Pharmaceutical International News - July 2007
Charity Attacks SMC’s Kidney Cancer Drug Ruling
Posted by Paul Fiddian on 10/07/2007 - 08:58:07
A charity has labelled the Scottish Medicines Consortium’s failure to make available a kidney cancer drug on the Scottish NHS as a “death sentence”. In the eyes of the regulator, the drug in question, Pfizer’s Sutent (sunitinib), did not represent good value for money – hence has not approved its use. However, the decision has been lambasted by the James Whale Fund, which has highlighted Sutent’s efficiency in treating advanced kidney cancer.
In response to the decision, Pfizer has announced its intention to provide the SMC with fresh new evidence relating to Sutent. This was based, the drugs giant stated, on improved clinical data that depicted Sutent’s patient benefits more evidently, and that which came out after the SMC’s initial verdict.
Regarding the verdict, the James Whale Fund’s reaction was one of pure outrage. James Whale himself, who founded the charity, stated the following: "By deciding not to fund Sutent the SMC has effectively issued a death sentence to the 660 patients living with kidney cancer in Scotland”. He continued: “Despite the overwhelming evidence supporting Sutent doctors will be forced to say 'no' to patients who need access to this life-saving treatment."
The charity stated that the effects of the SMC’s decision to disapprove Sutent’s use in Scotland would trickle down to England and Wales, where it believes approximately 6,000 patients will be affected. Backing this assertion up, James Whale highlights the historical element of these kinds of rulings, where, in general terms, English and Welsh Primary Care Trusts tended to follow the example of the SMC.
Comment from Pfizer was provided by the company’s medical director – Dr David Gillen. Dr Gillen stated: "Clearly we are disappointed in this initial ruling as it will prolong the struggle for many people with advanced kidney cancer currently fighting to access Sunitinib, potentially costing them precious months of life.”
"We're committed to doing all we can to make this drug more widely available and we are hopeful that these new data will enable the SMC to recommend the use of Sunitinib in kidney cancer patients in Scotland."
From the SMC’s perspective, the message seemed to be one of regret: a spokesman describing how the regulator was “truly disappointed” at having to reject Sutent. However, he added: "After analysing the manufacturer's own submission, we feel that there are significant uncertainties in evidence and calculations, leading us to conclude that Sunitinib's high cost in relation to its benefits has not yet been justified. We are delighted to learn from the manufacturer that the evidence supporting the efficacy of this drug is increasing.”
"We would be pleased to receive revised information at the earliest opportunity for inclusion in our rapid assessment process”, the spokesman concluded.
Away from the Scottish decision, in England, the equivalent National Institute for Health and Clinical Excellence (NICE) is as yet undecided regarding whether Sutent, which costs approximately £22,000 over a nine-month period, is suitable for use on the NHS.
Source – Pharmaceutical International Newsdesk
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