Regulatory strategies are often highly focused on activities required to achieve FDA approval or clearance. However, if pre-market planning ignores eventual reimbursement demands, products can struggle to achieve widespread market adoption.
From the earliest stages of product development, regulatory professionals are uniquely positioned to ensure commercial evidence requirements will be satisfied. This session will focus on key differences in how FDA and payers evaluate the performance of medical devices through their unique lenses. For emerging technologies in particular, lack of concordance between sponsors and FDA in the Q-Submission process can complicate, extend, and imperil regulatory reviews. Subsequently, widespread payer coverage routinely lags product approval - often for years. Tailoring a comprehensive evidence plan to address the needs of both stakeholders can help shorten this gap and optimize the potential for commercial success.
Focused areas of discussion will include:
• Key learnings from FDA appeals where clinical evidence has been insufficient to support market authorization • The role of Q-Submissions in assessing the appropriateness of clinical study designs • Typical payer approaches to assessing emerging technologies. Why is “reasonable and necessary” so often incongruent with “safe and effective”? • Strategies to consider when building evidence plans to increase the likelihood of success with payers and regulators • Optimizing efforts and communication across organizations to better support market access initiatives
Learning Objectives:
Describe the key differences in clinical data requirements between US FDA and payers
Facilitate development of a comprehensive evidence strategy and communication plan to minimize misunderstandings with FDA and chart an efficient plan for payer coverage
Anticipate, research, and pressure test the extent to which additional evidence may be needed to support reimbursement initiatives
