ADUCANUMAB-AVWA

Guidelines for Use

INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

Our guideline named ADUCANUMAB-AVWA (Aduhelm) requires the following rule(s) be met for approval:

1. You have Alzheimer’s disease 
2. You are > 50 years and < 85 years
3. ONE of the following: 
   1. Your doctor has submitted documentation showing the presence of amyloid beta plaque levels confirmed by an amyloid-positron emission tomography (PET) scan, [Common Procedural Terminology (CPT) code 78814]
   2. Your doctor has submitted documentation showing the presence of amyloid proteins in Cerebral Spinal Fluid (CSF) obtained from a lumbar puncture
4. You have mild cognitive impairment or mild dementia, consistent with stages 3 or 4 of Alzheimer’s disease, assessed using at least one of the following:
1. A Clinical Dementia Rating (CDR) global score of 0.5
2. A Repeatable Battery for Assessment of Neuropsychological Status (RBANS) delayed memory index score of < 85
3. a Mini-Mental State Examination (MMSE) score of > 24
5. Your doctor has submitted documentation that a baseline MRI of the brain has been obtained within the past year that confirms the following amyloid-related imaging abnormalities (ARIA) parameters:
1. No focal areas of superficial siderosis
2. < 10 microhemorrhages
3. No brain hemorrhage greater than 1 cm
6. The requested agent is prescribed by or in consultation with a neurologist, geriatric psychiatrist, or a geriatrician
7. The requested dose does not exceed 10mg/kg every 4 weeks
8. You do not meet ANY of the following exclusion criteria: 
1. Diagnosed concurrently with another potentially contributory medical, neurological, or psychiatric condition
2. Stroke or transient ischemic attack TIA within the past 12 months or any relevant:
3. Brain hemorrhage
4. Cerebrovascular abnormalities 
5. Cardiovascular disease
6. Bleeding disorders
7. Clinically significant hepatic disease
8. Clinically significant renal disease
9. Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection
10. Concurrent utilization of an antithrombotic agent other than low-dose aspirin
11. Any neurological and/or psychiatric condition that may be contributing to cognitive impairment above and beyond that caused by your Alzheimer’s disease

RENEWAL CRITERIA

Our guideline named ADUCANUMAB-AVWA (Aduhelm) requires the following rule(s) be met for renewal:

1. You have a history of the requested agent within the past 60 days
2. Your doctor has submitted updated documentation of clinical improvement or stabilization when compared to previous Clinical Dementia Rating (CDR) global score, Repeatable Battery for Assessment of Neuropsychological Status (RBANS) delayed memory index score, or Mini-Mental State Examination (MMSE) score
3. Your doctor has submitted updated documentation of brain MRI results (performed prior to seventh and twelfth doses) that demonstrates the following amyloid-related imaging abnormalities (ARIA) parameters:
1. < 10 microhemorrhages
2. < 2 focal areas of superficial siderosis
3. No brain hemorrhage greater than 1 cm
4. Prior authorization for continuation of therapy may be requested if subsequent clinical evaluation and brain MRI results demonstrate stabilization
4. The requested dose does not exceed 10mg/kg every 4 weeks
5. Your doctor has submitted documentation of decreases (or at a minimum, no increases) in amyloid beta plaque levels, confirmed by either an amyloid-positron emission tomography (PET) scan or amyloid protein concentrations in Cerebral Spinal Fluid (CSF) obtained from a lumbar puncture performed at the following frequencies (Note – the method of measuring amyloid beta plaque levels should be consistent for each re-evaluation period):
1. After the seventh dose of medication
2. At 24 months after initiating therapy (2nd valid PET scan or lumbar puncture should be performed after 18 months of treatment)
3. Every 18 months thereafter 

1. Your doctor attests that you remain a candidate for treatment, indicating you have not developed any of the following exclusionary criteria listed in the initial authorization criteria:

1. Diagnosed concurrently with another potentially contributory medical, neurological, or psychiatric condition
2. Stroke or transient ischemic attack TIA within the past 12 months or any relevant:
3. Brain hemorrhage
4. Cerebrovascular abnormalities 
5. Cardiovascular disease
6. Bleeding disorders
7. Clinically significant hepatic disease
8. Clinically significant renal disease
9. Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection
10. Concurrent utilization of an antithrombotic agent other than low-dose aspirin
11. Any neurological and/or psychiatric condition that may be contributing to cognitive impairment above and beyond that caused by your Alzheimer’s disease