Zytiga is now recommended in new draft guidance after further patient data and a revised Patient Access Scheme (PAS) convinced NICE to reconsider its previous rejection of the drug.
Dr Harpal Kumar, CEO of Cancer Research UK, said the decision is “wonderful news for patients” and believes the U-turn reflects “the public’s disappointment at the initial refusal”.
In February this year, NICE failed to recommend the treatment in combination with prednisone or prednisolone after deeming it to be too expensive – despite its clinical benefits.
At the time of the decision, Janssen said it would work closely with NICE to gain a positive recommendation. That included supplying a revised PAS and additional data on a subgroup of patients who may receive the most benefit from the cancer drug.
Janssen also submitted further information on the number of patients for whom Zytiga is licensed, enabling it to be considered under NICE’s end of life criteria.
Professor Johann de Bono from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, who led the pivotal trials of Zytiga, said he was “thrilled” the revised data has changed NICE’s original decision.
“Abiraterone acetate is one of only a handful of life-extending drugs for these men in the UK and, importantly, it can also improve quality of life,” he said. “Some of my patients have been taking abiraterone for several years through a clinical trial and are still pain free.”
Prostate cancer is the second most common cause of cancer deaths in UK men. More than 10,000 men die each year with a further 40,000 men diagnosed annually.