NICE Drug Reviews Terminated When Manufacturers Fail To Submit Evidence, July 2008, UK

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cancer / Oncology
Article Date: 23 Jul 2008 - 0:00 PDT

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Because insufficient evidence was provided by the manufacturers, NICE is unable to recommend the use the following treatments in the NHS:

-- bevacizumab in combination with paclitaxel for the first-line treatment of metastatic breast cancer

-- bevacizumab in addition to platinum-based chemotherapy for the first-line treatment of patients with inoperable advanced, metastatic or recurrent non-small-cell lung cancer (other than predominantly squamous cell histology)

-- carmustine implants as an adjunct to surgery in patients with recurrent glioblastoma multiforme (a type of brain cancer) for whom surgery is appropriate

-- cetuximab for the treatment of colorectal cancer following failure of oxaliplatin-containing chemotherapy

Andrew Dillon, NICE Chief Executive said:

"NICE is committed to producing timely guidance to the NHS using our fast-track single technology appraisal process. This process relies on the manufacturer to submit evidence so that we can appraise the treatment. Occasionally, manufactures either fail to make a submission or the submission is inadequate. Where this happens we work with the company to try and resolve the problem. If the problem cannot be resolved we will have to bring an appraisal to a conclusion without undertaking a full evaluation.

"In these circumstances, we will issue advice to the NHS which will say that 'NICE is unable to recommend the use of the technology'. The advice will explain why we have come to the conclusion to terminate the appraisal and will offer advice to the NHS on what to do next. Normally, this will be that the NHS should be cautious in considering use of the treatment. Of course, if sufficient evidence does become available in the future, we may take the opportunity to review and to revise our advice to the NHS."

About NICE

The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

NICE produces guidance in three areas of health:

-- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

-- health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS

-- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

NICE guidance is developed using the expertise of the NHS and the wider healthcare community including NHS staff, healthcare professionals, patients and carers, industry and the academic world.

http://www.nice.org.uk