CurrentCignaPolicy N/A

Topical Anesthetic - Lidocaine, Tetracaine Products Prior Authorization with Step Therapy Policy

Defines prior authorization and step therapy requirements for prescription coverage of lidocaine 7%/tetracaine 7% topical cream (Pliaglis and generics) and Synera topical patches for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyTopical Anesthetic - Lidocaine, Tetracaine Products Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeMinor editorial — no material clinical changes

Effective DateN/A

Next Review DateMay 7, 2025

Key ActionObtain prior authorization and ensure trial of one lidocaine cream and one lidocaine/prilocaine cream before requesting Pliaglis or Synera.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2named products covered/managed

1 weektypical approval duration

≥18 / ≥3minimum ages specified

Cosmetic usesexplicit non-covered indication

Coverage Criteria for Topical Lidocaine/Tetracaine Products

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inv-01: Initial Therapy - Pliaglis

Pliaglis (lidocaine 7%/tetracaine 7% cream) is covered when ALL of the following are met:

Pliaglis FDA-approved indication criteria: A) Patient is ≥ 18 years of age; AND B) The procedure is for a non-cosmetic condition; AND C) The medication will be applied to intact skin; AND D) Patient has tried BOTH of the following topical anesthetics: i) One lidocaine cream product; AND ii) One lidocaine/prilocaine cream product.approve for 1 week

Approvals provided for 1 week.

inv-02: Initial Therapy - Synera

Synera (lidocaine/tetracaine patch) is covered when ALL of the following are met for each indicated use:

Synera - Superficial Dermatological Procedures: A) Patient is ≥ 3 years of age; AND B) The procedure is for a non-cosmetic condition; AND C) The medication will be applied to intact skin; AND D) Patient has tried BOTH of the following topical anesthetics: i) One lidocaine cream product; AND ii) One lidocaine/prilocaine cream product.approve for 1 week

Approvals provided for 1 week.

Synera - Venipuncture or Intravenous Cannulation: A) Patient is ≥ 3 years of age; AND B) The medication will be applied to intact skin; AND C) Patient has tried BOTH of the following topical anesthetics: i) One lidocaine cream product; AND ii) One lidocaine/prilocaine cream product.approve for 1 week

Approvals provided for 1 week.

Coverage excludes use of these products for cosmetic conditions. Examples of cosmetic indications that will not be covered include dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser‑assisted tattoo removal.

Pliaglis and Synera are considered not medically necessary for any uses beyond their FDA‑approved indications and other uses supported by clinical evidence. Requests for these products for cosmetic indications (see examples above) will be denied as not medically necessary.

Initial Therapy Specifics

inv-14: Pliaglis initial therapy

Pliaglis initial approval criteria

Pliaglis initial therapy: Patient ≥18; procedure non-cosmetic; applied to intact skin; prior trial of one lidocaine cream AND one lidocaine/prilocaine cream; approve for 1 week.

inv-15: Synera initial therapy

Synera initial approval criteria

Synera initial therapy - procedures: Patient ≥3; procedure non-cosmetic; applied to intact skin; prior trial of one lidocaine cream AND one lidocaine/prilocaine cream; approve for 1 week.

Synera initial therapy - venipuncture/IV: Patient ≥3; applied to intact skin; prior trial of one lidocaine cream AND one lidocaine/prilocaine cream; approve for 1 week.

Step	Requirement	Coverage action
1
Trial of one lidocaine cream product

2
Trial of one lidocaine/prilocaine cream product

Requirement summary
Must try and fail (or have a contraindication to) both a lidocaine cream and a lidocaine/prilocaine cream prior to approval of Pliaglis or Synera
Coverage action

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Pliaglis (lidocaine 7%/tetracaine 7% topical cream), generics, and Synera. All approvals are time-limited as stated in the policy (typically approved for up to 1 week for covered indications).

PA required for Pliaglis, generics, and Synera
Approvals granted for the duration noted in the policy (e.g., 1 week for covered indications)

Step Therapy

Step Therapy Requirement

Step therapy must be met prior to approving Pliaglis (and generics) or Synera. For covered indications, the patient must have tried BOTH: 1) one lidocaine cream product; AND 2) one lidocaine/prilocaine cream product.

Step requirement: trial of one lidocaine cream product
Step requirement: trial of one lidocaine/prilocaine cream product

Billing Rule

Billing and Coding Requirements

When submitting claims, providers must use the most appropriate diagnosis and procedure codes in effect on the date of submission. Reimbursement will only be provided when services are submitted with covered diagnosis and/or procedure codes that align with the applicable coverage criteria.

Use current, appropriate codes as of the submission effective date
Claims without covered diagnosis or procedure codes under the applicable coverage policy will be denied

Denial Risk

Cosmetic Indications Not Covered

Requests or claims for cosmetic indications are excluded and will be denied. Examples of cosmetic indications include dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.

Cosmetic uses are not covered under the pharmacy benefit and will be denied
Examples: dermal filler injection; pulsed dye laser therapy; facial laser resurfacing; laser-assisted tattoo removal

Product Definitions

Pliaglis - definition and indication details

ProductPliaglis (lidocaine 7%/tetracaine 7% topical cream)

IndicationTopical local analgesia for superficial dermatologic procedures on intact skin in adults

Age limitAdults (≥ 18 years)

Application siteIntact skin only

Prior therapy requirementTrial of one lidocaine cream product AND one lidocaine/prilocaine cream product required prior to approval

Synera - definition and indication details

ProductSynera (lidocaine 70 mg/tetracaine 70 mg topical patch)

IndicationsLocal dermal analgesia for superficial dermatologic procedures and for venipuncture/intravenous cannulation

Age limitPatients ≥ 3 years of age

Application siteIntact skin only

Prior therapy requirementTrial of one lidocaine cream product AND one lidocaine/prilocaine cream product required prior to approval

Policy Summary

PayerCigna

PolicyTopical Anesthetic - Lidocaine, Tetracaine Products Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeMinor editorial — no material clinical changes

Effective DateN/A

Next Review DateMay 7, 2025

Key ActionObtain prior authorization and ensure trial of one lidocaine cream and one lidocaine/prilocaine cream before requesting Pliaglis or Synera.

SourceLink

On This Page

OpenPayer

Topical Anesthetic - Lidocaine, Tetracaine Products Prior Authorization with Step Therapy Policy

Coverage Criteria for Topical Lidocaine/Tetracaine Products

Initial Therapy Specifics

Step Therapy Requirements

Provider Actions and Billing Guidance

Coding Guidance

Product Definitions

Site of Care

Background