CurrentCignaPolicy N/A

Alzheimer's Disease Step Therapy Policy

Defines Cigna's step therapy requirements for coverage of listed Alzheimer's disease medications (AChE inhibitors and the memantine/donepezil combination) for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAlzheimer's Disease Step Therapy Policy

Policy CodePolicy N/A

Change TypeProduct list updates (Step 2A additions)

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain step therapy prior authorization and document trial of required Step 1 product before approving Step 2 products.

SourceLink

POLICY UPDATE CHANGES

Generic memantine and donepezil hydrochlorides extended-release capsules (generic Namzaric) were added to Step 2A Products.

Zunveyl (benzgalantamine delayed-release tablets) was added to Step 2A Products.

10products listed in header

2step therapy components

1authorization duration (yrs)

1A→2AAChEI sequencing

1B→2BAricept sequencing

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Coverage Criteria for Step Therapy

Generic acetylcholinesterase inhibitor criteria

Covered when ALL of the following are met:

Generic AChEI Step: Patient has tried one Step 1A Producttrial of one Step 1A product

If met, approve a Step 2A Product

Aricept 23 mg criteria

Covered when ALL of the following are met:

Aricept 23 mg Step: Patient has tried one Step 1B Producttrial of one Step 1B product

If met, approve Aricept 23 mg (Step 2B)

This policy does not include single-agent NMDA antagonists. Specifically, memantine alone is not covered under this step therapy policy and is excluded from the Step 1/Step 2 sequencing described in this document.

Use of any listed product that does not follow the step therapy sequencing requirement is considered not medically necessary and will not be covered. The program requires a trial of the specified Step 1 product (Step 1A for generic acetylcholinesterase inhibitors or Step 1B for Aricept 23 mg sequencing) before approving the corresponding Step 2 product; failure to meet this sequencing at the point of service may result in denial of coverage.

Product and Coding Information

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

All approvals for Step Therapy products are provided for one year in duration. Coverage for a Step 2 product will be determined only after the Step Therapy criteria are met at the point of service; if the Step Therapy rule is not met, coverage will follow the Step Therapy criteria in this policy.

Approvals duration: 1 year

Step Therapy

Step Therapy Sequencing Requirement

This program requires use of a Step 1 product prior to a Step 2 product. For generic acetylcholinesterase inhibitors the sequencing is Step 1A → Step 2A. For Aricept products the sequencing is Step 1B → Step 2B. Specific step definitions: Step 1A includes generic donepezil (excluding 23 mg), generic galantamine formulations, and generic rivastigmine formulations; Step 2A includes Adlarity, Aricept 5/10 mg, Exelon, Namzaric, Razadyne formulations, and Zunveyl. Step 1B includes Aricept 10 mg (tablet or ODT) and Step 2B is Aricept 23 mg (brand or generic).

Generic AChEIs: Step 1A → Step 2A

Definitions and Drug-Specific Notes

Memantine ER/donepezil (Namzaric)

Product indicationFixed‑dose combination of memantine ER and donepezil (Namzaric) indicated for treatment of moderate to severe dementia of the Alzheimer’s type

PrerequisitePatient must be stabilized on donepezil 10 mg once daily before use

Formulation noteMemantine ER/donepezil capsules contain extended‑release memantine plus donepezil

Clinical contextIntended for patients with moderate to severe Alzheimer’s disease

Background

Acetylcholinesterase inhibitors — including donepezil, rivastigmine, galantamine, and benzgalantamine — are indicated across varying severities of Alzheimer’s disease to address cholinergic deficits. The memantine/donepezil extended-release fixed-dose combination (Namzaric) is specifically indicated for moderate to severe Alzheimer’s disease in patients who are stabilized on donepezil 10 mg once daily. This step therapy policy groups therapies into two components to promote use of designated Step 1 products prior to Step 2 options.