Abstract
BackgroundMedicines 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.MethodsPotential 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.ResultsBased 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.ConclusionsThe 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.
Highlights
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 medi‐ cines (VAMs)
Literature review and data extraction To identify all relevant articles and available materials and to provide a rigorous scientific base for a comprehensive list of value propositions offered by VAMs, an systematic literature review (SLR) was conducted, supplemented by a targeted literature review (TLR)
The search syntax of the SLR resulted in 1349 hits, of which—after title, abstract and full-text screening—115 full-text articles were found eligible for inclusion
Summary
To ensure the sustainability of health care financing, international guidelines recommend the first-line use of off-patent medicines in major diseases [1, 2] In those diseases, where recent pharmaceutical innovation has Petykó et al Cost Eff Resour Alloc (2021) 19:57 gradually improving existing medicines, devices and services [6,7,8]. Value-added medicine (VAM) has been used in recent publications as a broad collective term, referring to all different types of medicines further developed by repositioning, reformulating or combining known molecules that address health care needs and deliver relevant improvements for patients, health care professionals and/or payers [10,11,12,13]. Some examples of VAMs created through the main repurposing models are presented in Additional file 1: Table S1 [17]
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