CurrentAetnaPolicy N/A

Roctavian (valoctocogene roxaparvovec) precertification request

Precertification form and required clinical information for Aetna coverage review of Roctavian gene therapy for patients with Hemophilia A; intended for prescribing providers and administration centers seeking authorization.

Policy Summary

PayerAetna

PolicyRoctavian (valoctocogene roxaparvovec) precertification request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed precertification form and clinical checklist to Aetna Precertification Notification to request authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page count

7checklist items

Aetna Precertprecert contact

Coverage Criteria for Roctavian (valoctocogene roxaparvovec)

Initial Therapy Criteria

Covered when ALL of the following are met (as indicated on the form):

Roctavian candidate criteria

Diagnosis of Hemophilia A
Drug prescribed by or in consultation with a hematologist
Severe disease with factor VIII activity less than or equal to 1 IU/dL<= 1 IU/dL
Absence of pre-existing antibodies to AAV5 confirmed by an FDA-approved test (e.g., AAV5 Detect-CDx)

Policy Summary

PayerAetna

PolicyRoctavian (valoctocogene roxaparvovec) precertification request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed precertification form and clinical checklist to Aetna Precertification Notification to request authorization.

SourceLink

On This Page

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The form’s checklist establishes specific exclusion conditions by implication. Patients with pre-existing antibodies to AAV5 confirmed by testing (i.e., a positive result on an FDA‑approved assay such as AAV5 Detect‑CDx) would fail the antibody criterion and are therefore excluded from coverage under these prerequisites. Similarly, patients with prior or active factor VIII inhibitors at or above the specified threshold (inhibitor titer ≥ 0.6 BU) do not meet the requirement for absence of inhibitors and would be excluded. A factor VIII activity above the severe‑disease threshold (greater than 1 IU/dL) also fails the severity criterion and is implied to exclude the patient from being a candidate per this checklist.

Coverage through this precertification pathway is only supported when all checklist items are satisfied. If any of the following are true, the checklist is not met and coverage is not supported by this form: the patient does not have a diagnosis of Hemophilia A; the patient does not have severe disease as defined by factor VIII activity > 1 IU/dL; the prescriber is not a hematologist or not in consultation with one; the patient has pre‑existing anti‑AAV5 antibodies (positive on an FDA‑approved test); the patient has prior or active factor VIII inhibitors with an inhibitor titer ≥ 0.6 BU; the patient previously received Roctavian; or the planned administration will not occur at an Aetna gene therapy designated center.

Coding and Clinical Thresholds

Administration/CPT codes to be provided by submitterCPT

Administration code(s) (CPT):

Place on form for provider to list applicable CPT codes

Diagnosis ICD codesICD-10

Primary ICD Code

Field for primary diagnosis ICD code

inv-06: Factor VIII activity

ThresholdFactor VIII activity ≤ 1 IU/dL

Clinical contextDefines severe Hemophilia A for eligibility on the precertification form

Checklist locationRequired clinical information section asks: 'Does the patient have severe disease with factor VIII activity levels less than or equal to 1 IU/dL?'

inv-07: Inhibitor titer

ThresholdInhibitor titer < 0.6 Bethesda Units (BU)

Clinical implicationAbsence of prior or active factor VIII inhibitors is required for coverage consideration

Checklist locationRequired clinical information section asks: 'Does the patient have an absence of prior or active factor VIII inhibitors (inhibitor titer must be less than 0.6 Bethesda Units [BU])?'

Provider Actions, Precertification, and Documentation

Prior Authorization

Precertification Requirement — Prior Authorization Required

Prior authorization is required for Roctavian (valoctocogene roxaparvovec-rvox). Submit a completed precertification request form and the clinical checklist to Aetna Precertification Notification for review before scheduling treatment.

Aetna Precertification Notification Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277
For Medicare Advantage Part B: Use Medicare Request Form

Note

No Step Therapy Details Provided on This Form

This precertification form does not include any step therapy or step edit details. If applicable, review the member’s benefit plan or contact Aetna to determine whether any step therapy requirements apply prior to approval.

Documentation Required

Required Documentation

Completed documentation must be included with every precertification submission. Incomplete or missing items may delay review.

Completed precertification request form (all fields legible and completed)
Patient demographics and contact information (Section A)
Aetna Member ID, group number, and other coverage details (Section B)
Prescriber credentials, NPI, license, specialty, and contact information (Section C)
Place of administration and dispensing provider/pharmacy details (Section D)
Product name, dose, and frequency (Section E)
Primary and other ICD-10 diagnosis codes (Section F)
Required clinical checklist items: Hemophilia A diagnosis, hematologist involvement, factor VIII activity ≤1 IU/dL, AAV5 antibody testing results, inhibitor titer <0.6 BU, prior exposure to the product, and designated gene therapy center name if applicable (Section G)
Signature and date on acknowledgment page (Section H)

Denial Risk

Denial / Information Risk

Incomplete, misleading, or unsigned documentation may result in denial of the request or requests for additional information. The requestor must sign and date the form; knowingly providing false information may constitute insurance fraud and lead to criminal and civil penalties.

Signature required: Request Completed By (Signature) and Date (Section H)
Plan may request additional information or clarification if needed
False or misleading information may result in denial and legal penalties

Background

Roctavian (valoctocogene roxaparvovec) is a gene therapy for patients with Hemophilia A. This precertification form collects the clinical elements Aetna requires to determine candidate eligibility, including confirmation of a diagnosis of Hemophilia A, that the drug is prescribed by or in consultation with a hematologist, documentation of severe disease (factor VIII activity ≤ 1 IU/dL), confirmation of the absence of pre‑existing AAV5 antibodies by an FDA‑approved test (for example, AAV5 Detect‑CDx), documentation that there are no prior or active factor VIII inhibitors (inhibitor titer < 0.6 BU), that the patient has not previously received Roctavian, and that administration will occur at an Aetna gene therapy designated center.

Definitions and Clinical Thresholds

inv-13: Definition — Severe Hemophilia A

DefinitionSevere Hemophilia A: Factor VIII activity ≤ 1 IU/dL

SourceRequired clinical information on precertification form

UseUsed as an eligibility criterion on the Roctavian precertification checklist

inv-14: Definition — Inhibitor titer

DefinitionInhibitor titer must be < 0.6 Bethesda Units (BU)

ContextSpecifies absence of prior or active factor VIII inhibitors for precertification

Checklist wording'inhibitor titer must be less than 0.6 Bethesda Units [BU]'

inv-15: Definition — Absence of pre-existing antibodies to AAV5

RequirementAbsence of pre-existing antibodies to AAV5 confirmed by an FDA-approved test (e.g., AAV5 Detect-CDx)

Checklist locationRequired clinical information section asks: 'Does the patient have an absence of pre-existing antibodies to AAV5 that was confirmed by an FDA-approved test (e.g., AAV5 Detect-CDx TM )?'

ImplicationPresence of anti-AAV5 antibodies would fail this precertification checklist item