Coverage of Roctavian (procedure code J1412) Begins January 2024; Prior Authorization Effective February 2024

Date: December 6, 2023

Attention: All Providers

Prior Authorization Effective Date: February 1, 2024

Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that on January 1, 2024, Roctavian will become a benefit of Medicaid and CHIP. Texas Health and Human Services Commission (HHSC) will require prior authorization for Roctavian (procedure code J1412) for Medicaid and CHIP, effective February 1, 2024.

Roctavian (valoctocogene roxaparvovec-rvox) is an adeno-associated virus vector-based gene therapy indicated to treat adult clients with severe hemophilia A (congenital Factor VIII deficiency with Factor VIII activity less than 1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 (AAV5) detected by a U.S. Food and Drug Administration (FDA) approved test.

Prior Authorization Requirements:

Coverage will be provided for one dose and may not be renewed

1. Patient is at least 18 years of age or older; AND
2. Patient has a confirmed diagnosis of severe Hemophilia A (congenital Factor VIII deficiency) diagnosed by a Factor VIII activity level less than 1 IU/dL (in the absence of exogenous Factor VIII); AND
3. Evidence of other bleeding disorders NOT related to Hemophilia A has been ruled out; AND
4. Patient has NO history of Factor VIII inhibitors and a negative screening test prior to treatment; AND
5. Patient baseline test (as determined by an FDA approved test) is negative for pre-existing antibodies to adeno-associated virus serotype 5 (AAV5); AND
6. Patient does NOT have any active infections, either acute or chronic; AND
7. Patient does NOT have stage 3 or 4 liver fibrosis or cirrhosis; AND
8. Patient does NOT have a known hypersensitivity to mannitol; AND
9. Patient has never received Roctavian treatment in their lifetime

Monitoring parameters:

1. Monitor liver function not limited to alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin, hepatic ultrasound and elastography or laboratory assessments for liver fibrosis upon initiation of therapy.
2. Monitor Liver function and liver enzymes weekly for at least 26 weeks post-infusions.
3. Monitor for and manage adverse reaction from corticosteroid use.
4. Monitor for elevated Factor VIII activity as thromboembolic events may occur with elevated Factor VIII activity above the upper limit of normal (ULN).
5. Monitor for hepatocellular malignancy in patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advances age)
6. Perform regular (annually) liver ultrasound and alpha-fetoprotein testing following administration.
7. Counsel patient regarding consuming alcohol post-administration of Roctavian.

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 step for Providers: Providers should 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.

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

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.