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Requests to use off-label cancer treatments handled differently by different trusts

Requests to use treatments off-label for rarer cancers are handled differently by different NHS organisations, according to a report from the Rarer Cancers Forum.

The authors of the report, entitled “Off limits — an investigation into NHS organisations’ policies and processes for determining requests for the use of off-label treatments for people with cancer” (PDF 630K), questioned NHS organisations under the Freedom of Information Act.

They claim that nearly one third of hospital trusts responding to the audit did not have a protocol in place to ensure high-quality clinical governance for off-label treatments. Some trusts said they actively discourage the practice of off-label prescribing: three primary care trusts reported that they have a policy of not funding off-label treatment requests, something the authors of the report suggest could be in breach of the NHS Act. Other trusts acknowledged the need for off-label prescribing.

Extrapolating data reported by 43 primary care trusts, the authors predict that there were over 3,000 requests for off-label treatment in England over the past three years, with just over 1,000 being rejected. Funding the rejected requests would have cost £21.9m, the authors say.

According to the report, the five most commonly requested off-label treatments for cancer are rituximab, sunitinib, lenalidomide, bortezomib and bevacizumab.

The report’s authors make a number of recommendations, including that all NHS trusts develop a protocol or policy for off-label prescribing. They also suggest that the Department of Health should make the production of information for patients on the use of off-label treatments a priority and recommend that the DoH, the Medicines and Healthcare products Regulatory Agency and the Association of the British Pharmaceutical Industry work together to produce guidance clarifying the circumstances under which pharmaceutical companies can provide information on the off-label use of their products to clinicians, charities and policy-makers.

Commenting on the report, David Thomson, chairman of the British Oncology Pharmacy Association and lead pharmacist at the Yorkshire cancer network, told The Journal that the authors do not clearly separate decisions about the use of non-expensive drugs that have been used for a number of years and decisions about new biotech off-label use where there is limited evidence and safety.

Mr Thomson also questioned the motives behind the report, which was funded by a number of pharmaceutical companies. He pointed out that pharmaceutical companies are not allowed to promote the use of off-label medicines.

Citation: The Pharmaceutical Journal URI: 10975985

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