CurrentCignaPolicy IP0021

Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Cigna coverage policy governing medical necessity review and formulary exceptions for prescription topical diclofenac products for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTopical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Policy CodePolicy IP0021

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateJan 1, 2025

Key ActionObtain prior authorization and document trial or intolerance to diclofenac 1% gel before coverage of listed topical diclofenac products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6specific non-covered topical diclofenac products listed

12 monthsauthorization duration (initial and reauthorization)

1required prior tried agent (diclofenac 1% gel)

IP0021policy number

Coverage Criteria for Topical Diclofenac Products

Initial Medical Necessity Criteria

Covered when documentation shows ONE of the following for each listed product

General prerequisite: There is documentation the individual has had an inadequate response, contraindication, or intolerance to diclofenac 1% gel.

Applies to diclofenac sodium 2% topical solution; diclofenac sodium 1.5% topical solution; Flector (diclofenac epolamine) 1.3% topical patch; Licart (diclofenac epolamine) 1.3% topical patch; Pennsaid (diclofenac sodium) 2% topical solution and most listed products.

Voltaren specific: Member has tried diclofenac sodium 1% gel (the bioequivalent generic) AND cannot take it due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction.

This is an additional requirement specific to Voltaren (diclofenac sodium 1% gel).

Reauthorization Criteria

Reauthorization conditions

Policy Summary

PayerCigna

PolicyTopical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Policy CodePolicy IP0021

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateJan 1, 2025

Key ActionObtain prior authorization and document trial or intolerance to diclofenac 1% gel before coverage of listed topical diclofenac products.

SourceLink

On This Page

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Reauthorization: Above medical necessity criteria continue to be met AND there is documentation of beneficial response to therapy.

Reauthorization approvals are up to 12 months.

The products listed in this policy are non-covered and require a formulary exception or prior authorization for coverage. Specifically, this policy supports medical necessity review for exception requests for the following topical diclofenac products: diclofenac sodium 2% topical solution, diclofenac sodium 1.5% topical solution, Flector® (diclofenac epolamine) 1.3% topical patch, Licart™ (diclofenac epolamine) 1.3% topical patch, Pennsaid® (diclofenac sodium) 2% topical solution, and Voltaren® (diclofenac sodium) 1% gel. Receipt of sample product does not satisfy criteria requirements for coverage.

Initial Therapy Requirements

Initial therapy

Initial coverage requires trial or documented intolerance to diclofenac 1% gel.

Initial requirement: Documentation of inadequate response, contraindication, or intolerance to diclofenac 1% gel is required prior to coverage of the listed non-covered topical diclofenac products (receipt of sample product does not satisfy criteria).

Voltaren has an additional formulation-specific requirement as described in policy.

Continuation / Maintenance Criteria

Continuation

Continuation is covered when initial criteria met and benefit documented.

Continuation: Medical necessity criteria are met AND there is documentation of a beneficial response to therapy.

Reauthorization duration is up to 12 months.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for the listed topical diclofenac products. Initial and reauthorization approvals are granted for up to 12 months.

Prior authorization required for diclofenac topical products listed in policy IP0021.
Approval duration (initial and reauthorization): up to 12 months.
Step requirement: Trial of diclofenac 1% gel is required unless there is documentation of inadequate response, contraindication, or intolerance.

Documentation Required

Required Supporting Documentation

Providers must document clinical justification supporting the request. For initial requests, include documentation of an inadequate response to, contraindication to, or intolerance of diclofenac 1% gel (or documentation of a clinically significant allergy or serious adverse reaction to inactive ingredients). For reauthorization/continuation requests, include documentation of ongoing beneficial response to the requested topical diclofenac product.

Initial requests: clinical notes or prior treatment history showing inadequate response, contraindication, or intolerance to diclofenac 1% gel (or formulation-specific allergy).
Reauthorization requests: documentation of continued clinical benefit from the covered topical diclofenac product (clinical assessment, pain/function measures, or treatment notes).

Step Therapy

Step Requirement and Formulary Exception Prerequisites

Step therapy applies: coverage is limited to members who have tried diclofenac 1% gel (or bioequivalent generic) and cannot use it due to inadequate response, contraindication, intolerance, or formulation-specific allergy/serious adverse reaction.

Document trial of diclofenac 1% gel (dates, dose, and reason for failure) or documentation of contraindication/intolerance.
If requesting a product due to allergy to inactive ingredients, include evidence the formulation difference would cause a significant allergic reaction.

Step Therapy Requirements and Trials

Product	Step requirement
diclofenac sodium 2% topical solution	Documentation of inadequate response, contraindication, or intolerance to diclofenac sodium 1% gel is required before coverage.
diclofenac sodium 1.5% topical solution	Documentation of inadequate response, contraindication, or intolerance to diclofenac sodium 1% gel is required before coverage.
Flector (diclofenac epolamine) 1.3% topical patch	Documentation of inadequate response, contraindication, or intolerance to diclofenac sodium 1% gel is required before coverage.
Licart (diclofenac epolamine) 1.3% topical patch	Documentation of inadequate response, contraindication, or intolerance to diclofenac sodium 1% gel is required before coverage.
Pennsaid (diclofenac sodium) 2% topical solution	Documentation of inadequate response, contraindication, or intolerance to diclofenac sodium 1% gel is required before coverage.
Voltaren (diclofenac sodium) 1% gel	Member must have tried diclofenac sodium 1% gel (bioequivalent generic) AND cannot take it due to a formulation difference in inactive ingredient(s) that would cause a significant allergy or serious adverse reaction.

Quantity Limitations

Topical NSAIDs — Quantity Limitations

Quantity limits referenceSee Quantity Limitations policy (1201)

Applies toTopical nonsteroidal anti-inflammatory drugs (NSAIDs) listed in this policy (diclofenac topical products)

Unit of measurePer Quantity Limitations policy (1201) — see that policy for specifics

Site of Care

Note

Ensure site of care and regimen are reasonable and supported

The site of care for topical products should be reasonable and clinically appropriate; dosage, frequency, duration, and site of care must be supported by evidence-based literature and adjusted based on severity and prior response.

Product Definitions

Diclofenac 1% gel

ProductDiclofenac 1% gel (Voltaren Arthritis Pain)

IndicationRelief of pain of osteoarthritis of joints amenable to topical treatment (e.g., knees, hands)

OTC availabilityAvailable over-the-counter as Voltaren Arthritis Pain; previously prescription Voltaren Gel

LimitationsNot assessed for use on joints of the spine, hip, or shoulder

Flector / Licart patches

ProductFlector (diclofenac epolamine) 1.3% topical patch

IndicationTopical treatment of acute pain due to minor strains, sprains, and contusions

Age indicationApproved for patients ≥ 6 years of age

Pennsaid 2% solution

ProductPennsaid (diclofenac sodium) 2% topical solution

IndicationTreatment of pain of osteoarthritis of the knee(s)

Formulation noteTopical solution specifically indicated for knee OA

Background

Topical diclofenac formulations are nonsteroidal anti-inflammatory drugs (NSAIDs) intended for localized pain control. These products are commonly used for conditions such as osteoarthritis affecting joints amenable to topical treatment (for example, knees and hands). Specific formulations and labeled indications vary by product: for example, diclofenac 1% gel is available over the counter and indicated for osteoarthritis pain, while diclofenac epolamine patches (Flector/Licart) are indicated for topical treatment of acute minor musculoskeletal injuries.