CurrentUnitedHealthcarePolicy IEXD0094.07

Roctavian® (Valoctocogene Roxaparvovec-Rvox) – Individual Exchange Medical Benefit Drug Policy

Medical benefit drug policy for Roctavian for Individual Exchange plans (all states except MA, NV, NY) defining medical necessity criteria, exclusions, related coding, and administrative requirements for use in adults with severe Hemophilia A.

Policy Summary

PayerUnitedHealthcare

PolicyRoctavian® (Valoctocogene Roxaparvovec-Rvox) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0094.07

Change TypeRevised coverage criteriaAdded section

Effective DateJan 1, 2026

Next Review Date

Key ActionPrescriber must attest to weekly ALT and factor VIII monitoring for at least 26 weeks and document required pre-treatment testing and HTC management; authorization limited to one lifetime treatment and no longer than 45 days from approval.

SourceLink

POLICY UPDATE CHANGES

Added criterion that provider does not request a planned inpatient admission for the sole purpose of administering Roctavian.

Replaced criterion requiring specific chronic Hemlibra or Hympavzi therapy with broader criterion requiring routine prophylaxis with a non-factor replacement therapy (examples listed).

Added Benefit Considerations section.

1Covered Indications

>=18Age restriction

1Lifetime treatments allowed

>=150Required prior factor exposure

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Coverage Summary

Covered with criteria: Roctavian is covered for adults with severe Hemophilia A (endogenous factor VIII activity < 1 IU/dL) when all policy criteria are met. Coverage is limited to one lifetime treatment, is restricted to patients aged >=18 years, and requires prior authorization and management by a Federally designated Hemophilia Treatment Center.

Initial Therapy Criteria (Medically Necessary)

Medically Necessary (Hemophilia A)

Roctavian is proven and medically necessary for the treatment of Hemophilia A when ALL of the following criteria are met:

ALL of the following

Patient is 18 years of age or older
Diagnosis and severity
- Diagnosis of severe hemophilia A
- Documentation of endogenous factor VIII levels less than 1% of normal factor VIII (< 0.01 IU/mL, < 1 IU/dL)< 1 IU/dL
Prior therapy or candidacy
- Patient is currently receiving routine prophylaxis for hemophilia A with a non-factor replacement therapy (i.e., Alhemo (concizumab-mtci), Hemlibra (emicizumab-kxwh), Hympavzi (marstacimab-hncq), Qfitlia (fitusiran))
- Factor prophylaxis with exposure days
  - Patient currently uses factor VIII prophylaxis therapy
  - Patient has had a minimum of 150 exposure days to a factor VIII agent>= 150 exposure days
- Patient has been determined to be an appropriate candidate for Roctavian by the Hemophilia Treatment Center based on willingness to adhere to initial and long-term monitoring and management
Patient does not have a history of inhibitors to factor VIII greater than or equal to 0.6 Bethesda units (BU)< 0.6 BU
Patient does not screen positive for active factor VIII inhibitors defined as greater than or equal to 0.6 Bethesda units (BU) prior to administration< 0.6 BU
Patient does not have pre-existing immunity to the AAV5 capsid as detected by the FDA-approved companion diagnostic test AAV5 DetectCDx
Patient has not gone through Immune Tolerance Induction (ITI)
Liver health assessments (ALT, AST, ALP, total bilirubin) and hepatic ultrasound and elastography are performed to rule out radiological liver abnormalities and/or sustained liver enzyme elevations
HIV status
- Patient is not HIV positive
- Patient is HIV positive and is virally suppressed with anti-viral therapy (i.e., < 200 copies of HIV per mL)< 200 copies per mL
Patient's hepatitis B surface antigen is negative
Hepatitis C status
- Patient's hepatitis C virus (HCV) antibody is negative
- Patient's HCV antibody is positive
- Patient's HCV RNA is negative
The patient is not currently using antiviral therapy for hepatitis B or C
Patient has not previously received treatment with Roctavian or other gene therapy product for the treatment of hemophilia A in the patient's lifetime
Roctavian is prescribed and managed by a bleeding disorder specialist on staff at a Hemophilia Treatment Center (HTC) that holds Federal designation as evidenced by being listed within the CDC's HTC directory
Prescriber attests that the patient's ALT and factor VIII activity will be monitored weekly for at least 26 weeks following administration and regularly thereafter per the prescribing informationweekly for >=26 weeks
Prescriber attests that counseling has been provided to the patient to abstain from consuming alcohol for at least one year following administration and regarding longer-term alcohol guidance1 year
Roctavian dosing is in accordance with FDA approved labeling
Provider does not request a planned inpatient admission for the sole purpose of administering Roctavian
Authorization will be issued for no more than one treatment per lifetime and for no longer than 45 days from approval<= 1 lifetime treatment; <= 45 days from approval

Not Medically Necessary / Not Proven

Roctavian is not proven or medically necessary for the following indications:

ANY of the following

The treatment of hemophilia B
The treatment of mild or moderate hemophilia A
The repeat administration of Roctavian for the treatment of hemophilia A
The treatment of hemophilia A after previously receiving another factor VIII gene therapy product
The routine combination treatment with chronically administered prophylactic therapy for hemophilia A

Applicable Codes

Covered HCPCSHCPCSCovered

J1412

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

Relevant Diagnosis CodesICD-10

D66	Hereditary factor VIII deficiency

Provider Actions & Administrative Requirements

Prior Authorization

Authorization limits (codes J1412)

Authorization issued for no more than one lifetime treatment and for no longer than 45 days from approval.

J1412

Documentation Required

Prescriber attestations and monitoring

Prescriber must attest to weekly monitoring of ALT and factor VIII activity for at least 26 weeks after administration and regular monitoring thereafter per the prescribing information. Prescriber must attest that counseling has been provided to the patient to abstain from alcohol for at least one year following administration and regarding longer-term alcohol guidance.

Documentation Required

HTC prescribing requirement

Clinical Evidence Summary

92-96%Reduction in mean annualized bleeding rate across cohorts and follow‑up

0.7Example mean ABR after treatment (phase1/2 end yr3)

Roctavian is an AAV5-based, single-dose gene therapy encoding the B-domain deleted human FVIII-SQ; phase 1/2 and a phase 3 single-arm trial showed increased factor VIII activity and marked reductions in annualized bleeding rates. Clinical trials excluded patients with detectable pre-existing AAV5 antibodies and those with significant liver disease or abnormal liver function.

Background & Definitions

Roctavian (valoctocogene roxaparvovec-rvox) is an AAV5 vector-based, single-dose gene therapy encoding B-domain deleted hFVIII-SQ. Trials (phase 1/2 dose-escalation and a phase 3 single-dose study) demonstrated clinically meaningful rises in FVIII expression and substantial reductions in bleeding (large reductions in ABR), and enrolled adults with severe hemophilia A while excluding those with pre-existing AAV5 antibodies and significant liver disease or liver test abnormalities.

Term	Definition
Severe hemophilia A	Factor VIII activity less than 1% of wild type (< 1 IU/dL)
AAV5 DetectCDx	FDA-approved companion diagnostic test to detect pre-existing antibodies to AAV5 capsid
Exposure days	Days of exposure to factor VIII agent (policy uses minimum of 150 exposure days when applicable)

Revision History

01/01/2026coverage_criteria_revisionLatest

Added criterion that provider does not request a planned inpatient admission for the sole purpose of administering Roctavian; replaced criterion specifying chronic Hemlibra or Hympavzi therapy with a broader requirement that the patient is currently receiving routine prophylaxis with a non-factor replacement therapy (examples listed: Alhemo, Hemlibra, Hympavzi, Qfitlia). This revision is material.

01/01/2026policy_section_addedLatest

Added Benefit Considerations section (non-material addition).