Thokagevistk Katia, Coppo Céline, Rey Laetitia, Carelli Amanda, Díez Veronica, Vaselenak Sarah, Oliveira Liana, Patel Ajay, Sicari Emilia, Ramos Teresa, Schach Susanne, Schirghuber Erika, Simpson Alex, Choquet Remy, Le Lay Katell
Roche, 4 Cr de l'Île Seguin, 92100 Boulogne-Billancourt, France.
IQVIA, 17 bis Tsse. des Reflets, 92400 Courbevoie, France.
J Mark Access Health Policy. 2024 May 20;12(2):105-117. doi: 10.3390/jmahp12020009. eCollection 2024 Jun.
BACKGROUND: Real-world evidence (RWE) can reinforce clinical trial evidence in health technology assessment (HTA). OBJECTIVES: Review HTA bodies' (HTAbs) requirements for RWE, real uses, and acceptance across seven countries (Brazil, Canada, France, Germany, Italy, Spain, and the United Kingdom) and outline recommendations that may improve acceptance of RWE in efficacy/effectiveness assessments and appraisals processes. METHODS: RWE requirements were summarized based on HTAbs' guidelines. Acceptance by HTAbs was evaluated based on industry experience and case studies. RESULTS: As of June 2022, RWE methodological guidelines were in place in three of the seven countries. HTAbs typically requested analyses based on local data sources, but the preferred study design and data sources differed. HTAbs had individual submission, assessment, and appraisal processes; some allowed early meetings for the protocol and/or results validation, though few involved external experts or medical societies to provide input to assessment and appraisal. The extent of submission, assessment, and appraisal requirements did not necessarily reflect the degree of acceptance. CONCLUSION: All the countries reviewed face common challenges regarding the use of RWE. Our proposals address the need to facilitate collaboration and communication with industry and regulatory agencies and the need for specific guidelines describing RWE design and criteria of acceptance throughout the assessment and appraisal processes.
Int J Technol Assess Health Care. 2021-2-24
J Manag Care Spec Pharm. 2020-12
Pharmacoeconomics. 2021-3
Int J Technol Assess Health Care. 2020-7-10