NICE draft guidance rules against earlier use of Johnson & Johnson's prostate cancer drug Zytiga

The National Institute for Health and Care Excellence issued draft guidance recommending against use of Johnson & Johnson's Zytiga (abiraterone) for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed and in whom chemotherapy is not yet clinically indicated. The company said it was disappointed with the decision but would "work constructively" with the agency.

NICE already backs use of Zytiga as a second-line treatment after a docetaxel containing chemotherapy regimen. The new use of the drug was approved by the European Commission last year.

According to NICE, study data submitted by Johnson & Johnson indicated that when compared with placebo, Zytiga could extend time to progression. However, the agency said the assessment committee was concerned that the COU-AA-302 trial was stopped early and that the results never reached the level needed to prove whether the drug improved survival. The committee also raised concerns with the way the company calculated estimated cost-effectiveness of Zytiga. The therapy costs 2930 pounds ($4910) for a month's treatment, with Johnson & Johnson agreeing an undisclosed patient access scheme with the Department of Health.

NICE chief executive Andrew Dillon noted that "although [Zytiga] is not a new drug, it is the first treatment to become available at this point in the treatment pathway. We know how important it is for patients to have the option to delay chemotherapy and its associated side effects." However, Dillon indicated that Johnson & Johnson's "own economic model showed that the drug would not be cost-effective at this stage - because of this we cannot recommend the drug in this preliminary guidance." He added "we hope that during this consultation, the manufacturer uses this opportunity to look again at its submission and provides the committee with additional information which may enable them to reconsider."

Paul Workman, deputy chief executive of the Institute of Cancer Research, whose scientists discovered the drug, urged the NHS and Johnson & Johnson to reach a deal on a fair price as soon as possible. Zytiga "has in part been a victim of the success of prostate cancer medicine, since men who have not yet received chemotherapy now live for longer than two years, meaning NICE could not apply its end of life criteria," he added.

To read more Top Story articles, click here.