Prioritize Economic Research in Biopharma Development

In the realm of biopharmaceuticals, the quest for novel treatments entails not only proving efficacy but also a critical consideration of health economics and outcomes research (HEOR). This comprehensive evaluation of the economic and clinical impacts of healthcare interventions is indispensable for the successful commercialization of new drugs.

Neglecting HEOR can lead to the creation of a potent medicine that fails to reach patients due to payer reluctance, resulting in a lack of coverage and accessibility. This oversight can lead to patient disappointment and negative perceptions of the developer. Conversely, developers who demonstrate a favorable economic impact can hasten market entry and broaden patient access. This approach benefits all stakeholders.

HEOR analysis, even when it reveals financial constraints, offers invaluable insights for drug pricing and copay assistance strategies, mitigating adverse outcomes. Depending on the trial phase and therapeutic focus, economic data can guide strategic decisions on protocol adjustments for future trials or post-FDA approval marketing tactics.

Traditionally, HEOR has been sidelined due to its complexity and the extensive data requirements from various healthcare entities, posing a challenge in the already lengthy and costly clinical trial process. However, the advent of decentralized clinical trials (DCTs) has shifted this paradigm, offering a more flexible framework for data collection and HEOR integration.

As a co-founder of a virtual CRO specializing in DCTs, I have witnessed the integration of HEOR analysis as a seamless component of clinical research, providing critical insights into the economic implications of new therapies. The evolution of claims and health information exchanges facilitates a cost-effective and compliant access to patient data, enabling sponsors to leverage this information for pre-screening and economic analysis.

HEOR is particularly pertinent in the context of value-based healthcare, which emphasizes optimal patient outcomes relative to care costs. With the projected doubling of value-based care's value, capturing evidence of a product's economic value is more crucial than ever.

The integration of HEOR in DCTs offers several advantages, including real-world relevance and faster market access. DCTs generate evidence across diverse populations and settings, reflecting routine clinical practice complexities. This data is instrumental in assessing the generalizability and long-term outcomes of pharmaceutical interventions.

HEOR evidence can expedite market access by providing stakeholders with a comprehensive understanding of an intervention's value proposition. By adopting a decentralized research model, sponsors can showcase cost-effectiveness and favorable outcomes, streamlining regulatory approvals and reimbursement negotiations.

This is especially relevant for pharmaceutical companies investing in digital healthcare applications, often as companion therapies. These digital therapeutics have struggled with market access and payer coverage, but HEOR analysis during clinical trials can provide the necessary evidence for coverage.

In practice, a pharmaceutical company conducting a DCT for a chronic condition like diabetes can integrate HEOR to identify economic endpoints and develop health economic models to estimate long-term cost-effectiveness and broader economic impact.

Incorporating HEOR into a DCT involves identifying relevant economic endpoints, engaging patients effectively, and integrating economic endpoints into data collection and analysis. Investing in HEOR analysis upfront is akin to purchasing an insurance policy for the return on investment, offering both efficacy and financial insights.

As DCTs evolve, HEOR will be essential for maximizing the impact of pharmaceutical interventions in a value-based healthcare environment. Integrating HEOR methodologies from the outset enhances decision-making, improves patient outcomes, and accelerates market access for innovative treatments.