Evaluation of high-technology medicines considering budget impact and societal value: a three-tier approach using incretin-based therapy as an example

Objective: To develop a three-tier approach to assessing the value of high-technology medicines, provide a rationale for the approach, and demonstrate its applicability using incretin-based therapy as an example.

Material and methods. A conceptual study was carried out using a descriptive analysis of publicly available clinical, financial, investment, and regulatory data. The theoretical framework was based on approaches to broader health technology value assessment, including the ISPOR Value Flower and recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine. Sources were selected purposively; no systematic review was conducted.

Results. A three-tier approach was proposed, including clinical value, value for the healthcare system, and an extended third tier divided into broader societal impacts of disease and treatment (3A) and the innovation and industrial impacts of pharmaceutical technology development and manufacturing (3B). By using incretin-based therapy as an example, the analysis showed that the expansion of indications and the market was accompanied by changes in corporate revenue structure, investment activity, and manufacturing infrastructure. In 2025, Mounjaro^® and Zepbound^® accounted for approximately 56% of Eli Lilly’s revenue, while glucagon-like peptide-1-based products for the treatment of type 2 diabetes and products for the treatment of obesity accounted for approximately 75.9% of Novo Nordisk’s revenue. Market capitalization, capital raised, and corporate revenue are not direct measures of clinical or societal value.

Conclusion. A broader assessment of high-technology medicines requires separate consideration of their clinical, pharmacoeconomic, societal, and innovation and industrial impacts. Innovation and industrial impacts should not be incorporated directly into the calculation of the incremental cost-effectiveness ratio; instead, they should be presented as a separate analytical domain to inform industrial and science technology, and innovation policy.

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