PMD166 - REVIEW OF NICE MEDICAL TECHNOLOGIES EVALUATION PROGRAMME (MTEP) FOR MEDICAL DEVICES

Abstract

The NICE medical technologies evaluation programme (MTEP) selects and evaluates new or innovative medical technologies to support the NHS in rapid adoption of efficient and cost effective medical devices and diagnostics. This study aimed to review the MTEP and evaluate factors relevant in the decision process and the likelihood of positive Medical Technology Guidance (MTG). The study was conducted to assess whether MTEP can simplify access to evaluation, speed up the evaluation process, and increase capacity for device reviews within NICE to better support the NHS in this area. All MTGs published from 2010 to 2017 were reviewed with the following data fields extracted: submission date, publication date , submitting company size and submission outcome. Between 2010 and 2017, a total of 34 MTGs were published. On average, four MTGs were published each year (range 1-7). The outcomes were: 25 recommended, three restricted, and six not recommended. Twelve small (<50 employees), 8 medium sized (<250 employees) (SMEs) and 14 large enterprises were represented. For the evaluative process, time for publication varied widely between four to 22 months. Over the period assessed, uptake of MTEP was lower than initially expected due to the cost-saving criterion, which may neglect some beneficial new technologies. The evaluation process timeline varied immensely as certain companies may have better resources required to support a submission. To assist in streamlining NICE evaluations, the MedTech Early Technical Assessment (META) tool was developed to assist companies towards a better understanding of the requirements needed to demonstrate product value to the NHS leading towards a successful application. It helps to identify data gaps that impact product approval or could create delay in market entry This may help to reduce variation in the time to publication and improve innovation by offering vital guidance to SMEs.