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

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 proces

SUBMITTER: Petyko ZI 

PROVIDER: S-EPMC8406013 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature