Evidence requirements for market access purposes for medical technologies in Europe

This free webinar provides an overview of the comprehensive process to establish pathway-specific and fact-based evidence requirements for medical technologies to meet the requirements of reimbursement, funding and HTA authorities


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

What topics are reviewed?

Understanding market access barriers

Initial step to understand the current market access situation and the key barriers for the product

Determining market access strategy

Within one country, market access processes may differ depending on the evidence situation for the product, its cost, existing payment mechanism

Collecting information about the requirements of authorities

MTRC employes unique approach, based on the review of the previous reimbursement / HTA decisions to understand the exact evidence requirements for similar types of products

Analyzing current evidence situation for the product

One of the key steps to determine evidence gaps. Based on a focused systematic literature review. Includes in-depth analysis of existing studies

Determining evidence gaps and building evidence generation strategy

Evidence gap analysis helps to understand, what is missing to support market access activities for the product. Once gaps are understood, a strategy can be put in place to generate additional required evidence

View extract from the webinar

This 9-minute extract presents principle of gathering information about evidence requirements for target processes


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