Proper assessment of medical values and innovativeness of IVDs

Committee:
IVD (In Vitro Diagnostics)
status:
Good progress
Published:
The medical value and innovativeness of IVDs have not been directly reflected to reimbursement point discussion. Discussions are underway regarding the evaluation of innovations of IVDs for the 2024 revision of medical reimbursement.

Recommendations

  • EBC requests the establishment of ‘challenge applications’ system for tests whose clinical usefulness had not been shown at initial reimbursement decision but has been verified/validated with actual clinical data after the reimbursement coverage.
  • In addition, the committee requested a marketability assessment for low volume tests.