NI3 Patient Access Schemes in the New NHS

Abstract

OBJECTIVES:The NICE Scientific Advice (SA) programme was established in 2009. It provides written advice to pharmaceutical companies and device manufacturers about development plans for their products to ensure they produce relevant evidence for future submission to NICE. Herein we present a detailed analysis of the NICE SA programme over the past three years. METHODS: The NICE SA process involves assessment of the manufacturer's briefing book with input from external clinical experts, health economists and methodological experts. Following a faceto-face meeting between the manufacturer, the expert panel and the SA technical team, a formal written report summarising the advice is produced. In addition, NICE SA provides advice alongside the European Medicines Agency (EMA) and other Health Technology Assessment (HTA) agencies. Whilst such collaborations do not include a formal written report, advice is given verbally at joint meetings. Following these meetings, NICE SA provides a commentary on the manufacturer's minutes, clarifying the issues identified from the perspective of NICE. RESULTS: To date the programme has successfully completed 52 formal written advice projects. Requests for advice alongside the EMA and other HTA agencies have been steadily increasing with 13 projects completed since 2010. We produced detailed analyses of all requests to the NICE SA programme to date. Specifically, we will report on the types of questions posed in manufacturers' briefing books including questions on health economic evaluation. We will include a breakdown by therapeutic area, frequency of requests by company, type of company, profiles of participants at meetings, and trends over time. CONCLUSIONS: We will reflect on how the various models of advice projects differ, how manufacturers can get the most from the process, and how the NICE SA programme is expected to evolve.