Medical Drug Criteria (MDC)

Policy Num: P1.002.019
Policy Name: LAVIV (Azficel-T)
Policy ID: [P1.002.019][Ac L M- P-]

Last Review: September 02, 2025
Next Review: September 20, 2026

Related Policies:

LAVIV (Azficel-T)

Popultation Reference No.	Populations
1	Individuals: Indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

Summary

Azficel-T is an autologous cellular product composed of fibroblasts indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. Dermal fibroblasts are collected from the post-auricular biopsy tissue and aseptically expanded using standard tissue-culture procedures until sufficient cells for three doses are obtained. Expanded cells are then suspended in a cell medium. As a replacement for lost dermal constituents in the aging or skin deformation process, treatment with autologous fibroblasts has shown to improve wrinkle and acne scar appearance than with placebo treatment. Intradermal administration of autologous dermal fibroblasts into irradiated skin following surgical procedures was associated with an improved healing process of subsequent surgical wounds. Azficel-T is marketed in the US as Laviv for intradermal injection.

Policy Statements

Azficel-T is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. This is considered a cosmetic procedure.

Policy Guidelines

For autologous intradermal injection only.

Only healthcare providers who have completed a Fibrocell-approved training program should administer LAVIV.

Inject LAVIV at 0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions at 3-6 week intervals.

DOSAGE/ADMINISTRATION

A single vial of LAVIV contains approximately 18 million autologous fibroblasts in a 1.2 milliliters suspension, sufficient to administer 1 milliliter of product.

Inject LAVIV at 0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions at 3-6 week intervals.

REQUIRED MEDICAL INFORMATION

None.

EXCLUSION CRITERIA

Allogeneic use of LAVIV.
Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin.
Active infection in the facial area.

BENEFIT APPLICATION

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Based on benefits or contract language, LAVIV (Azficel-T) may be considered either a pharmacy or a medical benefit.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

3. National Center for Biotechnology Information (2025). PubChem Compound Summary for Azficel-T. Retrieved August 22, 2025 from https://pubchem.ncbi.nlm.nih.gov/compound/Azficel-T.

Codes

Codes	Number	Description
HCPCs Code	Not Determinded

Policy History

Date	Action	Description
September 2, 2025	MDC Creation	LAVIV® (azficel-T) is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. This is considered as a cosmetic procedure.