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pharmafile | September 15, 2008 | News story | Sales and Marketing | NICE, rcc
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 not backing the use of four new kidney cancer drugs. This recommendation suggests 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 National Institute of Health and Clinical Excellence (NICE) said 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 finalised, this guidance would mean that RCC patients in the UK will not be able to receive these therapies on the 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. However, response rates for both 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The draft guidance is the latest in a series of negative recommendations from NICE to affect premium-price targeted cancer drugs, including Avastin for colorectal, lung and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.
In order to attempt to persuade NICE to reverse its decision, the developers of these drugs may consider offering substantially discounted prices in the UK. This would follow Roche's decision to reduce the price of its non-small cell lung cancer drug Tarceva (erlotinib) in the UK in July 2008, in order to satisfy NICE's cost-effectiveness criteria. Alternatively, the companies could propose a risk-sharing scheme, where they offer to reimburse the cost of the drug for patients who do not respond sufficiently to treatment, as Johnson & Johnson did for its multiple myeloma drug, Velcade (bortezomib), in 2007. Either of these measures, however, would considerably restrict revenue from the drugs in comparison to other major markets.
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