IN WHAT SEQUENCE DO COMPANIES SUBMIT HEALTH TECHNOLOGY APPRAISAL (HTA) DOSSIERS IN THE UK AND IRELAND, AND IN WHAT SEQUENCE ARE THEY PUBLISHED?
Author(s)
Norman DL, Marshall JD
MAP BioPharma Limited, Cambridge, UK
Presentation Documents
OBJECTIVES: Identify trends in the sequence that manufacturers submitted HTA dossiers and the sequence in which guidance was published by the National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), All Wales Medicines Strategy Group (AWMSG) and National Centre for Pharmacoeconomics (NCPE). METHODS: The 30 most recent NICE technology guidance publications (up to June 2017) were reviewed. Where NICE guidance was a review, the date of the original guidance was used. The sequence of publication dates of any corresponding SMC, AWMSG and NCPE guidance was calculated. AWMSG and NCPE start dates were obtained for the submission sequence. SMC guidance was assumed to take 18 weeks. NICE start dates were calculated as 8-weeks after the Final Scope date, where available, otherwise appraisals were excluded due to the variability in the length of the NICE process prohibiting estimation of start date. RESULTS: Six of the 30 appraisals were terminated by NICE while four were multiple technology appraisals, and were excluded. All remaining 20 appraisals had corresponding submissions to SMC. SMC guidance was published first in 75% cases. NCPE performed 12 appraisals, published at variable steps within the sequence. AWMSG reviewed three appraisals. The most frequent first submission was to NICE (75%). The modal submission sequence was NICE followed by the SMC but the modal publication sequence was SMC followed by NICE. CONCLUSIONS: Submissions are most often made to NICE first but SMC are usually first to publish recommendations. This is likely due to the shorter timelines of the SMC process compared with NICE. Sequencing of submissions to NCPE were variable, which may be due to international reference pricing strategy, or due to limited manufacturer resource since some companies are structured with one team covering the UK and Ireland. AWMSG completed few HTAs owing to the applicability of NICE decisions to England and Wales.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP155
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
Multiple Diseases