Prostate cancer (metastatic, hormone relapsed, not treated with chemotherapy) - abiraterone acetate (with prednisolone) [ID503]

Anticipated publication date:

Abiraterone acetate for the treatment of metastatic hormone relapsed prostate cancer not previously treated with chemotherapy
 
Status
Suspended
Anticipated publication date
TBC
Process
STA
Referral date
November 2011
Description

Scoped as part of Batch 20

Provisional Schedule

Closing date for invited submissions / evidence submission: 16 January 2014
1st appraisal committee meeting: 15 April 2014
2nd appraisal committee meeting 18 June 2014

Project Team

Associate Director: Elisabeth George
Technical Lead: Mary Hughes
Communications manager: Alice Law
Project manager:

Jeremy Powell

Technical Advisor: Jo Holden

Timeline

Key events during the development of the guidance

Date
Update
16 September 2014

The company holding the marketing authorisation for abiraterone has requested to make a submission including an amended Patient Access Scheme. In recognition of the exceptional circumstances, NICE has agreed that the appraisal can be referred back to the Appraisal Committee once the discussions on the amended PAS have been concluded with the Department of Health. In the meantime, we are suspending the appeal stage of this appraisal topic. This allows the company to discuss the amended PAS with the Department of Health, to submit further evidence to NICE and for the Appraisal Committee to consider the impact on cost-effectiveness of abiraterone for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed and in whom chemotherapy is not yet clinically indicated.

03 January 2014

The appraisal was restarted in November 2013.

21 February 2013

This appraisal has been suspended because the manufacturer of abiraterone has informed us that they will not be able to make a submission for this appraisal at this time.

03 August 2012

Following on from advice received from the manufacturer, this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early December 2012.

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