Amtagvi (lifileucel) medical prior authorization
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Prior authorization form and medical coverage criteria for Amtagvi (lifileucel) administered under the medical benefit (J9999). Defines patient eligibility, clinical exclusion criteria, dosing limits, provider and site requirements, and documentation/submission instructions for approval of a single lifetime treatment course.
No material clinical/coverage changes
Coverage Summary
Prior authorization is required for Amtagvi (lifileucel) administered under the medical benefit (HCPCS J9999). The prior authorization form and medical coverage criteria define patient eligibility, clinical exclusion criteria, dosing limits, provider and site requirements, and documentation/submission instructions for approval of a single lifetime treatment course.
Amtagvi is provided as patient-specific infusion bag(s) with a single-dose, one-time lifetime administration: 1 treatment course (1 dose) per lifetime. The form captures member and prescriber information, clinical eligibility, dosing schedule, and site of administration details necessary for authorization.
Provider Actions & Submission Requirements
Submit signed prior authorization request
Prescribing physician must sign and clearly print name on the prior authorization request and fax complete information to 1-877-535-1391. Incomplete, incorrect, or illegible submissions may delay authorization.
Support each criterion with documentation
All documentation, including laboratory results, diagnostics, and chart notes, must be provided to support each clinical criterion checked on the authorization form. Failure to provide required documentation may result in denial or delay of the request.
- Lab results
- Diagnostic reports
- Chart notes / clinical documentation
Provider specialty requirement
Ensure the requesting provider is an oncologist, or a dermatologist with an oncology consult or oncology specialty documented on the request form.
Dose and dispensing limits
Dose and dispensing limits: Amtagvi is a single lifetime treatment (one treatment course, one dose per lifetime). Product NDC 73776-0001-xx describes Amtagvi as 7.5 x 10^9 to 72 x 10^9 viable cells suspended in 1 to 4 patient-specific infusion bag(s). Use HCPCS code J9999 for medical benefit billing. Note that the product may be provided in 1–4 patient-specific infusion bags and should be billed on the medical benefit.
- Single lifetime dose allowed (1 treatment course)
- Product NDC: 73776-0001-xx
- HCPCS: J9999
- Contains 1 to 4 patient-specific infusion bags; bill under medical benefit
Urgent review process
For urgent review requests—where lack of treatment could seriously jeopardize life, health, or the member’s ability to regain maximum function—the practitioner should call the AvMed Pre-Authorization Department to request an urgent review.
Applicable Codes
| J9999 | Not otherwise classified drugs (used here for Amtagvi lifileucel) |
| 73776-0001-xx | Amtagvi contains 7.5 x 10^9 to 72 x 10^9 viable cells suspended in 1 to 4 patient-specific infusion bag(s) |
Background
Amtagvi (lifileucel) is a cell therapy product supplied in patient-specific infusion bag(s) and administered as a single-dose, one-time lifetime therapy. The product is represented on the form as Amtagvi (lifileucel) for medical benefit billing.
The prior authorization form collects details to document clinical eligibility, dosing and dosing limits (including number of infusion bags and viable cell counts), and the provider/site of administration. The form requires the prescribing physician's signature and provider contact information; incomplete or illegible submissions may delay authorization.
Treatment course is defined as 1 dose (single administration) of Amtagvi per lifetime.
Clinical Evidence & Metrics
All authorization criteria must be met and supported with documentation (lab results, diagnostics, chart notes). Key clinical prerequisites include: patient age of 18 years or older; diagnosis of unresectable or metastatic melanoma (excluding uveal melanoma); administration by an oncologist or a dermatologist with oncology consult/specialty; prior therapy with a PD-1 blocking antibody (and if BRAF V600 mutation-positive, prior BRAF inhibitor with or without a MEK inhibitor); and eligibility for IL-2 (aldesleukin) per the manufacturer's prescribing label.
Important exclusions and clinical thresholds that must be met prior to treatment include: only a single lifetime dose allowed; no uncontrolled brain metastases; no clinically significant active systemic infection; no hemorrhage grade ≥2 within 14 days prior to therapy; cardiac function thresholds of LVEF not less than 45% and NYHA class ≤ 1; and pulmonary threshold of FEV1 > 60%. Concurrent prophylactic systemic corticosteroids should not be given.
Revision History
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.