Gene Therapy for Treatment of Wounds in Dystrophic Epidermolysis Bullosa -
Prior Authorization Request Form for Zevaskyn® (prademagene zamikeracel),

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Medical Policy #229 Gene Therapy for Treatment of Wounds in Dystrophic Epidermolysis Bullosa - Zevaskyn

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for Zevaskyn 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#:

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  Please check off if the patient has the following diagnosis: Recessive dystrophic epidermolysis bullosa (RDEB) 

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

  1. Patient has wounds associated with recessive dystrophic epidermolysis bullosa (RDEB); AND

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  2. Documented biallelic pathogenic mutations in the collagen type VII alpha 1 chain (COL7A1) gene; AND

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  3. Positive expression of the non-collagenous region 1 of the type 7 collagen protein (NC1+) in the skin; AND

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  4. Presence of at least one chronic wound (e.g., stage 2 wounds that have an area ≥ 20 cm2 ) and have been present for at least 3 months; AND

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  5. Presence of clinical manifestations of RDEB, such as extensive skin blistering, skin erosions, or scarring; AND 
  6. Prescribed by or in consultation with a dermatologist or a wound care specialist; AND

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  7. Prescriber agrees that the affected wound has not been previously treated with Zevaskyn; AND

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  8. NO active infection, active squamous cell carcinoma, or history of squamous cell carcinoma in the targeted wound(s)

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  HCPCS Codes Code Description J3389 prademagene zamikeracel, per treatment [Zevaskyn] C9399 Unclassified drugs or biologicals J3590 Unclassified biologics

  Providers should enter the relevant diagnosis code(s) below: Code Description Q81.2 Epidermolysis bullosa dystrophica  XHR0XGA- XHR7XGA Prademagene Zamikeracel, Genetically Engineered Autologous Cell Therapy 

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

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