How the HTAR will contribute to a value-based decision-making for medicinal products across the EU
| Authors | |
|---|---|
| Year of publication | 2026 |
| Type | Peer-reviewed scientific article |
| Magazine / Source | British Journal of Clinical Pharmacology |
| MU Faculty or unit | |
| Citation | |
| web | https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70437 |
| Doi | https://doi.org/10.1002/bcp.70437 |
| Keywords | health technology; HTA; HTAR; medicinal products; value |
| Attached files | |
| Description | The European Union Health Technology Regulation 2021/2282 (HTAR) introduces jointassessment of health technologies (including medicinal products and medical devices)across EU Member States. It was signed into law in 2021 and came into full force inJanuary 2025. HTAR includes some core domains such as Joint Clinical Assessment(JCA), which refers to the relative effectiveness assessment of new technologies thathave submitted a marketing authorization application to the EMA. It further includesJoint Scientific Consultation, which allows health technology developers to seek adviceat an early stage in order to plan evidence generation in line with HTA needs.Such joint work will feed into respective national decision-making processes. While aJCA report will arguably fit directly into appraisal processes based on an added bene-fit framework, countries performing cost-effectiveness appraisal will be expected toincorporate a JCA into their value frameworks. In assessing the value of a new tech-nology, however, HTA agencies face challenges stemming from the complexity ofnew technologies, a weakened evidence paradigm and a delay in access.The authors argue that HTAR can contribute towards solving some of the challengesthrough the reestablishment of evidence standards even for complex technologies,reduction of redundancies and a build-up of assessment capacity. Together with thesuggested changes in the pharmaceutical regulation, HTAR may shorten the delay forlate-access countries. HTAR is argued to be a major step towards a longer-term goalof equitable, efficient and high-quality healthcare in Europe, potentially leadingtowards the direction of one European HTA body. |
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