UK's NICE turns down renal cancer drugs from Roche, Bayer, Wyeth and Pfizer

In a move that has angered cancer patient organizations, as well as four leading drugmakers, the UK's National Institute for Health and Clinical Excellence (NICE) has turned down an appeal for four renal cancer drugs to be allowed under the National Health Service.

Issuing guidance on the use of Roche/Genentech's Avastin (bevacizumab), Bayer's Nexavar (sorafenib) and Wyeth's Torisel (temsirolimus) for the treatment of renal cell carcinoma, the NICE said that it is not recommending these agents as first-line treatment for this condition and the use of sorafenib and Pfizer's Sutent (sunitinib) for second-line treatment options for people with renal cell carcinoma. Earlier this year, the agency cleared Sutent as a first- line treatment for kidney cancer. The decision came despite the drugmakers offering to reduce the prices of their drugs to the NHS.

People who are currently being given these treatments for advanced and/or metastatic renal cell carcinoma should have the option to continue their therapy until they and their clinicians consider it appropriate to stop, the NICE stated.

Peter Littlejohns, Clinical and Public Health Director,  said: 'We are very aware that renal cancer is a devastating disease for the individual and their family. We recommended the use of sunitinib for first-line renal cancer in March 2009, so one of these new treatments is now available. 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 programs or in other treatment areas. 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.'

The appeal against the Final Appraisal Determination from Roche, Wyeth Pharmaceuticals, the James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support, have not been upheld, the NICE noted.

Responding to NICE's negative decision, Duleep Allirajah, policy manager at Macmillan Cancer Support, says: 'We are extremely disappointed by NICE's decision not to make these drugs available to all kidney cancer patients on the NHS.  These innovative drugs are proven to significantly improve patients' quality of life and so it is hugely frustrating that despite this, NICE is not allowing patients to access them. NICE is creating a division by allowing some kidney cancer patients to use Sutent as an initial treatment and denying those who need it as a second treatment. It's desperately unfair. Ruling out Avastin, Nexavar and Torisel will also mean patients unsuitable for Sutent are left with very few treatment options. The fact that kidney cancer patients in Wales can access these drugs highlights the inequalities that exist between nations.'

Also commenting on the news, Stella Pendleton, executive director of the Rarer Cancers Forum, said: 'this is a deeply disappointing decision and a bitter blow,' adding: that it  is 'harrowing' for patients 'to know that effective treatments are available but they can't get them on the NHS.'

Wyeth responded by noting that the most severely ill advanced renal cell cancer patients in England and Wales (numbering around 390 people) have been dealt a blow by the NICE's decision not to recommend Torisel .  It added that, as the only treatment evaluated in NICE's recent Health Technology Appraisal of kidney cancer drugs to have demonstrated a significant extension to life in this severely ill group of patients, the rejection of Torisel will be seen as further limiting the options available to patients fighting advanced kidney cancer.