Clinical Criteria for Leqembi® (procedure code J0174) effective November 1, 2023

Date: September 26, 2023

Attention: Physicians

Effective date for prior authorization criteria: November 1, 2023

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective November 1 2023, the Texas Health and Human Services (HHSC) will be implementing prior authorization criteria for Leqembi® (procedure code J0174) for fee-for-service Medicaid. Leqembi (Lecanemab-irmb) is an amyloid-beta directed antibody indicated for early stages of Alzheimer’s disease.

Prior Authorization Requirements:

Criteria for Initial Approval:

1. Patient has Alzheimer’s disease (Diagnosis codes: G30.0, G30.1, G30.8 or G30.9) AND
2. Prescriber attestation that other forms of dementia, except Alzheimer’s disease has been ruled out by appropriate lab and/or diagnostic testing AND
3. Patient has presence of amyloid-beta plaques AND
4. Patient has mild cognitive impairment or mild dementia caused by Alzheimer’s disease AND
5. Patient currently not taking any anti-coagulant (except aspirin prophylactically) or have a history of clotting disorder AND
6. Patient has received brain-magnetic resonance imaging (MRI) within the past year evaluating for pre-existing Amyloid Related Imaging Abnormalities (ARIA)

Criteria of Continuation of Therapy:

1. Patient has met all the initial approval criteria at the time of initial approval AND
2. Patient has NOT progressed to moderate to severe dementia caused by Alzheimer’s disease AND
3. Patient experienced a positive clinical response to therapy evidenced by no observed increase in amyloid plaque or radiographic assessments have indicated stability compared to baseline AND
4. Patient has been evaluated for evidence of ARIA with documentation from MRI prior to 5^th, 7^th, and 14^th infusions AND
5. Patient has not experienced any complications or unacceptable toxicities during treatment with Leqembi

Monitoring Parameters:

1. Patient has been evaluated for ARIA on MRI prior to 5^th dose, 7^th dose, and 14^th dose
2. Patients 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 with clinical evaluation

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.

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

Next steps for providers: Prescribers should share this communication with their staff. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting member has met all approval criteria in support for Leqembi approval.

Note: If request is for a non-FDA approved dose or indication, 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 Leqembi, we will promptly communicate those changes to you.

If you have any questions, please email TCHP Pharmacy at: tchppharmacy@texaschildrens.org.For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.