Development of a core evaluation framework of value-added medicines: report 1 on methodology and findings View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-08-31

AUTHORS

Zsuzsanna Ida Petykó, Zoltán Kaló, Jaime Espin, Kateřina Podrazilová, Tomáš Tesař, Nikos Maniadakis, Frank-Ulrich Fricke, András Inotai

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. More... »

PAGES

57

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12962-021-00311-6

DOI

http://dx.doi.org/10.1186/s12962-021-00311-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1140768707

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/34465350


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