Prior Authorization Criteria for Aduhelm

Date: December 28, 2021Attention: All ProvidersEffective Date: January 1, 2022Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated to the COVID-19 event.  TCHP reserves the right to update and/or change this information without prior notice due to the evolving nature of the COVID-19 event. Call to action: HHSC will add the drug Aduhelm (procedure code J0172) as of Jan. 1, 2022 and implement these criteria for fee-for-service Medicaid on Feb. 1, 2022. Key Details: Aduhelm (Aducanumab-avwa) is an amyloid-beta directed antibody indicated to treat Alzheimer’s disease (AD) by reducing amyloid-beta plaques. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. Additional Information: Initial prior authorization approval of Aduhelm (Aducanumab-avwa) J0172 infusion therapy will be considered when the following criteria are met:

• The client has a confirmed diagnosis of Alzheimer’s disease (G30.0, G30.1 G30.8 G30.9).
• The prescriber attestation of other forms of dementia except Alzheimer’s disease were ruled out by appropriate lab or another diagnostic testing.
• The prescriber’s confirmation of amyloid beta-plaques presence
• Clinical testing must confirm client has mild cognitive impairment caused by Alzheimer’s disease or mild stage of Alzheimer’s disease
• The client must currently not be taking any anti-coagulant (except for aspirin at a prophylactic dose or less) or have a history of a clotting disorder.
• Documentation the client has received a baseline brain-magnetic resonance imaging (MRI) before initiating treatment (within the past year).

Monitoring requirements during the treatment period:

• The prescriber must monitor for amyloid-related imaging abnormalities (ARIA) during the first eight treatment doses, particularly during titration.
• Prescriber attestation to obtain an MRI prior to the 7th and 12th infusion to check for ARIA.
• Clients with severe amyloid-related imaging abnormalities hemosiderin deposition (ARIA-H) may continue therapy only if radiographic stabilization has been confirmed by a follow-up MRI and supported by clinical evaluation.

For renewal or continuation therapy client must meet the following requirements:

• The client continues to meet the initial authorization approval criteria.
• The client has not progressed to moderate or severe dementia caused by AD.
• The client experienced positive clinical response to therapy as demonstrated by no increase in amyloid plaque or radiographic stabilization as compared to baseline.
• Documentation of MRI before the 7th and 12th infusion to check for ARIA.
• The client has not experienced any complications or unacceptable toxicities during Aduhelm treatment.

For access to all provider alerts,log into: www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers. Resources: Refer to the Outpatient Drug Services Handbook Chapter of the TMPPM for more details on the clinical policy and prior authorization requirements.