Presentation (CTI)

OBJECTIVES: Traditional due diligence for healthcare investments focuses on clinical data and regulatory pathways, yet investment returns increasingly depend on market access success, pricing sustainability, and payer acceptance. Health economics and outcomes research (HEOR) is typically perceived as a cost center serving pharmaceutical manufacturers. This conceptual work proposes a paradigm shift: repositioning HEOR as a risk mitigation tool for healthcare investors, where modest economic evidence investment protects substantially larger clinical development capital at risk.
METHODS: We developed a conceptual framework examining the economic logic of HEOR investment relative to clinical development expenditure and market access outcomes. The framework integrates three dimensions: (1) investment magnitude differential between HEOR programs and clinical trials; (2) market share compression attributable to poor value positioning; and (3) policy exposure from regulatory changes including the US Inflation Reduction Act, potential Most Favored Nation pricing, and EU Joint Clinical Assessment. The framework maps HEOR engagement intensity to investment stages from preclinical through M&A.
RESULTS: The proposed de-risking paradigm identifies that comprehensive HEOR programs ($0.5-2M) represent an order of magnitude less investment than Phase III trials ($50-300M), creating asymmetric return potential. Poor value positioning can compress achievable market share substantially in key markets, while policy shifts create valuation variance that traditional financial models fail to capture. The framework specifies HEOR deliverables calibrated to each development stage: rationality checks and target product profile economic framing at preclinical/Phase I, preliminary cost-effectiveness modeling at Phase II, complete HTA dossiers at Phase III, and investor-ready value packages at M&A.
CONCLUSIONS: HEOR can function as a risk mitigation instrument with asymmetric return characteristics when framed for investment decision-making rather than regulatory submission. This paradigm shift enables investors to quantify market access risk, translate clinical uncertainty into economic terms, and protect clinical development capital through staged economic evidence generation.