Negative NICE draft guidance on Janssen's Zytiga for prostate cancer

In draft guidance published this morning, the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has not recommended US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Zytiga (abiraterone) for prostate cancer which has spread in people whose first treatment has failed, have no or mild symptoms and for whom chemotherapy is not yet clinically indicated.

NICE already recommends abiraterone as a “second-line” treatment after a docetaxel containing chemotherapy regimen. 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.

Sir Andrew Dillon, NICE chief executive, said: “Although abiraterone 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, so we are disappointed not to be able to recommend abiraterone for use in this way. 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. 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.”

Janssen disappointed but will work to address concerns

For its part, Janssen said it is disappointed that the NICE Appraisal Consultation Document (ACD) published today does not recommend the use of Zytiga for the treatment of men with advanced (metastatic) hormone relapsed prostate cancer (mCRPC) who have not previously been treated with chemotherapy.“Janssen will now work constructively with NICE to address the concerns they have raised at this stage in the process,” the company said.

The clinical evidence submitted by the manufacturer came from one trial (COU-AA-302), NICE noted. Although the results indicated that, when compared with placebo, abiraterone could extend time to progression, the Committee was concerned that as the trial was stopped early and that the results never reached the level needed to prove whether abiraterone improved survival.

The committee also felt there were a number of issues with the way the manufacturer calculated 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 (ERG) to fully validate and critique. However, the manufacturer’s current data showed that abiraterone cannot be considered value for money.

Drug cost per QALYs