COMPARING HTA OUTCOMES FOR CENTRALLY AUTHORISED MEDICINAL PRODUCTS IN GREAT BRITAIN 2011-2015

• Published in: Value in health Vol. 20; no. 5; p. A19
• Main Authors: Maignen, FM, Zamora, B, O'Neill, P, Garau, M, Lorgelly, P
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01.05.2017
• Subjects: Access; Appraisal; Cancer; Centralization; Clinical outcomes; Cost analysis; Drug therapy; Drugs; Health care; Health care access; Health care delivery; Herbal medicine; Hybrids; Marketing; Orphans; United Kingdom > UK
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: Marketing authorisation is the first step in making new medicines available in national health systems. Most new substances are approved in the European Union via the centralised procedure (coordinated by the European Medicines Agency), which was designed to facilitate access to new and efficacious therapies. Many health care systems in Europe then evaluate new technologies according to their effectiveness and cost effectiveness. We compared the outcomes of HTA evaluations for centrally authorised products (CAPs) in Great Britain. METHODS: The Medicine Tracker is a proprietary database of products, which includes detailed and structured information on CAPs, e.g. indications (initial and extensions), regulatory and HTA outcomes and dates of decisions. We analysed and compared the outcomes of evaluations conducted by the National Institute for Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) for all the CAPs which received an authorisation (initial or extension) between 01/01/2011 and 31/ 12/2015. RESULTS: 416 authorisations (excluding generics, hybrids, biosimilars) were granted between 2011 and 2015 (including 67 orphan medicinal products). 171 (30%) are for anti-cancer medicines. 50% of the 416 CAPs were referred to NICE including 60% (103) of the anti-cancer medicines. 75% of NICE appraised CAPs received a positive recommendation and only 21 products (13%) were rejected. Anti-cancer medicines were disproportionally affected by NICE negative recommendations (OR of receiving a negative recommendation compared with other products 4.19 [2.26, 7.75]). The odds of receiving a positive recommendation from the SMC was significantly lower for orphans compared with non-orphan medicinal products; OR 0.42 [0.21, 0.83]. 25 products were appraised in all 3 countries, there was low agreement in terms of recommendations, Kappa 0.479, p≤ 0.001. CONCLUSIONS: Despite the centralised procedure increasing the availability of new medicines, this does not systematically translate into wider access in Great Britain.