RT Journal Article
T1 Development of a core evaluation framework of value-added medicines: report 1 on methodology and findings.
A1 Petykó, Zsuzsanna Ida
A1 Kaló, Zoltán
A1 Espin, Jaime
A1 Podrazilová, Kateřina
A1 Tesař, Tomáš
A1 Maniadakis, Nikos
A1 Fricke, Frank-Ulrich
A1 Inotai, András
K1 Expert panel
K1 Generic price erosion
K1 Incremental innovation
K1 Repurposed medicine
K1 Value assessment framework
K1 Value domain
K1 Value proposition
K1 Value-added medicines
AB Medicines that are based on known molecules and are further developed to address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers are called value-added medicines (VAMs). The evaluation process of VAMs is heterogeneous across countries, and it has been primarily designed for originator pharmaceuticals with confirmatory evidence collected alongside pivotal clinical trials. There is a mismatch between evidence requirements by public decision-makers and evidence generated by manufacturers of VAMs. Our objective was to develop a core evaluation framework for VAMs. Potential benefits offered by VAMs were collected through a systematic literature review and allocated to separate domains in an iterative process. The draft list of domains and their applicability were validated during two consecutive virtual workshops by health policy experts representing countries with different economic statuses, geographical and decision-making contexts. Based on 158 extracted studies, the final consensus on the evaluation framework resulted in 11 value domains in 5 main clusters, including unmet medical needs, health gain (measured by health care professionals), patient-reported outcomes, burden on households, and burden on the health care system. The proposed framework could reduce the heterogeneity in value assessment processes across countries and create incentives for manufacturers to invest in incremental innovation. However, some domains may not be equally relevant or accepted in all countries, therefore the core framework needs thorough adaptation in specific jurisdictions.
SN 1478-7547
YR 2021
FD 2021-08-31
LK http://hdl.handle.net/10668/18485
UL http://hdl.handle.net/10668/18485
LA en
DS RISalud
RD Apr 14, 2025