Janssen And NICE Urged To Talk After Zytiga Rejection

Last week, the UK’s drug approval body the National Institute for Health and Care Excellence (NICE) issued its draft guidance which does not recommend Johnson & Johnson unit Janssen’s prostate cancer drug Zytiga (abiraterone).

NICE did not recommend Zytiga as treatment for patients whose disease has metastasized regardless of previous androgen deprivation therapy, who have few symptoms, and who has yet to undergo chemotherapy treatment. The institute previously recommended the drug as treatment after docetaxel containing chemotherapy. The regulatory authority cited Janssen’s pricing as major factor in the decision.

Sir Andrew Dillon, NICE’s chief executive, said, “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 demonstrated that the drug does not offer enough benefit to justify its price.” The institute also pointed out that clinical results submitted by Janssen did not clarify how much Zytiga actually extended life, though the drug did delay progression of the disease before chemotherapy.

Reactions to NICE’s rejection of Zytiga were anything but nice, with Prostate Cancer UK calling the decision a ‘kick in the teeth’ for men with progressive prostate cancer. The charity urged both Janssen and NICE to reopen discussions and “do whatever is necessary to get abiraterone pre-chemotherapy across the line without delay”.

Paul Workman, interim chief executive of the Institute of Cancer Research where the drug was discovered, was similarly disappointed and argued that the drug’s benefits are the best option for those suffering from prostate cancer. He also encouraged both sides to leave no stone unturned in order to make the drug available to patients at a price that the NHS could afford.

Dr. Peter Barnes, medical director at Janssen, said, “We are very disappointed with this decision… These men will eventually be able to receive abiraterone on the NHS after chemotherapy anyway, but will be denied the option of taking it earlier on in their illness.” Janssen has said that it will be appealing the decision.