Printer Friendly Version
Printer Friendly Version
S.5.01.606
Amtagvi (lifileucel)
Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.
Amtagvi (lifileucel) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Amtagvi (lifileucel) is considered not medically necessary for the treatment of unresectable or metastatic melanoma as there are other treatment options covered by the Plan that hold the same place in treatment guidelines (National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium (NCCN) level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A).
Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
01/20/2025: New policy added.
12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated to correct the spelling of lifileucel. Sources updated.
Amtagvi prescribing information. Iovance Biotherapeutics Inc. October 2024. Last accessed September 2025.
None