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Table 56: Alzheimer’s Agents


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Drug Category: CNS Agents

Medication Class/Individual Agents: Alzheimer’s Agents

I. Prior-Authorization Requirements

 Alzheimer's Agents – Anti-Amyloid Monoclonal Antibodies

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

aducanumab-avwa Aduhelm PA  
lecanemab-irmb Leqembi 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):1,2

  • There is modest evidence to support the efficacy of cholinesterase inhibitors in mild-to-severe AD and memantine in moderate-to-severe AD.
  • Cholinesterase inhibitors should be considered for patients with dementia with Lewy bodies (DLB).
  • Cholinesterase inhibitors can be considered for patients with mild-to-moderate dementia associated with Parkinson's disease (PDD), although the data is weak.
  • Memantine has not been shown to improve cognition in patients with DLB or PDD.
  • The benefit of memantine for mild-to-moderate AD is unclear. Memantine may provide modest benefits and has few adverse effects; it may be considered for members with moderate-to-severe AD. 

 

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.

2. Rabins PV, Rovner BW, Rummans T, Schneider LS, Tariot PN. Guideline Watch (October 2014): Practice Guideline for the Treatment of Patients With Alzheimer's Disease and Other Dementias. Focus (Am Psychiatr Publ). 2017 Jan;15(1):110-128. doi: 10.1176/appi.focus.15106. Epub 2017 Jan 11.

 

 Alzheimer's Agents – Cholinesterase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

donepezil 10 mg tablet Aricept PA   - < 6 years and PA > 2 units/day # , A90
donepezil 5 mg, 23 mg tablet Aricept PA   - < 6 years and PA > 1 unit/day # , A90
donepezil orally disintegrating tablet PA   - < 6 years and PA > 1 unit/day A90
donepezil patch Adlarity PA  
galantamine extended-release capsule Razadyne ER PA   - > 1 unit/day # , A90
galantamine solution PA   A90
galantamine tablet PA   - > 2 units/day A90
rivastigmine capsule PA   - > 2 units/day A90
rivastigmine patch Exelon PA   - > 1 unit/day BP, A90

 Alzheimer's Agents – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

memantine / donepezil extended-release Namzaric PA  

 Alzheimer's Agents – NMDA Receptor Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

memantine extended-release Namenda XR PA   - < 6 years and PA > 1 unit/day # , A90
memantine solution PA   A90
memantine tablet Namenda PA   - < 6 years and PA > 2 units/day # , A90
memantine titration pack Namenda PA   - < 6 years and PA > 49 units/28 days A90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA 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.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Alzheimer’s Disease (AD)
  • Dementia associated with Parkinson’s Disease
  • Mild cognitive impairment (MCI) or mild dementia due to AD

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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

Adlarity

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • requested quantity is ≤ 4 units/28 days; and
    • medical necessity for the requested formulation instead of donepezil tablets or ODT.

 

Aduhelm

  • Documentation of all of the following is required: 
    • diagnosis of mild cognitive impairment (MCI) or mild dementia associated with Alzheimer’s Disease (AD); and
    • prescriber is a specialist in the treatment of dementia of AD; and
    • medical records documenting baseline (within the past three months) cognitive function based on one of the following objective assessments:
      • Mini Mental State Exam (MMSE) score ≥ 24; or
      • Montreal Cognitive Assessment (MoCA) score ≥ 15; or
      • Saint Louis University Mental Status Examination (SLUMS) score ≥ 16.1; and
    • medical records documenting confirmed evidence of clinically significant AD neuropathology based on one of the following: 
      • Cerebral Spinal Fluid (CSF) biomarkers; or 
      • Amyloid positron emission tomography (PET); and
    • member has had a brain magnetic resonance imaging (MRI) in the previous twelve months; and
    • appropriate dosing; and 
    • member and/or authorized representative (e.g., power of attorney, invoked health care proxy) has been informed of the known and potential risks and lack of established clinical benefit associated with Aduhelm treatment; and
    • member does not have any of the following non-AD neurodegenerative disorders:
      • probable dementia with Lewy bodies by consensus criteria; and
      • suspected frontotemporal degeneration; and
      • dementia in down syndrome; and
    • member has not had any of the following in the past year:
      • stroke or transient ischemic attack; and
      • any unexplained loss of consciousness; and 
    • member does not have coagulopathy or requirement for therapeutic anticoagulation and/or dual antiplatelet therapy (only aspirin ≤ 325 mg/day monotherapy is allowed); and
    • member does not have any of the following neurological or psychiatric conditions:
      • uncontrolled seizure disorder; and
      • uncontrolled mood disorder, anxiety disorder, or psychosis; and
    • member does not have significant cerebrovascular disease as established by brain MRI showing any of the following:
      • acute or sub-acute hemorrhage; and
      • prior macro-hemorrhage or prior subarachnoid hemorrhage (unless finding is not due to an underlying structural or vascular hemorrhage); and 
      • ≥ four microhemorrhages; and
      • cortical infarct; and
      • > one lacunar infarct; and
      • superficial siderosis; and
      • history of diffuse white matter disease; and
    • member does not have any of the following cardiovascular conditions:
      • uncontrolled hypertension; and
      • coronary artery disease (including unstable angina and myocardial infarction); and
      • heart failure; and
      • arrhythmia; and
      • clinically significant carotid atherosclerosis and/or peripheral arterial disease; and
    • inadequate response, adverse reaction, or contraindication to Leqembi; and
    • member does not have any uncontrolled clinically significant chronic medical conditions (e.g., liver disease, kidney disease, pulmonary disease, autoimmune disease requiring chronic immunosuppression, malignant neoplasm, active chronic infection [HIV, HCV], poorly controlled diabetes mellitus).
  • For recertification, documentation of all of the following is required: 
    • appropriate dosing; and
    • attestation that all MRI monitoring has been completed in accordance with the FDA-approved label; and
    • medical records documenting current (within the last three months) cognitive function based on one of the following objective assessments:
      • MMSE; or
      • MoCA: or
      • SLUMS; and
    • one of the following (Amyloid-related imaging abnormalities-hemosiderin [ARIA-H], microhemorrhages):
      • member has had no new incident microhemorrhage; or
      • member has had one to four new incident microhemorrhage(s) and microhemorrhages are asymptomatic (no clinical symptoms); or
      • member has had five to nine new incident microhemorrhages and microhemorrhages are asymptomatic (no clinical symptoms) and the microhemorrhages have been stabilized; or
      • member has had one to nine new incident microhemorrhages and microhemorrhages resulted in mild, moderate or severe clinical symptoms and the microhemorrhages have been stabilized; and
    • one of the following (ARIA-H, superficial siderosis): 
      • member has had no new incident areas of superficial siderosis; or
      • member has had one new incident area of superficial siderosis and superficial siderosis is asymptomatic (no clinical symptoms); or
      • member has had two new incident areas of superficial siderosis and superficial siderosis is asymptomatic (no clinical symptoms) and the superficial siderosis has been stabilized; or
      • member has had one to two new incident areas of superficial siderosis and superficial siderosis resulted in mild, moderate or severe clinical symptoms and the superficial siderosis has been stabilized; and
    • one of the following (Amyloid-related imaging abnormalities-edema [ARIA-E]):
      • member has had no new ARIA-E; or
      • member has mild ARIA-E on MRI and ARIA-E is asymptomatic (no clinical symptoms); or
      • member has had moderate or severe ARIA-E on MRI and ARIA-E is asymptomatic (no clinical symptoms) and the ARIA-E is stable; or 
      • member has had mild, moderate or severe ARIA-E on MRI and ARIA-E resulted in mild, moderate or severe clinical symptoms and the ARIA-E is stable; and
    • one of the following:
      • member does not have any of the following:
        • initiation of anticoagulation; and
        • development of active immune-mediated/autoimmune conditions (e.g., Crohn’s disease, systemic lupus erythematosus, aplastic anemia, myasthenia gravis, meningitis/encephalitis); and
        • initiation of immunomodulatory medications (e.g., cancer immunotherapies, rituximab, azathioprine); and
        • development of other neurologic conditions (e.g., intracerebral bleeds, traumatic brain injury, stroke); or
      • clinical rationale for continued use of Aduhelm in a member with at least one of the above noted conditions.   

   

galantamine solution

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requested quantity is ≤ 6 mL/day; and
    • one of the following:
      • inadequate response or adverse reaction to galantamine tablets or galantamine extended-release capsules; or
      • medical necessity for the solution formulation instead of solid oral formulation.

    

 Leqembi

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a specialist in the treatment of dementia or AD; and
    • medical records documenting confirmed evidence of clinical significant AD neuropathology based on one of the following
      • amyloid PET; or
      • cerebral spinal fluid (CSF) biomarkers; and
    • member has had a brain magnetic resonance imaging (MRI) within the last twelve months; and
    • appropriate dosing; and 
    • medical records documenting baseline (within the last three months) cognitive function based on one of the following objective assessments; 
      • MMSE score ≥ 22; or
      • MoCA score ≥ 15; or
      • SLUMS score ≥ 16.1.
  • For recertification, documentation of all of the following is required: 
    • appropriate dosing; and
    • attestation that all MRI monitoring has been completed in accordance with the FDA-approved label; and
    • medical records documenting current (within the last three months) cognitive function based on one of the following objective assessments:
      • MMSE; or
      • MoCA; or
      • SLUMS.

    

memantine solution

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requested quantity is ≤ 10 mL/day; and
    • one of the following:
      • inadequate response or adverse reaction to memantine tablets or memantine extended-release capsules; or
      • medical necessity for the solution formulation instead of solid oral formulation. 

   

Namzaric

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one unit/day; and 
    • medical necessity for the use of the combination product instead of the commercially available separate agents. 

 

    

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.

    

In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.

 

Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers (agents considerd to be used only for seizure diagnoses are not included), naltrexone, and viloxazine] within a 45-day period) for members < 18 years of age

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ two mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

 

  • For regimens including ≥ three mood stabilizers, documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
      • one of the following:
        • member has a seizure diagnosis only; or
        • member has an appropriate psychiatric diagnosis, with or without seizure diagnosis, and one of the following:
          • cross-titration/taper of mood stabilizer therapy; or
          • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
        • member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed; or
        • member has psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically relevant therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
          • cross-titration/taper of mood stabilizer therapy; or
          • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

  

donepezil and memantine for members < six years of age

  • For all requests, individual drug PA criteria must be met first where applicable.  
  • Documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.
   
 Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 07/2011

Last Revised Date: 05/2024


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Last updated 05/16/24

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