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Drug Category: CNS Agents

Medication Class/Individual Agents: Alzheimer’s Agents

I. Prior-Authorization Requirements

 Alzheimer's Agents – Cholinesterase Inhibitors

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

donepezil 10 mg tablet Aricept # PA   - < 18 years and PA > 60 units/month
donepezil 23 mg tablet Aricept PA  
donepezil 5 mg tablet Aricept # PA   - < 18 years and PA > 30 units/month
donepezil orally disintegrating tablet PA   - < 18 years and PA > 30 units/month
galantamine extended-release capsule Razadyne ER # PA   - < 18 years and PA > 30 units/month
galantamine solution PA  
galantamine tablet Razadyne # PA   - < 18 years and PA > 60 units/month
rivastigmine capsule PA   - < 18 years and PA > 60 units/month
rivastigmine patch Exelon PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

American Psychiatric Association (APA): Practice guideline for the treatment of patients with Alzheimer’s disease (AD) and other dementias (2007)1

  • Cholinesterase inhibitors should be offered to patients with mild to moderate AD and may be helpful for patients with severe AD.
  • Cholinesterase inhibitors should be considered for patients with mild to moderate dementia associated with Parkinson’s disease and dementia with Lewy bodies.
  • The constructs of mild cognitive impairment and vascular dementia are evolving and have ambiguous boundaries with AD. The efficacy and safety of cholinesterase inhibitors for patients with these disorders are uncertain; therefore, no specific recommendation can be made at this time, although individual patients may benefit from these agents.
  • Memantine may provide modest benefits and has few adverse effects; it may be considered for patients with moderate-to-severe AD. There is some evidence of benefit in mild disease and very limited evidence of benefit in vascular dementia.

1. Rabins PV, Blacker D, Rovner BW, Rummans T, Schneider LS, Tariot PN, et al. American Psychiatric Association practice guideline for the treatment of patients with Alzheimer's disease and other dementias. Second edition. Am J Psychiatry. 2007 Dec;164(12 Suppl):5-56.

 

 Alzheimer's Agents – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

memantine / donepezil extended-release Namzaric PA  

 Alzheimer's Agents – NMDA Receptor Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

memantine extended-release Namenda XR BP PA  
memantine solution Namenda PA  
memantine tablet Namenda # PA   - <18 years and PA > 60 units/month
memantine titration pack Namenda PA   - < 18 years and PA > 49 units/month
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Alzheimer’s Disease
  • Dementia associated with Parkinson’s Disease (rivastigmine)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

 

donepezil 23 mg tablet 

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity does not exceed 30 tablets/month; and
    • an inadequate response to donepezil 20 mg/day for three consecutive months.

 

galantamine solution

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity does not exceed 180 mL/month; and
    • one of the following:
      • an inadequate response or adverse reaction to galantamine tablets or galantamine extended-release capsules; or
      • clinical rationale for solution formulation over solid oral formulation.

 

 memantine extended-release

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity does not exceed 30 capsules/month; and
    • an inadequate response or adverse reaction to memantine immediate-release tablets or solution

  

memantine solution

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity does not exceed 300 mL/month; and
    • one of the following:
      • an inadequate response or adverse reaction to memantine tablets or memantine extended-release capsules; or
      • clinical rationale for solution formulation over solid oral formulation.

 

Namzaric

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity does not exceed 30 capsules/month; and
    • one of the following:
      • member has been treated with stable doses of the separate agents for a minimum of three months; or
      • member has been stabilized for at least three months on Namzaric.

 

rivastigmine patch

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity does not exceed 30 units/month; and
    • one of the following:
      • an inadequate response or adverse reaction to rivastigmine capsules; or
      • clinical rationale for transdermal patch over solid oral formulation.

 

All agents at quantities requested above FDA approved limits

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting titration to doses exceeding FDA-recommendations.

 

All agents for members < 18 years of age

  • Documentation of all of the following is required:
    • individual drug PA criteria must be met first where applicable; and
    • medical necessity for use in a pediatric member; and
    • prescriber is a psychiatrist or neurologist or a psychiatry or neurology consult is provided.


Original Effective Date: 07/2011

Last Revised Date: 08/2019


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Last updated 08/29/19