Table 2.
Date | Event | Comment |
---|---|---|
December 2012 | Marketing authorisation AA extended to pre-docetaxel | |
April 2014 | ACM 1 | ACD 1: not recommended (AC concluded that all the ICERs estimated by both the company and the ERG fell substantially above the range normally considered cost effective, i.e. £20,000–30,000 per QALY gained) |
June 2014 | ERG addendum 1 | ERG response to comments raised during ACD consultation on the benefit of delaying chemotherapy |
June 2014 | ACM 2 | FAD 1: not recommended (AC concluded that all the ICERs estimated by both the company and the ERG fell substantially above the range normally considered cost effective, i.e. £20,000–30,000 per QALY gained) |
September 2014 | Appraisal suspended pending revised PAS | |
April 2015 | ERG addendum 2 | ERG response to new PAS |
October 2015 | ACM 3 | Request new data from company |
November 2015 | ERG addendum 3 | ERG response to the company’s response to NICE’s request for additional information |
November 2015 | ACM 4 | ACD 2: not recommended (AC most plausible ICER likely between £35,500 and £59,600 per QALY gained) |
January 2016 | ERG addendum 4 | ERG response to the company’s response to ACD |
February 2016 | ACM 5 | FAD 2: recommended (AC most plausible ICER likely between £28,600 and £32,800 per QALY gained; see Sect. 5) |
AA abiraterone acetate, ACM Appraisal Committee Meeting, ACD Appraisal Consultation Document, AC Appraisal Committee, ICER incremental cost-effectiveness ratio, ERG Evidence Review Group, QALY quality-adjusted life-year, PAS patient access scheme, FAD Final Appraisal Determination, NICE National Institute for Health and Care Excellence