01/06/2025

As of Jan 1, 2025, Kisunla procedure code J0175 is a benefit of Texas Medicaid and effective Feb. 1, 2025, the Health and Human Service Commission requires prior authorization for J0175.

HHSC will consider initial prior authorization approval of Kisunla infusion therapy when all the following criteria are met:

• The client has confirmed diagnosis of Alzheimer’s disease (G30.0, G30.1, G30.8, or G30.9).
• Prescriber attests those other forms of dementia, except Alzheimer’s disease, has been ruled out by appropriate lab or other diagnostic testing.
• Prescriber’s confirmation of the presence of amyloid beta-plaques.
• Clinical testing must confirm that the client has mild cognitive impairment caused by Alzheimer’s disease or mild stage of Alzheimer’s disease.
• Documentation that the client has received baseline brain-magnetic resonance imaging before initiating treatment (within the past year) to evaluate the pre-existing Amyloid Related Imaging Abnormalities.
• Prescriber attests to test for ApoE#4 status and counsel ApoE#4 homozygotes clients on higher incidence of developing ARIA before initiation of treatment.

The following are monitoring requirements during the Kisunla treatment period:

• The prescriber must ensure the client is not currently taking any anti-coagulant (except for aspiring at a prophylactic dose or less) or for amyloid have a history of clotting disorder.
• The prescriber must monitor for amyloid-related imaging abnormalities (ARIA) during the first 24 weeks.
• The prescriber attests to obtaining an MRI before the 2^nd, 3^rd, 4^th and 7^th infusion to check for asymptomatic 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 the renewal or continuation of Kisunla therapy, the following requirements must be met:

• The client continues to meet all the initial authorization approval criteria.
• The client has not progressed to moderate or serve dementia caused by AD.
• The client experienced a positive clinical response to therapy as demonstrated by no increase in amyloid plaque or radiographic stabilization as compared to baseline.
• Documentation of MRI (prior to 2^nd, 3^rd, 4^th and 7^th infusion) to check for ARIA with Kisunla treatment.
• The client has not experienced any complications or unacceptable toxicities during treatment with Kisunla.

Additional Information:

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.

If you have questions or require assistance, please reach out to our Medicaid Provider Network Team at 1-855-212-1615 or email Texas Medicaid Network Department.

The above material is for informational purposes only and is not a substitute for the independent medical judgment of a physician or other health care provider. Physicians and other health care providers are encouraged to use their own medical judgment based upon all available information and the condition of the patient in determining the appropriate course of treatment. The fact that a service or treatment is described in this material, is not a guarantee that the service or treatment is a covered benefit, and members should refer to their certificate of coverage for more details, including benefits, limitations and exclusions. Regardless of benefits, the final decision about any service or treatment is between the member and their health care provider