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NICE rejects three bowel cancer drugs

Merck's Erbitux, Roche's Avastin and Amgen's Vectibix fail to win backing of UK's cost-effectiveness watchdog

NICE has ruled against the use of three drugs in advanced colorectal cancer.

The cost-effectiveness watchdog issued final draft guidance against the use after first-line chemotherapy of Merck's Erbitux (cetuximab), Roche's Avastin (bevacizumab) and Amgen's Vectibix (panitumumab) in metastatic colorectal cancer.

The National Institute for Health and Clinical Excellence (NICE) rejected the drugs over concerns about cost-effectiveness (with the drugs' most plausible ICERs ranging from £88,000 to £150,000 or higher per QALY gained).

NICE also cited specific uncertainties surrounding overall survival gain, overall survival and the magnitude of survival benefit granted by the drugs.

The three drugs also didn't meet the watchdog's criteria to be considered under special arrangements as treatments for patients facing the end of their lives.

NICE Chief Executive Andrew Dillon said: “We have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them.

“The independent appraisal committee which drafted the recommendations does not feel it has enough evidence, especially in the case of bevacizumab, to feel confident in recommending these drugs for use on the NHS.”

To treat the various stages of colorectal cancer, NICE recommends treatment with: 5-fluorouracil plus folinic acid in combination with oxaliplatin (FOLROX); 5-fluorouracil plus folinic acid in combination with irinotecan (FOLFORI); 5-fluorouracil, capecitabine and tegafur in combination with uracil (and folinic acid); irinotecan as monotherapy; or, Erbitux (in a highly specific patient population, and not for metastatic disease). 

Erbitux (in conjunction with chemotherapy) has been recommended by NICE in this capacity since June 2009.

In the UK Avastin is currently recommended for the treatment of bowel, breast, kidney and non-small cell lung cancers. However, it was rejected for the treatment of metastatic breast cancer, and last week the FDA reversed its approval for Avastin in breast cancer in the US because of the drug's poor benefit/side-effect profile.

Vectibix is indicated as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

It is not a surprise decision from NICE, which published initial – negative - guidance of its decision in September this year.

The consultees may now appeal against NICE's recommendation. Until the guidance is confirmed, local arrangements for use of these treatments must be made.

25th November 2011

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