Posted by Michael Wonder on 24 Jul 2024
Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
23 July 2024 - The FDA designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious conditions that may offer improvements over available therapies.
Once breakthrough drugs and devices are approved, however, devices face a far less predictable pathway and a longer timeline to achieving reimbursement, including coverage by payers such as Medicare, compared to breakthrough pharmaceuticals, even though both involve years of development, significant investment, commitment of resources, running of clinical trials, and market launch preparations.
