In new draft guidance, the National Institute for Health and Care Excellence (NICE) says it does not recommend Janssen’s Zytiga (abiraterone) for prostate cancer which has spread in people whose first treatment has failed, who have no or mild symptoms and for whom chemotherapy is not yet clinically indicated.

NICE already recommends Zytiga as a second-line treatment after a docetaxel-containing chemotherapy regimen, and this current appraisal looks at how well the drug works when people with the disease have few symptoms and chemotherapy would not yet be given.

Abiraterone is not a new drug, but it is the first treatment to become available at this point in the treatment pathway, noted NICE’s chief executive, Sir Andrew Dillon.

“We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way,” said Sir Andrew.

“However, the manufacturer’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, as a public consultation opened on the Institute’s preliminary recommendation.

The clinical evidence submitted by Janssen came from one trial (COU-AA-302), and the results indicated that, when compared with placebo, Zytiga could extend time to progression. However, NICE’s independent appraisal committee was concerned that, as the trial was stopped early, the results never reached the level needed to prove whether the drug improved survival.

The committee also felt there were a number of issues with the way the manufacturer had calculated its estimated cost-effectiveness. The health economic model was particularly complex and the committee felt that it was not transparent enough for the Evidence Review Group to fully validate and critique.

It also found that the company’s current data showed that Zytiga cannot be considered value for money.

“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,” said Sir Andrew.

Zytiga costs £2,930 (excluding VAT) for 120 tablets, and Janssen has agreed a patient access scheme (PAS) with the Department of Health which involves a single confidential discount applied to the drug’s list price across all indications.

The drug is available through the Cancer Drug Fund.