The National Institute for Health and Clinical Excellence (NICE)'s final decision not to recommend Sanofi's Jevtana (cabazitaxel) for NHS use in advanced prostate cancer could herald a re-emergence of the postcode lottery, an expert has warned.
Sanofi had appealed NICE's final draft guidance, which said it did not recommend the routine use of cabazitaxel in combination with prednisone or prednisolone as a second-line treatment for prostate cancer, but this appeal has been dismissed on all points, says NICE.
"Although cabazitaxel can extend life for some patients, its price remains well above what the independent committee appraising this drug considered acceptable, given the benefits it offers," said NICE chief executive Sir Andre Dillon.
The committee had considered that the most plausible Incremental Cost Effectiveness Ratio (ICER) for the drug in combination with prednisone or prednisolone would be above £87,500 per Quality-Adjusted Life Year (QALY) gained.
"Cabazitaxel is also associated with a number of side effects, and the committee was concerned about the nature of the health-related quality-of-life information provided by the manufacturer," Sir Andrew added.
However, Professor Jonathan Waxman of Imperial College London said that the cost argument on which NICE has based its decision "is false, giving a much higher estimate of true cost than applies in reality."
"As a result, yet another successful and effective cancer treatment is denied our patients, a mortifying blow to cancer care in England. As the only route to access is now the Cancer Drugs Fund, a temporary arrangement that operates very differently around the country, I fear we're heading towards a re-emergence of the postcode lottery," said Prof Waxman.
Sanofi points out that only seven of the 10 Cancer Drugs Funds in England offer unrestricted access to Jevtana and that Wales, Northern Ireland and Scotland have no similar fund in place.
The Scottish Medicines Consortium (SMC) does not recommend the drug for this condition, notes NICE.
Campaigners says that prostate cancer patients, their families and charities are now awaiting NICE's final decision on Janssen's Zytiga (abiraterone), on which the Institute issued a negative draft decision in February stating that the drug did not meet the end-of-life criteria for reimbursement.
Jevtana and Zytiga are the only two licensed drugs available in the UK that offer the hope of extra time and quality-of-life benefits to men living with advanced prostate cancer, said Emma Malcolm, chief executive of Prostate Action.
"Men with advanced prostate cancer have so few treatment options available to them that they should be able to access both of these new treatments," she said.
Owen Sharp, chief executive of the Prostate Cancer Charity, added that NICE's rejection of Jevtana is "a huge blow" and means that there is now even more riding on the Institute's final decision regarding Zytiga, as this “breakthrough drug is the only treatment option that may be approved for universal use in the NHS which can offer these men the hope of extended, good-quality life."
"It is now critical that if men with prostate cancer are at last to be given the choice and access to effective treatment options, NICE and the manufacturer need to work together to find a way to make this drug routinely available on the NHS," said Mr Sharp.