CurrentBaylor Scott & White Health PlanPolicy 304

Valoctocogene roxaparvovec-rvox (Roctavian) Coverage

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This prior authorization policy governs coverage of valoctocogene roxaparvovec-rvox (Roctavian), a one-time gene therapy for adults with severe hemophilia A. It applies to members whose requests are reviewed under the applicable benefit plan and requires clinical documentation demonstrating medical necessity.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyValoctocogene roxaparvovec-rvox (Roctavian) Coverage

Policy CodePolicy 304

Change TypeMaterial coverage update

Effective DateAugust 1, 2026

Last ReviewJul 23, 2026

Next Review DateJuly 23, 2027

Key ActionSubmit documentation showing that all coverage criteria are met before requesting Roctavian authorization.

SourceLink

POLICY UPDATE CHANGES

The policy added a requirement for a history of Factor VIII therapy for at least 150 exposure days.

The policy excludes members previously treated with valoctocogene or another gene therapy for hemophilia A.

The policy changed the requirement from excluding concomitant emicizumab use to requiring discontinuation of all prophylactic hemophilia A therapy after treatment.

The policy states that repeat administration is experimental and investigational because effectiveness of repeat treatment has not been established.

≥18 yearsMinimum member age

≤1 IU/dLFactor VIII activity threshold

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CurrentBaylor Scott & White Health PlanPolicy 304

Valoctocogene roxaparvovec-rvox (Roctavian) Coverage

Customize your policy alerts

Sign up for baylor_scott_and_white_health_plan Policy 304 alerts

Get alerted when Policy 304 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyValoctocogene roxaparvovec-rvox (Roctavian) Coverage

Policy CodePolicy 304

Change TypeMaterial coverage update

Effective DateAugust 1, 2026

Last ReviewJul 23, 2026

Next Review DateJuly 23, 2027

Key ActionSubmit documentation showing that all coverage criteria are met before requesting Roctavian authorization.

SourceLink

POLICY UPDATE CHANGES

The policy added a requirement for a history of Factor VIII therapy for at least 150 exposure days.

The policy excludes members previously treated with valoctocogene or another gene therapy for hemophilia A.

The policy changed the requirement from excluding concomitant emicizumab use to requiring discontinuation of all prophylactic hemophilia A therapy after treatment.

The policy states that repeat administration is experimental and investigational because effectiveness of repeat treatment has not been established.

≥18 yearsMinimum member age

≤1 IU/dLFactor VIII activity threshold

Required Factor VIII exposure

1 lifetimeMaximum treatment course

Coverage Criteria

Initial Therapy Criteria

Covered when ALL of the following criteria are met:

Initial therapy criteria

Diagnosis: Member has severe hemophilia A with Factor VIII activity ≤ 1 IU/dL≤ 1 IU/dL
Prescriber specialty: Medication is prescribed by or in consultation with a hematologist
Member age: Member is at least 18 years old≥ 18 years
Prior prophylactic therapy: Member has been receiving prophylactic therapy for hemophilia A for at least 1 yearat least 1 year
Prior Factor VIII exposure: Member has a history of Factor VIII therapy for at least 150 exposure daysat least 150 exposure days
No exclusionary conditions
- No FVIII inhibitors: Member does not have FVIII inhibitors
- No detectable AAV5 antibodies: Member does not have detectable AAV5 antibodies
- No HIV infection: Member does not have HIV infection
- No substantial liver disease: Member does not have substantial liver dysfunction, substantial liver fibrosis, or liver cirrhosis
- No prior hemophilia A gene therapy: Member has not previously received valoctocogene or another gene therapy for hemophilia A
Post-treatment discontinuation: Prophylactic therapy for hemophilia A will be discontinued following administration of valoctocogene

Repeat Treatment

Not medically necessary or experimental and investigational:

Repeat treatment: Repeat administration of valoctocogene roxaparvovec-rvox is experimental and investigational because the effectiveness of this strategy has not been establishedOne treatment per lifetime

Other Indications

Not medically necessary or experimental and investigational:

Other indications: Valoctocogene roxaparvovec-rvox for all indications other than the covered severe hemophilia A indication is experimental and investigational because the effectiveness of this strategy has not been established

Coverage may be considered for initial treatment of adults with severe hemophilia A when all policy criteria are met. Repeat administration, treatment for indications other than the covered severe hemophilia A indication, and treatment in members with FVIII inhibitors, detectable AAV5 antibodies, HIV infection, substantial liver dysfunction, substantial liver fibrosis, liver cirrhosis, or prior treatment with valoctocogene or another hemophilia A gene therapy are not medically necessary or are considered experimental and investigational.

BSWHP considers more than one valoctocogene roxaparvovec-rvox (Roctavian) treatment per lifetime not medically necessary. Repeat administration is considered experimental and investigational because the effectiveness of this treatment strategy has not been established.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J1412

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

Factor VIII activity threshold

Required Factor VIII activity≤ 1 IU/dL

Covered indicationSevere hemophilia A in an adult meeting all policy criteria

Severe classificationLess than 1 IU/dL or less than 1% of normal

Member age threshold

Minimum age≥ 18 years

PopulationAdult member

Policy requirementMember age must be at least 18 years for covered treatment

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required before valoctocogene roxaparvovec-rvox (Roctavian®) may be considered for coverage.

Step Therapy

Prior Prophylactic and Factor VIII Therapy Required

Confirm and document the member’s required prior hemophilia A treatment history and planned post-treatment management.

Prophylactic therapy for at least 1 year.
Factor VIII therapy for at least 150 exposure days.
Prophylactic hemophilia A therapy must be discontinued following Roctavian administration.

Clinical Background

Hemophilia A is a genetic bleeding disorder caused by Factor VIII deficiency. It may result in spontaneous bleeding, hemorrhage, or prolonged bleeding after injury or surgery. Severe hemophilia A is characterized by Factor VIII activity below 1 IU/dL or below 1% of normal. Roctavian is a one-time gene therapy that uses an AAV5 capsid to deliver a functional F8 gene intended to enable endogenous Factor VIII production in adults with severe hemophilia A.

Hemophilia Severity Definitions

Severe hemophilia A definition

Factor VIII activityLess than 1 IU/dL

Percent of normalLess than 1% of normal

Clinical severitySevere hemophilia A

Moderate hemophilia definition

Factor VIII activity1–5 IU/dL

Percent of normal1%–5% of normal

Clinical severityModerate hemophilia

Initial Roctavian Treatment

Initial treatment may be considered when ALL policy criteria are met:

Initial Roctavian treatment criteria

Severe hemophilia A: Member has severe hemophilia A with Factor VIII activity ≤ 1 IU/dL≤ 1 IU/dL
Hematologist involvement: Roctavian is prescribed by or in consultation with a hematologist
Adult member: Member is at least 18 years old≥ 18 years

Step Therapy Requirement

Step	Requirement	Duration / Threshold
1	Prior hemophilia A treatment before Roctavian	Prophylactic therapy for at least 1 year and Factor VIII therapy for at least 150 exposure days

Lifetime Treatment Limit

Valoctocogene roxaparvovec-rvox (Roctavian)

Lifetime limitOne treatment per lifetime

Repeat administrationNot medically necessary; considered experimental and investigational

RationaleEffectiveness of repeat treatment has not been established

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyValoctocogene roxaparvovec-rvox (Roctavian) Coverage

Policy CodePolicy 304

Change TypeMaterial coverage update

Effective DateAugust 1, 2026

Last ReviewJul 23, 2026

Next Review DateJuly 23, 2027

Key ActionSubmit documentation showing that all coverage criteria are met before requesting Roctavian authorization.

SourceLink

On This Page

Required prophylactic therapy duration

Minimum durationAt least 1 year

Therapy typeProphylactic therapy for hemophilia A

TimingThe member must have received prophylactic therapy before Roctavian treatment

Required Factor VIII exposure history

Minimum exposure historyAt least 150 exposure days

TherapyFactor VIII therapy

TimingThe exposure history is required before Roctavian treatment

Liver laboratory exclusion thresholds

Liver enzyme and bilirubin exclusionALT, AST, GGT, total bilirubin, or Alk Phos >1.25 x ULN

Coagulation exclusionINR ≥1.4

Coverage implicationThese findings constitute substantial liver dysfunction and exclude medically necessary coverage

Liver fibrosis exclusion criteria

Batts-Ludwig scoreGrade 3 or 4 excludes coverage

METAVIR scoreGrade 3 or 4 excludes coverage

Clinical conditionSubstantial liver fibrosis

Documentation Required

Clinical Documentation Required

Submit clinical documentation demonstrating that all medical-necessity criteria are met for Roctavian.

Severe hemophilia A with FVIII activity ≤ 1 IU/dL.
Prescription by or consultation with a hematologist.
Member is at least 18 years old.
No listed exclusionary condition, including FVIII inhibitors, detectable AAV5 antibodies, HIV infection, substantial liver disease or fibrosis, cirrhosis, or previous hemophilia A gene therapy.

Note

Clinical Review Required

All requests will be reviewed by a clinical pharmacist and medical director before a coverage determination is made.

Ensure the submission includes complete clinical records and supporting laboratory and treatment-history documentation for clinical review.

Denial Risk

Exclusionary Conditions and Noncovered Use

Roctavian is not covered when an exclusionary clinical condition is present or when it is requested for an indication other than the covered treatment of severe hemophilia A meeting the policy criteria.

Exclusions include FVIII inhibitors, detectable AAV5 antibodies, HIV infection, substantial liver dysfunction or fibrosis, cirrhosis, and prior treatment with valoctocogene or another hemophilia A gene therapy.
Requests for all other indications are considered experimental and investigational.

Denial Risk

Repeat Lifetime Treatment Limitation

Only one Roctavian treatment per member’s lifetime is considered medically necessary. Repeat administration is experimental and investigational because the effectiveness of repeat treatment has not been established.

Verify that the member has not previously received Roctavian or another hemophilia A gene therapy before submitting a request.
Do not request repeat lifetime treatment as medically necessary.

Mild hemophilia definition

Factor VIII activity5–40 IU/dL

Percent of normal5% to less than 40% of normal

Clinical severityMild hemophilia

Prophylactic therapy history: Member has been receiving prophylactic therapy for hemophilia A for at least 1 yearat least 1 year

Factor VIII therapy history: Member has a history of Factor VIII therapy for at least 150 exposure daysat least 150 exposure days

Absence of exclusionary conditions

No FVIII inhibitors: Member does not have FVIII inhibitors
No detectable AAV5 antibodies: Member does not have detectable AAV5 antibodies
No HIV infection: Member does not have HIV infection
No substantial liver disease: Member does not have substantial liver dysfunction, substantial liver fibrosis, or liver cirrhosis
No prior gene therapy: Member has not previously received valoctocogene or another gene therapy for hemophilia A

Discontinuation of prophylaxis: Prophylactic therapy for hemophilia A will be discontinued following administration of valoctocogene