[PHP139] Value Added Medicines: The Need To Establish One Common Terminology For Repurposed Medicines

[PHP139] Value Added Medicines: The Need To Establish One Common Terminology For Repurposed Medicines

2016 Value in Health

Rémuzat, C. | Toumi, M. | Volume: 19, Issue: 7, Pages: A463-A464,

OBJECTIVES: Even if the concept of value added medicines or repurposing of existing molecules has been known for many years, no common terminology has been agreed and their full potential value is not always rewarded, creating a disincentive for further development. Study objective was to propose a common framework/typology for value added medicines allowing for better assessment of their value. METHODS: A literature review was conducted in Medline, Embase, Cochrane databases, Generics and Biosimilars Initiative (GaBI), Google Scholar, European Medicines Agency, European Commission websites and available grey literature to identify the different nomenclatures describing the concept of value added medicines and to propose a common typology. RESULTS: Various nomenclatures were found for the concept of value added medicines, either broad or more restricted definitions based on outcomes and/or processes. Suggested typology we developed for value added medicines included two different algorithms. One algorithm related to the categories of value added medicines typology itself and one related to disease environment as the general context of disease and target population cannot be disconnected from the typology when assessing the whole product value. The first algorithm included 6 dimensions: 1) Repurposing model, i.e., drug repositioning (indication extension), drug reformulation, drug-drug combination; 2) Regulatory status; 3) Targeted indication; 4) Combination to a device or service; 5) Patient benefit; 6) Impact on society. The second algorithm included 4 dimensions: 1) Population; 2) Disease burden; 3) Disease severity and chronicity; 4) Unmet needs. CONCLUSIONS: This harmonised typology for value added medicines might allow better differentiating these products and enhancing their value assessment. Contrary to products like generic medicines, biosimilar medicines and hybrids, there is no regulatory definition for value added medicines. The recent European Commission STAMP initiative related to repurposing of established medicines raised this issue and will consider the opportunity to provide a definition.

https://www.doi.org/10.1016/j.jval.2016.09.680