CurrentCignaPolicy IP0709

ZTlido for Individual and Family Plans

Coverage policy for ZTlido (lidocaine 1.8% topical system) for Cigna Individual and Family Plans, describing indications, medical necessity criteria, and conditions considered not covered.

Policy Summary

PayerCigna

PolicyZTlido for Individual and Family Plans

Policy CodePolicy IP0709

Change TypeNew policy

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization and document a trial of lidocaine 5% patch (required for Individual and Family Plans) before approval; approvals generally granted for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

New policy established for ZTlido (lidocaine 1.8% topical system) effective 1/1/2025.

1 yearauthorization duration

PHNFDA-approved covered indication

Trial of 5% patchIFP preferred product requirement

MultipleOther supported uses

Several listedNot covered conditions

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Coverage Criteria for ZTlido (lidocaine 1.8% topical system)

Medical Necessity Criteria

ZTlido is considered medically necessary when ONE of the following criteria are met:

FDA-approved indication: Postherpetic Neuralgia (PHN): Approve for 1 year if the patient meets the following: Preferred product criteria are met for the product(s) as listed in the below table.1 year approval

Preferred product criteria per policy; see Individual and Family Plans requirements for lidocaine 5% patch trial.

Low Back Pain (other use with supportive evidence): Approve for 1 year if the patient meets ALL of the following criteria: After trying at least three pharmacologic therapies with each one from a different class of medication used to treat low back pain; Preferred product criteria are met for the product(s) as listed in the below table.1 year approval

Examples of classes include acetaminophen, NSAIDs (e.g., etodolac, meloxicam, nabumetone), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), duloxetine, gabapentin (see policy).

Neuropathic Pain (other use with supportive evidence): Approve for 1 year if Preferred product criteria are met for the product(s) as listed in the below table.1 year approval

For neuropathic pain due to radiculopathy or sciatica, refer to Conditions Not Covered section.

Osteoarthritis (other use with supportive evidence): Approve for 1 year if the patient meets ALL of the following criteria: After trying at least three pharmacologic therapies with each one from a different class of medication used for the treatment of osteoarthritis; Preferred product criteria are met for the product(s) as listed in the below table.1 year approval

Examples of therapies include acetaminophen, celecoxib, other NSAIDs, salicylates, intraarticular glucocorticoids, hyaluronan, topical capsaicin (see policy).

The following uses are considered experimental, investigational, or unproven and are not covered: carpal tunnel syndrome (limited open-label data and excluded from AAOS guideline consideration), fibromyalgia (no available data), and myofascial pain as adjunctive therapy (limited small studies; larger controlled trials needed). Also considered not covered are pain associated with rib fractures, radiculopathy, rheumatoid arthritis, and sciatica due to limited or absent evidence supporting topical lidocaine use in these conditions.

Any other use of ZTlido or lidocaine topical systems that is not specifically listed as covered or supported by evidence in this policy is considered experimental, investigational, or unproven and is not covered.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are generally for 1 year when criteria are met; duration should be reasonable and clinically appropriate, adjusted for severity, alternative treatments, and prior response to therapy.

Prior authorization required and duration typically 1 year when criteria are met.
Dosage, frequency, duration, and site of care must be reasonable and supported by evidence-based literature.

Denial Risk

Denial Risk Conditions

Requests may be denied if the patient has not met specific trial requirements or if the requested use is not supported by the policy. For Individual and Family Plans, coverage of ZTlido (lidocaine topical system 1.8%) requires a prior trial of lidocaine 5% patch (Lidoderm, generics). Receipt of sample product does not satisfy coverage criteria.

Denial risk if required prior trial of lidocaine 5% patch not documented for Individual and Family Plans.
Denial risk if requested indication is listed under Conditions Not Covered or otherwise lacks supportive evidence.
Receipt of sample product alone is insufficient documentation for approval.

Documentation Required

Documentation Requirements

Documentation submitted with the request must support the applicable benefit plan terms and the clinical rationale for the requested therapy. Clinical notes should document prior therapies tried, response to those therapies, diagnosis, and rationale for the requested product. Receipt of sample product does not satisfy documentation or trial requirements.

Document the applicable plan language if it affects coverage determinations.
Include clinical notes showing prior medication trials, classes tried, treatment durations, and responses.
Samples do not substitute for documented trials or other required documentation.

Step Therapy

Prior Trial Requirements for Certain Non‑FDA Indications

For certain non‑FDA indications (for example, low back pain or osteoarthritis), the policy requires prior trials of at least three pharmacologic therapies with each agent from a different medication class before approval will be considered.

Examples of classes for low back pain: acetaminophen, NSAIDs, muscle relaxants, duloxetine, gabapentin; examples of NSAIDs and muscle relaxants are provided in policy.
Examples of classes for osteoarthritis include acetaminophen, celecoxib, NSAIDs, salicylates, intraarticular therapies, topical agents; at least three different classes must be tried and documented.

Initial Therapy Requirements

Initial Therapy Criteria

Initial coverage requirements for Individual and Family Plans and other uses with supportive evidence

Individual and Family Plans requirement: Patient has tried lidocaine 5% patch (Lidoderm, generics) before ZTlido; Preferred product criteria must be met.trial of lidocaine 5% patch

Receipt of sample product does not satisfy criteria.

Other uses (low back pain, osteoarthritis): Patient has tried at least three pharmacologic therapies with each one from a different medication class appropriate to the condition prior to approval; Preferred product criteria are met.three prior therapies

Examples of classes and agents provided in policy (e.g., acetaminophen, NSAIDs, muscle relaxants, duloxetine, gabapentin for low back pain; acetaminophen, celecoxib, NSAIDs, intraarticular therapies, topical agents for osteoarthritis).

Step Therapy Requirements

Requirement	Details
Step requirement before ZTlido approval	For specified non‑FDA indications (e.g., low back pain, osteoarthritis) patient must have trialed and failed at least three pharmacologic therapies, each from a different medication class appropriate to the condition; preferred product criteria must be met. Approvals for these uses are for 1 year.
Individual and Family Plans (IFP) additional requirement	For IFP members, the patient must have tried lidocaine 5% patch (Lidoderm, generics) prior to ZTlido; receipt of sample product does not satisfy this requirement. Approvals generally granted for 1 year when criteria are met.

Background

Lidocaine topical systems (including ZTlido [lidocaine 1.8% topical system] and lidocaine 5% patches) are topical local anesthetics indicated for relief of pain associated with postherpetic neuralgia (PHN). Lidocaine produces local analgesia by stabilizing neuronal membranes through inhibition of sodium channels with limited systemic absorption. Comparative data referenced in the policy indicate ZTlido provides equivalent lidocaine exposure and peak concentration to the lidocaine 5% patch; approvals and authorization duration are aligned with the PHN indication and supporting evidence for other uses when specified criteria are met.