UK's NICE Herceptin ruling takes two weeks

The UK's National Institute for Health and Clinical Excellence (NICE) has published draft guidance on Swiss drug major Roche's anticancer agent Herceptin (trastuzumab) for early breast cancer, only two weeks after the drug was approved for that condition by the European Medicines Agency (EMEA). The NICE recommends that Herceptin should be used for the treatment of women with early-stage HER2-positive breast cancer, except where there are concerns about the patient's cardiac function.

Unless there are appeals against the decision, which was widely welcomed by the industry and patient groups alike, final guidance is expected in early July. At that point, those Primary Care Trusts within the National Health Service in England and Wales that have refused to provide patients with Herceptin would be required to do so, within three months, or face court-imposed sanctions. The Herceptin case has fuelled debate in the UK about the delay between a decision to rule that a drug is safe for patient use and the question of funding or reimbursement.

Andrew Dillon, the NICE's chief executive said: "these proposals are very good news for women with HER2-positive breast cancer. Herceptin, for these women is clinically- and cost-effective in the early stage of the disease." He added that the NICE "looks forward to being able to issue final guidance" in a few weeks time.