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LILLY SUPPORT SERVICES FOR KISUNLA GETS YOUR PATIENTS STARTED AND HELPS KEEP THEM ON TRACK WITH KISUNLA

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CARE COORDINATION

To help patients navigate treatment as smoothly as possible, this service on behalf of your patients helps facilitate confirmation of requirements across their Kisunla treatment team, such as MRIs or other medical documentation to manage Kisunla treatment. Reminders will be provided to HCPs when additional documentation or tests are needed for patients on Kisunla. Lilly Support Services for Kisunla helps your patients navigate the logistics associated with treatment to support a smoother experience while on Kisunla.

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INFUSION CENTER LOCATOR

Assistance is available to locate an infusion center that is preferable for patients to receive their Kisunla infusion. Lilly Support Services for Kisunla can triage appropriate patient documentation to the chosen infusion center to ensure patients can get started on treatment as soon as possible.*

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APPOINTMENT REMINDERS

Remembering multiple sites of care and staying on top of appointments could be difficult for patients, but Lilly Support Services for Kisunla is here to help. For patients enrolled, appointment reminders for infusions may be provided to help keep patients on track.

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NURSE NAVIGATOR

Customized support by a registered nurse will be available for patients throughout their treatment journey based on patients’ needs. Nurse support helps patients understand what to expect with an infusion, answer questions about treatment and when to contact their HCP if needed, discuss next steps, and offer additional support as needed.

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LILLY-CONDUCTED BENEFITS INVESTIGATION

Lilly Support Services for Kisunla provides assistance to research patient’s insurance coverage to help identify the lowest out-of-pocket cost associated with the treatment of Kisunla. A copy of Summary of Benefits will be sent to the HCP’s office, infusion center, and patient. Resources for Coverage Authorization and Appeals are also available. CMS registry enrollment information may be shared with the infusion center upon referral.

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FIELD REIMBURSEMENT MANAGER (FRM) SUPPORT

FRMs are experienced access professionals committed to helping navigate the complex access and reimbursement environment to help patients get access to Kisunla. FRMs are integrated with Support Programs, understand Support Program resources, access challenges, affordability options, and the infusion center network.

SAVINGS

Lilly Support Services for Kisunla can assist your eligible commercially insured patients in understanding how to save on treatment with Kisunla.

*The list of infusion centers provided in the locator is not comprehensive, and other infusion centers may be available to you and your patients. These lists are maintained by a third party and inclusion in the locator is not an endorsement of any of the centers.

Governmental beneficiaries excluded, terms and conditions apply.

Lilly Support Services is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

MRI=magnetic resonance imaging; CMS=Centers for Medicare & Medicaid Services.

Starting your patients on Kisunla is easy with your partners at Lilly Support Services for Kisunla

Enroll your patients in Lilly Support Services for Kisunla to get them started on Kisunla and access customized support throughout their treatment journey

1. Select Enrollment Option

  • Digital Enrollment Portal
  • With digital enrollment, your patients can get started on treatment as soon as possible

    • Simplified, easy-to-use digital enrollment process
    • Provides convenient option to obtain patient HIPAA (Health Insurance Portability and Accountability Act) authorization
    • Visit enroll.LillySupportServices.Lilly.com
  • Fax/Printed Enrollment Form
  • With fax enrollment, it is important to complete all required sections to prevent delays in your patients starting treatment. If any information is missing, Lilly Support Services for Kisunla or a Field Reimbursement Manager (FRM) will follow up with the office to obtain missing information.

2. Complete Enrollment Form

Please review Enrollment Form in detail to ensure all required information is completed. Completing the entire Enrollment Form will ensure that there are no delays in patients starting treatment. This information is shared with the infusion center to start patients on treatment as soon as possible.

Important information to know for completing Enrollment Form

  • Patient HIPAA authorization is required for enrollment into Lilly Support Services for Kisunla. There are convenient options to assist with obtaining patient HIPAA authorization:
    • If patient is present, they can sign the Enrollment Form in the office.
    • If Enrollment Form is submitted to Lilly Support Services without patient’s signature, Lilly Support Services can send patient a link to sign electronically or patient can call into Lilly Support Services to provide HIPAA authorization verbally.
  • HCP signature must be on Enrollment Form

3. Submit Completed Enrollment Form based on Preferred Option

Submit completed Lilly Support Services for Kisunla Enrollment Form via:

  • Digital Enrollment Portal
  • Fax to Lilly Support Services at 1-844-731-2697

What to expect after Enrollment Form is Submitted

After Enrollment Form is submitted, HCP office will receive confirmation from Lilly Support Services for Kisunla that Enrollment Form was received.

After enrollment is confirmed, a welcome communication will be provided to patients confirming enrollment into Lilly Support Services for Kisunla. Patients will receive a welcome call to help set patients’ expectations for next steps in treatment. Your patients can call Lilly Support Services at 1-800-LillyRx (1-800-545-5979) if they have any questions or concerns about coverage, savings, or additional support and resources offered by Lilly Support Services.

The appropriate information will be shared with the infusion center to ensure that patients can start treatment as soon as possible.

Lilly Support Services for Kisunla is here for your patients to help guide them during their Kisunla treatment journey. Enroll your patients in Lilly Support Services today!


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Centers for Medicare & Medicaid Services (CMS) covers Kisunla under Coverage with Evidence Development (CED)1,2

National Coverage Determination (NCD) on monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease (AD) (200.3)

CMS provides coverage for1:

  • Patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD

Coverage criteria—drugs in class that receive traditional FDA approval1:

  • Patient must be enrolled in Medicare
  • Patients must have a diagnosis of MCI due to AD or mild AD dementia, with documented evidence of beta-amyloid plaques in the brain
  • Physician must participate in a qualifying registry* with an appropriate clinical team and follow-up care

*For more information on qualifying registries, visit https://www.cms.gov/medicare/coverage/coverage-evidence-development/monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease-ad

Prescribing clinicians or their staff shall submit at first baseline treatment via the dedicated CMS CED data submission portal and every 6 months for up to 24 months (5 total assessments).3

Lilly is committed to supporting patients, providers, and infusion centers with navigating the Medicare reimbursement landscape. To register your patient with CMS, submit here: Alzheimer’s form.

To learn more about registry requirements and billing and coding for Kisunla, please review the Billing and Coding Guide.


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Infusion

For Prescribing HCPs: Lilly is committed to supporting patients throughout the treatment journey, including the infusion process

Visit the Kisunla locator tool for assistance finding an infusion center for your patients

Locate an Infusion Center

For Infusion Centers: Lilly is committed to providing infusion education for your center and support for patients to help keep their infusion treatment on track

Infusion training is available online through our Infusion Digital Training Guide.

For information on how to store, administer, and prepare the infusion, download the Infusion Preparation Handbook.

For information on billing and coding for Kisunla, download the Billing and Coding Guide.

Kisunla can be shipped from your Authorized Specialty Distributor of Record, which can be found on trade.lilly.com . Please contact your distributor directly for specific product availability.

If you are interested in providing infusion services for Kisunla at your infusion center, add your site to our locator tool at admin.infusioncenter.org.

Additional Resources

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Patient Support Enrollment Form

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Prescriber’s Guide

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Kisunla Billing and Coding Guide

Used to educate billing staff and instill confidence in submitting claims for Kisunla and associated services related to diagnosis and treatment.

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Sample Appeal Form

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Sample Letter of Medical Necessity Form

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Care Coordination Form

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Infusion Checklist

Used as a reference guide for the infusion staff and provides information on the 3 steps to consider when administering Kisunla: pre-infusion, counseling, and post-infusion.

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Infusion Preparation Handbook

Contains important information on the administration of Kisunla, including complete details about infusion dosing, storage, preparation, and safety monitoring.

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Patient Wallet Card

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View the latest coverage information from the Centers for Medicare & Medicaid Services

Savings Card

Savings Card

Eligible, commercially insured patients with coverage for Kisunla can obtain a Savings Card by enrolling into Lilly Support Services for Kisunla.

Your patient may pay as little as $0 for each infusion of Kisunla.*

*Governmental beneficiaries excluded, terms and conditions apply.

Next Steps:

  1. Select Lilly Conducted Benefits Investigation on the Enrollment Form.
  2. Upon completion of the Lilly-Conducted Benefits Investigation and confirmation of coverage for Kisunla, if your patient is eligible for the Kisunla Savings Card, Lilly Support Services will offer the Savings Card to your patient.
  3. If your patient accepts enrollment into the Kisunla Savings Card Program, their Savings Card information will be emailed to your patient and faxed to your office.

Terms and Conditions

By enrolling in the Kisunla Savings Card Program (“Program”) and using the Kisunla Savings Card (“Card”), you attest that you meet the eligibility criteria, agree to, and will comply with the terms and conditions described below:

Card Eligibility:

(1.) You have been prescribed Kisunla (donanemab-azbt) consistent with FDA-approved product labeling.

(2.) You are enrolled in a commercial insurance plan.

(3.) You are not participating in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program.

(4.) You are a resident of the United States or Puerto Rico; and

(5.) You are 18 years of age or older.

You must have coverage for Kisunla through your commercial insurance, but your insurance does not cover the full cost, to pay as little as $0 for each infusion of Kisunla, up to a maximum of 15 infusions, and be enrolled in the Program. For enrolled patients, the Program may provide support for infusions with a date of service that falls within 120 days prior to the date the enrollment form is received by the Program. Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary fees and separate maximum annual savings of $9,450 per calendar year. After the monthly and/or annual maximum savings are reached, you will be responsible for paying any remaining monthly/annual out-of-pocket costs. To receive Program savings, your healthcare provider must submit a claim for coverage to your medical insurance provider.

If your medical insurance provider does not cover the full cost of the claim, your healthcare provider must then submit an Explanation of Payment (EOP) form and a CMS 1450 or 1500 form including the name of the insurer and plan demonstrating Kisunla was the medication administered to Lilly Support Services for Kisunla within 180 days of the infusion date of Kisunla. You understand and agree Lilly will make a payment of your Program on your behalf to your healthcare provider. Subject to Lilly USA, LLC’s (“Lilly”) right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2024.

Additional Terms and Conditions

If you have an insurance plan that is participating in an alternate funding program (“AFP”) that requires you to apply to the Kisunla Savings Card Program or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of Kisunla, you are not eligible for and are prohibited from using the Kisunla Savings Card Program. AFPs include programs where coverage, reimbursement, or patient out-of-pocket costs for a product in some way vary based on the availability of a manufacturer copay program. AFPs may modify, delay, deny, restrict, or withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent upon a member’s use of Kisunla Savings Card Program. You agree to inform Kisunla Savings Card Program if you are or become a member of such an alternate funding program.

You are responsible for any applicable taxes, fees, and any amount that exceeds the monthly or annual maximum savings. Monthly and annual maximums are set at Lilly’s sole and absolute discretion and may be changed with or without notice at any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or otherwise modify the Card savings for any reason, including but not limited to if your commercial insurance plan imposes additional requirements which limit or prevent you from receiving coverage for Kisunla, only allows partial coverage for Kisunla, removes coverage for Kisunla and requires you to utilize the Card, does not provide a material level of financial assistance for the cost of Kisunla, or does not apply Card payments to satisfy your copayment, deductible, or coinsurance for Kisunla.

Program savings are limited to the copay or coinsurance costs for Kisunla only, subject to a monthly and annual maximum savings, outlined above. The Program will not cover, and shall not be applied toward, the cost of any dosing procedure, any other healthcare provider service or supply charges or other treatment costs, or any costs associated with a hospital stay. Participation in the Program requires a valid patient HIPAA authorization. Card savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available; California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card eligibility criteria, terms and conditions every time you use the Card. If at any time you begin receiving coverage under any state, federal, or government funded healthcare program, you understand that you will no longer be eligible for the Kisunla Savings Card and agree to call Lilly Support Services at 1-800-LillyRx (1-800-545-5979) to stop participation.

You may not seek reimbursement from your health insurance, any third party, or any health savings, flexible spending, or other healthcare reimbursement accounts, for any amount of the savings received through the Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, incentive, or similar offer involving Kisunla. You agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade, or to counterfeit the Card. The Card is not insurance. Lilly has the sole right to interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. Lilly’s sole discretion to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions includes the right to terminate any individual Card if Lilly determines, in its sole discretion, that a patient does not satisfy the Card’s eligibility criteria or is using or has attempted to use the Card inconsistently with these Terms and Conditions. Eligibility criteria, and terms and conditions for the Kisunla Savings Card Program may change from time to time; the most current version can be found at https://kisunla.lilly.com/hcp/support-resources. You may be required to obtain a new Card, including if any Card terms and conditions have been terminated, rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly’s right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without notice, and for any reason. The Card expires and savings end on 12/31/2024.

References:

  1. CMS.gov. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N). Accessed February 20, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305
  2. CMS.gov. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease (AD). Accessed February 20, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=375&ncdver=1
  3. CMS.gov. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease (AD). Accessed February 20, 2024. https://www.cms.gov/medicare/coverage-evidence-development/monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease-ad

IMPORTANT SAFETY INFORMATION FOR Kisunla (donanemab-azbt)

WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES

Monoclonal antibodies directed against aggregated forms of beta amyloid, including Kisunla, can cause amyloid-related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur. Serious intracerebral hemorrhages >1 cm, some of which have been fatal, have been observed in patients treated with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with Kisunla.

ApoE ε4 Homozygotes: Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including Kisunla, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with Kisunla; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA.

Consider the benefit of Kisunla for the treatment of Alzheimer’s disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with Kisunla.

Kisunla is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis.

Amyloid-Related Imaging Abnormalities (ARIA)

Kisunla can cause ARIA-E, which can be observed on magnetic resonance imaging (MRI) as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer’s disease (AD), particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy, such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E.

ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur. When present, reported symptoms associated with ARIA may include, but are not limited to, headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time. In addition to ARIA, intracerebral hemorrhages (ICH) >1 cm in diameter have occurred in patients treated with Kisunla.

Incidence of ARIA

Symptomatic ARIA occurred in 6% (52/853) of patients treated with Kisunla. Clinical symptoms associated with ARIA resolved in approximately 85% (44/52) of patients.

Including asymptomatic radiographic events, ARIA was observed with Kisunla: 36% (307/853); placebo: 14% (122/874). ARIA-E was observed with Kisunla: 24% (201/853); placebo: 2% (17/874). ARIA-H was observed with Kisunla: 31% (263/853); placebo: 13% (111/874). There was no increase in isolated ARIA-H for Kisunla vs placebo.

Incidence of ICH

ICH >1 cm in diameter was reported in 0.5% (4/853) of patients after treatment with Kisunla vs 0.2% (2/874) on placebo. Fatal events of ICH have been observed.

Risk Factors for ARIA and ICH

ApoE ε4 Carrier Status

The risk of ARIA, including symptomatic and serious ARIA, is increased in apolipoprotein E ε4 (ApoE ε4) homozygotes. 17% (143/850) of patients in the Kisunla arm were ApoE ε4 homozygotes, 53% (452/850) were heterozygotes, and 30% (255/850) were noncarriers. The incidence of ARIA was higher in ApoE ε4 homozygotes (Kisunla: 55%; placebo: 22%) than in heterozygotes (Kisunla: 36%; placebo: 13%) and noncarriers (Kisunla: 25%; placebo: 12%). Among patients treated with Kisunla, symptomatic ARIA-E occurred in 8% of ApoE ε4 homozygotes compared with 7% of heterozygotes and 4% of noncarriers. Serious events of ARIA occurred in 3% of ApoE ε4 homozygotes, 2% of heterozygotes, and 1% of noncarriers.

The recommendations for management of ARIA do not differ between ApoE ε4 carriers and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. An FDA-authorized test for detection of ApoE ε4 alleles is not currently available. Currently available tests may vary in accuracy and design.

Radiographic Findings of Cerebral Amyloid Angiopathy (CAA)

Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.

The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, were identified as risk factors for ARIA. Patients were excluded from enrollment in Study 1 for findings on neuroimaging of prior ICH >1 cm in diameter, >4 microhemorrhages, >1 area of superficial siderosis, severe white matter disease, and vasogenic edema.

Concomitant Antithrombotic or Thrombolytic Medication

In Study 1, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed. The majority of exposures to antithrombotic medications were to aspirin. The incidence of ARIA-H was 30% (106/349) in patients taking Kisunla with a concomitant antithrombotic medication within 30 days vs 29% (148/504) in patients who did not receive an antithrombotic within 30 days of an ARIA-H event. The incidence of ICH >1 cm in diameter was 0.6% (2/349) in patients taking Kisunla with a concomitant antithrombotic medication vs 0.4% (2/504) in those who did not receive an antithrombotic. The number of events and the limited exposure to non-aspirin antithrombotic medications limit definitive conclusions about the risk of ARIA or ICH in patients taking antithrombotic medications.

One fatal ICH occurred in a patient taking Kisunla in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent. Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (eg, tissue plasminogen activator) to a patient already being treated with Kisunla.

Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with Kisunla. Advise patients to carry information that they are being treated with Kisunla.

Caution should be exercised when considering the use of Kisunla in patients with factors that indicate an increased risk for ICH and in particular for patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.

Radiographic Severity

The majority of ARIA-E radiographic events occurred early in treatment (within the first 24 weeks), although ARIA can occur at any time and patients can have more than one episode. The maximum radiographic severity of ARIA-E in patients treated with Kisunla was mild in 7% (59/853), moderate in 15% (128/853), and severe in 2% (14/853). Resolution on MRI after the first ARIA-E event occurred in 63% of patients treated with Kisunla by 12 weeks, 80% by 20 weeks, and 83% overall after detection. The maximum radiographic severity of ARIA-H microhemorrhage in patients treated with Kisunla was mild in 17% (143/853), moderate in 4% (34/853), and severe in 5% (40/853). The maximum radiographic severity of ARIA-H superficial siderosis in patients treated with Kisunla was mild in 6% (47/853), moderate in 4% (32/853), and severe in 5% (46/853). Among patients treated with Kisunla, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes 3% (4/143) vs heterozygotes 2% (9/452) or noncarriers 0.4% (1/255). The rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes 22% (31/143) vs heterozygotes 8% (38/452) or noncarriers 4% (9/255).

Monitoring and Dose Management Guidelines

Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with Kisunla. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.

Recommendations for dosing in patients with ARIA-E and ARIA-H depend on clinical symptoms and radiographic severity. Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, interrupt treatment, or permanently discontinue Kisunla. See Prescribing Information for additional dosing considerations.

There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data for dosing patients who experienced recurrent episodes of ARIA-E.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients who were treated with Kisunla. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.

Infusion-Related Reactions (IRR)

IRRs were observed with Kisunla: 9% (74/853); placebo: 0.5% (4/874); the majority (70%, 52/74) occurred within the first 4 infusions. IRRs typically occur during infusion or within 30 minutes post-infusion. IRRs were mostly mild (57%) or moderate (39%) in severity. IRRs resulted in discontinuations in 4% (31/853). Signs and symptoms of IRRs include chills, erythema, nausea/vomiting, difficulty breathing/dyspnea, sweating, elevated blood pressure, headache, chest pain, and low blood pressure.

In the event of an IRR, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Pretreatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing may be considered.

Adverse Reactions: The most common adverse reactions reported in ≥5% of patients treated with Kisunla (n=853) and ≥2% higher than placebo (n=874): ARIA-H microhemorrhage (25% vs 11%), ARIA-E (24% vs 2%), ARIA-H superficial siderosis (15% vs 3%), headache (13% vs 10%), IRRs (9% vs 0.5%).

Please see full Prescribing Information, including Boxed Warning regarding ARIA, and Medication Guide.

DN HCP ISI APP

INDICATION

Kisunla is indicated for the treatment of Alzheimer’s disease (AD). Treatment with Kisunla should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.