Lessons from the Recent Uptake of Health Economic Evaluation of Innovative Drugs in the French Regulatory Framework
Lawrenceville, NJ, USA—February 18, 2019—Value in Health, the official journal of ISPOR—the professional society for health economics and outcomes research, announced today the publication of new research showing that the use of cost-effectiveness opinions issued by the French National Health Authority improved the information available to support the pricing decisions for new hepatitis C drugs. The report, “Was It Worth Introducing Health Economic Evaluation of Innovative Drugs in the French Regulatory Setting? The Case of New Hepatitis C Drugs,” was published in the February 2019 issue of Value in Health.
Taking the example of new direct-acting antivirals—sofosbuvir (Sovaldi®), simeprevir (Olysio®), daclatasvir (Daklinza®), ledipasvir-sofosbuvir (Harvoni®), ombitasvir-combo (Viekirax®), and dasabuvir (Exviera®)—against hepatitis C virus, the authors assessed whether and how the cost-effectiveness opinions issued by the French National Health Authority improved the information available to support pricing decisions. More precisely, the analysis examined what specific information—if any—was provided on the drugs’ value.
The research results show that the cost-effectiveness opinions did in fact bring to the fore 3 issues prone to impact the incremental cost utility ratio but were not available to decision makers through clinical opinions or published cost-utility analysis: 1) the stage of treatment initiation, 2) the modeling of the disease progression, and 3) the uncertainty around the efficacy rates. Therefore, the analysis shows that, in the case of the direct-acting antivirals, the use of cost-effectiveness opinions has enhanced the information available to the decision makers on the value of the treatments.
“Since 2013, pharmaceutical manufacturers have been required to submit an economic dossier to the French Health Authority for market access,” said author Valerie Clement, MRE, Faculte d’Economie, Universite de Montpellier, Montpellier, France. “The Commission d’Evaluation Economique et de Sante Publique is in charge of the review and issues a cost-effectiveness opinion. These opinions assess the reliability and the methodological consistency of the dossier and provide comments that highlight the salient features of the drugs’ value for money (essentially, adding health economic evaluation to the clinical evaluation of the drugs). Among the very first drugs subject to this new regulatory framework were the newest direct-acting antivirals for hepatitis C virus. This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework.”
ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2017 impact factor score is 5.494. Value in Health is ranked 3rd among 94 journals in healthcare sciences and services, 3rd among 79 journals in health policy and services, and 6th among 353 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
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