The UK's National Institute for Health and Clinical Excellence (NICE) has issued its final appraisal document recommending the use of Pfizer's Sutent (sunitinib) as a first-line treatment for patients with metastatic renal cell carcinoma (RCC). However, sunitinib is the only one of four drugs being appraised that has been preliminarily cleared for use on the NHS, once again raising the question of drug access in the UK compared to the rest of Europe.
NICE is also currently appraising the use of Roche/Genentech's Avastin (bevacizumab), Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib) and Wyeth's Torisel (temsirolimus) for the treatment of advanced and/or metastatic RCC. Following the independent advisory Committee meeting on 14th January, NICE has decided to split this appraisal in two in order to get guidance out to the NHS as quickly as possible. In the first appraisal, sunitinib is recommended as a first-line treatment option in advanced and/or metastatic RCC for patients who are suitable for immunotherapy with an ECOG performance status of 0 or 1. Sunitinib demonstrated a significant improvement in progression-free survival versus interferon alpha. The median survival of patients treated with sunitinib exceeded two years. In September 2008, NICE had issued an appraisal consultation document that advised against the use of all four medicines for the treatment of advanced and/or metastatic RCC. The latest announcement reverses NICE's previous recommendation regarding the coverage of sunitinib, making it the only one of the four medicines under review, that is so far recommended for coverage.
Sunitinib, an oral multi-kinase inhibitor, was first approved in January 2006 for advanced RCC. The drug works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Pfizer has agreed a patient access scheme with the Department of Health, in which the first treatment cycle of sunitinib is free to the NHS.
In the second appraisal, bevacizumab, sorafenib and temsirolimus are not recommended as first-line treatment options for advanced and/or metastatic RCC. In addition, the two drugs also licensed for second-line treatment of advanced or metastatic RCC, sorafenib and sunitinib, are not recommended for this indication. Guidance on bevacizumab, sorafenib and temsirolimus for first-line treatment and sorafenib and sunitinib for the second-line treatment of RCC is available for public consultation via NICE until 4th March.
In a statement from Wyeth, the company commented that it believes that denying patients access to the benefits of temsirolimus in extending life-expectancy compared to standard existing therapy is a devastating and cruel blow to patients and their families. Temsirolimus, despite being found to be clinically effective, has been deemed not to be cost-effective in the current assessment.
Similarly disappointing news was announced in Scotland, as the Scottish Medicines Consortium (SMC) published its guidance on the use of GSK's Tyverb (lapatinib) and Eli Lilly's Alimta (pemetrexed), ruling that in both cases the manufacturer did not present a sufficiently robust economic case to gain acceptance. Lapatinib is approved in Europe, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer, while pemetrexed is indicated, in combination with cisplatin, for the first-line treatment of patients with locally-advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Despite clinical evidence that the two drugs can extend patients' lives by around two months and six weeks, respectively, the price that this comes at is still not seen as cost-effective.
Matthew Dennis - Editor, Cancer Drug News
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