OBJECTIVES:

Recent changes to regulatory and reimbursement frameworks have increased evidence requirements for medical devices (MDs) with an effort to align them with pharmaceuticals. However, these draft frameworks tend to ignore the differences between MDs and pharmaceuticals. These changes are potentially adding barriers to patient access, during a time when timely access is needed. We thoroughly reviewed the current reimbursement guidance for MDs and provide critical considerations for the decade ahead.

METHODS:

We conducted a pragmatic review of reimbursement documents comparing evidence requirements for MDs and pharmaceuticals. Based on a thematic analysis of the challenges associated with this guidance, we provide critical considerations for using high-quality clinical evidence and appropriate assessment methods.

RESULTS:

MD appraisal frameworks are being revised as part of wider reimbursement process initiatives that also cover pharmaceuticals, without clear distinction in the evidence requirements between them. To ensure requirements are feasible and appropriate to MDs, we argue for several points to be considered: (1) sufficient time between regulatory and payer submissions to allow for transparent evidence generation, (2) evidence requirements should be clearly distinct from those for pharmaceuticals given unique limitations when conducting clinical trials for MDs, (3) consider conditional approval where feasible by requiring a comprehensive post-approval data collection framework, and (4) accept wider use of real-world evidence in lieu of clinical trial settings to provide more comprehensive evidence packages.

CONCLUSIONS:

The recent reimbursement trend for MDs to increasingly align with those for pharmaceuticals only ignores the fundamental differences in the way MDs and pharmaceuticals are developed and used. This also risks manufacturers being unable to meet these requirements. As a result, effective and safe MDs may not become available to patients. It is therefore vital that payers consider assessment frameworks that are both feasible and adequate, tailored to the risks of MDs, and support patients and manufacturers alike.