DO FRENCH HEALTH ECONOMICS AND CLINICAL HTA COMMITTEES HAVE COHERENT APPRAISALS OF CLINICAL TRIALS?

Author(s)

Hanna E1, Rémuzat C2, Jadot G3, Toumi M1
1Aix-Marseille University, Marseille, France, 2Creativ-Ceutical, Paris, France, 3Lyon 1 University, Villeurbanne, France

OBJECTIVES:  In France, the Economic and Public Health Assessment Committee (CEESP) and the transparency committee (TC) are 2 independent committees affiliated to the French health authority (Haute Autorité de Santé: HAS). TC assesses medicinal products clinical evidences and provides recommendations on reimbursement for public authorities whereas CEESP provides recommendations on health economics evaluations. These 2 committees operate in parallel without any coordination or communication of information which constitutes a specificity of the French system. The aim of this study was to evaluate the consistency in evaluating clinical trials between CEESP and TC. METHODS:  All available CEESP published opinions were searched in HAS website, then the TC opinions for the same products were downloaded. Major comments on clinical trials were extracted from both reports by two different analysts. Comments were classified as limited number of included patients (<50), non-comparative trials, and insufficient data based on CEESP opinion and then compared to TC opinion. RESULTS:  Twenty published CEESP opinions were identified. Aside health economics comments, CEESP had no comments on clinical trials in 11 reports, while TC identified limitations in 8 reports. In 2 CEESP reports insufficient data was claimed, 4 had a limited number of included patients and 3 non-comparative trials. Out of the 9 comments reported by CEESP, 8 were mentioned also on TC opinions. However, TC presented more detailed evaluation and discussion of all the product clinical trials. CONCLUSIONS:  A strong coherence in the assessment of clinical trials can obviously be concluded from this comparison. These results raise the issue of effort and work duplication due to the parallel and independent work between the 2 committees. On the other hand, this coherence reveals the homogeneity of the HAS assessment culture.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PHP157

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

×