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.

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. 

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.