COMPARISON OF HTA DOSSIER REQUIREMENTS ACROSS EUROPE

Author(s)

Casamayor M, Van Engen AQuintiles Global Consulting, Hoofddorp, Noord-Holland, Netherlands

OBJECTIVES: Submitting an HTA dossier a cardinal step in gaining market access for new drugs. While funding decisions lay on an array of criteria a well designed global value dossier (GVD) will facilitate development of national dossiers. In order to gain a better understanding of the optimal structure of a GVD we reviewed differences in requirements and recent changes in countries like Germany and Spain. METHODS: Country-specific guidelines for HTA submissions and dossiers submitted in the last 3 years have been scrutinized to identify the key differences across European agencies (AWMSG, CVZ, DGFPS, G-BA, HAS/CEPS, NCPE, NICE, SMC, TLV). Criteria reviewed included the guidelines strictness, and the need of comparative effectiveness, health economic and budget impact evidence. RESULTS: The majority of agencies reviewed (89%) have a well defined template but the outline differs markedly between them. Differences relate to the requested contents (clinical and budgetary outcomes only [33%] vs. a more cost-effectiveness framework [67%]), and to the perspective from which the evidence is reviewed (societal [17%] versus national health system or statuary health insurance perspective [83%]). Additional differences are the preferred type of economic model (cost utility versus cost per clinical benefit) and budget impact (incremental budget impact versus net costs) and weight given to indirect treatment comparisons when head-to-head studies are lacking. CONCLUSIONS: Our review illustrates the lack of standardization of the requirements across European HTAs. This renders the development of a GVD easily adaptable to country-specific submissions, a difficult task. Our review suggests that the GVD should be orchestrated around the needs for NICE and implemented with the particularities of the different HTAs.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP124

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×