CMS has finalized its plan to cover the controversial Alzheimer's disease drug Aduhelm under Medicare.
The CMS process incorporated over 10,000 stakeholder comments and more than 250 peer-reviewed documents into the final determination, according to an April 7 press release.
Four things to know about the coverage:
1. FDA-approved monoclonal antibodies directed against amyloid for Alzheimer's treatment, such as Aduhelm, may be covered in randomized controlled trials conducted under an investigational new drug application if they are based on evidence of efficacy from a change in surrogate endpoint and are reasonably likely to predict clinical benefit.
2. FDA-approved monoclonal antibodies directed against amyloid that have evidence of efficacy from a direct measure of clinic benefits are covered in CMS-approved prospective comparative studies. Study data may be collected in a registry.
3. CMS-approved studies must include a study population representative of the national population with mild cognitive impairment from Alzheimer's and a neurocognitive evaluation and instruments to determine cognition and function.
4. Studies approved by the FDA must answer three questions, according to CMS:
- Does the anti-amyloid mAb meaningfully improve health outcomes?
- Do the benefits and harms depend on the characteristics of patients, the clinicians and settings?
- How do the benefits and harms change over time?
The coverage finalization comes after a slow rollout of the drug amid criticism of its high cost, severe potential side effects and conflicting trial results over its effectiveness.
The intense debate over whether it worked and the FDA process to approve it led to large payers refusing to cover the drug last fall until more evidence was available.
To encourage coverage from commercial and public plans, manufacturer Biogen slashed the drug's price tag from $56,000 to $28,000 in January. Commercial payers were largely waiting on an early coverage decision from CMS before following suit, despite physicians calling for coverage only during clinical trials.
"This final National Coverage Determination reflects CMS' commitment to provide the American public with a transparent, trusted, evidence-based decision — without regard to cost — that is made only after a thorough analysis of public feedback. Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants," CMS Administrator Chiquita Brooks-LaSure said.
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