CMS is proposing to deny coverage of Lilly’s Alzheimer’s “rule-out” diagnostic Amyvid. The decision is important for biopharma manufacturers for several reasons, both as a demonstration that the agency really will refuse to pay for FDA approved drugs—and for how CMS thinks it can actually use its authority to encourage research on effective AD therapies.
The Centers for Medicare & Medicaid Services is proposing only very limited coverage for Lilly’s recently launched diagnostic agent Amyvid, concluding that the evidence does not support routine payment for use of the scan to rule out Alzheimer’s in patients with early signs of dementia.
The proposed coverage decision