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