169 Form

Gene Therapies for Hemophilia B – Prior Authorization Request Form for Hemgenix® (Etranacogene dezaparvovec), #169

Medical Policy #168 Gene Therapies for Hemophilia A or B

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for Hemgenix 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: Hemophilia B with congenital Factor IX deficiency

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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. Individual has severe or moderately severe hemophilia B as defined by a plasma Factor IX (FIX) activity level ≤ 2%, as documented by written physician attestation AND historical records OR chart; AND

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  3. Must currently be on factor IX therapy with greater than 150 prior exposure days to treatment; OR

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  4. Individual meets one of the following: a. Current or historical life-threatening hemorrhage, OR b. Repeated, serious spontaneous bleeding episodes

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  5. Individual does not have a history of FIX inhibitors or a positive screen results of ≥ 0.6 Bethesda Units (BU) using the Nijmegen-Bethesda assay; AND

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  6. Individual has received a liver health assessment including enzyme testing [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin] AND a hepatic ultrasound and elastography; AND

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  7. Medication is being prescribed by or in consultation with a hematologist or a prescriber who specializes in hemophilia B; AND

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  8. Individual does not have a history of receiving gene therapy or under consideration for treatment for another gene therapy for hemophilia B; AND

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  9. Individual is HIV negative or has a controlled HIV infection; AND

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  10. Individual does not have an active hepatitis B and/or hepatitis C infection.

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  HCPCS Codes Code Description J1411 Injection, etranacogene dezaparvovec-drlb, per therapeutic dose

  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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