Has Medicare Approved Donanemab? A Guide to Coverage for Alzheimer's Treatment

In July 2024, the FDA granted traditional approval to donanemab (brand name Kisunla) for the treatment of early symptomatic Alzheimer's disease. This critical development directly influences coverage for beneficiaries asking, 'Has Medicare approved donanemab?' The answer is a qualified yes, with specific conditions to ensure patient safety and collect real-world data.

Quick Summary

Medicare broadly covers donanemab (Kisunla) following its traditional FDA approval, provided beneficiaries have confirmed amyloid plaques, meet specific clinical criteria, and enroll in a CMS-approved patient registry for evidence collection.

Key Points

• Medicare Coverage Confirmed: Following full FDA approval in July 2024, Medicare provides broad coverage for donanemab (Kisunla) for eligible beneficiaries.

• Registry Requirement: Coverage depends on enrollment in a CMS-approved patient registry to collect real-world data and monitor treatment outcomes.

• Eligibility Criteria: Patients must have confirmed amyloid plaques and be in the early symptomatic stage of Alzheimer's (MCI or mild dementia).

• Associated Costs: Original Medicare beneficiaries will pay 20% coinsurance for donanemab infusions and associated services like MRIs, after meeting their Part B deductible.

• Safety Monitoring: Frequent MRI scans are necessary to monitor for side effects like ARIA (brain swelling or bleeding), a known risk, especially for APOE $\epsilon$4 carriers.

• Limited Duration Treatment: Unlike other amyloid therapies, donanemab treatment can be stopped once amyloid plaques are cleared from the brain.

Traditional FDA Approval Paves the Way for Donanemab

In a landmark decision on July 2, 2024, the U.S. Food and Drug Administration (FDA) granted traditional (full) approval to donanemab (Kisunla™) for treating early symptomatic Alzheimer's disease. This decision was based on compelling evidence from clinical trials like TRAILBLAZER-ALZ 2, which showed the drug's effectiveness in slowing cognitive decline. For patients and their families, this full approval represented a significant step forward, moving donanemab from an accelerated approval pathway to a status that would trigger broader coverage from Medicare.

CMS Coverage with Evidence Development (CED) Requirements

Following the FDA's full approval, the Centers for Medicare & Medicaid Services (CMS) confirmed it would provide coverage for donanemab under its existing National Coverage Determination (NCD) for monoclonal antibodies directed against amyloid for Alzheimer's disease. This coverage is provided under a specific framework known as Coverage with Evidence Development (CED).

This means that for Medicare to cover donanemab infusions and associated care, two key conditions must be met:

1. The prescribing physician and their clinical team must participate in a qualifying patient registry. This registry is designed to collect real-world data on how the drug works in the broader Medicare population, tracking patient outcomes and safety.
2. The beneficiary receiving the drug must also be enrolled in a CMS-approved patient registry.

The registry data helps answer important treatment questions and ensures ongoing safety monitoring outside of the controlled clinical trial environment. This approach is intended to strike a balance between providing access to new, innovative treatments and ensuring they are safe and effective for the Medicare population over the long term.

Who is Eligible for Donanemab Under Medicare?

For Medicare to cover donanemab, beneficiaries must meet specific eligibility criteria, which are consistent with the FDA label and clinical trial parameters. These include:

• Diagnosis: The patient must have a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The treatment is not indicated for more advanced stages of the disease.
• Confirmed Amyloid Pathology: The presence of beta-amyloid plaques in the brain must be confirmed. This is typically done via a positron emission tomography (PET) scan or a lumbar puncture (spinal tap).
• Safety Monitoring: Patients must undergo regular magnetic resonance imaging (MRI) scans throughout treatment to monitor for Amyloid-Related Imaging Abnormalities (ARIA), a common side effect.
• Registry Enrollment: As a condition of Medicare coverage, the patient must be enrolled in a CMS-approved registry.

Required Baseline Assessments

Before starting treatment, a comprehensive evaluation is needed:

• Cognitive Assessment: Tests like the MMSE or MoCA are used to confirm early symptomatic Alzheimer's.
• MRI Scan: A baseline MRI is required to rule out other potential causes of dementia and assess for exclusionary findings, such as significant cerebrovascular disease.
• APOE Genotyping: Testing for the APOE $\epsilon$4 gene is encouraged, as homozygotes have a significantly higher risk of ARIA. This helps inform the risk-benefit discussion.

Understanding the Costs and Potential Side Effects

Costs to Beneficiaries For those enrolled in Original Medicare, donanemab is covered under Part B, which handles outpatient drugs and infusions. Beneficiaries are responsible for the Part B deductible, followed by a standard 20% coinsurance of the Medicare-approved amount. Costs can vary significantly based on whether a patient has supplemental coverage (like a Medigap plan) or a Medicare Advantage plan. In 2024, the manufacturer listed the price at $32,000 per year, though this does not account for insurance coverage or associated costs like MRIs and infusions.

Potential Side Effects (ARIA) As with other amyloid-targeting therapies, the most common side effect is Amyloid-Related Imaging Abnormalities (ARIA), which can present as brain swelling (ARIA-E) or bleeding (ARIA-H). While often asymptomatic, ARIA can sometimes cause serious symptoms, including headache, confusion, dizziness, and seizures. Regular MRI scans are crucial for monitoring this risk, especially for APOE $\epsilon$4 carriers.

Donanemab vs. Lecanemab: Key Coverage Differences

While both donanemab (Kisunla) and lecanemab (Leqembi) are amyloid-targeting monoclonal antibodies, there are several key differences to consider:

Feature	Donanemab (Kisunla)	Lecanemab (Leqembi)
Infusion Frequency	Once per month	Twice per month (every 2 weeks)
Treatment Duration	Limited duration; can be stopped once amyloid plaques are cleared	Ongoing treatment
Infusion Time	30 minutes, plus observation	Approximately 1 hour, plus observation
ARIA Risk	Risk of ARIA, potentially higher than lecanemab, especially for APOE $\epsilon$4 carriers	Risk of ARIA, lower than donanemab
Medicare Coverage	Covered under CED via patient registry	Covered under CED via patient registry

The Future of Alzheimer's Treatment and Medicare

Medicare's coverage for donanemab is a testament to the evolving landscape of Alzheimer's treatment. The CED framework ensures that as new therapies become available, they can be accessed by beneficiaries while still gathering necessary real-world data to inform future coverage decisions. For individuals with early-stage Alzheimer's and their families, these advancements, coupled with clear coverage pathways, provide a new sense of hope and purpose.

It is vital for patients to engage in a shared decision-making process with their healthcare team. This includes understanding the potential benefits and risks of treatment, navigating the logistical requirements, and preparing for any associated costs. Resources from CMS and the Alzheimer's Association can provide further clarity on Medicare coverage. You can find more information on the official CMS website at cms.gov.

Conclusion

The question, "Has Medicare approved donanemab?" has a positive but conditional answer. Following its full FDA approval in July 2024, Medicare provides broad coverage for donanemab under a Coverage with Evidence Development (CED) framework. This requires beneficiaries with mild cognitive impairment or mild dementia due to Alzheimer's, and confirmed amyloid plaques, to enroll in a CMS-approved registry. While this approach helps ensure the drug is used appropriately and safely, it requires careful consideration of the costs, potential side effects, and registry participation. Navigating these requirements with a healthcare team is crucial for accessing this promising new therapy.

Frequently Asked Questions

Has Medicare approved donanemab, or is it still under review?

Yes, Medicare has approved donanemab (Kisunla) for broad coverage following its full FDA approval in July 2024. The approval is contingent on beneficiaries meeting specific eligibility criteria and enrolling in a CMS-approved registry for data collection.

What is the CMS-approved registry for donanemab?

The Centers for Medicare & Medicaid Services (CMS) created a registry system, known as Coverage with Evidence Development (CED), to gather information on newly approved Alzheimer's drugs like donanemab. Physicians treating Medicare beneficiaries with donanemab must enroll their patients and submit data to this registry.

What are the eligibility requirements for donanemab Medicare coverage?

To qualify for Medicare coverage, patients must have a diagnosis of early symptomatic Alzheimer's (mild cognitive impairment or mild dementia) and have biomarker evidence of amyloid plaques, typically confirmed by a PET scan or CSF test. Patients must also be enrolled in a CMS-approved registry.

How much will donanemab cost with Medicare?

Under Original Medicare Part B, beneficiaries typically pay 20% of the Medicare-approved amount for the drug, after meeting their annual deductible. Total costs can vary depending on a patient's additional insurance coverage, such as a Medigap plan or Medicare Advantage plan.

Does Medicare cover the costs of required MRI scans for donanemab treatment?

Yes, Medicare Part B covers the necessary services associated with donanemab treatment, including the baseline and follow-up MRI scans required to monitor for ARIA. The 20% coinsurance rule applies to these services as well.

Can I get donanemab if I have a genetic risk factor for ARIA?

While individuals with the APOE $\epsilon$4 gene have a higher risk of developing ARIA, having the gene does not automatically disqualify you from donanemab treatment. Healthcare providers are encouraged to discuss the specific risks with patients before treatment initiation.

How does donanemab coverage differ from lecanemab (Leqembi) coverage?

Medicare covers both donanemab and lecanemab under the same CED framework, with the same registry requirement. Key differences lie in administration frequency (donanemab is monthly, lecanemab is bi-weekly) and treatment duration (donanemab can be stopped once plaques are cleared).