Navigating Large Evidence Bases for MTEP Submissions and for the New NICE HealthTech Program
Author(s)
Emily E. Moss, BA, Alex Jenkins, PhD, Sophie Tatman, MSc, Evelyne Priestman, MSci, MSc.
Petauri, Bicester, United Kingdom.
Petauri, Bicester, United Kingdom.
OBJECTIVES: Medtech companies are increasingly looking to submit to the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) but tight budgets raise issues with adequate evidence generation for submissions.
METHODS: A review of the number of MTEP submissions since its inception in 2011, guidelines for handling evidence in company submissions, and submissions that fully adhered to the guidelines was conducted, to identify a systematic approach that helps companies meet MTEP requirements.
RESULTS: Since 2011, there have been 66 pieces of guidance published, with 10 currently in development. The publications peaked in 2021 (n=11) and 2022 (n=11), with a drop in published guidance in 2023 (n=1) and 2024 (n=2). The guidelines to companies regarding clinical and economic evidence have remained the same, stating that “evidence should be systematic and transparent”, and recommend using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. For clinical evidence, a meta-analysis should be conducted where appropriate. In total, only 39/65 submissions conducted a systematic review, with external assessment groups having to perform additional searches, even for the submissions that were systematically conducted, to ensure all evidence was identified.
CONCLUSIONS: To meet the MTEP guidelines, companies should aim to identify all clinical and economic evidence in a systematic and transparent way. Medtech budgets can be small compared with pharmacological budgets, therefore innovative methods need to be used to meet the MTEP requirements. Rapid reviews using the Cochrane method (20% quality check of screening) could be a suitable alternative to a full systematic review with double-screening while ensuring that the search strategy is systematic, and conducted in multiple databases.
METHODS: A review of the number of MTEP submissions since its inception in 2011, guidelines for handling evidence in company submissions, and submissions that fully adhered to the guidelines was conducted, to identify a systematic approach that helps companies meet MTEP requirements.
RESULTS: Since 2011, there have been 66 pieces of guidance published, with 10 currently in development. The publications peaked in 2021 (n=11) and 2022 (n=11), with a drop in published guidance in 2023 (n=1) and 2024 (n=2). The guidelines to companies regarding clinical and economic evidence have remained the same, stating that “evidence should be systematic and transparent”, and recommend using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. For clinical evidence, a meta-analysis should be conducted where appropriate. In total, only 39/65 submissions conducted a systematic review, with external assessment groups having to perform additional searches, even for the submissions that were systematically conducted, to ensure all evidence was identified.
CONCLUSIONS: To meet the MTEP guidelines, companies should aim to identify all clinical and economic evidence in a systematic and transparent way. Medtech budgets can be small compared with pharmacological budgets, therefore innovative methods need to be used to meet the MTEP requirements. Rapid reviews using the Cochrane method (20% quality check of screening) could be a suitable alternative to a full systematic review with double-screening while ensuring that the search strategy is systematic, and conducted in multiple databases.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA246
Topic
Health Technology Assessment, Medical Technologies
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas