TRENDS IN EARLY ENGAGEMENT BETWEEN INDUSTRY AND HTA- ANALYSIS OF SCIENTIFIC ADVICE SERVICE PROVIDED BY NICE SINCE 2009
Author(s)
Maignen FM1, Osipenko L1, Gajraj E1, Chivers R2
1National Institute for Health and Care Excellence, LONDON, UK, 2National Institute for Health and Clinical Excellence, Manchester, UK
OBJECTIVES: Regulatory Scientific Advice (SA) provided by EMA, FDA, MHRA and other agencies is highly demanded by manufacturers but health technology assessment (HTA) scientific advice is still far from becoming a routine step in the product development cycle. NICE has been running an advisory service for 5.5 years. METHODS: This work presents analysis of requests to the programme: types of advice projects, number and type of requests per company, clinical indication, stage of clinical development when the advice is sought, reason for seeking advice and current development and regulatory status of products. RESULTS: Between 2009 and 2014 NICE conducted 109 advisory projects (107 medicinal products and two diagnostic tests). 23 of these projects were done in parallel with regulatory agencies and/or other HTA bodies. 78% of all requests were in the following four therapeutic areas: oncology, neurology, rheumatology and cardiology. Majority of products (61%) were in phase II of clinical development when advice was sought. At the time of this analysis, 71 products (66%) were still in development, 6 (5.5%) were subject of a review for a marketing authorisation (MA), 8 (7.5%) had received a MA, the authorisation was not granted to 2 products (2%) and the clinical development was discontinued in 20 cases (19%). Most products that received NICE scientific advice are yet to be referred to the technology appraisals programme. CONCLUSIONS: Over the last few years, requests for scientific advice diversified into personalised medicines, regenerative medicines and products for rare and very rare diseases. Most HTA scientific advice requests continue to come from top 20 Pharma companies, however we are starting to see an increasing number of inquiries and project bookings from small-medium size companies.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP223
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases