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Donanemab-azbt (Kisunla) Procedure Code J0175 for Alzheimer’s Disease Therapy a Benefit Effective January 1, 2025

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Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.

Effective for dates of service on or after January 1, 2025, donanemab-azbt (Kisunla) procedure code J0175 will be a benefit of Texas Medicaid.

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

Procedure code J0175 with prior authorization may be reimbursed to the following provider types and places of service:

Place of ServiceProvider Type
OfficePhysician Assistant, Nurse Practitioner, Clinical Nurse Specialist, Physician
Outpatient HospitalHospital, Rural Emergency Hospital

Prior Authorization Initial Requests

Initial therapy for donanemab-azbt (Kisunla) may be approved for a six-month duration if all the following criteria are met:

  • The client has a confirmed diagnosis of Alzheimer’s disease (G300, G301, G308, or G309).
  • The prescriber attests that other forms of dementia except Alzheimer’s disease have been ruled out by appropriate lab or other diagnostic testing.
  • The prescriber confirms that amyloid beta-plaques are present.
  • Clinical testing confirms that the client has mild cognitive impairment caused by Alzheimer’s disease or is in a mild stage of Alzheimer’s disease.
  • Documentation states that the client has received a baseline brain magnetic resonance imaging (MRI) prior to initiating treatment (within the past year) to evaluate for pre-existing amyloid-related imaging abnormalities (ARIA).
  • The prescriber attests to having tested for ApoE ε4 status and counseled clients with ApoE ε4 homozygotes on the higher incidence of developing ARIA prior to initiation of treatment.

The following are the monitoring requirements during the donanemab-azbt (Kisunla) treatment period:

  • The prescriber must ensure that the client is not currently taking an anticoagulant (except for aspirin at a preventive dose or less) or does not have a history of a clotting disorder.
  • The prescriber must monitor for ARIA during the first 24 weeks of treatment.
  • The prescriber must attest to having obtained a brain MRI prior to the second, third, fourth, and seventh infusion to check for asymptomatic ARIA.
  • Clients with severe amyloid-related imaging abnormalities with hemosiderin deposition (ARIA-H) may continue therapy only if radiographic stabilization has been confirmed by a follow-up brain MRI and supported by clinical evaluation.

Recertification/Extension

For renewal or continuation of donanemab-azbt (Kisunla) therapy, the client must meet the following requirements:

  • The client continues to meet all the initial authorization approval criteria.
  • The client has not progressed to moderate or severe dementia caused by Alzheimer’s disease.
  • The client has experienced a positive clinical response to therapy as demonstrated by no increase in amyloid plaques or radiographic stabilization as compared to baseline.
  • Documentation is provided of a brain MRI prior to the second, third, fourth, and seventh infusion to check for ARIA with donanemab-azbt (Kisunla) treatment.
  • The client has not experienced any complications or unacceptable toxicities during donanemab-azbt (Kisunla) treatment.

Aducanumab-avwa (Aduhelm) (Procedure Code J0172)

On February 1, 2025, aducanumab-avwa (Aduhelm) (procedure code J0172) will be removed from the Texas Medicaid Provider Procedures Manual (TMPPM), Outpatient Drug Services Handbook, subsection 6.6, “Alzheimer’s Disease (AD).”

For more information, call the TMHP Contact Center at 800-925-9126.