CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Valoctocogene roxaparvovec-rvox (Roctavian) gene therapy — Coverage Criteria

Defines medical necessity, clinical eligibility, and billing/coding guidance for Roctavian for adults with severe hemophilia A, and the administrative requirements for coverage by Blue Cross NC.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyValoctocogene roxaparvovec-rvox (Roctavian) gene therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeCoding and operational updates (HCPCS, revenue codes, dosing language)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization that documents all medical necessity criteria, required labs, anti‑AAV5 testing, inhibitor status, and that dosing is a one‑time 6 x 10^13 vg/kg per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Added revenue codes 0891 and 0892 associated with HCPCS code(s) for the policy.

Adjusted maximum units language to specify one-time, single-dose infusion per lifetime rather than a numeric unit value.

HCPCS code J1412 listed as the billing code for valoctocogene roxaparvovec-rvox (Roctavian).

J1412HCPCS code for Roctavian

One-timeDose allowed per lifetime

180 daysDuration of approval

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FDA single-dose vector genomes

0891, 0892Added revenue codes

Medical Necessity and Exclusion Criteria

Initial Therapy

Covered when ALL of the following are met:

Primary eligibility: Patient is 18 years of age or older AND male AND has a diagnosis of hemophilia A (congenital factor VIII deficiency) [medical record documentation required] AND baseline factor VIII activity ≤ 1 IU/dL [medical record documentation required] AND no active inhibitors to factor VIII AND no history of inhibitors to factor VIII<= 1 IU/dL

medical record documentation required

Inhibitor testing: Nijmegen modified Bethesda assay < 0.6 BU on two consecutive occasions at least one week apart within the past 12 months [medical record documentation required, including test results]<0.6 BU x2

medical record documentation required, including test results

Therapy history: Patient is not on any bypassing agents (e.g., FEIBA, NovoSeven, SevenFact) AND is on prophylactic factor VIII therapy AND has had minimum of 150 exposure days AND has not had any previous gene therapy (including the requested agent)>=150 exposure days

medical record documentation required

Anti-AAV5 and infectious disease: No anti-AAV5 antibodies (test within past 3 months) AND hepatitis B surface antigen negative [tests within past 3 months] AND (HCV antibody negative OR HCV antibody positive with HCV RNA negative) AND no other active infectionserologies within past 3 months

medical record documentation required, including anti-AAV5 test within 3 months

HIV and immunosuppression: Either HIV negative OR HIV positive with viral load within past 12 months <1000 copies/mL; AND patient does not have another immunosuppressive disorder [medical record documentation required]HIV VL <1000 if positive

medical record documentation required, including lab results within the past 12 months

Liver and renal function: No significant (stage 3 or 4) liver fibrosis or cirrhosis AND no history of hepatic malignancy AND no significant liver dysfunction (ALT, bilirubin, or alkaline phosphatase ≤ 3x ULN; INR <1.5) AND creatinine <1.4 mg/dL [medical record documentation required, labs within past 3 months]labs within past 3 months; creatinine <1.4 mg/dL

medical record documentation required

Dosing and authorization limits: Requested dose must be within FDA labeled dosing (one-time IV dose of 6 x 10^13 vector genomes per kg) AND requested quantity does not exceed one lifetime treatment; duration of approval 180 daysone treatment course per lifetime

medical record documentation required; distribution from specialty pharmacy may be required

Patients with current active malignancy (with the exception of non‑melanoma skin cancer) are excluded from coverage. In addition, a history of hepatic malignancy excludes the patient from coverage for valoctocogene roxaparvovec‑rvox; medical record documentation is required to verify cancer status.

The following additional exclusion and contraindication criteria must be met to establish ineligibility: presence of anti‑AAV5 antibodies (testing required within the past 3 months), presence of active inhibitors to factor VIII or a prior documented history of inhibitors, and any history of prior gene therapy including the requested agent. Significant liver disease excludes coverage — specifically, stage 3 or 4 liver fibrosis or cirrhosis or laboratory evidence of significant liver dysfunction (ALT, bilirubin, or alkaline phosphatase >3× ULN or INR ≥1.5). Renal dysfunction with creatinine ≥1.4 mg/dL also renders the patient ineligible. All exclusions require supporting medical record documentation and recent laboratory test results as specified.

Billing Codes, Dosing and Key Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J1412

Valoctocogene roxaparvovec-rvox, intravenous infusion

Applicable Revenue CodesRevenue

0891	Special Processed Drugs - FDA Approved Cell Therapy (revenue code)
0892	Special Processed Drugs - FDA Approved Gene Therapy (revenue code)

inv-06: Factor VIII activity threshold for severe hemophilia A (< 1 IU/dL)

ThresholdFactor VIII activity < 1 IU/dL (baseline residual level ≤ 1 IU/dL defines severe disease)

Documentation requiredMedical record documentation of baseline factor VIII level (lab test)

Applicable populationAdults (≥18 years) with hemophilia A (congenital factor VIII deficiency)

inv-07: Nijmegen modified Bethesda assay requirement (< 0.6 BU on two occasions ≥1 week apart within past 12 months)

Assay requirementNijmegen modified Bethesda assay < 0.6 BU on two consecutive occasions at least 1 week apart within the past 12 months

Documentation required

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The prior authorization request must document that the patient meets ALL listed medical necessity criteria and that the requested dose and quantity are within policy limits (FDA‑labeled dosing and the policy's maximum units/one-time, single‑dose per lifetime). Include evidence of prior gene therapy status and any distribution channel coordination if applicable.

Affected product: valoctocogene roxaparvovec‑rvox (Roctavian) — HCPCS J1412
Duration of approval: 180 days (one treatment course per lifetime)
Requested dose must match FDA‑labeled dosing (6 x 10^13 vg/kg IV, one‑time)

Note

Provider Operational Steps

Providers must take the following operational steps when seeking authorization and administering therapy: obtain and submit all required baseline and recent laboratory testing; verify and document prior exposure days and prior gene therapy history; confirm absence of current bypassing agents; coordinate specialty pharmacy distribution with Blue Cross NC when required; and ensure dosing requests do not exceed the maximum units per lifetime.

Therapy Background

Valoctocogene roxaparvovec‑rvox (Roctavian) is an AAV5‑based gene therapy1 IU/dL. Patient selection requires comprehensive pre‑treatment evaluation including testing for anti‑AAV5 antibodies, assessment of factor VIII inhibitors (Nijmegen modified Bethesda assay), confirmation of prior factor VIII exposure, and evaluation of hepatic, renal, and infectious disease status.

Key Definitions and Assay Criteria

inv-15: Definition of severe hemophilia A — congenital factor VIII deficiency with factor VIII activity < 1 IU/dL

DefinitionSevere hemophilia A is congenital factor VIII deficiency with factor VIII activity < 1 IU/dL

SynonymsAlso referred to as classic hemophilia or congenital factor VIII deficiency

Population noteApplies to adults meeting other eligibility criteria (see coverage criteria)

inv-16: Definition of Nijmegen modified Bethesda assay requirement for inhibitors (<0.6 BU on two occasions ≥1 week apart within past 12 months)

Assay definitionNijmegen modified Bethesda assay measures factor VIII inhibitors; requirement: < 0.6 BU on two consecutive occasions at least 1 week apart within the past 12 months

Clinical purpose

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyValoctocogene roxaparvovec-rvox (Roctavian) gene therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeCoding and operational updates (HCPCS, revenue codes, dosing language)

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Medical record documentation of Nijmegen modified Bethesda assay results (two tests ≥1 week apart) within past 12 months

PurposeDemonstrates absence of active or historical inhibitors to factor VIII

inv-08: Dose — 6 x 10^13 vg/kg, one-time single-dose vector per lifetime

FDA‑labeled doseOne-time, single IV dose of 6 x 10^13 vector genomes (vg) per kg of body weight

Dose frequencySingle-dose vector; one treatment course per lifetime (maximum units = one-time, single-dose infusion per lifetime)

HCPCS codeJ1412 (valoctocogene roxaparvovec-rvox, IV infusion)

inv-09: Minimum exposure days to factor VIII prophylaxis (≥ 150 exposure days)

Minimum exposure daysPatient must have ≥ 150 exposure days to factor VIII prophylaxis

ContextPatient must be on prophylactic therapy with a factor VIII agent (e.g., Advate, Eloctate, Recombinate)

Documentation requiredMedical record documentation of prophylactic factor VIII therapy and exposure days

Submit complete medical record documentation with the PA request
Coordinate with Blue Cross NC and specialty pharmacy if distribution channel restriction applies
Confirm requested HCPCS code (J1412) and appropriate revenue codes (e.g., 0891, 0892) on claims

Documentation Required

Required Documentation

Required medical record documentation must be submitted with the prior authorization request and include the following elements to support medical necessity: diagnosis, baseline factor VIII level, inhibitor testing (including Nijmegen modified Bethesda assay results), exposure day history, prior gene therapy status, and relevant infectious disease and liver/kidney labs.

Diagnosis of hemophilia A (congenital factor VIII deficiency)
Baseline factor VIII residual level (≤ 1 IU/dL) with lab report
Inhibitor testing: Nijmegen modified Bethesda assay < 0.6 BU on two occasions ≥1 week apart within past 12 months
Documentation of no current or prior inhibitors to factor VIII
History of prophylactic factor VIII therapy with ≥150 exposure days (medical record or infusion logs)
Anti‑AAV5 antibody testing (negative) with results within past 3 months
HIV status and, if positive, viral load within past 12 months (<1000 copies/mL)
Hepatitis B surface antigen and HCV testing (HCV Ab and, if positive, HCV RNA) within past 3 months
Liver function tests (ALT, bilirubin, alkaline phosphatase, INR) and creatinine within past 3 months
Documentation of no active infection, no significant liver fibrosis/cirrhosis, no active malignancy (except non‑melanoma skin cancer), and no other bleeding disorders

Denial Risk

Denial Risk — Missing Documentation

Missing or incomplete documentation may result in denial of the prior authorization. Common deficiencies that lead to denial include absent or outdated diagnostic confirmation, missing baseline factor VIII level or lab report, lack of Nijmegen Bethesda assay results or insufficient timing (two tests ≥1 week apart), missing exposure day documentation, absent anti‑AAV5 or other required infectious disease tests, or failure to document absence of prior gene therapy.

Denial risk if diagnosis, baseline labs, or inhibitor testing are not provided
Denial risk if Nijmegen modified Bethesda assay results are missing or not two tests ≥1 week apart within 12 months
Denial risk if exposure days (≥150) are not documented
Denial risk if anti‑AAV5 antibody testing or recent infectious/liver/kidney labs are missing
Denial risk if prior gene therapy status is not documented

Used to confirm absence of active or historical inhibitors to factor VIII prior to gene therapy

Documentation requiredReport of both assay results in medical record within past 12 months