Prior Authorization Criteria for Kisunla Effective February 1, 2025

Date: December 24, 2024

Attention: All Providers 

Prior authorization effective date: February 1, 2025

Call to action: The purpose of this communication is to inform providers that on January 1, 2025, Kisunla will become a benefit of Medicaid and CHIP. Health and Human Services commission (HHSC) will require prior authorization for Kisunla (procedure code J0175) for Medicaid and CHIP, effective February 1, 2025.

Kisunla (Donanemab-azbt) is an amyloid-beta directed antibody indicated to treat Alzheimer’s disease (AD) by reducing amyloid-beta plaques in clients with mild cognitive impairment or mild dementia stage of disease

Criteria for Initial Approval:

• Patient has a confirmed diagnosis of Alzheimer’s disease (G30.0, G30.1, G30.8, or G30.9); AND
• Patient has amyloid beta plaques; AND
• Patient has mild cognitive impairment caused by Alzheimer’s disease or a mild stage of Alzheimer’s disease; AND
• Patient has received a baseline brain-magnetic resonance imaging (MRI) before initiating treatment (within the past year) to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA).

Monitoring parameters:

• Providers monitors for Amyloid-related imaging abnormalities (ARIA) during the first 24 weeks

Provider Attestation requirements:

• Provider rules out other forms of dementia, except Alzheimer’s disease by appropriate lab or other diagnostic testing; AND
• Providers provides confirmation of the presence of amyloid beta-plaques; AND
• Provider tests for ApoE ε4 status and counsel ApoE ε4 homozygotes clients on higher incidence of developing ARIA before initiation of treatment; AND
• Provider obtains an MRI before the 2nd, 3rd, 4th and 7th infusion to check for asymptomatic ARIA; AND
• Provider ensures that the client is not currently taking any anti-coagulant (except for aspirin at a prophylactic dose or less) or have a history of clotting disorder; AND
• Provider confirms radiographic stabilization by a follow-up MRI and supported by clinical evaluation to continue therapy in patients with severe amyloid related imaging abnormalities-hemosiderin deposition (ARIA-H).

Criteria for Continuation of therapy:

• Patient has met all initial requirements for initial approval; AND
• Patient has not progressed to moderate or severe dementia caused by AD; AND
• Patient has experienced a positive clinical response to therapy as demonstrated by no increase in amyloid plaque or radiographic stabilization as compared to baseline; AND
• Patient has documentation of MRI (prior to (prior to 2nd, 3rd, 4th and 7th infusion) to check for ARIA with Kisunla treatment; AND
• Patient has not experienced any complications or unacceptable toxicities during treatment with Kisunla.

Next step for providers: Providers should refer to the Outpatient Drug Services Handbook chapter of the Texas Medicaid Provider Procedure Manual for more details on the clinical policy and prior authorization requirements.

Note: If request is for a non-FDA approved dose, indication, or age medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.

If and when there any updates or changes related to the coverage for Kisunla, we will promptly communicate those changes to you.

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.  
For access to all provider alerts, log into: www.texaschildrenshealthplan.org/provideralerts.