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HAS submissions seeking market access of a new drug in France require demonstration of its additional benefit. The Transparency Committee assesses the efficacy, effectiveness, safety, and tolerance of the drug, whereas the CEESP committee assesses the efficiency of the drug, both based on direct or indirect treatments comparisons.
Indirect Treatments Comparisons (ITCs) are statistical approaches that aim to facilitate indirect comparisons of multiple treatments that have not been studied in head-to-head studies, to help clinicians and policymakers make informed decisions. ITCs occupy a prominent position in the pyramid of evidence-based medicine, and its use has grown rapidly over the past decade.
Methodological and technical supports (recommendations, guidelines, checklists) are available to conduct and assess ITCs. In France, the HAS released in 2009, a guideline for ITC implementation and submission, and the CEESP has updated the Methodological Guidance - Choices in methods for economic evaluation in 2020. In addition, the HAS highly recommends the UK’ NICE guideline and related technical supports for ITC technical issues. International guidelines (ISPOR, PRISMA, etc.) are also available for setting, conducting, reporting, and assessing ITCs.
Beside the existence of resources for performing and reporting an ITC, submitted dossiers to the HAS (CT, CEESP) appraisal have generated major concerns on the ITC, which can call into question the credibility and validity of the indirect comparisons.
This webinar aims to contribute to the vulgarization of the ITC as a powerful evidence tool to help in decision making process, highlight the operational appraisal of ITCs by the HAS, and gather theoretical guidelines, including a review of the published HAS opinions from 2015 to 2020 (CT and CEESP opinions). Examples of HAS concerns related to several types of ITCs will also be illustrated.
This webinar justifies the need of defining technical supports that will be a referential between researchers, pharmaceutical firms, and consulting companies who perform ITCs, and authorities who assess them, and will open discussion to find consensual solutions and clarifications to improve the quality of the future submitted ITCs.
Solutions to help life sciences organizations drive healthcare forward and get the right treatments to patients, faster.
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