Scoped as part of Batch 20
|Closing date for invited submissions / evidence submission:||16 January 2014|
|1st appraisal committee meeting:||15 April 2014|
|2nd appraisal committee meeting||18 June 2014|
|Executive Lead:||Carole Longson|
|Technical Lead:||Mary Hughes|
|Communications manager:||Alice Law|
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.
The appraisal was restarted in November 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.
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.