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Master Thesis

Place des comparaisons indirectes dans l’évaluation des médicaments en vue de leur accès au remboursement en France

Abstract : Objective: To evaluate a new drug, Health Technology Assessment (HTA) agencies must have comparative data. With the lack of clinical trials versus all different comparators, pharmaceutical companies have started using more methods of indirect treatment comparison like network meta-analysis. The main objective is to evaluate impact of indirect treatment comparison methods in HTA by the French National Authority for Health (HAS). Methods: Two retrospective studies were conducted. The first was realized using the keyword "indirect" or "network" in an internal database of HAS which contains HTA opinions of the Transparency Committee (CT) in order to select those mentioning indirect comparisons, from July 2009 to October 2014. The second study analyzed efficiency opinions issued by the Commission of Economic Evaluation and Public Health (CEESP) from October 2013 to December 2014. For each opinion of the two retrospective studies we recorded notably: method of indirect comparison used, acceptability/criticisms, and impact on decision-making. Results: In the first study, about 50% (30/61) of indirect comparisons identified in the opinions (n = 60 with indirect comparisons) were deemed unacceptable from a methodological point of view by the CT. About 10% of indirect comparisons (6/61) were valid, allowed to prioritize the treatment, and were consistent with the "improvement of the medical service provided" (ASMR) assigned. In the second study (CEESP), out of 14 opinions of efficiency identified, 4 included indirect comparisons (29%), and these were all acceptable. Conclusion: CT uses the results of indirect comparisons as complementary evidence, and not as decisive elements on which to base the ASMR. On the contrary, CEESP validates more frequently results of indirect comparisons integrated into the health economic models. This apparent difference in the way of considering and using indirect treatment comparisons by these two commissions of the HAS may be explained by their different objectives.
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Master Thesis
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Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Tuesday, September 29, 2015 - 10:34:14 AM
Last modification on : Wednesday, August 23, 2017 - 4:29:36 PM
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  • HAL Id : dumas-01206476, version 1



Marine Guichard. Place des comparaisons indirectes dans l’évaluation des médicaments en vue de leur accès au remboursement en France. Sciences pharmaceutiques. 2015. ⟨dumas-01206476⟩



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