ModifiedHealth NetPolicy CP.PCH.30

Clinical Policy: Memantine ER (Namenda XR), Memantine/Donepezil ER (Namzaric)

Defines medical necessity criteria, prior authorization requirements, dosing limits, and continuation criteria for memantine extended-release (Namenda XR) and memantine/donepezil extended-release (Namzaric) for commercial and HIM lines of business.

Policy Summary

PayerHealth Net

PolicyMemantine ER (Namenda XR), Memantine/Donepezil ER (Namzaric)

Policy CodePolicy CP.PCH.30

Change TypeMaterial revision — generics addedIL HIM step bypass added

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis of moderate to severe dementia, age ≥18, step therapy and dosing limits (note: IL HIM bypass applies per IL HB 5395).

SourceLink

POLICY UPDATE CHANGES

Policy/criteria revised to also include generic memantine ER and memantine/donepezil ER as options.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Clarified requirement that if Namenda XR or Namzaric is requested, generic components must be used unless contraindicated or adverse effects occur.

Revised policy/criteria section to also include generic memantine ER and memantine/donepezil ER; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

28 mgMax memantine dose

10 mgMax donepezil in Namzaric

Moderate–severe

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12 moTypical approval duration

3Q 2025Annual review

IL HB 5395IL step bypass

Coverage Criteria for Memantine ER and Memantine/Donepezil ER

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Moderate to Severe Dementia):

Initial Approval - Moderate to Severe Dementia

Diagnosis and Age: Diagnosis of moderate to severe dementia; member is age >= 18 years.age >= 18
See policy I.A.1-2
Donepezil step therapy: Failure of donepezil at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.
For Illinois HIM requests, this step therapy requirement does not apply as of 1/1/2026 per IL HB 5395
Product substitution requirements: If request is for Namenda XR, member must use generic memantine extended‑release capsules unless contraindicated or clinically significant adverse effects are experienced; if request is for Namzaric, member must use the individual generic components (donepezil and memantine) concurrently unless contraindicated or clinically significant adverse effects are experienced.
See policy I.A.4-5
Dose limit: Requested dose does not exceed one of the following: (a) Namenda XR: memantine ER 28 mg per day; or (b) Namzaric: memantine 28 mg and donepezil 10 mg per day.
See policy I.A.6

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Moderate to Severe Dementia):

Continued Therapy - Moderate to Severe Dementia

Ongoing status: Member currently receiving the medication via the Centene benefit OR member previously met the initial approval criteria OR member is currently receiving medication and enrolled in a state/product with continuity of care regulations.
See policy II.A.1
Clinical response: Member is responding positively to therapy.
See policy II.A.2
Dose increase limit: If a dose increase is requested, the new dose does not exceed: (a) Namenda XR: memantine ER 28 mg per day; or (b) Namzaric: memantine 28 mg and donepezil 10 mg per day.
See policy II.A.3

Other Indications

Other diagnoses/indications:

Recent label change (within 6 months): If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, new dosing), follow the applicable formulary/no‑coverage or non‑formulary policy for the relevant line of business (CP.CPA.190, HIM.PA.33, HIM.PA.103 as appropriate).

Off‑label or not‑listed uses: If the requested use (diagnosis, age, dosing regimen) is not specifically listed under section III and criterion 1 above does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial; HIM.PA.154 for HIM).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies: CP.CPA.09 for commercial lines and HIM.PA.154 for Health Insurance Marketplace (HIM).

Coverage and administration of benefits for requests subject to this clinical policy are governed by the member's coverage documents and applicable law. Decisions are subject to all terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate of coverage, policy, or contract of insurance, as well as state and federal requirements and Health Plan administrative policies.

Uses for indications not covered by this policy and not supported by the referenced off‑label use policies or other evidence are considered not authorized and may be denied. Providers should refer requests for off‑label uses to the applicable off‑label policy (CP.CPA.09 or HIM.PA.154) and submit supporting documentation when applicable.

Coding and Dosing Limits

Product availability / NDC referencemixed

NDC	Product availability and strengths listed (see product availability section)

Covered NDC/CPT/HCPCSmixed

No codes listed

Maximum daily doses — inv-09: Memantine and Namzaric

Memantine ER (Namenda XR) maximum daily dose28 mg per day

Memantine/donepezil (Namzaric) maximum daily dosesMemantine 28 mg + Donepezil 10 mg per day

Memantine ER titrationInitial dose 7 mg PO QD, increase by 7 mg per day at one-week intervals to a maximum of 28 mg/day

Namzaric titrationInitial dose 7 mg/10 mg PO QD, increased in 7 mg memantine increments per week to memantine 28 mg/ donepezil 10 mg

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for memantine ER (Namenda XR) and memantine/donepezil ER (Namzaric) as well as their generic equivalents. Approval is granted when the specified clinical criteria in the policy are met. Providers must submit documentation supporting medical necessity.

Affected products: memantine ER (Namenda XR), memantine/donepezil ER (Namzaric), and generic memantine and memantine/donepezil ER formulations
Prior authorization requirement effective per this clinical policy

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) demonstrating that the member has met all approval criteria. Providers are expected to retain supporting documentation and exercise professional medical judgment when requesting authorization.

Background

Namenda XR (memantine ER) and Namzaric (memantine/donepezil ER) are FDA‑approved for the treatment of moderate to severe Alzheimer’s‑type dementia. Namzaric is indicated for patients stabilized on donepezil 10 mg once daily. Dosing and titration guidance for memantine ER and memantine/donepezil ER are provided in the policy (memantine ER titrated in 7 mg increments to a maximum of 28 mg/day; Namzaric titrates memantine to 28 mg while coadministered with donepezil 10 mg/day).

Definitions

Moderate to severe Alzheimer9s disease — inv-19

IndicationTreatment of moderate to severe Alzheimer’s disease (moderate to severe dementia)

Memantine ER dosing and titrationStart 7 mg PO QD, increase by 7 mg per day at one-week intervals to 28 mg/day

Namzaric dosing and titrationStart 7 mg/10 mg PO QD, increase memantine by 7 mg weekly to 28 mg memantine with donepezil 10 mg

Namzaric prescribing noteNamzaric requires use of individual generic components (donepezil and memantine) concurrently unless contraindicated when generics are required

Health Plan definition — inv-20

Definition of Health Plan'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Policy Summary

PayerHealth Net

PolicyMemantine ER (Namenda XR), Memantine/Donepezil ER (Namzaric)

Policy CodePolicy CP.PCH.30

Change TypeMaterial revision — generics addedIL HIM step bypass added

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis of moderate to severe dementia, age ≥18, step therapy and dosing limits (note: IL HIM bypass applies per IL HB 5395).

SourceLink

On This Page

Continued Approval Duration: Approval duration: Commercial — 12 months or duration of request, whichever is less; HIM — 12 months.

Examples of acceptable documentation: office progress notes, medication history, relevant diagnostic testing, evidence of prior medication trials and tolerability

Documentation should be available upon request and kept in the member’s medical record

Step Therapy

Donepezil Step Requirement and Product Substitution

For initial approval of memantine- or memantine/donepezil–containing products, failure of donepezil at maximally indicated doses is required prior to approval unless donepezil is contraindicated or the member experienced clinically significant adverse effects. For Namenda XR and Namzaric, use of the individual generic components (generic memantine ER or concurrent generic donepezil and memantine) is required unless contraindicated or adverse effects are experienced. Dosing limits apply (Namenda XR ≤ 28 mg/day; Namzaric: memantine 28 mg and donepezil 10 mg/day).

Donepezil step required unless contraindicated or intolerant
Namenda XR: member must use generic memantine ER unless contraindicated or intolerant
Namzaric: member must use concurrent donepezil and memantine generics unless contraindicated or intolerant
Dose limits: Namenda XR 28 mg/day; Namzaric memantine 28 mg + donepezil 10 mg/day

Step Therapy

Step Therapy Bypass for Illinois HIM

Per Illinois HB 5395, the donepezil step therapy requirement does not apply for Illinois Health Insurance Marketplace (HIM) requests as of 1/1/2026. Providers submitting requests for Illinois HIM beneficiaries should indicate state-specific status to allow the step therapy bypass.

Step therapy bypass applicable only to Illinois HIM members (effective 01/01/2026)
Providers should document beneficiary is enrolled in Illinois HIM when requesting bypass

Denial Risk

Non‑FDA Approved Indications

Requests for non–FDA–approved (off‑label) indications that are not addressed in this policy require sufficient documentation of efficacy and safety per the plan’s off‑label use policies (CP.CPA.09 for commercial and HIM.PA.154 for Health Insurance Marketplace) or other evidence of coverage. Absent such documentation, coverage may be denied.

Off‑label requests must reference supporting literature or applicable off‑label policy (CP.CPA.09 or HIM.PA.154)
Coverage decisions for non‑FDA indications are subject to plan evidence of coverage and medical necessity review

Scope of policy useThis clinical policy is a guide to medical necessity and assists coverage decisions and administering benefits; it does not constitute a contract or guarantee of payment

Provider responsibilityProviders are expected to exercise professional medical judgment and are responsible for medical advice and treatment of members