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. 2016 Aug 26;35(2):191–202. doi: 10.1007/s40273-016-0445-5

Table 2.

Timeline

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