Regulatory Focus™ > News Articles > NICE Denies Avastin Indication for Breast Cancer

NICE Denies Avastin Indication for Breast Cancer

Posted 18 April 2012 | By Alexander Gaffney, RAC 

The UK's National  Institute for Health and Clinical Excellence (NICE) announced in a draft guidance it will not approve Roche's breast cancer drug Avastin (bevacizumab) due to "too many uncertainties" about the drug's cost effectiveness, writes In Pharm.

"The draft guidance, which is out for consultation, has not recommended Avastin as first line treatment for metastatic breast cancer in combination with chemotherapy drug capecitabine," wrote In Pharm.

NICE's decision follows that of the US Food and Drug Administration (FDA), which removed Avastin's indication for breast cancer in November 2011, and released the full text of its rationale for that decision in late February 2012.

FDA determined Avastin was not beneficial to patients with HER2-negative metastatic breast cancer (MBC), and after a public hearing, withdrew its indication for that condition.

NICE came to a similar conclusion, said In Pharm, noting, "although median progression-free survival with bevacizumab plus capecitabine was 2.9 months more than with capecitabine alone, it was unclear whether that meant an improvement in overall survival."

Avastin's cost-effectiveness was also questioned by the body, which takes the price of a drug into account when determining whether a medicinal product is eligible for National Health Service reimbursement.

"[It] has so far not been proven to be clinically - or cost effective," said Sir Andrew Dillon, chief executive of NICE. "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." 

NICE's final guidance is not expected until August 2012, and has been in development since November 2008.


Read more:

NICE - Breast cancer (metastatic) - bevacizumab (1st line, with capecitabine) [ID54]

In Pharm - NICE rejects Avastin for breast cancer

Regulatory Focus - Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe