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

The following are agents containing an N-methyl-D-aspartate (NMDA) receptor antagonist and requiring prior authorization: memantine extended-release (Namenda XR®) and memantine/donepezil hydrochloride (Namzaric™). FDA Approved Indication(s) Namenda XR and Namzaric are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Namzaric is only indicated in patients stabilized on 10 mg of donepezil hydrochloride once daily. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Namenda XR and Namzaric are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Moderate to Severe Dementia (must meet all):

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 or b): a. Namenda XR: 28 mg (1 capsule) per day; 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 Page 1 of 5

   CLINICAL POLICY Memantine, Memantine/Donepezil
   B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) 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 and HIM.PA.154 for health insurance marketplace.
      II. Continued Therapy A. Moderate to Severe Dementia (must meet all):
4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
5. Member is responding positively to therapy;

6. If request is for a dose increase, new dose does not exceed (a or b): a. Namenda XR: 28 mg (1 capsule) per day; 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 B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 2 of 5

   CLINICAL POLICY Memantine, Memantine/Donepezil
   criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration NMDA: N-methyl-D-aspartate Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose 23 mg/day donepezil (Aricept®/Aricept ODT®)
   Mild to moderate Alzheimer’s disease: 5 mg to 10 mg PO QD Moderate to severe Alzheimer’s disease: 10 to 23 mg PO QD
   Moderate to severe Alzheimer’s disease:
   5 mg to 20 mg PO QD memantine
   (Namenda®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 20 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to memantine hydrochloride (Namenda XR/Namzaric), or donepezil hydrochloride/piperidine derivatives (Namzaric), or to any excipients used in the formulation. • Boxed warning(s): none reported. V. Dosage and Administration
   Drug Name Memantine ER (Namenda XR) Memantine/donepezil (Namzaric) Dosing Regimen Initial dose 7 mg PO QD, increase by 7 mg per day at one-week intervals
   Initial dose 7 mg/10 mg PO QD, increased in 7 mg increments per week
   Maximum Dose 28 mg/day 28 mg/10 mg/day Page 3 of 5

   CLINICAL POLICY Memantine, Memantine/Donepezil
   VI. Product Availability
   Drug Name Memantine ER (Namenda XR) Memantine/donepezil (Namzaric) Availability Capsule: 7 mg, 14 mg, 21 mg, 28 mg Titration pack: 7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg Capsule: 7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg, 28 mg/10 mg
   Titration pack: 7 x 7mg/10 mg, 7 x 14 mg/10 mg, 7 x 21 mg/10 mg, 7 x 28 mg/10 mg VII.