New free webinar from MTRC: Evidence requirements for market access purposes for medical technologies in Europe


May 2022

Understanding evidence requirements of reimbursement/HTA authorities is critical for the success of medical technologies.

Typically, evidence generation is driven by the need, determined by the outside clinical experts and internal regulatory and clinical specialists. Market access perspective is often not taken into account.

A high-level understanding of evidence requirements is common. For example, for a novel treatment method, at least one RCT and some supportive studies of other designs (e.g. case series) are needed. However, there are many situations when this general wisdom is not applicable. It could be the case of diagnostic technology (e.g. endoscopy or other imaging), in-vitro diagnostic test, or technology, for which RCT design is not feasible. Also, there are many other relevant nuanced questions, like selection of the target population, comparator, outcomes, duration of follow-up, publication and reporting practice.

MTRC presents a free webinar on its holistic approach to determining evidence requirements for medical technologies, which consists of six steps:

  • Understand market access barriers

  • Determine market access strategy – target processes

  • Gather information about evidence requirements for target processes

  • Gather information about the current evidence situation for the product and a relevant class of products

  • Determine evidence gaps

  • Develop evidence generation strategy / recommendations for study design

Watch webinar here

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