CurrentBlue Cross Blue Shield - IowaPolicy 05.05.12

Roctavian (valoctocogene roxaparvovec) gene therapy for severe hemophilia A — Coverage Criteria

Defines medical necessity, prior authorization requirements, dosing limits, and documentation needed for Roctavian for adults with severe hemophilia A; applies to Wellmark/Blue Cross Blue Shield - Iowa members governed by their contract.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRoctavian (valoctocogene roxaparvovec) gene therapy for severe hemophilia A — Coverage Criteria

Policy CodePolicy 05.05.12

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateOct 1, 2025

Key ActionObtain prior authorization with required documentation and attest to outcome data submission to the Evio platform if approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=18patient age requirement

<=1% FVIIIsevere hemophilia A

6e13 vg/kgrecommended dose

1 per lifetimedose limit

negativeAAV5 antibody

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Coverage Criteria for Roctavian (valoctocogene roxaparvovec)

Initial therapy

Authorization of one month for one dose may be granted when ALL of the following are met:

Age: Member is 18 years of age or older

Sex assignment: Member was assigned male at birth

Prior therapy: Member has been receiving factor VIII prophylaxis or emicizumab (Hemlibra) for at least 12 months

Severity: Member has severe hemophilia A defined by factor VIII (FVIII) activity level ≤1% (≤1 IU/dL)<=1% (<=1 IU/dL)

AAV5 antibody: Member does not have pre-existing antibodies to AAV5 confirmed by an FDA-approved test (e.g., AAV5 DetectCDx)negative

Inhibitor status: Member does not have prior or active factor VIII inhibitors (inhibitor titer < 0.6 BU by Nijmegen-Bethesda assay)<0.6 BU

Liver assessment: Member has received a liver health assessment including ALT, AST, ALP, total bilirubin AND a hepatic ultrasound and elastography

No prior Roctavian: Member has not received treatment with the requested medication previously

Prescriber: Medication is prescribed by or in consultation with a hematologist or a prescriber who specializes in hemophilia A

HIV status: Member is HIV negative

Hepatitis: Member does not have an active hepatitis B and/or hepatitis C infection

Thrombosis history: Member does not have a history of thrombosis or thrombophilia

Alcohol and hepatotoxic meds counseling: Provider attestation that member has been counseled to abstain from alcohol for at least 1 year post-infusion and avoid concomitant hepatotoxic medications

Provider attestation required

Discontinue prophylaxis attestation: Provider attestation of discontinuation of regular prophylactic therapy after appropriate time frame for FVIII levels to reach therapeutic levels following gene therapy

Provider attestation required

Repeat treatment of Roctavian for any indication is considered investigational. Safety and efficacy beyond a single dose have not been established; therefore approval is limited to one treatment course per lifetime.

Roctavian is considered not medically necessary for members who do not meet the criteria set forth in this policy.

Coding and Dose Information

Covered HCPCS / drug codeHCPCSCovered

J1412

Injection, valoctocogene roxaparvovec-rvox, per ml, containing nominal 2 x 10^13 vector genomes

Unclassified drug HCPCSHCPCS

C9399

Unclassified drugs or biologicals

Unclassified biological HCPCSHCPCS

J3590

Unclassified biologicals

Dose (inv-07)

Recommended dose6 x 10^13 vector genomes per kg

Unit of measurevector genomes per kilogram of body weight

Approval noteApprovals may be subject to dosing limits per FDA labeling and practice guidelines

Dose contextSingle intravenous infusion authorized for one dose per lifetime when criteria met

Prior Authorization, Documentation, and Reporting Requirements

Prior Authorization

Prior authorization required

Prior authorization is required. The provider must attest that, if approved, clinical outcome data will be submitted to the Evio provider portal at the requested cadence.

Authorization limited to one month for one dose total
Provider must attest to outcome data submission to the Evio platform

Prior Authorization

Prior prophylaxis requirement

Member must have been receiving factor VIII prophylaxis or emicizumab (Hemlibra) for at least 12 months prior to authorization.

Documentation Required

Background

Roctavian (valoctocogene roxaparvovec-rvox) is an AAV5-based gene therapy indicated for adults with severe congenital hemophilia A (factor VIII deficiency). The safety and efficacy of repeat dosing have not been studied; when approved, therapy is limited to a single treatment course and treated patients are expected to have clinical outcome data reported via the Evio provider portal as required by the policy.

Key Definitions

Severe hemophilia A (inv-13)

DefinitionCongenital factor VIII deficiency with factor VIII activity ≤1% (≤1 IU per deciliter)

FDA indication contextRoctavian indicated for adults with severe hemophilia A without AAV5 antibodies detected by an FDA-approved test

Severity thresholdFactor VIII activity < 1 IU/dL (≤1%)

Factor VIII inhibitor negative (inv-14)

Required inhibitor statusAbsence of factor VIII inhibitor confirmed by a Bethesda assay

Titer thresholdInhibitor titer must be < 0.6 Bethesda Units using the Nijmegen-Bethesda assay

Documentation