- Prior Authorization is required for the following special formulation products:
- donepezil (Adlarity®) transdermal system
- donepezil (Aricept®) and 23 mg tablets
- rivastigmine (Exelon®) solution and patch
- memantine (Namenda®) solution and tablets
- galantamine (Razadyne®) solution and extended release capsules
- Member must have a documented reason why the special formulation is clinically necessary over the regular formulation
- Application of Age Restriction for ages 0-50 with the following approval criteria.
- FDA approved diagnosis
memantine extended-release (ER) capsules (Namenda XR®) Approval Criteria:
- An FDA approved diagnosis for the treatment of moderate-to-severe Alzheimer’s type dementia; AND
- A patient-specific, clinically significant reason why the member cannot use memantine immediate-release tablets.
memantine er/donepezil (Namzaric™ ) Approval Criteria:
- Member must have a patient-specific, clinically significant reason why the separate immediate release products which do not require a prior authorization cannot be used in place of this combination product; AND
- A quantity limit of 30 capsules per 30 days will apply.
Aduhelm® (Aducanumab-avwa) Approval Criteria:
- An FDA approved diagnosis of mild cognitive impairment or mild dementia stage of Alzheimer’s disease [stage 3 or stage 4 Alzheimer’s disease based on the Global Deterioration Scale (GDS)]. Diagnosis must be confirmed by at least 2 of the following:
- Mini-Mental State Exam (MMSE) score between 24 and 30; OR
- Clinical Dementia Rating Global Score (CDR-GS) equal to 0.5; OR
- Montreal Cognitive Assessment (MoCA) score ≥19; OR
- Quick Dementia Rating System (QDRS) score ≤5; AND
- Member must have presence of amyloid pathology confirmed by a positive amyloid positron emission tomography (PET) scan or cerebral spinal fluid (CSF) test; AND
- Aduhelm® must be prescribed by, or in consultation with, a neurologist (or an advanced care practitioner with a supervising physician who is a neurologist); AND
- Other known medical or neurological causes of dementia have been ruled out (i.e., vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Parkinson’s disease dementia); AND
- Member must not have brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities that increase the risk of hemorrhage; AND
- Prescriber must verify member and/or caregiver has been counseled on the risks of amyloid related imaging abnormalities (ARIA) that may occur and testing for ApoE ԑ4 status has been completed if appropriate; AND
- Member must not be taking anticoagulant or antiplatelet agents except for aspirin 325mg per day or less, and the prescriber must attest that the increased safety risks for developing ARIA with the concomitant use have been discussed and are acceptable to the member prior to initiating Aduhelm®; AND
- Member must not have had a stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past year; AND
- Member must not have any contraindications to brain magnetic resonance imaging (MRI) or PET scans; AND
- Member must not have any pre-treatment localized superficial siderosis, ≥10 brain microhemorrhages, or a brain hemorrhage >1cm within 1 year of treatment initiation as safety with Aduhelm® has not been established in patients with these conditions; AND
- Member must have a recent (within 1 year) brain MRI prior to initiating treatment with Aduhelm® and prior to the 7th infusion (1st dose of 10mg/kg) and 12th infusion (6th dose of 10mg/kg); AND
- The prescriber must confirm that the member will be monitored for amyloid-related imaging abnormalities (ARIA) during the first 8 doses of treatment with Aduhelm®, particularly during titration, and also throughout treatment; AND
- If ≥10 new incident microhemorrhages or >2 focal areas of superficial siderosis [radiographic severe amyloid related imaging abnormalities-hemosiderin deposition (ARIA-H)] are observed on MRI, prescriber must confirm that treatment will be continued with caution and only after a clinical evaluation and a follow-up MRI demonstrating radiographic stabilization (i.e., no increase in size or number of ARIA-H); AND
- Aduhelm® must be administered by a health care professional in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Approvals will not be granted for self-administration; AND
- Aduhelm® must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment and stored in the refrigerator; AND
- Member’s weight must be provided and have been taken within the last 4 weeks to ensure accurate weight-based dosing; AND
- A patient-specific, clinically significant reason why the member cannot use Leqembi™ (lecanemab-irmb) must be provided; AND
- Initial approvals will be for 6 months. Confirmation that MRI has been completed and is acceptable to the provider prior to 7th infusion is required for continuation; AND
- Subsequent approvals will be for 6 months and prescriber must document that the member has responded well to therapy compared to pretreatment baseline status as evidenced by improvement, stability, or slowing in cognitive and/or functional impairment using the same baseline test(s) performed at initiation of therapy; AND
- Approval quantities will be dependent on the member’s weight and dosing based on the Aduhelm® Prescribing Information; AND
- The maximum dose approvable is 10mg/kg per 28 days; and
- Approvals will not be granted for concurrent use with other amyloid beta-directed monoclonal antibodies.