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Int J Health Policy Manag. 2022;11(5): 642-650. doi: 10.34172/ijhpm.2020.198
PMID: 33131224        PMCID: PMC9309934

Original Article

The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs

Rick A. Vreman 1,2 ORCID, Lourens T. Bloem 1,3 ORCID, Stijn van Oirschot 1, Jarno Hoekman 1,4, Menno E. van der Elst 3, Hubert GM Leufkens 1, Olaf H. Klungel 1,5, Wim G. Goettsch 1,2, Aukje K. Mantel-Teeuwisse 1 * ORCID

Cited by CrossRef:


1- Kaló Z, Niewada M, Bereczky T, Goettsch W, Vreman R, Xoxi E, Trusheim M, Callenbach M, Nagy L, Simoens S. Importance of aligning the implementation of new payment models for innovative pharmaceuticals in European countries. Expert Review of Pharmacoeconomics & Outcomes Research. 2024;24(2):181 [Crossref]
2- Everest L, Blommaert S, Chu R, Chan K, Parmar A. Parametric Survival Extrapolation of Early Survival Data in Economic Analyses: A Comparison of Projected Versus Observed Updated Survival. Value in Health. 2022;25(4):622 [Crossref]
3- ten Ham R, Frederix G, Wu O, Goettsch W, Leufkens H, Klungel O, Hoekman J. Key Considerations in the Health Technology Assessment of Advanced Therapy Medicinal Products in Scotland, The Netherlands, and England. Value in Health. 2022;25(3):390 [Crossref]
4- Hogervorst M, Møllebæk M, Vreman R, Lu T, Wang J, De Bruin M, Leufkens H, Mantel-Teeuwisse A, Goettsch W. Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts. BMJ Open. 2023;13(8):e072309 [Crossref]
5- Vreman R, Strigkos G, Leufkens H, Schünemann H, Mantel-Teeuwisse A, Goettsch W. Addressing uncertainty in relative effectiveness assessments by HTA organizations. Int J Technol Assess Health Care. 2022;38(1) [Crossref]
6- Sehdev S, Chambers A. Is It Time to Commit to a Process to Re-Evaluate Oncology Drugs? A Descriptive Analysis of Systemic Therapies for Solid Tumour Indications Reviewed in Canada from 2017 to 2021. Current Oncology. 2022;29(3):1919 [Crossref]
7- Hug K. How Proven is a ‘Proven Intervention’? Ethics of Placebo Controls in Light of Conditional Approval Programs. Regen Med. 2023;18(7):561 [Crossref]