Medicare Alzheimer’s Coverage Policy Advancing Clinical Trial Diversity Efforts
Medicare national coverage determination for Alzheimer’s drugs has been a ‘game changer’ in terms of motivating industry to boost diversity in clinical studies in the disease, trial expert says.
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Roche’s gantenerumab has failed to make the grade in its GRADUATE studies, leaving the field wide open for Eisai and Biogen’s lecanemab.
Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.
Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.