Strategic Early Value Assessment: A Key to Successful Drug Launches and Beyond

OBJECTIVES: Early drug valuation is pivotal for a successful launch and sustained market performance. Key factors include disease epidemiology, unmet needs, competitive landscape, efficacy, safety, quality of life impact, target patient population, pricing, and market-specific health system dynamics. This valuation is crucial for investors to assess the asset's potential upside value. The overall goal of this research was to understand the significance of a comprehensive early drug valuation, as well as to identify the critical, influencing factors.

METHODS: A targeted literature review of select HTA reports and Market Access / HEOR papers was conducted to identify critical attributes for early assessment of pharmacologic therapies. Subsequently, a reputable expert in global market access and pricing was interviewed to further validate, substantiate, and challenge our findings and hypotheses derived from secondary research.

RESULTS: After reviewing a plethora of in-market data and identifying key factors influencing value optimization, as well as their respective levels of impact, we hypothesized that the most significant drivers of value in early drug assessment process are product-specific evidence generation package, comparator price/position, and manufacturer portfolio/negotiation strength. This hypothesis was validated through an interview with an in-market expert, who provided additional insights into market-specific considerations when conducting early assessments.

CONCLUSIONS: Using a systematic early drug value assessment, key stakeholders and decision makers can pre-emptively identify opportunities to enhance a product’s value proposition, thereby optimizing pricing and access. It is crucial to consider all key variables driving a product value and market success to optimize the early assessment methodology for maximum accuracy.