SMALL AND MEDIUM-SIZED ENTERPRISES- HOW DO THEY FARE IN THE UK MEDICAL TECHNOLOGIES EVALUATION PROGRAMME (MTEP)?
Author(s)
Ridley CJ, Marsh W
Costello Medical Consulting Ltd, Cambridge, UK
Presentation Documents
OBJECTIVES: Health technology assessment (HTA) of medical devices is rarer than pharmaceuticals, due to limited clinical evidence, shorter lifespan and variable pricing. In contrast to pharmaceuticals, the majority of medical device manufacturers (MDMs) are small and medium-sized enterprises (SMEs). The Medical Technologies Evaluation Programme (MTEP), developed in 2010 by the UK National Institute for Health and Care Excellence (NICE), promotes development and market access of new medical technologies. However, barriers for SMEs include costs and high clinical evidence requirements. In this study, we assess how well the MTEP provides a route to market for SMEs. METHODS: We extracted data from the 36 published/draft medical technology guidances (MTGs), identified the size of manufacturers and analysed how SMEs (defined as MDMs with <500 employees) compare to larger MDMs in terms of guidance output, recommendation status and time to publication. RESULTS: Whilst 98% of UK MDMs are SMEs, we show that only 63% of MTG sponsors are SMEs. The annual number of MTGs fluctuates, but overall presents a cumulative annual increase of 0.2 MTGs. However, there is an annual decrease of 0.1 MTGs for SMEs. For large MDMs, 100% of MTGs published were positive, compared to 71% for SMEs. Finally, SMEs experience a longer mean time to publication (15.9 vs. 12.8 months, p=0.27) and a much wider range in publication time (23 vs. 8 months), driven by a considerably higher maximum time to publication. CONCLUSIONS: The MTEP is an important step towards improving HTA for medical devices. However, much remains to be done to improve participation by SMEs. SMEs appear less likely to submit applications, and receive fewer positive recommendations. A lack of clinical evidence was cited in every case of non-recommendation; suggesting SME’s struggle to meet NICE’s evidence requirements. Therefore, we present considerations for NICE to improve SME participation in the MTEP.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PMD118
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases