Our regular column where we select the latest published from September 2024 across the spectrum of #RWE and #HTA. This month, we feature:
- Why is the market design for innovative pharmaceuticals not well understood? Francisco Olivença, Jose Diaz, Sreeram Ramagopalan and Lou Garrison Jr
- Development of stakeholder-informed recommendations for inclusion of family spillover effects in health technology assessment. David Campbell, Rajshree Pandey, Lisa Bloudek, Josh Carlson, Christopher Wallick, David Veenstra and Stacey Kowal
- Analysis of factors associated with use of real-world data in single technology appraisals of cancer drugs by the National Institute for Health and Care Excellence. Jiyeon Kang and John Cairns
- Development of a Canadian guidance for reporting real-world evidence for regulatory and health-technology assessment (HTA) decision making. @Mina Tadrous, Theresa Aves, Christine Fahim and colleagues
- PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage. Kazuhiro Kajiyama, Maki Komamine, Naoya Horiuchi, Toyotaka Iguchi, Yoshiaki Uyama
- Adopting a framework for rapid real-world data analyses in safety signal assessment. Lu Wang, Negar Golchin, Stephanie von Klot, Claudia A Salinas, Katrin Manlik, Vaishali Patadia, PhD, MBA, MPH, Mary K Miller, Julius Asubonteng, Rachel McDermott, Julie Barberio & Geoffrey Gipson
- Examining the effect of missing data and unmeasured confounding on external comparator studies: case studies and simulations. Gerd Rippin, Héctor Sanz, Wilhelmina E Hoogendoorn, Nicolás M Ballarini, Joan A Largent, Eleni Demas, Douwe Postmus, Theodor Framke, Lukas M Aguirre Dávila, Chantal Quinten & Francesco Pignatti
- Analytical methods for comparing uncontrolled trials with external controls from real-world data: a systematic literature review and comparison to European regulatory and health technology assessment practice. Milou A Hogervorst, Kanaka V Soman, Helga Gardarsdottir, Wim Goettsch & Lourens T Bloem
- Drugs anticipated to be selected for the Medicare Drug Price Negotiation Program in 2025. Emma M Cousin, Sean Sullivan, Ryan N Hansen, Nico Gabriel, Ayuri S Kirihennedige & Inmaculada (Inma) Hernandez
Read at The Evidence Base®
#heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy
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