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Three recommendations to overcome challenges associated with surrogate endpoints for healthcare decision-making in oncology


“Surrogate endpoints are often associated with challenges in assessing the value of new treatments influencing health technology assessment (HTA) outcomes and negotiable prices,” says Sophie Boukouvalas, Consultant. In this update, Sophie summarizes research that identified some of the key challenges associated with surrogate endpoints in oncology from a payer perspective and provides three recommendations to ensure an optimal HTA submission.

This is an extract from an ISPOR Europe 2023 poster by the experts at Avalere Health. Please get in touch for a conversation about leveraging these insights in your market access strategies.


No study has recently assessed the use of surrogate endpoints in oncology and how this affects a new product in development

With the continuous emergence of new technologies that fill high unmet medical needs in oncology, accelerated time to market for earlier patient access has gained importance. Increasing costs of drug development and intense competition between treatment options have enhanced the need for early market access using surrogate endpoints.

Experts at Avalere Health conducted research to identify the key challenges associated with surrogate endpoints in oncology from a payer perspective and provide recommendations to ensure an optimal HTA submission.


Three recommendations for trial design and evidence generation to overcome the market access challenges associated with surrogate endpoints

The targeted literature review included 16 articles and 19 HTA reviews evaluating PFS and DFS/iDFS as surrogate endpoints.

Results from the research demonstrated a need for:

  1. Early assessment of trial design: Validation of a surrogate outcome specific to the population and technology type under consideration, and therefore trial design, plays an important role. Cross-functional collaboration allowing for early assessment of trial design is crucial when incorporating surrogate endpoints, to support successful market access.
  2. Evidence that supports the relationship between the surrogate endpoint and the outcome: As emerging technologies become more targeted to specific patient populations, including treatments with different classes, there is often a lack of evidence to support the relationship between the surrogate endpoint and the patient-relevant outcome.
  3. Evidence generation that is aligned with payers’ expectations: HTA agencies frequently require more evidence than regulators, given that they focus on a longer-term perspective. Innovative approaches, leveraging information across trials, and real-world evidence can be used to address current challenges and support evidence generation.


Get in touch for a confidential conversation

Please get in touch with us if you would like to discuss the points raised in this summary and find out how Avalere Health can help you navigate the global policy, access, value, and evidence landscape.

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