LILLY SUPPORT SERVICES™ FOR KISUNLA GETS YOUR PATIENTS STARTED AND HELPS KEEP THEM ON TRACK WITH KISUNLA
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.
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.*
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.
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.
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.
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
- 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 digital enrollment, your patients can get started on treatment as soon as possible
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!
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.
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
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
Patient Support Enrollment Form
Prescriber’s Guide
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.
Patient Wallet Card
Referral Checklist
Used to facilitate an accurate referral to a neurologist or dementia specialist
Care Coordination Form
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.
Infusion Preparation Handbook
Contains important information on the administration of Kisunla, including complete details about infusion dosing, storage, preparation, and safety monitoring.
Sample Appeal Form
Sample Letter of Medical Necessity Form
View the latest coverage information from the Centers for Medicare & Medicaid Services
EHR Resources
Prescribing in your EHR System
Help patients get started on Kisunla
Savings Card
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) for an approved use consistent with FDA-approved product labeling;
(2) You are enrolled in a commercial drug insurance plan and have coverage for Kisunla but your insurance does not cover the full cost of Kisunla (i.e., you have a copay or coinsurance obligation);
(3) You are not enrolled 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.
Card Terms and Conditions
You must (a) have commercial drug insurance that covers Kisunla but your insurance does not cover the full cost and (b) have a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $0 for each infusion of Kisunla. The Program will cover your copay or coinsurance for Kisunla, up to a maximum monthly savings of up to wholesale acquisition cost plus usual and customary fees and a separate maximum annual savings of up to $9,200 per calendar year. Card may be used for a maximum of up to 15 infusions 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. 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.
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 Benefits (EOB) form and a CMS 1450 or 1500 form to https://medicalclaimsportal.opushealth.com within 180 days of the infusion date of Kisunla. The submitted form must include the name of the insurer and plan and demonstrate that Kisunla was the medication administered. You understand and agree that Lilly will make a payment of your Program savings 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 12/31/2025.
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 drug 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. THIS 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. Card expires and savings end on 12/31/2025.
References:
- 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
- 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
- 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