CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Roctavian (valoctocogene roxaparvovec-rvox) IV gene therapy for severe hemophilia A

Policy governs coverage, authorization, dosing, monitoring, and billing for a single lifetime intravenous dose of Roctavian for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members per listed medical necessity criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRoctavian (valoctocogene roxaparvovec-rvox) IV gene therapy for severe hemophilia A

Policy CodePolicy N/A

Change Typeclarified

Effective Date01/01/2024

Next Review Date

Key ActionSubmit medical records/chart notes documenting diagnosis, genetic/mutation testing, prior therapies, factor VIII activity, inhibitor testing results, AAV5 antibody test results, and infectious/hepatic status via PA web portal upload or fax; records will be reviewed at time of submission.

POLICY UPDATE CHANGES

Effective date and HCPCS effective date listed as 01/01/2024; J1412 HCPCS effective 01/01/2024 included.

1Lifetime Doses Allowed

44Max Vials per Dose (one-time)

D66Covered Diagnosis Code

Coverage Summary

Roctavian (valoctocogene roxaparvovec-rvox) is an AAV5-based gene therapy indicated for adults with severe hemophilia A who are AAV5 antibody negative. Coverage is provided with specific medical necessity criteria and is limited to a single lifetime intravenous dose. The policy scope includes Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members. Key safety concerns include liver enzyme elevations and infusion-related reactions among other adverse events.

Quick Facts & Key Thresholds

Lifetime Doses Allowed1

Max Vials per Dose (one-time)44 vials one time only

Covered Diagnosis CodeD66 (Hereditary factor VIII deficiency)

Factor VIII activity for diagnosis≤ 1 IU/dL (in the absence of exogenous factor VIII)

Factor VIII inhibitor titer requirement< 0.6 BU on 2 consecutive occasions at least one week apart within the past 12 months

Factor VIII activity indicating stopping prophylaxis> 5 IU/dL (discontinue routine prophylactic exogenous factor VIII)