- Zytiga (abiraterone) is recommended by the UK National Institute for Health and Excellence (NICE) for end-of-life prostate cancer patients after they having received chemotherapy.
- NICE just issued new final draft guidance regarding use of Zytiga in men with prostate cancer. Citing lack of sufficient cost-effectiveness and data, the agency is not recommending use of Zytiga in men who have not yet received chemotherapy .
- Advocacy agencies such as Prostate Cancer UK are frustrated with this ruling, as well as with Janssen’s alleged inability to product compelling data.
The crux of the issue, according to NICE, is a lack of compelling cost-effectiveness data from Janssen. Zytiga costs roughly $4900 for a 30-day supply of 120 tablets. The drug is currently available via the Cancer Drugs Fund, which pays money into the National Health Service (NHS) to support drugs not recommended by NICE. Janssen has also set up a patient-access and cost-sharing program -- but access to the drug is still quite limited.
Advocates are pushing for approval so that patients may have access to a potentially life-saving drug, but also expressed severe disappointment in Janssen's data presentation. “An inflexible NICE process plus the drug company’s inability to produce all the requested data has led to this being just the latest in a string of hugely disappointing rulings on prostate cancer drugs," said Prostate Cancer UK CEO Owen Sharp. "This decision is unjust and it needs to be overturned so that men in desperate need can receive the most effective drugs, wherever they live."
Janssen is appealing the decision and NICE would like more cost-effectiveness data.