LEQEMBI® (lecanemab-irmb) Eisai Patient Support Enrollment

How can I enroll
my patient
in Eisai
Patient Support?

Eisai Patient Support (EPS) offers support programs
to help eligible patients afford the cost of LEQEMBI^® (lecanemab-irmb).
Enroll
How can I better understand access
for patients prescribed LEQEMBI?

Access & Reimbursement Managers (ARM) support patient
access and may provide relevant coverage and related
information to healthcare providers and staff.
Request an Access & Reimbursement Manager
What are Patient Navigators?

Patient Navigators may speak to HCPs and their offices to relay
information regarding patient access to LEQEMBI^® (lecanemab-irmb).
Enroll
Will my patient's insurance cover
LEQEMBI^®
(lecanemab-irmb)?

Eisai Patient Support (EPS) will conduct a benefits
investigation to determine a patient’s coverage for LEQEMBI.
Enroll
Where can I find billing and coding
information for LEQEMBI^®
(lecanemab-irmb)?

Eisai Patient Support (EPS) has information regarding billing
and coding for LEQEMBI.
Enroll
Where can I find an infusion
provider for LEQEMBI^®
(lecanemab-irmb)?

Learn where you can find information about infusion
centers in your area.
Enroll
Where can I get LEQEMBI^®
(lecanemab-irmb)?

Eisai Patient Support (EPS) has a specialty distributor
list for more information on how to order LEQEMBI.
Enroll
Where can I find more resources
for LEQEMBI^®
(lecanemab-irmb)?

Explore sample letters, patient organizations, and
other tools to assist with patient access to LEQEMBI.
Enroll

For more information regarding the Centers for Medicare & Medicaid Services (CMS) coverage of Alzheimer's drugs for Medicare patients, click here.

How can I enroll my patient
in Eisai Patient Support?

Patients who enroll in EPS will receive a dedicated Patient Navigator
who can help them know what to expect at each step of treatment with LEQEMBI

EPS offers coverage and reimbursement information, including:

Benefit verification
Prior authorization information
Appeal information
Financial assistance program information:

To find out more information and eligibility requirements for these programs, see below.

Full terms and conditions

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LEQEMBI Copay
Assistance Program

The LEQEMBI Copay Assistance Program is sponsored by Eisai. This program is available to help eligible commercially insured patients with their medication cost. Patients with a state or federally funded insurance, such as Medicare Part B or Medicaid, are not eligible for the program.

Copay Assistance Program terms and conditions

Patient must be prescribed LEQEMBI for an FDA-approved indication. Patient must have private, commercial health insurance that provides coverage for LEQEMBI. The offer is not valid for patients enrolled in state and federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DOD, or TRICARE, that cover outpatient care, including for physician-administered or prescription drugs, or otherwise cover LEQEMBI. The offer is not valid for uninsured or self-paying patients, or for LEQEMBI treatments reimbursed in full by any third-party payer. Patient must be 18 years or older. Patient must be a resident of, and product must be administered in, the United States or Puerto Rico.

The benefit available under the LEQEMBI Copay Assistance Program is limited to patient's out-of-pocket cost for LEQEMBI, as indicated in documentation provided by the patient's health insurance provider, including a CMS-1500 or UB-04 Form AND an insurance explanation of benefits (EOB) with itemized charges which include the billing code for LEQEMBI. Eligible patients who participate in the Program may pay as little as $0 out-of-pocket per date of treatment. Eisai Inc. will pay up to $10,000 per calendar year toward an eligible patient's out-of-pocket costs for LEQEMBI, including deductibles, copays and coinsurances. Depending on the patient's insurance plan, patient could have additional financial liability for any amounts over Eisai's maximum benefit. The offer is not valid for any other out-of-pocket costs, including medical administration charges. Supporting documentation must be submitted to the LEQEMBI Copay Assistance Program within 365 days of the date of treatment or the request will be rejected. In order to be eligible for reimbursement under LEQEMBI Copay Assistance Program, claims for LEQEMBI must be submitted by provider to patient's private health insurance separately from other services and products. Additional instructions regarding required documentation in support of each claim will be provided by the program following confirmation of eligibility and enrollment. The LEQEMBI Copay Assistance Program will process eligible claims for patient out-of- pocket costs for LEQEMBI incurred for product administered up to 180 days prior to the date the patient is enrolled in the program.

Upon enrollment in the program, each patient will be issued a 16-digit virtual debit card. By enrolling in this program, the patient is providing consent for the LEQEMBI Copay Assistance Program to provide payment information for any approved claims, in the form of the 16-digit virtual debit card number, directly to the provider or alternate site of care identified on this enrollment form to be applied directly to the patient's out-of-pocket costs for LEQEMBI. By enrolling in the program and accepting payment, provider agrees to put the value of the patient LEQEMBI Copay Assistance Program directly toward the patient's out-of-pocket costs for LEQEMBI only. If provider has already received payment from the patient for the patient's out-of-pocket cost for LEQEMBI covered by the program, provider agrees to refund the amounts received back to the patient.

Patient and provider agree not to seek reimbursement for any or all of the benefit received by the patient through the LEQEMBI Copay Assistance Program. Patients and providers are responsible for complying with all requirements to disclose to insurance carriers and third-party payers the benefit received from the LEQEMBI Copay Assistance Program. The offer may not be combined with any other discount, coupon, free trial or offer. Federal law prohibits the selling, purchasing, trading, or counterfeiting of this offer. Void outside the USA and where prohibited by law. Eisai Inc. reserves the right to rescind, revoke, or amend this offer at any time without notice. The value of this offer is not contingent on any prior or future purchases. This offer is solely intended to provide savings on the purchase of LEQEMBI. This offer may not be accepted by all providers or alternate sites of care. The LEQEMBI Copay Assistance Program is not an insurance program. No membership fees.
LEQEMBI Temporary
Supply Program

The Temporary Supply Program (“TSP”) provides a temporary free supply of up to 75 days of LEQEMBI for eligible, commercially insured patients awaiting a coverage determination from their insurance provider for five or more business days.

Temporary Supply Program terms and conditions

Patient must have a valid prescription for LEQEMBI for an FDA-approved indication. Patient must have private, commercial insurance that provides coverage for drugs through a medical benefit. The TSP is not available for uninsured patients or patients enrolled in state and federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE. Patient must be 18 years or older. Patient must be a resident of, and product must be administered in, the United States or Puerto Rico. Patient must meet the financial eligibility criteria for enrollment in the Patient Assistance Program for LEQEMBI in order to be eligible for the TSP.

In order to be eligible for the TSP, the patient must be new to LEQEMBI therapy and must be awaiting a final coverage determination from their insurance provider for five or more business days and the patient’s provider has submitted a first-level appeal of the prior authorization denial. If an enrolled patient’s appeal is subsequently approved, patient will no longer be eligible to receive temporary supply of LEQEMBI. In order for patient to continue to be eligible for the TSP, the patient’s provider must agree to appropriately pursue insurance coverage for the patient until a final coverage determination is made. Limit of one enrollment (up to 75-day supply while coverage is pending) per patient per lifetime. The TSP will ship each treatment of LEQEMBI directly to the provider or alternate site of care identified on this enrollment form. Enrolled patients will be evaluated for continued TSP eligibility prior to each shipment. By accepting shipment, provider agrees to administer the temporary supply of LEQEMBI only to the enrolled patient named in the materials accompanying the shipment and to discard unused amounts in open vials. Provider further agrees that LEQEMBI provided under the TSP may not be sold, traded, bartered, transferred, or returned for credit. LEQEMBI provided under the TSP must be maintained separately from commercial inventory. If the enrolled patient is no longer on therapy or otherwise cannot use the temporary supply of LEQEMBI, provider agrees to promptly contact Eisai Patient Support to arrange for product return or disposal.

No patient, pharmacy, payor or other third-party may be billed for the temporary supply of LEQEMBI. Patients and providers must not submit any claim for reimbursement for product dispensed pursuant to the TSP to any third-party payor, including Medicare, Medicaid, or any other federal or state health care program. Patient cannot seek to have any part of the value of the free product received through the TSP count towards any applicable out-of-pocket spending calculations for drugs (eg, deductible or out-of-pocket cap). The free LEQEMBI provided under the TSP is not contingent on any past or future purchases of any product, under the patient’s insurance benefit or otherwise. Eligibility determinations are made without regard to patient’s commercial insurance provider, choice of physician or infusion provider. Patients are free to change physicians or infusion providers at any time. The TSP is not a health insurance, financial support, or cost savings program. Limitations may apply. Eisai reserves the right to rescind, revoke, or amend the TSP at any time without notice. Additional terms and conditions and eligibility criteria apply. Contact the Eisai Patient Support Program for additional information.
LEQEMBI Patient
Assistance Program

The LEQEMBI Patient Assistance Program is for patients who need help paying for LEQEMBI. This program provides LEQEMBI at no cost to uninsured and financially burdened patients who meet the program eligibility criteria.

Patient Assistance Program terms and conditions

The Patient Assistance Program (''Program'') provides free drug for eligible patients who meet financial need and insurance coverage criteria. Patients must have a valid prescription for LEQEMBI for an FDA-approved indication. Patient must be either uninsured or insured but without insurance coverage for LEQEMBI (ie, the insurer must have denied a first-level appeal of an initial coverage denial) or without enough coverage to pay for LEQEMBI. Patient must have a household income equal to or less than 500 percent of the Federal Poverty Level. Patient must be 18 years or older. Patient must be a resident of, and product must be administered in, the United States or Puerto Rico. Commercially insured patients and Federal health care program beneficiaries who qualify for the Program are enrolled for the entire calendar year. Uninsured patients who qualify for the Program are enrolled for a rolling 12-month period. During the Program enrollment period, patients must receive all LEQEMBI doses through the Program only. Patients cannot be administered commercial units of LEQEMBI, and neither patients nor providers may submit claims for commercial units of LEQEMBI, during the Program enrollment period. All patients must re-enroll at the end of their respective Program approval period to ensure they continue to meet the Program's eligibility criteria. Eisai reserves the right to reassess eligibility for patients with commercial insurance during the enrollment period.

The Program will ship each dose of LEQEMBI directly to the provider or infusion center identified in patient’s enrollment form. Quantities of Product shipped are limited to the number of vials the prescribing physician confirmed in writing are needed and clinically appropriate for the designated patient for a one-month supply of the Product. By accepting shipment, provider agrees to administer the free supply of LEQEMBI only to the enrolled patient and to discard unused amounts in open vials. Product provided through the Program may not be sold, traded, bartered, transferred, or returned for credit. LEQEMBI provided under this Program must be maintained separately from commercial inventory. If the enrolled patient is no longer on therapy or otherwise cannot use the free supply of LEQEMBI, provider agrees to promptly contact the Eisai Patient Support Program to arrange for product return or destruction. If provider fails to meet any Program requirements, the Program will cease sending any additional Program product to the provider until the provider comes into compliance.

No patient, pharmacy, payor, or other third-party may be billed for the free drug provided pursuant to the Program. Patients and providers must not submit any claim for reimbursement for product pursuant to this Program to any third-party payor, including Medicare, Medicaid, or any other federal or state health care program. Patient cannot apply the value of the free product received through this Program toward any insurance benefit out-of-pocket spending calculations such as Medicare Part D True Out-of-Pocket Costs (TrOOP). The free LEQEMBI provided under the Program is not contingent on any past or future purchases of any product, under the patient's insurance benefit or otherwise. Eligibility determinations are made without regard to patient's insurance provider (if any), choice of physician or infusion provider. Patients are free to change physicians or infusion providers at any time. The Program is not health insurance. Limitations may apply. Eisai reserves the right to rescind, revoke, or amend this Program at any time without notice. Additional terms and eligibility criteria apply. Contact the Eisai Patient Support Program for additional information.

Enrolling in EPS is simple, but requires both patients
and healthcare professionals to participate.

Work with your patient to complete the enrollment form. Patients may enroll digitally by visiting
LEQEMBIConsent.com.

A completed enrollment form should be faxed to 1-833-770-7017. Once EPS receives this form, the enrollment verification process can begin.

If you or your patient needs additional assistance with enrollment,
you may call EPS at (1-833-453-7362) to speak with a Patient Navigator.

Download the
enrollment form Descarga el formulario de
inscripción en español

How can I better understand access
for patients prescribed LEQEMBI?

Access & Reimbursement Managers (ARM) support patients' access to prescribed Eisai
products by providing relevant information and addressing provider questions regarding
insurance coverage, coding, billing, and patient access issues. They may also educate
healthcare providers and their staff about Eisai Patient Support programs.

Please complete the form below, and an ARM will contact you shortly.

All fields are required.

First Name

Last Name

Email Address

Phone Number

NPI #

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Preferred Time of Day

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Topic

By ticking this checkbox, you agree to be contacted by an Access & Reimbursement Manager.

Please note that your personal information will be used by Eisai Inc. (“Eisai”) to respond to your request. By submitting your information, you are agreeing to Eisai’s Legal Notices and US Privacy Policy. The Privacy Policy will govern the collection, use, disclosure, and retention of your personal information. Please do not check the box unless you have read and agree with the terms of that US Privacy Policy. By checking the box you agree that you have read, understand, and agree to these conditions.

Thank you! An ARM will contact you soon.

We are sorry! Please click HOME to return to the EPS Leqembi Homepage.

What are Patient Navigators?

Patient Navigators assist patients with their treatment
journey, and may speak with HCPs and their office to relay
information regarding patient access to LEQEMBI, including:

Benefit verification to assess product coverage
Prior authorization assistance to understand requirements and payer decisions
Billing and coding information
Information about financial assistance programs for patients
Assistance finding an infusion site of care

Will my patient's insurance
cover LEQEMBI?

Coverage for LEQEMBI is available primarily through a patient's medical benefits and may vary
significantly by payer, specific health insurance plan, and patient. Contact the health plan to
understand the process, diagnostic requirements, duration of approval, and other relevant
information. Payers may base coverage decisions on formal policies or make decisions on a
case-by-case basis.

Below, you can find basic information about different types of insurance and what to do if your
patient receives a denial of coverage.

Types of insurance

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Commercial insurance

Coverage for LEQEMBI varies among plans offered by commercial payers. Third-party payers, including health maintenance organization (HMO) plans, managed care organizations, and others, may provide coverage for LEQEMBI. However, specific coverage requirements and restrictions vary based on plan type. The lack of a formal published policy from a particular payer does not necessarily mean that LEQEMBI is not covered by that payer.
Medicare

Medicare Part B

The Medicare Part B drug benefit covers prescription drugs administered in a pharmacy, doctor’s office, or hospital outpatient setting. The Part B benefit is federally run. The federal government sets a monthly premium, and beneficiaries must pay a deductible and coinsurance. Patients typically pay 20% of the Medicare-approved amount for doctors’ services and outpatient care. Health care providers are reimbursed for 80% of the amount.

Medicare Part C

Medicare Advantage is a Medicare-approved plan from a private company that offers an alternative to Original Medicare for your health and drug coverage. These “bundled” plans include Part A, Part B, and usually Part D. Plans may have lower out-of-pocket costs and provide some additional benefits that Original Medicare doesn’t cover. Medicare pays a fixed amount for your care every month to the companies offering Medicare Advantage Plans. In most cases, you can only use doctors who are in the plan’s network, and you may need to get approval from your plan before it covers certain drugs or services. These rules can change each year.

On July 6, 2023, the Centers for Medicare and Medicaid Services (CMS) released information regarding coverage for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) for Medicare patients. For more information, click here.
CMS has updated the list of approved studies for Coverage with Evidence Development (CED) of amyloid positron emission tomography (PET) scans. For more information, refer to this link or contact your local Medicare Administrative Contractor.
Medicaid

Medicaid is a government insurance program that covers low-income parents and children, people who are elderly, and people with disabilities. State Medicaid programs and the federal government share the costs of covering most medical expenses for Medicaid beneficiaries.

Coverage and reimbursement for LEQEMBI through Medicaid vary from state to state, as each state Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of offerings covered.

Download Health Insurance
Brochure for patients

What can you do if your patient receives a denial of coverage?

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Requesting an exception

Coverage of LEQEMBI is determined by the member’s medical benefits. Providers or patients should contact the health plan directly to determine whether LEQEMBI is covered by the plan. If LEQEMBI is not covered by the plan, an exception may be requested by the patient and prescriber. Determinations are made on a case-by-case basis and subject to all of the terms, conditions, limitations, and exclusions of the member’s contract including medical necessity requirements.
“Prior authorization
required” categorization

Prior authorization is a requirement for the physician to obtain approval from the health insurance plan prior to prescribing LEQEMBI.
Appealing a denial

An appeal is a request to change a denial made by a health plan. A representative/prescriber or patient may appeal the denial of coverage. The prescriber will need to provide a reason why he or she believes the coverage decision was incorrect and what the expected outcome should be. Along with the request form, the health plan may require supporting documentation such as previous medical necessity-related denials, the patient’s medical records, and documentation from the healthcare professional or facility. The payer may ask if the patient has tried and failed another therapy before trying LEQEMBI. In this case, it is important to include documentation of any previous treatments in the appeal letter.

See ‘Where can I find more resources for LEQEMBI?’ at the bottom of the page for
helpful sample letter resources.

Where can I find billing and coding
information for LEQEMBI?

Please check with your patient's payer to verify coding or special billing requirements. Correct
coding is the responsibility of the provider submitting a claim for the item or service.

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ICD-10 diagnosis codes

ICD-10 diagnosis code	Description of diagnosis code
G30.0	Alzheimer’s disease with early onset
G30.1	Alzheimer’s disease with late onset
G30.8	Other Alzheimer’s disease
G30.9	Alzheimer’s disease, unspecified
G31.84	Mild cognitive impairment, so stated

CPT drug administration codes

Current Procedural Terminology (CPT) codes are 5-digit numeric codes established by the American Medical Association (AMA) that describe medical procedures and services. LEQEMBI is administered as an intravenous infusion over approximately 1 hour, once every 2 weeks. The following CPT codes may be appropriate to report LEQEMBI administration services:

CPT code	Description
96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug (includes highly complex biologic agent administration, eg, monoclonal antibody agents)
96415	Each additional hour
96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specific substance or drug), initial up to 1 hour
96366	Each additional hour

As of January 1, 2023, Medicare requires claims for drugs delivered in single-use containers to use either the JW modifier (drug amount discarded/not administered to any patient) or JZ modifier (zero drug amount discarded/not administered to any patient) on all claims. Other payers may have similar requirements.

Payers may require physicians to report a different drug administration code when billing for LEQEMBI. We recommend verifying a health plan’s coding policies. For assistance relating to payer-specific policies and other questions regarding coding, call EPS using the phone number at the top of the site.

HCPCS level II codes

Healthcare Common Procedure Coding System (HCPCS) codes are 5-digit alphanumeric codes that are assigned to drugs by the Centers for Medicare and Medicaid Services (CMS). LEQEMBI has been assigned a unique HCPCS code in the “J” series (known as J codes): J0174. Some payers may not have updated their HCPCS code files as of yet and until doing so may require the unclassified J code as listed below. Providers should contact their local commercial payers and Medicaid plans for specific information on reporting drugs using the unclassified HCPCS codes.

HCPCS code Description

J3590 Unclassified biologics

J0174 Injection, lecanemab-irmb, 1mg

As of January 1, 2023, Medicare requires claims for drugs delivered in single-use containers to use either the JW modifier (drug amount discarded/not administered to any patient) or JZ modifier (zero drug amount discarded/not administered to any patient) on all claims. Other payers may have similar requirements.

We recommend verifying an insurer’s coding policies. For assistance relating to payer-specific policies and other questions regarding coding, call EPS using the phone number at the top of the site.
National Drug Codes (NDCs)

NDCs are unique, 10-digit, 3-segment numeric identifiers assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The NDC number identifies the labeler, product, and trade package size. LEQEMBI has been assigned the following NDC numbers based on the different available package sizes:

NDC Vial/carton Dose/vial

62856-215-01 500 mg/5 mL (100 mg/mL) Single-dose vial (white flip cap)

62856-212-01 200 mg/2 mL (100 mg/mL) Single-dose vial (dark grey flip cap)

Some payers require providers to report 11-digit NDCs when reporting a drug on a claim form. Converting the 10-digit NDC for LEQEMBI to an 11-digit NDC requires adding a zero in the product code section (the middle section) of the NDC. Here is one example of how to report using the 11-digit NDC:

LEQEMBI 10-digit NDC LEQEMBI 11-digit NDC

62856-215-01 62856-0215-01

HCPCS code	Description
J3590	Unclassified biologics
J0174	Injection, lecanemab-irmb, 1mg

NDC	Vial/carton	Dose/vial
62856-215-01	500 mg/5 mL (100 mg/mL)	Single-dose vial (white flip cap)
62856-212-01	200 mg/2 mL (100 mg/mL)	Single-dose vial (dark grey flip cap)

LEQEMBI 10-digit NDC	LEQEMBI 11-digit NDC
62856-215-01	62856-0215-01

Download the Coding
Quick Reference Guide

Where can I find an infusion
provider for LEQEMBI?

For assistance finding a convenient location for your patients to receive
their LEQEMBI treatment, visit the the LEQEMBI locator tool.*

*This tool is developed, hosted and maintained by NICA, an organization independent from Eisai. Eisai does not control or validate the content on the NICA Infusion Center Locator website. By making this link available, Eisai is not endorsing or recommending any particular infusion provider. The list of infusion providers searchable in the Locator is not comprehensive. Other infusion providers may be available to patients. An infusion site that would like to request to be added to the NICA Infusion Center Locator may contact NICA. When using the NICA Infusion Center Locator, it is the responsibility of the referring prescriber and/or patient to contact the site directly for any site-specific questions, including to confirm whether a site offers the prescribed medication, accepts the patient's insurance, and has schedule availability.

Where can I get LEQEMBI?

LEQEMBI is available through certain distributors.

Download the Specialty
Distributor Guide

Where can I find more resources
for LEQEMBI?

Downloadable resources

Considerations for composing sample letters

Sample letter of medical necessity

Sample prescription drug coverage exception request form

Sample appeals letter

Prior authorization checklist

Click below to learn more about clinical trial data for LEQEMBI, how LEQEMBI works,
and how to take appropriate patients from diagnosis to infusion with LEQEMBI.

Visit the LEQEMBI HCP site

Patient organizations for Alzheimer’s disease

Explore patient advocacy organizations that may provide additional information or assistance,
including educational tools, counseling, and support groups.*

Alzheimer’s Association patient support organization

Us Against Alzheimer’s patient support organization

*The organizations listed are independent from Eisai. Eisai does not influence or control the operations or eligibility criteria for these
independent programs. This information is provided for informational purposes only.

Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary
significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement
decisions are made by individual payers following the receipt of claims. For additional
information, customers should consult with their payers for all relevant coding, reimbursement,
and coverage requirements. It is the sole responsibility of the provider to select the proper code
and ensure the accuracy of all claims used in seeking reimbursement. All services must be
medically appropriate and properly supported in the patient medical record.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

LEQEMBI^®(lecanemab-irmb) 100 mg/mL injection for intravenous use is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)

Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.
Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (~15% of patients with AD) treated with this class of medications 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 LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA.
Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.

CONTRAINDICATION

LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

AMYLOID-RELATED IMAGING ABNORMALITIES

Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.

Incidence of ARIA

Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.

Incidence of ICH

ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

Risk Factors of ARIA and ICH

ApoE ε4 Carrier Status

Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings of 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, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.

Concomitant Antithrombotic or Thrombolytic Medication

In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.
Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody 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 (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. 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 LEQEMBI.

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

Radiographic Severity With LEQEMBI

Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).

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 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, 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.

HYPERSENSITIVITY REACTIONS

Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. 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 (IRRs)

IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.
In the event of an IRR, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.

ADVERSE REACTIONS

The most common adverse reactions reported in ≥5% with LEQEMBI and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%).

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

LEQEMBI^®(lecanemab-irmb) 100 mg/mL injection for intravenous use is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)

Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.
Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (~15% of patients with AD) treated with this class of medications 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 LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA.
Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.

CONTRAINDICATION

LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

AMYLOID-RELATED IMAGING ABNORMALITIES

Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.

Incidence of ARIA

Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.

Incidence of ICH

ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

Risk Factors of ARIA and ICH

ApoE ε4 Carrier Status

Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings of 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, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.

Concomitant Antithrombotic or Thrombolytic Medication

In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.
Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody 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 (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. 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 LEQEMBI.

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

Radiographic Severity With LEQEMBI

Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).

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 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, 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.

HYPERSENSITIVITY REACTIONS

Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. 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 (IRRs)

IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.
In the event of an IRR, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.

ADVERSE REACTIONS

The most common adverse reactions reported in ≥5% with LEQEMBI and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%).

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

How can I enroll my patient in Eisai Patient Support?

Eisai Patient Support (EPS) offers support programs to help eligible patients afford the cost of LEQEMBI® (lecanemab-irmb).

How can I better understand access for patients prescribed LEQEMBI?

Access & Reimbursement Managers (ARM) support patient access and may provide relevant coverage and related information to healthcare providers and staff.

What are Patient Navigators?

Patient Navigators may speak to HCPs and their offices to relay information regarding patient access to LEQEMBI® (lecanemab-irmb).

Will my patient's insurance cover LEQEMBI® (lecanemab-irmb)?

Eisai Patient Support (EPS) will conduct a benefits investigation to determine a patient’s coverage for LEQEMBI.

Where can I find billing and coding information for LEQEMBI® (lecanemab-irmb)?

Eisai Patient Support (EPS) has information regarding billing and coding for LEQEMBI.

Where can I find an infusion provider for LEQEMBI® (lecanemab-irmb)?

Learn where you can find information about infusion centers in your area.

Where can I get LEQEMBI® (lecanemab-irmb)?

Eisai Patient Support (EPS) has a specialty distributor list for more information on how to order LEQEMBI.

Where can I find more resources for LEQEMBI® (lecanemab-irmb)?

Explore sample letters, patient organizations, and other tools to assist with patient access to LEQEMBI.

How can I enroll my patient in Eisai Patient Support?

Full terms and conditions

LEQEMBI Copay Assistance Program

LEQEMBI Temporary Supply Program

LEQEMBI Patient Assistance Program

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What are Patient Navigators?

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WARNINGS AND PRECAUTIONS

AMYLOID-RELATED IMAGING ABNORMALITIES

WARNINGS AND PRECAUTIONS

AMYLOID-RELATED IMAGING ABNORMALITIES

How can I enroll
my patient
in Eisai
Patient Support?

Eisai Patient Support (EPS) offers support programs
to help eligible patients afford the cost of LEQEMBI^® (lecanemab-irmb).

How can I better understand access
for patients prescribed LEQEMBI?

Access & Reimbursement Managers (ARM) support patient
access and may provide relevant coverage and related
information to healthcare providers and staff.

Patient Navigators may speak to HCPs and their offices to relay
information regarding patient access to LEQEMBI^® (lecanemab-irmb).

Will my patient's insurance cover
LEQEMBI^®
(lecanemab-irmb)?

Eisai Patient Support (EPS) will conduct a benefits
investigation to determine a patient’s coverage for LEQEMBI.

Where can I find billing and coding
information for LEQEMBI^®
(lecanemab-irmb)?

Eisai Patient Support (EPS) has information regarding billing
and coding for LEQEMBI.

Where can I find an infusion
provider for LEQEMBI^®
(lecanemab-irmb)?

Learn where you can find information about infusion
centers in your area.

Where can I get LEQEMBI^®
(lecanemab-irmb)?

Eisai Patient Support (EPS) has a specialty distributor
list for more information on how to order LEQEMBI.

Where can I find more resources
for LEQEMBI^®
(lecanemab-irmb)?

Explore sample letters, patient organizations, and
other tools to assist with patient access to LEQEMBI.

How can I enroll my patient
in Eisai Patient Support?

LEQEMBI Copay
Assistance Program

LEQEMBI Temporary
Supply Program

LEQEMBI Patient
Assistance Program

How can I better understand access
for patients prescribed LEQEMBI?

Will my patient's insurance
cover LEQEMBI?

“Prior authorization
required” categorization

Where can I find billing and coding
information for LEQEMBI?

Where can I find an infusion
provider for LEQEMBI?

Where can I find more resources
for LEQEMBI?