(Source: PharmaTimes 2015-06-11）
The rejection of yet another promising cancer drug by NHS cost regulators has sparked a renewed call for reform of the system and the introduction of adaptive licensing to help speed up patient access to innovative medicines.
The National Institute for Health and Care Excellence has today published draft guidelines rejecting the use of Astellas’ Xtandi (enzalutamide) to treat patients with advanced prostate cancer before chemotherapy.
The drug is already available on the NHS to treat late-stage forms of the condition, and it was hoped that NICE would expand its scope so that it could be given earlier in the treatment pathway.
“Enzalutamide has been shown to have a great range of benefits when prescribed to men who have not previously had chemotherapy. However, what should be a cut and dry decision to recommend it seems to have come down to issues about cost and uncertainties with the clinical trial data,” said Owen Sharp, Chief Executive of Prostate Cancer UK, and called for reform of the drug appraisals process in England.
Paul Workman, Chief Executive of The Institute of Cancer Research, London, said the decision “underlines the fact that there is clearly an NHS bottleneck for cancer drugs - with many exciting new drugs being blocked either by NICE or for the Cancer Drugs Fund, or both”.
Part of the solution would be to introduce flexible, adaptive licensing, he argues. “NICE needs to have the confidence to initially approve drugs tested in smaller groups of patients, and drug companies need to be realistic that at an early stage they may need to initially set lower prices. As more data showing the drug is effective emerge from bigger trials, the cost of the drug can increase”.
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