FDA approves Kisunla for early Alzheimer's, raising hope and questions
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A new hope for Alzheimer's patients is here with the recent approval of Kisunla (donanemab-azbt) by the US Food & Drug Administration (FDA) on July 2, 2024. Developed by Eli Lilly, this medication targets early symptomatic Alzheimer's disease and received fast-tracked approval through the FDA's Accelerated Approval program. It reached the market quicker, but there are still some questions about its long-term effectiveness.1

Key points about Kisunla

  • Intended use. Kisunla is specifically for patients in the early stages of Alzheimer's disease, such as those with mild cognitive impairment or mild dementia. It's not recommended for those with more advanced stages of the disease.2
  • How it works. Kisunla is a monthly intravenous (IV) infusion that targets amyloid plaques in the brain, which are linked to Alzheimer's disease. This treatment can slow cognitive and functional decline by up to 35%. Kisunla is given less frequently than other treatments, potentially making it more convenient.2
  • Price and coverage. The annual wholesale cost of Kisunla is set at $32,000, higher than its competitor, Leqembi, which costs $26,500. However, Kisunla might be more affordable for patients who only need short-term treatment, with potential costs ranging from $12,522 for six months to $48,696 for 18 months. It's primarily covered under the medical benefit, but Medicare coverage remains a challenge due to existing National Coverage Determination (NCD) restrictions for this class of drugs.3,4

Safety and efficacy concerns2

Risks. The FDA has included a boxed warning for Kisunla about the potential for amyloid-related imaging abnormalities (ARIA), which can include brain swelling or bleeding. Patients with certain risk factors may be more vulnerable.

Monitoring. Close monitoring is required, with several brain MRIs needed before and during treatment to check for ARIA. This monitoring adds a layer of complexity and concern for both patients and healthcare providers.

Gallagher's perspective: Questions for payers and providers

While Kisunla offers a promising option for early Alzheimer's, several critical questions remain:

  1. Do any clinical trial results demonstrate whether it improves Alzheimer's progression in real-world cases?
  2. If there are benefits, how long will the benefits last?
  3. Can Kisunla provide value to Alzheimer's patients with more advanced stages of the disease beyond the FDA's current recommended use?
  4. Will these findings lead to changes to the NCD, which currently eliminates the majority of their real-world use?

If Medicare eventually covers Kisunla, it will be a Part B benefit. Payers should consider prior authorization to ensure that patients meet certain qualifications. Some requirements should include:3,4

Factor Requirement
Age 60-85. If younger, provide documentation to support early onset Alzheimer's.
Prescriber Neurologist or geriatrician.
Physical and neurological examination
  • Document cognitive decline for at least 6 months.
  • Observe walking and abnormal movements to assist in ruling out other conditions, such as Parkinson's disease.
  • Rule out specific alternative neurodegenerative disease or causative factors.
Diagnosis of early Alzheimer's Meet the minimum cognitive test (MMSE, RBANS, CDR-GS) and provide tests documentation.
Neuroimaging
  • Receive Amyloid PET scans and MRIs to rule out other causes as well as ongoing monitoring.
  • Pre-treatment MRI shows no significant pathological findings.
Coverage Patient has Centers for Medicare Services (CMS)-approved coverage with evidence development (CED) registry. Required for patients with Medicare: registry number, CED submission date and submission number if applicable.
Initial approval Payers should consider approval for 6 months before approving longer-term durations.
Reauthorization
  • Either repeat MRI to monitor ARIA, or amyloid PET imaging results.
  • Either cognitive testing using approved cognitive tests that shows the patient still has mild impairment, or PET imaging.

Potential exclusion criteria include any medical or neurological condition (other than Alzheimer's) that might be a contributing cause of the patient's cognitive impairment, such as the patient had a stroke or transient ischemic attack (TIA) in the past year; relevant brain hemorrhage; bleeding disorder; seizure disorder; cerebrovascular abnormalities. Another exclusion is if the patient is taking blood thinners, except for aspirin at a prophylactic dose or less.

Kisunla will be a direct competitor to Eisai/Biogen's Leqembi. While Kisunla's limited-duration dosing and monthly administration are felt to be positive differentiators compared to Leqembi, the agent's safety profile is generally viewed less favorably. Note that Leqembi's label requires four brain MRIs before drug infusion, whereas Kisunla requires five.

Potential challenges

  • Provider acceptance. Use of these agents has been limited until more accepted data on safety and efficacy is available.
  • Prior authorization. Payers that cover Kisunla will likely require prior authorization with detailed approval criteria.
  • Side effects may prove to be a major limiting factor.
  • Required provider attestation that monitoring for ARIA will be conducted via MRI before initiation and before the second, third, fourth, and seventh infusions of Kisunla.
  • Trials. Phase IV confirmatory trials must be conducted to verify the treatment has clinical benefit.
  • Coverage for patients on Medicare is still a question.

The road ahead for Kisunla

Kisunla's journey is just beginning, and while it's exciting to see new treatments emerge, the impact on Alzheimer's patients has yet to be seen. Ongoing studies and real-world use will determine if Kisunla truly offers hope for those battling this devastating disease.

Sources

1"FDA Approves Treatment for Adults With Alzheimer's Disease," US Food & Drug Administration, 2 Jul 2024.

2"Kisunla," Eli Lilly, accessed 28 Jul 2024.

3"CNS: Alzheimer's Disease," IPD Analytics, accessed 30 Jul 2024. Subscription required.

4"Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD)," US Centers for Medicare and Medicaid Services, revised Nov 2022.

Disclaimer

Information related to drug trend predictions and prospective drug approval and/or market dates is subject to change without notice, due to a number of factors that include timing and outcome of FDA approval and/or legal proceedings, including patent infringement cases. Actual dates may differ from those expressed or implied in this report depending upon a number of factors that include: difficulty in predicting timing and outcome of legal proceedings, including patent related matters such as patent settlements and patent infringement cases; outcome of litigations arising from challenging validity or non-infringement of patents covering products; difficulty of predicting timing of FDA approvals; court and FDA decisions on exclusivity periods, and ability of competitors to extend exclusivity periods for products.

This publication is provided for general informational purposes only and should not be considered medical advice, diagnosis or treatment recommendations.

Consulting and insurance brokerage services to be provided by Gallagher Benefit Services, Inc. and/or its affiliate Gallagher Benefit Services (Canada) Group Inc. Gallagher Benefit Services, Inc. is a licensed insurance agency that does business in California as "Gallagher Benefit Services of California Insurance Services" and in Massachusetts as "Gallagher Benefit Insurance Services." Neither Arthur J. Gallagher & Co., nor its affiliates provide accounting, legal or tax advice.