Provider Alert! HHSC to Add Skysona® as Medicaid and CHIP Benefit July 1, 2023, Prior Authorization Effective September 1, 2023
Date: August 24, 2023
Attention: All Providers
Effective Date: September 1, 2023
Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective September 1, 2023, the Texas Health and Human Services (HHSC) will be implementing required prior authorization criteria for Skysona® (procedure code J3590) for Medicaid and CHIP. Skysona® will become a benefit of Medicaid and CHIP on July 1, 2023. Skysona® (betibeglogene autotemcel) is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
Authorization Requirements:
Prior authorization is required for Skysona® (elivaldogene autotemcel). The request for this single-dose therapy must include all the following documentation to support patient meets all approval criteria:
- Patient is a male between the ages of 4 years to 17 years.
- Patient has a documented diagnosis of cerebral adrenoleukodystrophy (ICD 10 – E71.511, E71.520, E71.521, E71.528, and E71.529)
- Patient has a variant in the ABCD1 gene as evident by a genetic test.
- Patient’s CALD is caused by the presence of a variant of the ABCD1 gene causing elevated very long fatty acid (VLCFA) and not secondary to head trauma.
- Patient has early, active CALD as defined by all the following:
- Client is asymptomatic or mildly symptomatic with neurologic function score (NFS) of less than or equal to 1; AND
- Client has gadolinium enhancement on brain magnetic resonance imaging (MRI); AND
- Client has a Loes score ranging from 0.5 to 9.
- Patient has not had hematopoietic stem cell transplant (HSCT), is eligible for HSCT, and is unable to find a matched related donor
- Patient’s screening result is negative for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus 1 & 2 (HIV-1/HIV-2) and Human T-lymphotropic virus 1 & 2 (HTLV-1/HTLV-2) prior to the collection of cells for manufacturing.
- Prescriber must attest to monitor clients closely for evidence of life-threatening hematological malignancy through complete blood count (CBC) at least every six months and through assessment for possible clonal expansion a least twice in the first year and annually thereafter.
- Prescriber must attest to monitor client for signs of bleeding and infections after the treatment with Skysona® as life threatening bacterial/viral infection may occur as well as thrombocytopenia and prolonged cytopenia.
- Patient must avoid taking anti-retroviral medications for at least one month prior to initiating medication for stem cell mobilization and for the expected duration for elimination of the medications, and until all cycles of apheresis are complete.
- Skysona® (elivaldogene autotemcel), J3590 is limited to one transfusion treatment per lifetime.
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 Skysona® 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 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.
