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 ProgramThe 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.
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LEQEMBI Temporary
Supply ProgramThe 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 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 ProgramThe 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. 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.
CMS has updated the list of approved studies for Coverage with Evidence Development (CED) of amyloid PET scans. For more information, refer to this link or contact your local Medicare Administrative Contractor.
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.
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. -
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.
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” categorizationPrior 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
LEQEMBI is an amyloid beta–directed antibody indicated for the treatment of
Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with
mild cognitive impairment or mild dementia stage of disease, the population in
which treatment was initiated in clinical trials. There are no safety or effectiveness
data on initiating treatment at earlier or later stages of the disease than were
studied.Providers should use current ICD-10 codes to report a patient’s diagnosis on claim
submissions. Below is a list of ICD-10 diagnosis codes that may be reasonably
related to a diagnosis within the product’s approved label. Other codes may be
appropriate. Some payers may require secondary codes.Correct coding is the responsibility of the provider submitting a claim for the item or
service. Please see FDA-approved indication for LEQEMBI and check with the
payer to verify coding or special billing requirements.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
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.
Where can I find more resources
for LEQEMBI?
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.
Patient organizations for Alzheimer’s disease
Explore patient advocacy organizations that may provide additional information or assistance,
including educational tools, counseling, and support groups.*
*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.
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.
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.
Thank you! An ARM will contact you soon.
We are sorry! Please click HOME to return to the EPS Leqembi Homepage.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment 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 amyloid beta, including LEQEMBI, can cause amyloid related imaging abnormalities (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 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.
- Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, 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 Alzheimer’s disease and potential risk of serious adverse events associated with ARIA 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
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LEQEMBI can cause ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and
ARIA-H as microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer’s disease. ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E.
ARIA-H and ARIA-E can occur together. - ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur. Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time.
ARIA Monitoring and Dose Management Guidelines
- Obtain recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with LEQEMBI. Obtain an MRI prior to the 5th, 7th and 14th infusions.
- 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, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
- Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. 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.
- There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data in dosing patients who experienced recurrent ARIA-E.
Incidence of ARIA
- In Study 2, symptomatic ARIA occurred in 3% (29/898) of LEQEMBI-treated patients. Serious symptoms associated with ARIA were reported in 0.7% (6/898) of patients treated with LEQEMBI. Clinical symptoms associated with ARIA resolved in 79% (23/29) of patients during the period of observation.
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Including asymptomatic radiographic events, ARIA was observed in LEQEMBI: 21% (191/898); placebo: 9% (84/897).
ARIA-E was observed in LEQEMBI: 13% (113/898); placebo: 2% (15/897). ARIA-H was observed in LEQEMBI: 17% (152/898); placebo: 9% (80/897). There was no increase in isolated
ARIA-H for LEQEMBI vs placebo.
ApoE ε4 Carrier Status and Risk of ARIA
- In Study 2, 16% (141/898) of patients in the LEQEMBI arm were ApoE ε4 homozygotes, 53% (479/898) were heterozygotes, and 31% (278/898) were noncarriers.
- The incidence of ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Among patients treated with LEQEMBI, symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes compared with 2% of heterozygotes and 1% noncarriers. Serious events of ARIA occurred in 3% of ApoE ε4 homozygotes, and approximately 1% of heterozygotes and noncarriers.
- The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.
Radiographic Findings
- The majority of ARIA-E radiographic events occurred early in treatment (within the first 7 doses), although ARIA can occur at any time and patients can have more than 1 episode. The maximum radiographic severity of ARIA-E in patients treated with LEQEMBI was mild in 4% (37/898), moderate in 7% (66/898), and severe in 1% (9/898). Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. The maximum radiographic severity of ARIA-H microhemorrhage in LEQEMBI-treated patients was mild in 9% (79/898), moderate in 2% (19/898), and severe in 3% (28/898) of patients; superficial siderosis was mild in 4% (38/898), moderate in 1% (8/898) , and severe in 0.4% (4/898). Among LEQEMBI-treated patients, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes 5% (7/141), compared to heterozygotes 0.4% (2/479) or noncarriers 0% (0/278). Among LEQEMBI-treated patients, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes 13.5% (19/141), compared to heterozygotes 2.1% (10/479) or noncarriers 1.1% (3/278).
Intracerebral Hemorrhage
- Intracerebral hemorrhage >1 cm in diameter was reported in 0.7% (6/898) of patients in Study 2 after treatment with LEQEMBI compared to 0.1% (1/897) on placebo. Fatal events of intracerebral hemorrhage in patients taking LEQEMBI have been reported.
Concomitant Antithrombotic Medication:
Other Risk Factors for Intracerebral Hemorrhage:
HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred in LEQEMBI-treated patients. 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
- In Study 2, infusion-related reactions were observed in LEQEMBI: 26% (237/898); placebo: 7% (66/897), and the majority of cases in LEQEMBI-treated patients (75%, 178/237) occurred with the first infusion. Infusion-related reactions were mostly mild (69%) or moderate (28%) in severity. Infusion-related reactions resulted in discontinuations in 1% (12/898) of LEQEMBI-treated patients. Symptoms of infusion-related reactions 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 infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered.
ADVERSE REACTIONS
- In Study 2, the most common adverse reactions leading to discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to discontinuation in 2% (15/898) of patients treated with LEQEMBI compared to <1% (1/897) of patients on placebo.
- In Study 2, the most common adverse reactions reported in ≥5% of patients treated with LEQEMBI (N=898) and ≥2% higher than placebo (N=897) were infusion-related reactions (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.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment 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 amyloid beta, including LEQEMBI, can cause amyloid related imaging abnormalities (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 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.
- Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, 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 Alzheimer’s disease and potential risk of serious adverse events associated with ARIA 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
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LEQEMBI can cause ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and
ARIA-H as microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer’s disease. ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E.
ARIA-H and ARIA-E can occur together. - ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur. Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time.
ARIA Monitoring and Dose Management Guidelines
- Obtain recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with LEQEMBI. Obtain an MRI prior to the 5th, 7th and 14th infusions.
- 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, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
- Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. 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.
- There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data in dosing patients who experienced recurrent ARIA-E.
Incidence of ARIA
- In Study 2, symptomatic ARIA occurred in 3% (29/898) of LEQEMBI-treated patients. Serious symptoms associated with ARIA were reported in 0.7% (6/898) of patients treated with LEQEMBI. Clinical symptoms associated with ARIA resolved in 79% (23/29) of patients during the period of observation.
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Including asymptomatic radiographic events, ARIA was observed in LEQEMBI: 21% (191/898); placebo: 9% (84/897).
ARIA-E was observed in LEQEMBI: 13% (113/898); placebo: 2% (15/897). ARIA-H was observed in LEQEMBI: 17% (152/898); placebo: 9% (80/897). There was no increase in isolated
ARIA-H for LEQEMBI vs placebo.
ApoE ε4 Carrier Status and Risk of ARIA
- In Study 2, 16% (141/898) of patients in the LEQEMBI arm were ApoE ε4 homozygotes, 53% (479/898) were heterozygotes, and 31% (278/898) were noncarriers.
- The incidence of ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Among patients treated with LEQEMBI, symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes compared with 2% of heterozygotes and 1% noncarriers. Serious events of ARIA occurred in 3% of ApoE ε4 homozygotes, and approximately 1% of heterozygotes and noncarriers.
- The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.
Radiographic Findings
- The majority of ARIA-E radiographic events occurred early in treatment (within the first 7 doses), although ARIA can occur at any time and patients can have more than 1 episode. The maximum radiographic severity of ARIA-E in patients treated with LEQEMBI was mild in 4% (37/898), moderate in 7% (66/898), and severe in 1% (9/898). Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. The maximum radiographic severity of ARIA-H microhemorrhage in LEQEMBI-treated patients was mild in 9% (79/898), moderate in 2% (19/898), and severe in 3% (28/898) of patients; superficial siderosis was mild in 4% (38/898), moderate in 1% (8/898) , and severe in 0.4% (4/898). Among LEQEMBI-treated patients, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes 5% (7/141), compared to heterozygotes 0.4% (2/479) or noncarriers 0% (0/278). Among LEQEMBI-treated patients, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes 13.5% (19/141), compared to heterozygotes 2.1% (10/479) or noncarriers 1.1% (3/278).
Intracerebral Hemorrhage
- Intracerebral hemorrhage >1 cm in diameter was reported in 0.7% (6/898) of patients in Study 2 after treatment with LEQEMBI compared to 0.1% (1/897) on placebo. Fatal events of intracerebral hemorrhage in patients taking LEQEMBI have been reported.
Concomitant Antithrombotic Medication:
Other Risk Factors for Intracerebral Hemorrhage:
HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred in LEQEMBI-treated patients. 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
- In Study 2, infusion-related reactions were observed in LEQEMBI: 26% (237/898); placebo: 7% (66/897), and the majority of cases in LEQEMBI-treated patients (75%, 178/237) occurred with the first infusion. Infusion-related reactions were mostly mild (69%) or moderate (28%) in severity. Infusion-related reactions resulted in discontinuations in 1% (12/898) of LEQEMBI-treated patients. Symptoms of infusion-related reactions 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 infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered.
ADVERSE REACTIONS
- In Study 2, the most common adverse reactions leading to discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to discontinuation in 2% (15/898) of patients treated with LEQEMBI compared to <1% (1/897) of patients on placebo.
- In Study 2, the most common adverse reactions reported in ≥5% of patients treated with LEQEMBI (N=898) and ≥2% higher than placebo (N=897) were infusion-related reactions (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.