ModifiedCentenePolicy CP PMN.08

Lidocaine Transdermal (Lidoderm, ZTlido)

Covers medical necessity and prior authorization criteria for transdermal lidocaine patches for post-herpetic neuralgia and selected off‑label diabetic neuropathy use for Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyLidocaine Transdermal (Lidoderm, ZTlido)

Policy CodePolicy CP PMN.08

Change TypeMaterial updates to step therapy, generic product preference, and continued therapy requirements

Effective Date09.01.06

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Step therapy bypass for Illinois HIM requests per IL HB 5395 was added for postherpetic neuralgia.

Policy language revised to reference generic lidocaine transdermal patch instead of brand Lidoderm/ZTlido in multiple criteria.

For continued therapy, requirement added for trial/use of generic lidocaine transdermal patch.

Revised initial criteria to clarify redirection to systemic therapy if request exceeds 30 supply.

Revised Lidoderm/ZTlido to generic transdermal lidocaine in Policy/Criteria and added requirement of a trial of generic lidocaine patches for continued therapy.

For postherpetic neuralgia, added step therapy bypass for IL HIM per IL HB 5395.

3max patches/day

12hmax wear time/24h

6 mo

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Coverage Criteria

inv-01: Initial Approval — Post‑herpetic Neuralgia

Covered when ALL of the following are met:

Initial Authorization Criteria: 1) Diagnosis of post-herpetic neuralgia secondary to herpes zoster; 2) Age > 18 years; 3) For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395; 4) For requests exceeding a 30-day supply (90 patches), member must meet BOTH of the following: (a) trial of gabapentin at doses >= 1,800 mg/day unless contraindicated or clinically significant adverse effects; and (b) member must use generic lidocaine transdermal patch unless contraindicated or clinically significant adverse effects; 5) If member is < 64 years of age, failure of a >= 30-day trial of one tricyclic antidepressant (e.g., amitriptyline, nortriptyline, desipramine) unless contraindicated or clinically significant adverse effects; 6) Request does not exceed 3 patches per day.

Approval duration: 6 months

inv-02: Initial Approval — Diabetic Neuropathy (off‑label)

Covered when ALL of the following are met:

Diabetic Neuropathy Criteria: 1) Diagnosis of diabetic neuropathy; 2) Age >= 18 years; 3) Request is for Lidoderm; 4) Member must use generic lidocaine transdermal patch unless contraindicated or clinically significant adverse effects; 5) Trial of gabapentin at doses >= 1,800 mg/day unless contraindicated or clinically significant adverse effects; 6) For requests exceeding a 30-day supply (90 patches), member must meet additional step therapy requirements including TCA trial/failure if <64 years and SNRI trial/failure as specified; 7) Request does not exceed 3 patches per day.

Approval duration: 6 months

inv-03: Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continued Therapy Criteria: 1) Member is currently receiving medication via Centene benefit or has previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Member must use generic lidocaine transdermal patch unless contraindicated or clinically significant adverse effects; 4) If request is for a dose increase, the new dose does not exceed 3 patches per day.

Approval duration: 12 months

Requests for uses that are non‑FDA approved indications and are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When there is a conflict between this clinical policy and state Medicaid coverage provisions for a Medicaid member, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage requirements.

Uses of transdermal lidocaine for off‑label indications that are not addressed in this policy will not be authorized unless the provider supplies adequate supporting clinical documentation as required by the off‑label use policies referenced above (CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating efficacy and safety for the requested indication.

Initial Therapy Criteria

inv-21: Initial Therapy — initial therapy criteria group

Initial Therapy: See Initial Approval criteria for post-herpetic neuralgia and diabetic neuropathy: age >18, trial of gabapentin at doses >=1,800 mg/day when required, trial/failure of TCA or SNRI as specified by indication/age, use of generic lidocaine transdermal patch unless contraindicated, and quantity limits (<=3 patches/day).

inv-22: INITIAL THERAPY CRITERIA — Revised to redirect requests exceeding a 30-day supply to systemic therapy

Initial Therapy — Supply Threshold: Requests exceeding a 30-day supply are redirected to systemic therapy; initial criteria were revised to clarify redirection to systemic therapy if request exceeds a 30-day supply.30 days

Requests >30 days (90 patches) require step therapy/systemic therapy per policy

Continuation / Continued Therapy Criteria

inv-23: Continued Therapy — criteria for continued supply

Covered when ALL of the following are met:

Continued Therapy: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member responding positively to therapy; 3) Member must use generic lidocaine transdermal patch unless contraindicated or clinically significant adverse effects; 4) If request is for a dose increase, new dose does not exceed 3 patches per day.

inv-24: CONTINUATION CRITERIA — Requirements updated to require a trial of generic lidocaine patches

Continuation Criteria — Generic Trial Requirement: For continued therapy, requirement added for trial/use of generic lidocaine transdermal patch prior to approval of continued supply unless contraindicated or clinically significant adverse effects are experienced.

Requirement added during 3Q 2024 annual review

Step Therapy Requirements

Step	Requirement
1	Trial of gabapentin at doses ≥ 1,800 mg/day AND trial/failure of a tricyclic antidepressant (TCA) if member is <64 years, or trial/failure of a serotonin–norepinephrine reuptake inhibitor (SNRI) for diabetic neuropathy examples (duloxetine, extended‑release venlafaxine, desvenlafaxine); trials should be at up to maximally indicated doses unless contraindicated or clinically significant adverse effects occur.

Step

Requirement

Trial of gabapentin at doses ≥ 1,800 mg/day AND trial/failure of a tricyclic antidepressant (TCA) if member is <64 years, or trial/failure of a serotonin–norepinephrine reuptake inhibitor (SNRI) for diabetic neuropathy examples (duloxetine, extended‑release venlafaxine, desvenlafaxine); trials should be at up to maximally indicated doses unless contraindicated or clinically significant adverse effects occur.

Jurisdiction	Bypass / Exception
Illinois Health Insurance Marketplace (IL HIM)	Step therapy requirements do not apply for post‑herpetic neuralgia requests to IL HIM as of 1/1/2026 per IL HB 5395 (step therapy bypass added).

Quantity Limits

Lidocaine transdermal patch 5% — maximum patches per day

Maximum patches per day3 patches/day

Supply exceeding 30-day (90 patches) — additional requirements

Supply exceeding 30-day (90 patches)Requires additional step therapy documentation: trial of gabapentin at doses >=1,800 mg/day and trial/failure of a TCA or SNRI as specified (unless contraindicated).

Coding & Usage Parameters

Gabapentin trial dose

Gabapentin trial dose>= 1,800 mg/day

When requiredTrial required for requests exceeding 30-day supply and as part of step therapy prior to lidocaine patch use unless contraindicated.

Failure/contraindication allowanceNot required if gabapentin is contraindicated or causes clinically significant adverse effects.

Patch wear time

Patch wear timeUp to 12 hours in a 24-hour period

Typical applicationApply patches to intact skin over the most painful area.

Manufacturer maximum

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Transdermal lidocaine (lidocaine patch) is considered medically necessary for post‑herpetic neuralgia (PHN) secondary to herpes zoster only when all applicable approval criteria are met and supporting documentation is submitted.

Prior authorization required for transdermal lidocaine for PHN
Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria
Approval duration: 6 months

Step Therapy

Prior Authorization and Step Therapy Updates

Step therapy and prior authorization requirements have been updated: generic transdermal lidocaine is preferred and a trial of generic lidocaine patches may be required for continued therapy. Requests exceeding a 30‑day supply are redirected to systemic therapy per the revised initial criteria.

Prefer generic lidocaine transdermal patch; member must use generic lidocaine patch unless contraindicated or significant adverse effects occur

Definitions

TCA — examples and role in step therapy

Examples of TCAsAmitriptyline, nortriptyline, desipramine, imipramine

Role in criteriaFailure of a >=30-day trial of one TCA required for members <64 years as part of step therapy unless contraindicated.

Dosing notesTCAs may be dosed up to maximally indicated doses per Appendix B; used as comparator/step therapy option.

Generic transdermal lidocaine — policy reference

Reference to generic transdermal lidocainePolicy updated to prefer generic lidocaine transdermal patch (Lidoderm/ZTlido revised to generic).

Continued therapy requirementContinued therapy requires trial/use of generic lidocaine patches unless contraindicated.

Background

Transdermal lidocaine 5% patch is an amide local anesthetic indicated for relief of pain associated with post‑herpetic neuralgia. Brand examples include Lidoderm and ZTlido; policy language has been revised to reference the generic lidocaine transdermal patch where applicable. Patches are applied to intact skin at the most painful area, commonly up to 3 patches per day, and may be worn for up to 12 hours in a 24‑hour period.

Site of Care / Application

Note

Topical application to intact skin at home

Apply patches to intact skin over the most painful area; the patch is for topical/home use.

Apply up to 3 patches at once to intact skin to cover the most painful area (wear up to 12 hours in a 24‑hour period).

Revision History

2025-05-09annual_review

Added step therapy bypass for Illinois Health Insurance Marketplace (IL HB 5395) for post‑herpetic neuralgia; references reviewed and updated.

2024-05-28annual_review

Revised Lidoderm/ZTlido references to generic transdermal lidocaine across Policy/Criteria and added requirement that continued therapy include a trial of generic lidocaine patches; removed commercially unavailable brand alternatives in Appendix B.

2022-08-12annual_review

Revised initial criteria to clarify redirection to systemic therapy when requests exceed a 30‑day supply (90 patches).