Skip to main content

Prior Authorization Criteria for Valoctocogene Roxaparvovec-rvox (Roctavian) Effective February 1, 2024

Last updated on

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 February 1, 2024, prior authorization will be required for valoctocogene roxaparvovec-rvox (Roctavian), procedure code J1412.

Valoctocogene roxaparvovec-rvox (Roctavian) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adult clients with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity <1 IU/dL) without preexisting antibodies to adeno-associated virus serotype 5 (AAV5) detected by a U.S. Food and Drug Administration (FDA)-approved test.

Prior Authorization Criteria

Prior authorization requests for valoctocogene roxaparvovec-rvox (Roctavian) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Valoctocogene roxaparvovec-rvox (Roctavian) is a one-time infusion therapy indicated for the treatment of clients who meet the following criteria:

  • The client is 18 years of age or older.
  • The client has a confirmed diagnosis of severe hemophilia A (congenital factor VIII deficiency) as defined by a factor VIII activity level <1 IU/dL (in the absence of exogenous factor VIII).
  • Evidence is provided that other bleeding disorders not related to hemophilia A have been ruled out.
  • The client has no history of factor VIII inhibitors, and there is a negative screening test prior to treatment.
  • The client’s baseline test (as determined by an FDA-approved test) is negative for preexisting antibodies to AAV5.
  • The client’s baseline liver function must be assessed before valoctocogene roxaparvovec-rvox (Roctavian) infusion with documentation. Documentation must include, but is not limited to, results for the following:
    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST)
    • Alkaline phosphatase (ALP)
    • Total bilirubin
    • A hepatic ultrasound and elastography or laboratory assessments for liver fibrosis
  • The prescriber attests to counseling clients regarding consuming alcohol post administration of valoctocogene roxaparvovec-rvox (Roctavian).
  • The client has no active infections, either acute or chronic.
  • The client does not have stage 3 or 4 liver fibrosis or cirrhosis.
  • The client does not have a known hypersensitivity to mannitol.
  • The client has not previously received treatment with valoctocogene roxaparvovec-rvox (Roctavian) infusion.

Required Monitoring Parameters

All the following must be monitored after valoctocogene roxaparvovec-rvox (Roctavian) infusion:

  • Hepatic function and liver enzymes. ALT should be monitored weekly for at least 26 weeks post infusion as there are risks of hepatotoxicity. Monitor for and manage adverse reactions from corticosteroid use.
  • Monitor for elevated factor VIII activity, as thromboembolic events may occur with elevated factor VIII activity above the upper limit of normal (ULN).
  • 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, and advanced age). Perform regular (annual) liver ultrasound and alpha-fetoprotein testing following administration.

For more information, call the TMHP Contact Center at 800-925-9126.