A drug will not be made routinely available on the NHS for women with breast cancer from today after a watchdog ruled that it does not help improve patients’ quality of life or provide value for money.
New guidance for doctors issued by the National Institute for Health and Clinical Excellence (Nice) does not recommend Avastin (bevacizumab) to treat women with the disease, it said.
The drug works by starving cancerous tumours of blood and was being looked at as a treatment in combination with capecitabine, a type of chemotherapy, for breast cancer that had metastasised to other parts of the body.
The advisory body said that making Avastin available on the NHS was not a good use of resources because of its high cost, and the lack of evidence to show patients would have a better quality of life than if they were treated with chemotherapy alone.
Sir Andrew Dillon, Nice’s chief executive, said: “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.
“Evidence presented to the independent appraisal committee did not conclusively show that bevacizumab, in combination with capecitabine, could improve overall survival or improve a patient’s quality of life more than current treatment.
“These uncertainties combined with the high cost of bevacizumab mean the drug simply isn’t cost-effective.
“I understand this news will be disappointing to people, especially those with breast cancer that has spread elsewhere in their body. However, Nice recommends a range of treatments that the NHS can use to treat metastatic disease and these are outlined in our clinical guideline on the diagnosis and treatment of advanced breast cancer.”
Nice said that it is the responsibility of NHS trusts to make decisions locally on the funding of treatment.
If doctors feel that a particular patient is likely to benefit from a treatment not recommended by Nice, they can apply on behalf of their patient to an “exceptional case” committee or to the Cancer Drugs Fund.
Avastin was being looked at for cancer patients for whom treatment with other chemotherapy options was “not considered appropriate”, a spokeswoman said.
In December last year the US Food and Drug Administration announced it was recommending the removal of the breast cancer indication from the label for Avastin after it was not shown to be safe and effective for that use.
It said the risks include severe high blood pressure; bleeding and haemorrhage; the development of “holes” in parts of the body such as the nose and stomach, and heart attack or heart failure.
The agency reviewed four clinical studies of Avastin in women with breast cancer and found the drug does not prolong overall survival or provide a sufficient benefit in slowing disease progression to outweigh the “significant risk” to patients.
Dr Rachel Greig, senior policy officer at Breakthrough Breast Cancer, said: “We welcome new treatments for women with metastatic breast cancer as we know their options are limited and prolonging life is incredibly important to them and their families.
“However, we understand it was a difficult decision for Nice to make as this treatment combination can cause serious side effects and there is no evidence to show how this may affect a patient’s quality of life.”
Roche, which manufactures Avastin, said it was disappointed by the decision and criticised the way that Nice had reviewed data about the drug’s effectiveness.
A company spokeswoman said the drug, when used with capecitabine, was “proven to be an important treatment option for women who have a particularly aggressive form of breast cancer which has a poor prognosis”.
“The decision by Nice means women in England with advanced breast cancer and who have limited treatment options available to them will instead have to rely on their clinicians’ successful application to the Cancer Drugs Fund in order to receive treatment with Avastin.
“However, there is no similar access to Avastin for patients in Wales, Scotland and Northern Ireland as yet,” she said.
“Avastin has a well-established tolerability profile and the most frequently observed side effects in clinical trials were hypertension, fatigue, neuropathy and proteinuria.
“The most common side effects are manageable, with hypertension for example being treated with conventional antihypertensive medication.”