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[The following Press Release was issued by the WYETH PHARMACEUTICALS in August 2008] Wyeth concerned for renal cell cancer patients in the UKUK, 2008. Wyeth is concerned for the 6,000 patients1 with renal cell cancer in the UK since the National Institute for Health and Clinical Excellence (NICE) draft guidance on bevacizumab, sorafenib, sunitinib and temsirolimus in the treatment of advanced and/or metastatic renal cell carcinoma (RCC) has not recommended any of the four treatment options under review. TORISEL® (temsirolimus) was one of those four treatment options assessed and is licensed as a first-line treatment for people with advanced RCC who have at least three of six prognostic risk factors.2 Although the NICE Appraisal Committee was persuaded that temsirolimus is a clinically-effective first-line treatment for poor prognosis patients with aRCC, the Committee concluded that temsirolimus would not be a cost-effective use of NHS resources.3 This draft guidance could set a disturbing disparity between renal cell cancer treatments available in Europe and the UK since TORISEL is available to patients on the continent. Wyeth believes incorrect conclusions have been drawn through misinterpretation of the evidence and the draft guidance recommendation is derived from a flawed economic model. From the outset Wyeth made its position clear to NICE that TORISEL was an “ultra orphan” drug and as such should not be included in the assessment. “Ultra orphan” medicines are used to treat conditions with a prevalence of less than 1 in 50,0004. TORISEL meets this criterion as approximately 450 patients a year would be eligible for treatment in the UK. NICE itself has identified potential issues with the assessment and interpretation of the clinical and cost-effectiveness data for what are called “ultra orphan” medicines. Therefore it was inevitable that TORISEL would not be considered cost-effective under NICE’s conventional criteria as they fail to take account of the very small number of patients indicated for treatment with the drug and the relatively short period of treatment. Wyeth is not alone in believing that there should be reform to the NICE appraisal system for medicines for rarer conditions. A recent publication 2nd Parliamentary Summit on Rarer Cancers from the Rarer Cancers Forum made a call for action to “introduce reform to the NICE appraisal system for all orphan medicines, to enable faster review and reduce inequalities in access to medicines for patients with rare disease.”5 Also the Report on NICE’s own Citizens Council Meeting in February suggested that changes to reflect the severity of the disease should be taken into account.6 The implications of this draft guidance may set a worrying precedent for the approval of future cancer medicines especially since 30 new cancer medicines are anticipated by 2010.7 Wyeth is continuing its dialogue with NICE and is preparing its response to the draft guidance. The Appraisal Committee will consider the comments received from the consultees at their second meeting on 10th September at which time they will formulate the Final Appraisal Determination. In the absence of any appeals the NICE guidance is expected to be published in January 2009. |
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TORISEL is the first and only renal cell cancer therapy proven to extend overall survival in the treatment of advanced RCC in patients with poor prognosis compared with interferon-alpha.8 An open-label, randomised, phase 3 study compared TORISEL alone, a combination of TORISEL plus interferon-alpha, and interferon-alpha alone as first-line therapy in 626 patients with advanced RCC who had at least three of six prognostic risk factors.8
In this study, TORISEL alone significantly increased median overall survival by 49% compared with interferon-alpha alone (10.9 months for TORISEL vs. 7.3 months for interferon-alpha, P=0.0078).9 TORISEL was also associated with statistically significant improvement over interferon-alpha in the secondary end point of progression-free survival (PFS), when the disease does not get worse (3.8 months of PFS vs. 1.9 months of PFS, P≤0.001).9
TORISEL was granted a marketing authorisation for the EU on 19th November 2007 by the European Commission. TORISEL is indicated for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors.2
Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The National Kidney Federation is registered in England and Wales as a Company limited by guarantee (Company No 5272349) and awarded charitable status (Charity Number 1106735). Give as You Earn contributions No. CAF GY511.
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Page created: 1 September 2008
Last updated: 27 February 2011