Bevacizumab, sorafenib and temsirolimus are not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma. In addition, the two drugs also licensed for second-line treatment of advanced or metastatic renal cell carcinoma, sorafenib and sunitinib, are not recommended for this indication. People who are currently being treated with 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.
Professor 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 programmes 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 appeals against the Final Appraisal Determination from Roche, Wyeth Pharmaceuticals and James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support have not been upheld.
Information on the NICE appraisal of bevacizumab, sorafenib, sunitinib or temsirolimus as treatment options for advanced and/or metastatic renal cell carcinoma and the consultation documents are available at the NICE website.
Over a six-week cycle, the average total cost of drug acquisition for bevacizumab is £5982 per patient for the first cycle and £6117 for subsequent six-week cycles (approximately £53,000 per patient per year). The manufacturer of bevacizumab has agreed an access scheme with the Department of Health; the scheme rebates the costs of bevacizumab after 10,000 mg has been given to a patient in a year and rebates all of the interferon costs.
The price for a pack of 200-mg sorafenib tablets (112 tablets per pack) is £2980.47, excluding VAT – this is an increase in the price submitted to NICE for the purpose of this appraisal. The manufacturer of sorafenib has agreed a patient access scheme with the Department of Health, in which the first pack of sorafenib is free to the NHS.
The price for a pack of 50-mg sunitinib capsules (30 capsules per pack) is £3363.00, excluding VAT, according to British National Formulary (BNF) edition 55. The average daily cost of sunitinib is £74.74, and an average six-week cycle costs £3139. The manufacturer of sunitinib has agreed a patient access scheme with the Department of Health, in which the first treatment cycle of sunitinib is free to the NHS. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.
The price listed for temsirolimus in the BNF is £620 per vial.