NICE refuses to recommend Janssen’s Zytiga for prostate cancer

Wednesday, February 8, 2012 09:58 AM

The National Institute for Health and Clinical Excellence (NICE), the U.K. healthcare guidance body, has issued new draft guidance not recommending the use of Zytiga (abiraterone), developed by Janssen, in combination with prednisone or prednisolone for the treatment of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The draft guidance has been issued for consultation; it has not been issued to the National Health Service (NHS).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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs