The 90-Day Ambition: Historical Analysis of 200 NICE Appraisals to Assess Proportion-Achieving Final Guidance Within 90 Days of MHRA Approval
Author(s)
Mark Orchard, BSc, Neil Davies, MSc, Joanna Todd, PhD.
Cogentia Healthcare Consulting, Cambridge, United Kingdom.
Cogentia Healthcare Consulting, Cambridge, United Kingdom.
OBJECTIVES: As recently laid out by NICE, by aligning the first committee meeting with the date of MHRA approval, their aim is to publish final guidance within 90 days of a technology receiving marketing authorisation. The aim of this study was to analyse data for the most recent 200 NICE appraisals, to establish the proportion currently achieving the objective of final guidance published within 90 days of MHRA approval.
METHODS: We assessed data from 200 NICE appraisals (TA868 - TA1067). Of these 200 appraisals, 73 were excluded, either due to MHRA date being redacted throughout, or due to the appraisal being terminated. Time to final guidance was calculated based on the number of days between MHRA approval and the Technology Appraisal Guidance being published.
RESULTS: Of the 127 appraisals assessed, 20 received positive guidance within 90 days of MHRA approval. This included two appraisals, TA912 and TA956 where NICE recommended the technology on the day of MHRA approval.
CONCLUSIONS: Our results find that NICE are currently achieving their newly stated objective of 90 days between MHRA and final guidance for ~16% of appraisals. There are likely an array of contributing factors, including protracted negotiations, delays to company submissions, and complex appraisals where additional committee meetings are required. NICE’s proportionate approach to HTA should support an increase in this proportion over time.
METHODS: We assessed data from 200 NICE appraisals (TA868 - TA1067). Of these 200 appraisals, 73 were excluded, either due to MHRA date being redacted throughout, or due to the appraisal being terminated. Time to final guidance was calculated based on the number of days between MHRA approval and the Technology Appraisal Guidance being published.
RESULTS: Of the 127 appraisals assessed, 20 received positive guidance within 90 days of MHRA approval. This included two appraisals, TA912 and TA956 where NICE recommended the technology on the day of MHRA approval.
CONCLUSIONS: Our results find that NICE are currently achieving their newly stated objective of 90 days between MHRA and final guidance for ~16% of appraisals. There are likely an array of contributing factors, including protracted negotiations, delays to company submissions, and complex appraisals where additional committee meetings are required. NICE’s proportionate approach to HTA should support an increase in this proportion over time.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA312
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas