NICE confirms Herceptin guidance 'within weeks'

In collaboration with the Press Association

In response to the announcement today by Roche that Herceptin has been granted a licence for use in early breast cancer, NICE Chief Executive Andrew Dillon today said the organisation hoped to issue guidance on prescribing the drug "within weeks".

The European Commission approved the use of Herceptin yesterday for patients with early-stage HER2-positive breast cancer following surgery and standard chemotherapy. HER2-positive breast cancer, which affects approximately 20 per cent to 30 per cent of women with breast cancer, demands special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse. Herceptin was previously approved in the EU for the treatment of metastatic - advanced - HER2-positive breast cancer, so this new approval allows women with all stages of this aggressive disease, including early-stage breast cancer, to benefit from Herceptin treatment.

"Our appraisal of the clinical and cost effectiveness of Herceptin is already underway," said Andrew Dillon.

"We are working hard to ensure our review is completed as soon as possible, and we will update our timelines on the basis of the earlier than anticipated granting of the licence as indicated by the manufacturer. We are keen to ensure that guidance is available in a matter of weeks."

Professor John Toy, Cancer Research UK's medical director, said: "We welcome the news that Herceptin has been licensed for use in early stage breast cancer as it will remove the uncertainty that has surrounded prescribing an unlicensed medicine on the NHS. "We hope NICE will make a decision about whether Herceptin will be available on the NHS as soon as possible so that all patients who are eligible for the treatment can receive it regardless of their financial situation or where they live."