The UK's National Institute for Health and Care Excellence (NICE) have rejected enzalutamide for advanced prostate cancer before chemotherapy.
NICE chief executive Sir Andrew Dillon said: "The clinical trial results showed enzalutamide can extend life when compared with placebo, but it was not clear for how long.
"This was because there were uncertainties associated with way the company had carried out adjustments to take account of the effect on length of life of treatments used when enzalutamide is no longer effective.
"The Appraisal Committee was also concerned that the company had not adequately evaluated the uncertainties in its cost-effectiveness analyses."
The decision has been met with disappointment.
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said:
“Enzalutamide is an exciting drug currently available on the NHS to treat late-stage prostate cancer - and there is now very good evidence that it is beneficial to men if used earlier on in treatment, before they go through more toxic chemotherapy. It is very disappointing to hear that men will not be able to receive this innovative drug earlier in their treatment.
“Following last week's rejection of olaparib for ovarian cancer, this decision also 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. There is clearly an important problem that needs to be addressed urgently in order to convert more of the pioneering cancer research we've seen in recent years into concrete benefits for NHS patients.
“Part of the solution is flexible, adaptive pricing – 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. Some companies are willing to experiment with new pricing structures, and we hope to see more engagement between companies and NICE to bring down the barriers that are stopping cancer drugs from reaching NHS patients.”
“Enzalutamide is the first in a new class of medicines called androgen receptor inhibitors. Prostate cancer relies on testosterone to grow, so this drug has been designed to bind to the receptors on prostate cancer cells that normally interact with testosterone, and block this interaction.”
Source: ICR and NICE
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