The National Institute for Health and Clinical Excellence’s decision to reject an appeal to make Roche’s Avastin, Bayer's Nexavar and Wyeth's Torisel available on the National Health Service for renal cancer patients has unsurprisingly led to protests from the drugmakers and patient groups.

NICE has this morning issued guidance saying that Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) are not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma. In addition, the agency has turned down the use of Nexavar and Pfizer’s Sutent (sunitinib) as secondary treatment options for people with either form of the disease, adding that those patients who are currently receiving these treatments should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.

A year ago, NICE turned down all four drugs for first-line use but then changed its guidance to recommend Sutent at the beginning of 2009. However an appeal against that Final Appraisal Determination brought by Roche, Wyeth the James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support, have not been upheld.

Peter Littlejohns, NICE’s clinical and public health director, noted that “we are very aware that renal cancer is a devastating disease for the individual and their family” and following the about-turn over Sutent in March, “one of these new treatments is now available”. However, he added that the evidence to support the use of the other first and second line treatments “isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas”.

Prof Littlejohns concluded that “our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost”.

Roche has responded to the guidance by saying that it is “fundamentally flawed” and serves only to reduce treatment access and options “for those UK patients who are sadly dying from this disease whilst being available to other patients in comparable countries”. The company adds that the appraisal committee accepted Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already-approved Sutent “but turned it down simply because it has a licence in other indications - despite the fact that these indications are not currently routinely reimbursed on the NHS”.

The implication of this guidance, Roche claims, is that patients who are unsuitable for sunitinib “may be condemned to faster disease progression of their terminal cancer”. John Melville, general manager of Roche UK, said the decision is “entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda”.

He added that Avastin “demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end-of-life criteria which were devised for this very setting”. The company stated that it is “considering all options”.

Stella Pendleton, executive director of the Rarer Cancers Forum, said “this is a deeply disappointing decision and a bitter blow. It is “harrowing” for patients “to know that effective treatments are available but they can’t get them on the NHS”, she added.

Ms Pendleton went on to note that the guidance will be considered for review by June 2011 and that review and “reversal of this decision cannot come fast enough”.