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Therapies
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le vendredi 23 novembre 2018
Doi : 10.1016/j.therap.2018.10.004
Received : 15 May 2018 ;  accepted : 26 October 2018
Clinical added value of drugs: An empirical survey of French transparency committee opinions
 

Bruno Detournay a, , Thomas Borel b, Matthieu Trancart a, Corinne Emery a, Carole Coudray-Omnès a

LEEM working group on health technology assessment of drugsb

a CEMKA, 43 boulevard du Maréchal Joffre, 92340, Bourg-la-Reine, France 
b LEEM, 75017 Paris, France 

Corresponding author.
Summary
Objectives

To identify criteria used by French health authorities to assess the clinical added value (ASMR) of drugs seeking reimbursement.

Methods

We conducted a systematic review of the opinions of the transparency committee (TC) of the French national authority for health (HAS) between March, 2014 and October, 2016 in ten therapeutic areas. TC opinions content was coded and analysed using descriptive statistics and logistic models.

Results

The database comprised 160 opinion texts, which included ASMR assessments using a 5 level scale (1=highest ASMR 5=no ASMR). Main elements that were linked with ASMR 1,2,3,4 as compared to ASMR 5 were appraisal of the medical need, population size (<5000 patients), and clinical relevance of the evaluated results. The factors associated with ASMR 4 as compared to ASMR 1-3 were the safety profile and clinical relevance of the results. However, the factors associated with ASMR level varied according to the therapeutic area considered.

Conclusions

The assessment of the drug ASMR conducted by the French transparency commission of the HAS appears to be at least in part determined by criteria (medical need, population size) which reflect the burden of the disease but not reflect the ASMR of the medicine assessed. Other criteria used for the assessment of ASMR are not clearly defined and depend on the therapeutic domain. The lack of sufficient clarity and consistency in assessment of ASMR complicate the decision making process for drug development. Moreover, this situation can be a barrier for a harmonized process of ASMR assessment at European level.

The full text of this article is available in PDF format.

Keywords : Clinical added value, Assessment health technology, Comparative effectiveness research, Drug approval, France




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