The Centers for Medicare & Medicaid Services has released new information about patient data that clinicians will be required to provide to ensure Medicare coverage when prescribing Leqembi (lecanemab).
The drug is currently approved and covered for clinical trial use only, but is in line for traditional approval by the Food and Drug Administration. Traditional approval would open prescriptions to a broader patient population, and an FDA decision on that front is expected in early July.
Data reporting
CMS on June 1 announced that if the drug and any others in its class gain such approval, the agency will immediately provide coverage for qualified Medicare Part B beneficiaries with certain constraints. Prescribing doctors must participate in a free, patient data-sharing registry through a nationwide, CMS-facilitated portal.
In a fact sheet released June 22, CMS detailed what this will mean for clinicians. Prescribing physicians will need to report data that is relevant to CMS’s national coverage determination for the drug, the agency said.
Along with demographics and identification of the clinician submitter, the registries will also collect the patient’s demographic information, clinical diagnosis, prescriptions of anticoagulation or antiplatelet drugs, results of amyloid diagnostic tests, evidence of adverse events and the results of cognitive and overall function tests, among other facts.
Meaningful improvements
These data will help to answer questions about whether the drug meaningfully improves health outcomes for patients in broad community practice, CMS stated. It will also help to determine whether benefits and harms, such as brain hemorrhage and edema, are linked to characteristics of the patient, the treating clinicians and/or the treatment setting, and how those benefits and harms may change over time.
CMS will make the registry, “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Registry,” available nationwide on its website once Leqembi or any drug in its class is traditionally approved.
Leqembi is a monoclonal antibody that targets beta-amyloid plaques in the brain. In clinical trials, it has been shown to reduce progression of Alzheimer’s. It and other drugs in its class are associated with side effects such as headache and amyloid-related imaging abnormalities (ARIA).
