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 August 1, 2023, elivaldogene autotemcel (Skysona) will be a benefit of Texas Medicaid when submitted with procedure code J3590 for male clients who are 4 through 17 years of age.
Elivaldogene autotemcel (Skysona) is indicated to slow the progression of neurological dysfunction in boys who are 4 through 17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
Elivaldogene autotemcel (Skysona) is limited to one transfusion treatment per lifetime.
Prior Authorization Criteria
Beginning September 1, 2023, prior authorization will be required for elivaldogene autotemcel (Skysona) therapy.
Elivaldogene autotemcel (Skysona) is a one-time infusion therapy for clients who meet the following requirements:
- The client is a male who is 4 through 17 years of age.
- The client has a documented diagnosis of CALD (diagnosis code E71511, E71520, E71521, E71528, or E71529).
- The client has a variant in the ABCD1 gene as evident by a genetic test.
- The client’s CALD is caused by the presence of a variant of the ABCD1 gene causing elevated very long-chain fatty acids and not secondary to head trauma.
- The client has early, active CALD as defined by all the following:
- The client is asymptomatic or mildly symptomatic with a neurologic function score of 1 or less.
- The client has gadolinium enhancement on brain magnetic resonance imaging.
- The client has a Loes score ranging from 0.5 to 9.
- The client has not had a hematopoietic stem cell transplant (HSCT), is eligible for HSCT, and cannot find a matched related donor.
- The client’s screening result is negative for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV)-1 and HIV-2, and human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II) prior to the collection of cells for manufacturing.
- The client must avoid taking antiretroviral medications for at least one month prior to initiating medication for stem cell mobilization and for the expected duration for elimination of the medications until all cycles of apheresis are complete.
Prescriber attestations will be required for the following:
- To monitor the client closely for evidence of life-threatening hematological malignancy through complete blood counts at least every six months and through assessment for possible clonal expansion at least twice in the first year and annually thereafter
- To monitor the client for signs of bleeding and infections after the treatment with elivaldogene autotemcel (Skysona) because life-threatening bacterial or viral infections may occur as well as thrombocytopenia and prolonged cytopenia
For more information, call the TMHP Contact Center at 800-925-9126.