THE ASSOCIATION BETWEEN EUROPEAN MEDICINES AGENCY APPROVAL AND HEALTH TECHNOLOGY ASSESSMENT RECOMMENDATION

Author(s)

Lipska I*1;Hövels AM2, McAuslane N1 1Centre for Innovation in Regulatory Science, London, United Kingdom, 2Utrecht University, Utrecht, Netherlands

OBJECTIVES: To find the association between duration of the process of marketing authorization (MA) approval at European Medicines Agency  (EMA) and health technology assessment (HTA) recommendations in European Union (EU) countries. METHODS: EMA MA timing for new active substances (NASs) during 2007-2009 were analyzed based on publicly available information. HTA recommendations (positive, positive with restrictions, negative, not assessed) issued for the same medications in 6 EU countries (SMC, Scotland; AOTM Poland; CVZ, The Netherlands; HAS, France; NICE, UK; INFARMED, Portugal) were also analyzed based on public information.  Hypothesizing that EMA approval process timing might be an indicator of complexity and potential issues in the dossier, the potential for longer EMA approval times being associated with less beneficial HTA recommendation was investigated. Analyses were performed per country as EMA decisions are centralized but HTA recommendations are taken independently by member states. RESULTS: 86 NAS were approved by EMA in 2007-2009; mean time of approval was 460 days (median 423 days). In total, we expected 516 HTA recommendations (86 drugs assessed by 6 organizations).  We found in total 138 positive, 77 positive with restrictions, 67 negative recommendations. 234 expected recommendations for 6 HTA included in this study were not assessed (45,3% of all expected recommendations).  The association between HTA recommendation and approval time (in days) was analyzed using Spearman’s rho rank correlation. There was statistically significant negative correlation between approval time and HTA recommendation in the Netherlands. More time needed for EMA approval was associated with less beneficial HTA recommendations. Correlations in other countries were not statistically significant. CONCLUSIONS: Our research indicates that a longer EMA approval process is associated with a less beneficial HTA recommendation in the Netherlands. Further research is required whether this indicates that the same issues that cause delays at EMA are reconsidered at HTA authorities

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP8

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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