CurrentCignaPolicy IP0282

Topical diclofenac sodium 3% gel coverage policy (dermatology)

Cigna coverage policy governing medical necessity review and authorization of topical diclofenac sodium 3% gel for dermatologic indications (actinic keratoses, actinic cheilitis, and disseminated superficial actinic porokeratosis) for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTopical diclofenac sodium 3% gel coverage policy (dermatology)

Policy CodePolicy IP0282

Change TypeMaterial revision — prior-step requirement updated

Effective DateDec 15, 2024

Next Review Date

Key ActionObtain prior authorization and document failure, contraindication, or intolerance to BOTH topical 5‑fluorouracil and imiquimod before coverage is considered.

SourceLink

POLICY UPDATE CHANGES

Changed requirement from failure/contraindication/intolerance to ONE of 5-fluorouracil (cream/solution) or imiquimod 5% cream to requirement for BOTH agents for Actinic Keratoses.

Changed requirement from failure/contraindication/intolerance to ONE to BOTH for Actinic Cheilitis.

Changed requirement from failure/contraindication/intolerance to ONE to BOTH for Disseminated Superficial Actinic Porokeratosis (DSAP).

3Covered indications

6 monthsApproval duration

BothRequired prior agents

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Coverage Criteria

inv-01: Actinic Keratoses - Initial Therapy

Covered when documentation meets the following for each indication

Actinic Keratoses: Documentation of failure, contraindication, or intolerance to BOTH of the following: A) 5-fluorouracil cream or solution (2% or 5%); AND B) imiquimod 5% cream.both agents required

See Revision Details updating from 'ONE' to 'BOTH'

inv-03: Actinic Cheilitis and DSAP - Initial Therapy

Other covered dermatologic indications (require same prior-agent documentation)

Actinic Cheilitis: Documentation of failure, contraindication, or intolerance to BOTH of the following: A) 5-fluorouracil cream or solution (2% or 5%); AND B) imiquimod 5% cream.both agents required

Policy revision effective 12/15/2024

Disseminated Superficial Actinic Porokeratosis (DSAP): Documentation of failure, contraindication, or intolerance to BOTH of the following: A) 5-fluorouracil cream or solution (2% or 5%); AND B) imiquimod 5% cream.both agents required

Policy revision effective 12/15/2024

inv-02: Reauthorization Criteria

Reauthorization

Continuation Therapy: Above medical necessity criteria are met AND there is documentation of beneficial response to topical diclofenac 3% gel.benefit documented

Reauthorization up to 6 months

Use of topical diclofenac sodium 3% gel for indications other than the dermatologic conditions listed in this policy (actinic keratoses, actinic cheilitis, and disseminated superficial actinic porokeratosis) is considered experimental, investigational, or unproven and is not covered. Examples of non‑covered uses include osteoarthritis and other indications not specified in the Coverage Criteria; this list is not all‑inclusive and may be updated as new evidence becomes available.

Topical diclofenac 3% gel for the treatment of osteoarthritis is not considered medically necessary because its benefit is uncertain and supporting evidence is limited. The policy cites a single small randomized, placebo‑controlled trial of a diclofenac 3%/sodium hyaluronate 2.5% gel that showed only marginal additional analgesic effect when added to oral NSAID therapy, and other topical agents are indicated for osteoarthritis.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for topical diclofenac sodium 3% gel. Initial approvals are granted for up to 6 months; reauthorization may be granted for up to 6 months when continuation criteria are met.

Initial approval duration: up to 6 months
Reauthorization approval duration: up to 6 months

Step Therapy

Step Therapy Requirement

Coverage requires documented failure, contraindication, or intolerance to BOTH listed topical agents prior to approval.

Step therapy: Member must have failed, have a contraindication to, or be intolerant of BOTH A and B:
A. 5‑fluorouracil cream or solution (2% or 5%)
B. imiquimod 5% cream

Policy Identifier & Coding

Policy identifiermixed

IP0282

Coverage Policy Number (internal identifier)

Background

Diclofenac sodium 3% gel is a topical nonsteroidal anti‑inflammatory formulation indicated for the treatment of actinic keratoses. It is also used as a therapeutic option for related dermatologic conditions such as actinic cheilitis and may be effective for disseminated superficial actinic porokeratosis (DSAP). When used for dermatologic indications, sun avoidance is recommended during therapy and clinical response should be documented for reauthorization.

Definitions

Disseminated Superficial Actinic Porokeratosis (DSAP) — definition and treatment options

DefinitionDisseminated Superficial Actinic Porokeratosis (DSAP) is a dermatologic condition for which diclofenac gel has been studied as a potential treatment.

Studied pharmacologic optionsTopical 5-fluorouracil; topical vitamin D3 analogs; topical imiquimod; topical tacrolimus; topical retinoids (tretinoin, tazarotene); oral retinoids (isotretinoin, acitretin); and topical diclofenac.

Evidence summary for diclofenacAn open-label study (n=17) evaluated diclofenac sodium 3% gel: 12 weeks of therapy (with option to extend to 24 weeks). At Week 12 the target-area lesions had a mean reduction of 4% while total body lesions increased 12%; 10 patients who received 24 weeks showed a mean 10% increase in target-area lesions vs. 19% increase globally.

Clinical noteDiclofenac gel may be an option for DSAP but study results showed limited lesion reduction and some lesion increases over time; consider alternative topical or systemic agents listed above.