How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

Author:

Tafuri Giovanni12,Pagnini Margherita1,Moseley Jane1,Massari Marco2,Petavy Frank1,Behring Antje3,Catalan Arantxa4,Gajraj Elangovan5,Hedberg Niklas6,Obach Mercè4,Osipenko Leeza5,Russo Pierluigi2,Van De Casteele Marc7,Zebedin Eva‐Maria8,Rasi Guido1,Vamvakas Spiros1

Affiliation:

1. European Medicines Agency (EMA) 30 Churchill Place London E14 5EU UK

2. Italian Medicines Agency (AIFA) via del Tritone 181 ‐ 00187 Rome Italy

3. German Federal Joint Committee (G‐BA) Wegelystr. 8 D‐10623 Berlin Germany

4. Catalan Agency for Health Quality and Assessment (AQuAS) Carrer de Roc Boronat 81‐95 08005 Barcelona Spain

5. National Institute for Health and Care Excellence (NICE) 10 Spring Gardens London SW1A 2BU United Kingdom

6. Dental and Pharmaceutical Benefits Agency (TLV) Fleminggatan 7 112 26 Stockholm Sweden

7. National Institute for Sickness and Invalidity Insurance (INAMI) Avenue de Tervueren 211 1150 Bruxelles Belgium

8. Main Association of Austrian Social Security Institutions (HVB) Kundmanngasse 21 A‐1031 Vienna Austria

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference20 articles.

1. Key principles for the improved conduct of health technology assessments for resource allocation decisions

2. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers

3. Health economics and outcomes research within drug development

4. The role of health technology assessment bodies in shaping drug development

5. Pharmaceutical industry: a strategic sector for the European economy. European Commission Brussels 1.8.2014 SWD(2014) 216 final/2. Available athttp://ec.europa.eu/growth/sectors/healthcare/index_en.htm(last accessed March 2016)

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