MEDICAL DEVICE APPRAISAL IN THE UK- WHAT ARE THE COMMON PITFALLS OF MANUFACTURER LITERATURE REVIEWS?
Author(s)
Macnair P1, Marsh W2
1Costello Medical, London, UK, 2Costello Medical, Cambridge, UK
Presentation Documents
OBJECTIVES: During NICE’s Medical Technologies Evaluation Programme (MTEP), a manufacturer’s systematic literature review identifying relevant clinical evidence is appraised by an independent External Assessment Centre (EAC). Here, we audited reviews submitted to MTEP and determined whether the quality of the literature reviews had an impact on NICE guidance, in order to provide recommendations for conducting high-impact reviews. METHODS: EAC reports and Medical Technologies Guidance (MTG) documents of all published MTEP submissions for which both documents were available (N=34) were reviewed. The methodology of the clinical literature review, studies identified, types of EAC feedback (using 22 pre-defined categories), and the recommendation received were extracted. RESULTS: Amongst the 34 MTGs (33 literature reviews), the highest level of evidence identified was randomised controlled trials (RCTs) in 59%, controlled studies in 9%, and non-controlled studies in 32% of the submitted reviews. All reviews received ≥ CONCLUSIONS: Literature reviews supporting MTEP submissions typically fail to meet the methodological and reporting standards required for systematic literature reviews. Notably, we observed a wide variety in the quality of literature reviews in support of MTEP, which is surprising given the clear guidance in NICE’s MTEP submission template to be systematic and transparent
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PMD134
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Multiple Diseases