ModifiedHealth NetPolicy CP PCH.30

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

Defines medical necessity and prior authorization criteria for memantine extended-release (Namenda XR) and memantine/donepezil extended-release (Namzaric) for treatment of moderate to severe Alzheimer's-type dementia for Health Net members.

Policy Summary

PayerHealth Net

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

Policy CodePolicy CP PCH.30

Change TypeStep therapy addedgenerics included

Effective DateSep 1, 2020

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating criteria are met, including trial of generic memantine ER or individual generic components when required.

SourceLink

POLICY UPDATE CHANGES

Policy/criteria revised to include generic memantine ER as required step when Namenda XR is requested and to include memantine ER and memantine/donepezil ER generics in policy/criteria.

Step therapy requirement was added to the policy.

Approval duration for Commercial line changed to 12 months or duration of request, whichever is less.

Revised policy/criteria section to also include generic memantine ER and memantine/donepezil ER; added step therapy.

12 monthsApproval duration (Commercial)

28 mgMaximum Namenda XR dose

28/10Maximum Namzaric dose

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Coverage Criteria

inv-01: Initial Approval

Covered when ALL of the following are met for initial approval:

Initial Approval - Moderate to Severe Dementia: 1) Diagnosis of moderate to severe dementia; 2) Age >= 18 years; 3) Failure of donepezil at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 4) If request is for Namenda XR, member must use generic memantine extended-release capsules unless contraindicated or clinically significant adverse effects are experienced; 5) 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; 6) Dose does not exceed: a) Namenda XR 28 mg (1 capsule) per day; or b) Namzaric memantine 28 mg and donepezil 10 mg (1 capsule) per day.

Provider must submit documentation (e.g., office chart notes, lab results) supporting that member has met all approval criteria.

inv-02: Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy: 1) Member meets one of the following: a) currently receiving medication via the Centene benefit or b) member has previously met initial approval criteria (including members subject to state continuity of care where applicable); 2) Diagnosis of moderate to severe dementia (meets the same conditions as initial approval); 3) Member is responding positively to therapy; 4) If request is for a dose increase, the new dose does not exceed: a) Namenda XR 28 mg (1 capsule) per day; or b) Namzaric memantine 28 mg and donepezil 10 mg (1 capsule) per day.

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

inv-03: Revised coverage criteria (summary)

Policy/criteria revised

Revision summary: Revised to include generic memantine extended-release and generic memantine/donepezil extended-release formulations and to add a step therapy requirement requiring trial of generic memantine ER (or individual generic components for combination therapy) prior to brand products unless contraindicated or clinically significant adverse effects occur.

Refer to full policy for complete AND/OR logic and operational details; step therapy and inclusion of generics were added per the 3Q 2025 revision.

Non-FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the Health Net off‑label use policies (CP.CPA.09 for Commercial or HIM.PA.154 for Marketplace) or the member's evidence of coverage documents.

Use of memantine ER (Namenda XR) or memantine/donepezil ER (Namzaric) is contraindicated in individuals with a known hypersensitivity to memantine hydrochloride, to donepezil hydrochloride/piperidine derivatives (for combination products), or to any excipient contained in the formulation.

Coverage of memantine ER and memantine/donepezil ER is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). This clinical policy is a guide to medical necessity and does not guarantee payment; applicable state and federal requirements and Health Plan administrative policies also apply.

Requests for therapy for indications that are not FDA‑approved and are not addressed by this policy will not be authorized unless the provider supplies sufficient supporting clinical documentation that meets the Health Net off‑label use criteria (see CP.CPA.09 or HIM.PA.154) demonstrating efficacy and safety for the requested use.

This clinical policy is provided as a guide to assist in determining medical necessity. It does not define all conditions that may be considered not medically necessary and is not intended to substitute for professional medical judgment. Providers remain responsible for making treatment decisions and for following applicable coverage documents and administrative policies when submitting claims.

Coding

Covered drug namesmixedCovered

Namenda XR	memantine extended-release capsules (generic memantine ER available)
Namzaric	memantine/donepezil extended-release capsules (combination)

Affected coding referencesmixed

affected codes

Placeholder reference in document indicating certain codes are affected by step therapy/generic ER inclusion.

Maximum daily doses — Memantine products

Namenda XR maximum daily dose28 mg per day (1 capsule)

Namzaric maximum daily dosesMemantine 28 mg + Donepezil 10 mg per day (1 capsule)

Namenda XR typical titrationInitial 7 mg PO QD, increase by 7 mg per day at one-week intervals to 28 mg/day

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for memantine ER (Namenda XR) and memantine/donepezil ER (Namzaric). These products are medically necessary only when the clinical criteria in this policy are met, including applicable step-therapy requirements (e.g., trial of generic memantine ER before Namenda XR and use of individual generic components before Namzaric unless contraindicated).

Policy Number: CP PCH.30
Effective Date: 2020-09-01
Step therapy: members must try generic memantine ER prior to Namenda XR and the individual generic components (donepezil + memantine) prior to Namzaric unless contraindicated or clinically significant adverse effects occur

Documentation Required

Non‑FDA Indications — Documentation Required

Requests for therapies for non–FDA‑approved indications that are not specifically addressed in this policy may be denied unless the provider supplies sufficient documentation of efficacy and safety per the Health Plan off‑label use policies. Refer to CP.CPA.09 for commercial lines and HIM.PA.154 for Health Insurance Marketplace when applicable.

Background

Memantine extended‑release (Namenda XR) and the memantine/donepezil extended‑release combination (Namzaric) are N‑methyl‑D‑aspartate (NMDA) receptor antagonists indicated for the treatment of moderate to severe Alzheimer's‑type dementia. Namzaric is indicated for patients stabilized on donepezil 10 mg daily; typical dosing regimens titrate memantine ER up to a maximum of 28 mg/day and donepezil to 10 mg/day when used in combination.

Definitions

NMDA definition

NMDA abbreviationN-methyl-D-aspartate

NMDA definitionN-methyl-D-aspartate receptor antagonist

Contextual useAgents containing an NMDA receptor antagonist (e.g., memantine ER) require authorization

Health Plan — definition

Health Plan definitionA 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 roleThis clinical policy is effective as of the date determined by the Health Plan and guides medical necessity determinations