August 8, 2008

UK Watchdog’s Guidance Knocks Kidney Cancer Drugs

The UK's cost-effectiveness watchdog NICE has delivered another blow to the developers of targeted cancer therapies by recommending against the use of four new kidney cancer drugs in the UK. This recommendation suggests that NICE is likely to look unfavorably on a number of other targeted therapies in development, severely limiting future growth of the targeted cancer therapies market in the UK.

In its preliminary guidance report on a number of new targeted cancer therapies, the UK's National Institute of Health and Clinical Excellence (NICE) has stated that Avastin (bevacizumab; Genentech/Roche/Chugai), Nexavar (sorafenib; Bayer/Onyx), Sutent (sunitinib; Pfizer) and Torisel (temsirolimus; Wyeth) are not cost-effective for the treatment of advanced or metastatic renal cell carcinoma (RCC). If finalized, this guidance would mean that RCC patients in the UK will not be able to receive these therapies on the National Health Service (NHS).

RCC is the most common form of kidney cancer, with a forecast incidence of approximately 90,000 in the seven major markets in 2008. Until recently, treatment options for patients with advanced and metastatic RCC were very limited, with only two drugs available: the cytokine therapies interferon alfa and interleukin-2. Response rates for both of these drugs are low, and they confer considerable toxicity, making unmet need high in RCC. Since late 2005, however, the launch of Avastin, Sutent, Nexavar and Torisel in the EU has provided much-needed additional treatment options for these patients. In clinical trials, these drugs have all shown superior response rates, progression-free survival and tolerability compared to cytokine therapies.

The draft guidance is the latest in a series of negative recommendations from NICE to affect premium-price targeted cancer drugs, including Avastin for colorectal, lung and breast cancer, and Tykerb (lapatinib; GlaxoSmithKline) for breast cancer. NICE's recommendation for RCC suggests that, without offering large improvements in overall survival, expensive targeted therapies are unlikely to receive a positive recommendation, regardless of the level of unmet need in a particular indication.

This has implications for the majority of targeted therapies in clinical development for cancer, which look set to offer, at best, modest improvements in treatment outcomes and could struggle to satisfy NICE's cost-effectiveness criteria. Such cost-effectiveness restrictions will therefore significantly hamper growth of the oncology market in the UK, which already lags behind the other major EU markets.