096 Form

Lifileucel (Amtagvi®) for Melanoma Prior Authorization Request Form #096 Medical Policy #089 Adoptive Cell Therapies for Melanoma

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for Lifileucel (Amtagvi®) for Melanoma 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.

Complete Prior Authorization Request Form for Lifileucel (Amtagvi®) for Melanoma (096) using Authorization Manager.

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 

Physician Information Facility Information Name:

Name:
Address:

Address: Phone #:

Phone #: Fax#:

Fax#: NPI#:

NPI#:

Please check off if the patient is enrolled in a National Clinical Trial. National Clinical Trial # 

Please check off if the patient has the following diagnosis: Unresectable or metastatic melanoma 

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  Please check off that the patient meets ALL the following criteria and policy guidelines in MP 089:

  1. Individual is ≥ 18 years of age; AND

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  2. Has a diagnosis of unresectable or stage IV metastatic melanoma; AND

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  3. Must have progressive disease following at least one prior systemic therapy from the following categories: a. PD-1/PDL-1 blocking antibody; OR b. If BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor in combination with a MEK inhibitor; AND

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  4. Individual has an ECOG PS of 0 or 1; AND

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  5. Individual at least one partially resectable lesion or aggregate of lesions of a minimum 1.5 cm in diameter post-resection to generate tumor-infiltrating lymphocyte (TIL); AND

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  6. Has not previously received tumor-derived autologous T cell immunotherapy (including lifileucel) and is not being considered for treatment with any other adoptive cellular immunotherapy; AND

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  7. Does not have any of the following: a. Absolute neutrophil count (ANC) ≤1,000/mm3; OR b. Hemoglobin < 9.0 g/dL; OR c. Platelets ≤ 100,000/mm3; OR d. Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the upper limit of normal (ULN); OR e. Creatinine clearance < 40mL/min; OR f. Left ventricular ejection fraction (LVEF) < 45% or NYHA functional classification > Class 1; OR g. Has a forced expiratory volume in one second (FEV1) of ≤ 60% of predicted; OR h. Symptomatic and/or untreated brain metastases; OR i. Primary melanoma was of ocular/uveal origin; OR j. History of another primary malignancy that has not been in remission for at least 3 years prior to consideration of Amtagvi; OR k. Has a clinically significant active infection (e.g. requiring IV or long-term oral antimicrobial therapy); OR l. Has a primary immunodeficiency; or is on immunosuppressive medications (including but not limited to organ transplant) including systemic steroids; OR m. Will be pregnant or breastfeeding a child at the time of Amtagvi treatment; AND

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  8. Treatment is being administered at a certified TIL treatment center.

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  Please check off that the patient meets ALL the following criteria and policy guidelines in MP 089:

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  CPT CODES/ HCPCS CODES/ ICD CODES HCPCS codes: Code Description C9399 Unclassified drugs or biologicals J3490 Unclassified drugs J3590 Unclassified biologics

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

  Providers should enter other relevant code(s) below:

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  Code Description