RT Journal Article
T1 Development of a core evaluation framework of value-added medicines: report 2 on pharmaceutical policy perspectives.
A1 Kaló, Zoltán
A1 Petykó, Zsuzsanna Ida
A1 Fricke, Frank-Ulrich
A1 Maniadakis, Nikos
A1 Tesař, Tomáš
A1 Podrazilová, Kateřina
A1 Espin, Jaime
A1 Inotai, András
K1 Drug repurposing
K1 Evidence
K1 Generic reference pricing
K1 Incremental innovation
K1 Multi-criteria decision analysis
K1 Value assessment framework
K1 Value-added medicines
AB A core evaluation framework that captures the health care and societal benefits of value added medicines (VAMs, also often called repurposed medicines) was proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes across countries and to create incentives for manufacturers to invest into incremental innovation. However, this can be impactful only if the framework can be adapted to heterogeneous health care financing systems in different jurisdictions, and the cost of evidence generation necessitated by the framework takes into account the anticipated benefits for the health care system and rewards for the developers. The framework could potentially improve the pricing and reimbursement decisions of VAMs by adapting it to different country specific decision-contexts such as deliberative processes, augmented cost-effectiveness frameworks or formal multi-criteria decision analysis (MCDA); alternatively, some of its domains may be added to current general evaluation frameworks of medicines. The proposed evaluation framework may provide a starting point for practices based on which VAMs can be exempted from generic pricing mechanisms or can be integrated into the reimbursement and procurement system, allowing for price differentiation according to their added value. Besides evidence from RCTs, pricing and reimbursement decision processes of VAMs should allow for ex-ante non-RCT evidence for certain domains. Alternatively, relying on ex-post evidence agreements-such as outcome guarantee or coverage with evidence development-can also reduce decision uncertainty. The core evaluation framework for VAMs could trigger changes in the existing pricing, reimbursement and procurement practices by improving the appraisal of the added value created by incremental innovation.
SN 1478-7547
YR 2021
FD 2021-07-15
LK http://hdl.handle.net/10668/18202
UL http://hdl.handle.net/10668/18202
LA en
DS RISalud
RD Apr 10, 2025