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http://dx.doi.org/10.3390/jmahp13030033 | DOI Listing |
J Mark Access Health Policy
September 2025
CEReSS/UR3279-Health Services Research and Quality of Life Center, Aix-Marseille University, 13385 Marseille, France; (L.B.); (P.A.).
J Mark Access Health Policy
March 2025
IQVIA, 1101 CT Amsterdam, The Netherlands;
The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical nature of market access in ensuring innovation reaches patients, it should be no surprise that the EU HTAR will have impacts far beyond this function. Here, we utilize published EU HTAR guidance, a pragmatic literature review, internal analysis, and insights from engagements with manufacturers, to outline some of the key cross-functional considerations arising from JSC and JCA, and how manufacturers should account for these in their EU HTAR readiness plans.
View Article and Find Full Text PDFClin Pharmacol Ther
April 2025
Boston Consulting Group, Zurich, Switzerland.
The value of a medicine is defined by its impact on patients, caregivers, health system, and society. A pharmaceutical company will generate evidence to demonstrate this value in various studies, including randomized clinical trials, non-interventional and observational studies, real-world data analyses, modeling, and simulation. The quality and strength of the evidence supporting a medicine's effectiveness, safety and product quality will drive decisions by healthcare system stakeholders for marketing authorization (regulatory authorities).
View Article and Find Full Text PDFInt J Technol Assess Health Care
December 2024
Institute for Quality and Efficiency in Healthcare, Cologne, Germany.
Health Technology Assessment (HTA) in Europe has undergone significant evolution, culminating in the adoption of Regulation (EU) 2021/2282 on HTA (HTAR) aimed at fostering sustainable collaboration in HTA at the European Union (EU) level. The EUnetHTA 21 project, a 2-year initiative, was commissioned to address key methodological issues and prepare for the implementation of the HTAR. This commentary documents the outcomes of the EUnetHTA 21 project, focusing on Joint Clinical Assessments (JCAs), while analyzing challenges encountered and lessons learned for future collaboration under the HTAR.
View Article and Find Full Text PDFJ Mark Access Health Policy
September 2024
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.
National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings.
View Article and Find Full Text PDF