The cost effectiveness agency for England and Wales said that it would not recommend abiraterone, a drug considered to be a breakthrough second-line treatment for men with castration-resistant metastatic prostate cancer.
The National Institute for Health and Clinical Excellence said that abiterone’s cost was the main factor bearing on its negative draft guidance, which is now subject to public and manufacturer consultation. NICE indicated that it would be open to considering the drug if its manufacturer were to revise its discounting scheme to make it more affordable to the National Health Service.
Abiraterone (Zytiga, Janssen), which received fast-track approval from the Food and Drug Administration in April 2011 and was recommended by the European Medicines Agency in July 2011, is an oral drug that inhibits the production of androgens. It is administered along with prednisone or prednisolone for men whose disease has resisted surgical or medical castration and progressed following initiation of docetaxel-based chemotherapy.
In a double-blinded, manufacturer-sponsored, randomized controlled trial enrolling 1,195 men with previously treated late-stage castration-resistant prostate cancer, patients in the treatment arm (n = 797) saw overall survival of 14.8 months compared with 10.9 months for those in the placebo arm. The trial had to be unblinded early on the strength of the results (N. Engl. J. Med. 2011;364:1995-2005).
In announcing its negative decision, NICE acknowledged that there was sufficient clinical trial evidence to suggest that abiraterone could extend overall survival by more than 3 months compared with placebo. The agency also said that 4,300 people with castration-resistant metastatic prostate cancer were receiving docetaxel in England and Wales in 2011, with the number expected to rise to 5,500 this year, and that approximately 75% of these would be eligible for abiraterone treatment according to its licensed indication.
Abiraterone costs £2,930 in the United Kingdom for a 30-day supply. It is taken as a single dose of 1 g per day, in four tablets containing 250 mg each.
While abiraterone’s manufacturer agreed to discount the drug to the National Health Service by an undisclosed amount, NICE said that the incremental cost-effectiveness ratio for was £63,200 cost per quality-adjusted life year even with that discount, while the highest ICER for a NICE-recommended drug is currently £50,200 per QALY.
Current NICE recommendations for men whose disease has progressed after first-line docetaxel are mitoxantrone and best supportive care.