Table 56: Alzheimer’s Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: CNS Agents
Medication Class/Individual Agents: Alzheimer’s Agents
I. Prior-Authorization Requirements
Alzheimer's Agents – Anti-Amyloid Monoclonal Antibodies |
Clinical Notes |
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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
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. |
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Alzheimer's Agents – Cholinesterase Inhibitors |
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Alzheimer's Agents – Combination Products |
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Alzheimer's Agents – NMDA Receptor Antagonists |
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# | 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.
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.
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.
Kisunla
- 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
- inadequate response, adverse reaction, or contraindication to Leqembi; and
- medical records documenting baseline (within the last three months) cognitive function based on one of the following objective assessments;
- MMSE score ≥ 20; 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.
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, meprobamate, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone, prazosin, and viloxazine] within a 45-day period if one of the following is included: an antipsychotic, a benzodiazepine, divalproex/valproate, lithium, or a tricyclic antidepressant; or, pharmacy claims for any combination of five or more behavioral health medications [as defined above] 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, child adolescent psychiatrist [including psychiatric nurse practitioners], neurologist, pediatric neurologist, developmental and behavioral pediatrics) or consult is provided; and
- if member has been on the requested polypharmacy regimen for the past 12 months with no adjustments (i.e., dose decrease, attempted discontinuation), at least one of the following:
- previous efforts to reduce/simplify the regimen in the past 24 months resulted in symptom exacerbation; or
- family/caregiver does not support the regimen change at this time due to risk of exacerbation; or
- other significant barrier for therapy discontinuation.
- one of the following:
- For regimens including ≥ two 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, child adolescent psychiatrist [including psychiatric nurse practitioners], neurologist, pediatric neurologist, developmental and behavioral pediatrics) or consult is provided; and
- if member has been on the requested polypharmacy regimen for the past 12 months with no adjustments (i.e., dose decrease, attempted discontinuation), at least one of the following:
- previous efforts to reduce/simplify the regimen in the past 24 months resulted in symptom exacerbation; or
- family/caregiver does not support the regimen change at this time due to risk of exacerbation; or
- other significant barrier for therapy discontinuation; 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.
- one of the following:
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, child adolescent psychiatrist (including psychiatric nurse practitioners), neurologist, pediatric neurologist, developmental and behavioral pediatrics] or consult is provided; and
- if member has been on the requested agent for the past 12 months with no adjustments (i.e., dose decrease, attempted discontinuation), at least one of the following:
- previous efforts to reduce/simplify the regimen in the past 24 months resulted in symptom exacerbation; or
- family/caregiver does not support the regimen change at this time due to risk of exacerbation; or
- other significant barrier for therapy discontinuation.
- one of the following:
Original Effective Date: 07/2011
Last Revised Date: 01/2025
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Last updated 02/10/25