Full length ArticleEconomic viability of Stratified Medicine concepts: An investor perspective on drivers and conditions that favour using Stratified Medicine approaches in a cost-contained healthcare environment

- The effects of development time and time to peak sales are key value drivers responsible for a favourable economics of SM interventions.
- Appropriate tailoring of patient subgroups is essential to leverage policy incentive tools to reduce development time and costs.
- Driving diagnostic testing adoption is critical and associated with ensuring adequate access to the test.
- SM approaches for a very small sub-population are only economic viable if several economic drivers are addressed.

RationaleStratified Medicine (SM) is becoming a natural result of advances in biomedical science and a promising path for the innovation-based biopharmaceutical industry to create new investment opportunities. While the use of biomarkers to improve R&D efficiency and productivity is very much acknowledged by industry, much work remains to be done to understand the drivers and conditions that favour using a stratified approach to create economically viable products and to justify the investment in SM interventions as a stratification option.ConceptIn this paper we apply a decision analytical methodology to address the economic attractiveness of different SM development options in a cost-contained healthcare environment. For this purpose, a hypothetical business case in the oncology market has been developed considering four feasible development scenarios.ConclusionsThe article outlines the effects of development time and time to peak sales as key economic value drivers influencing profitability of SM interventions under specific conditions. If regulatory and reimbursement challenges can be solved, decreasing development time and enhancing early market penetration would most directly improve the economic attractiveness of SM interventions. Appropriate tailoring of highly differentiated patient subgroups is the prerequisite to leverage potential efficiency gains in the R&D process. Also, offering a better targeted and hence ultimately more cost-effective therapy at reimbursable prices will facilitate time to market access and allow increasing market share gains within the targeted populations.