The United Kingdom’s regulatory board, has rejected Avastin (bevacizumab) for the treatment of patients suffering from metastatic breast cancer. There is simply not enough proof that the drug is truly beneficial in upping survival rates. The medication can cost more than $8,000 per month, making it one of the costliest cancer treatments, and had revenues of more than six billion Swiss francs, or about $6.3 billion, in 2010.

The National Institute for Health and Clinical Excellence (NICE) chief executive Andrew Dillon states:

“The evidence for the effectiveness of [Avastin] in prolonging survival wasn’t robust. Overall, [the drug] didn’t show enough of a demonstrable benefit for it to be considered a cost-effective use of National Health Service resources. NICE is committed to ensuring the most effective and efficient treatments, both for patients and the NHS, are available to those who need them. With this in mind, we already recommend a range of treatment options for patients with metastatic breast cancer in our clinical guideline for advanced breast cancer.”

Roche responded, saying it was disappointed that NICE won’t recommend Avastin for women with advanced breast cancer in England and Wales. It noted that Avastin in combination with chemotherapy “is a valuable treatment option, halting the growth of tumors for an extra 5.5 months on average.”

Bevacizumab is currently approved by the U.S. Food and Drug Administration (FDA) for cancers that are metastatic (have spread to other parts of the body). It received its first approval in 2004 for combination use with standard chemotherapy for metastatic colon cancer and non-small cell lung cancer. In 2008, it was approved by the FDA for use in metastatic breast cancer, a decision that generated some controversy as it went against the recommendation of its advisory panel, who objected because it only slowed tumor growth but failed to extend survival.

In the US, Members of a Food and Drug Administration panel said in July 2010 that they also did not see enough of a benefit from Avastin in advanced breast cancer to justify its serious risks. The pharma giant is in a bit of trouble as the U.S. government is considering allowing generic versions of biological drugs to come to the market earlier by cutting the exclusivity period to seven from 12 years.

Roche said that NICE’s decision means that women in England will rely on their clinicians’ successful application to the Cancer Drugs Fund in order to receive treatment with Avastin. The U.K. Cancer Drugs Funds provides some GBP200 million a year to cancer patients.

NICE produces guidance in three main areas of health. The first is public health and guidance on the promotion of good health and the prevention of ill health for those working in the National Health Service (NHS), local authorities and the wider public and voluntary sector.

The second area of focus is health technologies and comment on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS.

Finally there is clinical practice and the appropriate treatment and care of people with specific diseases and conditions within the NHS.

Source: The National Institute for Health and Clinical Excellence

Written by Sy Kraft, B.A.