Valoctocogene Roxaparvovec-rvox (Roctavian) (Medicaid Expansion)

Policy ID: ME-I-271-004-01

Section: Injections

Effective Date: December 09, 2024

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

Valoctocogene roxaparvovec-rvox (Roctavian®) is a one-time gene replacement therapy for the prevention of bleeding episodes in adult individuals with severe hemophilia A, a genetic disease caused by the deficiency of clotting factor VIII (FVIII). Valoctocogene roxaparvovec-rvox (Roctavian) administration and follow-up requires a multidisciplinary team to provide adequate safety and access to care as necessary for recipients of gene therapy.

Valoctocogene roxaparvovec-rvox (Roctavian) is an adeno-associated virus (AAV) gene therapy composed of a recombinant AAV5 (rAAV5) vector containing a coagulation factor VIII complementary DNA driven by a liver-selective promoter.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Valoctocogene roxaparvovec-rvox (Roctavian) may be considered medically necessary as a one-time infusion for individuals with hemophilia A when ALL of the following criteria are met:

Individual is 18 years of age or older at the time of treatment decision; and
Confirmed diagnosis of severe hemophilia A (i.e., less than 1 IU/dL clotting factor activity); and
Prescribed by or in consultation with a hematologist or specialist with experience and expertise in the treatment of hemophilia A; and
Individual has been on prophylactic FVIII replacement therapy and/or emicizumab (Hemlibra) for at least 12 months prior to receiving gene therapy; and
Provider attestation that individual has been counseled regarding the risks of alcohol consumption and use of concomitant hepatotoxic medications after receiving valoctocogene roxaparvovec-rvox (Roctavian) and individual agrees to abstain from alcohol consumption for at least one (1) year following infusion; and
Individual does not have ANY of the following:
- Previous documented history of a detectable FVIII inhibitor (less than 0.6 Bethesda Units (BU), or less than 1.0 BU for laboratories with historical lower sensitivity cutoff for inhibitor detection of 1.0 BU); or
- Detectable AAV5 antibodies as determined by an FDA approved companion diagnostic; or
- Liver function levels (hepatic aminotransferases [ALT and AST], GGT, total bilirubin, and alkaline phosphatase) greater than 1.25 times the upper limit of normal or INR greater than 1.4; or
- Significant hepatic fibrosis or cirrhosis (stage 3 or 4 on the Batts-Ludwig scale or equivalent) ; or
- Individual does not have a contraindication to receiving corticosteroids or immunosuppressive agents in the event that they experience elevated ALT levels post infusion ;or
  - Note: ALT levels should be monitored closely post-infusion; if ALT levels elevate greater than 1.5 times the upper limit of normal, corticosteroids or alternative immunosuppressive agents should be initiated.
- Positive HIV status; or
- Chronic or active hepatitis B infection; or
- Active hepatitis C infection; or
- Other active or controlled chronic infection; or
- History of arterial or recurrent or unprovoked venous thromboembolic events (e.g., non- hemorrhagic stroke, pulmonary embolism, myocardial infarction, arterial embolus); and
Provider attestation of discontinuation of regular prophylactic therapy following appropriate timeframe for FVIII levels to reach therapeutic levels after steady state, after individual has received gene therapy; and
Acute factor product utilized prior to receiving gene therapy to be maintained for treatment of on-demand bleeds or perioperative management.

Length of Approval: One (1) course per lifetime

The use of Valoctocogene roxaparvovec-rvox (Roctavian®) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J1412

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA) -approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

D66

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2024 Effective December 09, 2024

Adopted Medicaid Expansion specific policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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