166 Form

Gene Therapies for Hemophilia A – Prior Authorization Request Form for Roctavian® (Valoctocogene roxaparvovec-rvox), #166

Medical Policy #168 Gene Therapies for Hemophilia A or B

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for Roctavian must be submitted.
▪ If the patient does not meet all the criteria listed below, please submit a letter of medical necessity with a request for Clinical Exception (Individual Consideration) explaining why an exception is justified.

Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.

To ensure the request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources • Refer to our Authorization Manager page for tips, guides, and video demonstrations. For out of network providers: Requests should still be faxed to 888-973-0726. Patient Information Patient Name:

Today’s Date: BCBSMA ID#:

Date of Treatment: Date of Birth:

Place of Service: Outpatient  Inpatient 

Distributor:

Physician Information Facility Information Name:

Name:
Address:

Address: Phone #:

Phone #: Fax#:

Fax#: NPI#:

NPI#:

Please check off if the patient has the following diagnosis: Congenital Hemophilia A 

Please check off that the patient meets ALL the following criteria:

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  1. Individual is 18 years of age or older; AND

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  2. Assigned male at birth; AND

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  3. Diagnosis of severe or moderately severe hemophilia A as defined by residual Factor VIII (FVIII) levels ≤ 1 IU/dL; AND

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  4. Currently receiving FVIII prophylaxis; AND

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  5. No history of FVIII inhibitors or a positive screen results of ≥ 0.6 BU using the Nijmegen-Bethesda assay; AND

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  6. No detectable pre-existing antibodies to the adeno-associated virus serotype 5 (AAV5) capsid; AND

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  7. No history of receiving gene therapy or under consideration for treatment for another gene therapy for hemophilia A; AND

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  8. Medications is being prescribed by or in consultation with a hematologist or a prescriber who specializes in hemophilia A; AND

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  9. A baseline liver health assessment including but not limited to ALT; AND

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  10. Educated regarding alcohol abstinence and concomitant use of certain medications (e.g., isotretinoin, efavirenz); AND
  11. HIV negative; AND
  12. No active hepatitis B and/or hepatitis C infection.

  HCPCS Codes Code Description C9399 Unclassified drugs or biologicals J1411 Injection, etranacogene dezaparvovec-drlb, per therapeutic dose J1412 Injection, valoctocogene roxaparvovec-rvox, per mL, containing nominal 2 × 10^13 vector genomes (Roctavian) J3490 Unclassified drugs J3590 Unclassified biologics

  Providers should enter the relevant diagnosis code(s) below: Code Description

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  Providers should enter other relevant code(s) below: Code Description

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