When is the Ideal Moment to Start HEOR Activities Within Product Development?
Health Economics and Outcomes Research (HEOR) has grown into a vital domain in the health and care industry. It plays a key role by offering vital insights into how drugs in the market affect both health and finances. With the means of data driven and evidence-based insights, it plays a critical role in the development and dissemination of new healthcare products by providing important findings regarding clinical development strategies, informing regulatory decisions, and supporting market access. Medical affairs teams in pharmaceutical companies are often concerned about the ideal time for beginning HEOR activities within the product development cycle. The simple answer to this question is: the earlier, the better.[1]
One can consider engaging in HEOR activities as early as the preclinical or discovery phases of product development. This way, HEOR insights can contribute significantly to the foundational understanding of the economic and clinical landscape. It has been observed that early HEOR involvement can result in more informed decision-making, and influence stakeholder engagement and investment decisions. HEOR helps identify and address potential market access barriers. By understanding the economic landscape and the outcomes that matter most to payers and patients, developers can tailor their products to meet these needs.[2]
HEOR activities can further strengthen evidence generation in Phase I and II clinical trials. This period is considered critical for gathering preliminary data on safety, efficacy, and health-related quality of life (HRQoL) outcomes. Complementing this data with observations from HEOR studies can help refine economic models and identify the most relevant clinical endpoints. Additionally, HEOR data in early phases can be very useful to inform trial design in Phase III studies, ensuring that all necessary economic and QOL endpoints are captured, to support future health technology assessments (HTAs).[3]
Advancing to Phase III clinical trials marks a very important milestone in the development of a new pharmaceutical product. At this stage, HEOR has a critical role of providing comprehensive data and evidence needed to confirm the product’s value proposition in the market. This is the phase where the most extensive and rigorous data on efficacy, safety, and outcomes are collected. HEOR activities in Phase III should define clinical endpoints, finalize economic models, undertake full cost-effectiveness analyses, and prepare dossiers required for regulatory submission and reimbursement applications. Embedding HEOR insights into Phase III activities can help predict and prevent potential concerns from regulatory agencies and payers. It showcases the value of the product not only through its clinical efficacy but also through the economic and patient-centered outcomes.[4,5]
Following Phase III and the acquisition of marketing authorization, the product is launched in the market and becomes available for prescription to patients in the real-world setting. Throughout this stage, the accumulating real-world evidence (RWE) further helps in refining the value of the product by evaluating the efficacy and performance of the product in the diverse patient population. This evidence further substantiates the ongoing research by providing invaluable and robust insights into long-term outcomes, adherence patterns, and overall economic impact of the product. Continuous HEOR efforts post-launch help to support ongoing market access, reimbursement renewals, and potential label expansions. They also provide feedback that can be used to optimize the product’s use and improve patient outcomes over time.[5]
In summary, HEOR is one continuous process that evolves over the whole cycle of product development. Early initiation of HEOR activities during the development process embeds economic and patient outcome considerations within the strategy of the product from the very beginning. This method not only increases the chances of a drug receiving the appropriate regulatory and reimbursement approval but also guarantees that new therapies are beneficial to both the patient and the medical system. Such proactive HEOR strategy, will put the pharmaceutical companies in a position to better navigate the complexities associated with market access, and to ensure that innovative therapies reach the patients who deserve them most.
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