The National Institute for Health and Clinical Excellence (NICE), the U.K. healthcare guidance body, has issued new draft guidance not recommending the use of Zytiga (abiraterone), developed by Janssen, in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed on or after docetaxel-containing therapy.
The draft guidance has been issued for consultation; it has not been issued to the National Health Service (NHS). Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
"Abiraterone is a drug that could potentially extend life by more than three months, compared with placebo. For patients one of the key benefits of this drug is that it can be taken orally at home. We are therefore disappointed not to be able to recommend it for use on the NHS,” said Sir Andrew Dillon, chief executive of NICE. “However, it is an expensive drug and the independent advisory committee that made this decision did not feel the drug provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount that the manufacturer has offered."
The committee also felt that the treatment did not meet the criteria to be considered under NICE's special arrangements for drugs treating people at the end of their life as the population for which it is licensed cannot be considered to be small.
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer can also consider whether it wishes to further reduce the acquisition cost to the NHS of the drug by proposing a revised patient access scheme.