The National Institute for Health and Clinical Excellence (NICE), the healthcare guidance body, opened a consultation on new, draft guidance which does not recommend bevacizumab (Avastin, Roche), for the first-line treatment of metastatic breast cancer, when used in combination with the chemotherapy drug, capecitabine.
Clinical effectiveness evidence submitted to the Independent Appraisal Committee compared bevacizumab (in combination with capecitabine) with capecitabine (plus placebo).
The committee concluded that, although the median progression-free survival benefit (the time point in the trial at which the 50% of people's cancers began to progress once again) associated with bevacizumab plus capecitabine was 2.9 months more than capecitabine monotherapy, it was unclear whether that benefit translated into an improvement in overall survival.
There was also no data to show if patients would have a better quality of life than if they were treated with chemotherapy alone - an important issue raised during the appraisal. Bearing in mind these uncertainties combined with the high cost of bevacizumab, the committee concluded this treatment was not a good use of limited NHS resources.
Sir Andrew Dillon, NICE Chief Executive, said: "We understand the need for effective treatments that can help patients live for as long as possible with a good quality of life. However, the evidence submitted to our independent appraisal committee did not conclusively show that bevacizumab could do either.
"The cost-effectiveness of the treatment was also an issue; we can't recommend a drug that has not been shown to work as well as, or better than, current treatments and costs much more. We want to ensure people have access to the best treatments the NHS can afford; bevacizumab has so far not been proven to be clinically or cost-effective."
Consultees, including the manufacturer, healthcare professionals and members of the public, are now able to comment on the preliminary recommendation during this period of public consultation. Any and all comments received will be fully considered by the committee and, following this meeting, the next draft of the guidance will be issued.
Breast cancer is one of the most common cancers in this country. In the UK, over 48,000 women and around 300 men are diagnosed with breast cancer each year. Some people will be diagnosed with advanced (metastatic) disease while others may develop metastatic breast cancer in the years following their initial diagnosis. In 2009, NICE published a clinical guideline on the diagnosis and treatment of people with advanced breast cancer, which recommends a range of treatment options, depending on the specific type of a patient's breast cancer.
Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
Source: NICE
* Office for National Statistics, Cancer Statistics registrations: Registrations of cancer diagnosed in 2008, England. Series MB1 no.39. 2010, National Statistics: London; ISD Online. Information and Statistics Division, NHS Scotland, 2010; Welsh Cancer Intelligence and Surveillance Unit. Cancer Incidence in Wales. 2010; Northern Ireland Cancer Registry 2010. Cancer Incidence and Mortality
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