance, but said it was now imperative that a well-organised system of HER2 testing be made available across the UK to allow eligible women to receive treatment with Herceptin quickly.

But given Herceptin’s price tag of up to £30,000 a year, and the fact that the government announced only this week that the NHS deficit had doubled to £512 million in 2005-6 compared to the previous year, concerns have already been raised that funding for Herceptin could exacerbate cutbacks in other areas.

Professor Mike Richards, the government’s cancer tsar, told the BBC that this would not occur, and that more money was being made available to the NHS each year. NICE has not yet released its predictions of the financial impact that the guidance will have on NHS spending.