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  • When is the Ideal Moment to Start HEOR Activities Within Product Development?

    When is the Ideal Moment to Start HEOR Activities Within Product Development?
    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.

    Become A Certified HEOR Professional – Enrol yourself here!

    References:

    1. Holtorf AP, Brixner D, Bellows B, Keskinaslan A, Dye J, Oderda G. Current and future use of HEOR data in healthcare decision-making in the United States and in emerging markets. American health & drug benefits. 2012 Nov;5(7):428.
    2. Van Nooten F, Holmstrom S, Green J, Wiklund I, Odeyemi IA, Wilcox TK. Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research. Drug discovery today. 2012 Jun 1;17(11-12):615-22.
    3. Zou KH, Baker CL, Cappelleri JC, Chambers RB. Data Sources for Health Economics and Outcomes Research. InStatistical Topics in Health Economics and Outcomes Research 2017 Nov 22 (pp. 1-13). Chapman and Hall/CRC.
    4. Garrison Jr LP, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real‐world data for coverage and payment decisions: the ISPOR real‐world data task force report. Value in health. 2007 Sep;10(5):326-35.
    5. Chou JW, Portelli A, Cournoyer A. De-risking Market Launch: Leveraging HEOR Evidence Planning to Support Informed Payer Decisions. J Clin Pathways. 2022;8(8):63-65.

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  • The Value of Medical Affairs in Every Phase of a Pharmaceutical Product Life Cycle

    The Value of Medical Affairs in Every Phase of a Pharmaceutical Product Life Cycle
    The Value of Medical Affairs in Every Phase of a Pharmaceutical Product Life Cycle

    In the dynamic landscape of pharmaceuticals, the role of medical affairs has evolved significantly over the years. The involvement of medical affairs is crucial at every stage of a pharmaceutical product’s life cycle, shaping decisions, guiding strategies, and ultimately, optimizing patient outcomes. As products move through their life cycle – from discovery and development to launch, growth, and eventually decline – medical affairs play a pivotal role in ensuring the product’s success and the well-being of patients.[1]

    During the early phases of the development of a pharmaceutical product, medical affairs teams are instrumental in guiding the clinical development strategy. They work closely with researchers to design studies that will generate robust evidence supporting the efficacy and safety of the drug. Collaboration with key opinion leaders (KOLs) and academic institutions helps inform research priorities and refine product development strategies. This phase requires a deep understanding of the disease, the target population, and the regulatory environment. Medical affairs professionals also play a crucial role in identifying and addressing potential safety concerns early in the process, thereby reducing the risk of regulatory delays or withdrawals later on.[2]

    Medical Affairs professionals also dedicate significant effort to identifying healthcare experts who can offer crucial support during the regulatory approval process. Upon approval, the launch of a new drug is a critical juncture where medical affairs can significantly impact its success. These teams are responsible for developing and implementing a comprehensive educational program for healthcare providers, ensuring they are well informed about the drug’s benefits and how to use it effectively. Additionally, they manage post-marketing surveillance programs to monitor the drug’s performance in real-world settings, providing valuable data for regulatory submissions and informing future development strategies.[3]

    During the post-marketing surveillance phase, medical affairs teams continue to monitor the drug’s safety and efficacy in a broader patient population. They analyze data from spontaneous reports, clinical trials, and observational studies to identify any new safety signals or effectiveness issues. This information is vital for maintaining the drug’s market authorization and for making informed decisions about potential label updates or new indications.[4]

    As a pharmaceutical product ages, opportunities for repositioning, repurposing, and lifecycle management emerge. Drug manufacturers must keep track of patient outcomes, respond to inquiries about off-label use, remain aware of market realities, and keep abreast of regulatory developments as they pertain to their late-life cycle drugs. Medical affairs teams are key players in these efforts, leveraging their expertise to explore new uses for the drug, such as treating different patient populations or using the drug in combination therapies. They also work on developing new formulations or delivery methods to extend the drug’s patent life and maintain its market position. This phase requires a strategic approach, balancing the need for innovation with the realities of the market and regulatory landscape.[5]

    In summary, medical affairs serve as the linchpin throughout the product life cycle, driving scientific innovation, ensuring regulatory compliance, and fostering meaningful engagement with stakeholders. From guiding clinical development to ensuring safe and effective use in the market, these teams are essential for the success of pharmaceutical products. Their contributions extend beyond the immediate benefits of a drug; they also contribute to the overall health of patients and the sustainability of the healthcare system. As the pharmaceutical industry continues to evolve, so too will the role of medical affairs, necessitating ongoing adaptation and innovation to meet the changing needs of patients and healthcare providers. By leveraging their expertise in research, clinical development, and medical communications, medical affairs professionals contribute to the success and sustainability of pharmaceutical products, ultimately improving patient outcomes and advancing healthcare.

    Become A Certified HEOR Professional – Enrol yourself here!

    References:

    1. Medical Affairs Specialist. The Role of Medical Affairs: From Research Design to Commercialization [Internet]. Available from: https://medicalaffairsspecialist.org/blog/the-role-of-medical-affairs-from-research-design-to-commercialization
    2. Farrington AD, Frøstrup AG, Dahl P. The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations. Pharm Med. 2023;37(6):417–424. https://doi.org/10.1007/s40290-023-00501-y
    3. Krendyukov A, Nasy D. Medical affairs and innovative medicinal product strategy development. Pharmaceutical Medicine. 2022 Apr;36(2):71-82.
    4. Aissel. The Role of Medical Affairs in the Pharmaceutical Industry [Internet]. Available from: https://www.aissel.com/blog/The-Role-of-Medical-Affairs-in-the-Pharmaceutical-Industry#:~:text=The%20Role%20of%20Medical%20Affairs,external%20stakeholders%20of%20the%20company.

    MarksMan Healthcare

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