CurrentCignaPolicy N/A

Topical Nonsteroidal Anti-Inflammatory Drugs — Diclofenac Drug Quantity Management Policy

Defines retail and home-delivery quantity limits and medically necessary overrides for topical diclofenac formulations used for osteoarthritis and actinic keratoses for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTopical Nonsteroidal Anti-Inflammatory Drugs — Diclofenac Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateAug 5, 2025

Key ActionSubmit supporting documentation (indication and number of affected joints or lesions) when requesting quantity-limit overrides.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

500 gRetail max — diclofenac 1% gel

112 gRetail max — Pennsaid (2% soln)

150 mLRetail max — diclofenac 1.5% soln

100 gRetail max — diclofenac 3% gel

1 yrException approval duration

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Coverage Criteria — Quantity Limits and Overrides

Quantity limits and medically necessary overrides

Drug Quantity Limits: retail and home delivery maximums apply. Exceptions are covered as medically necessary only when the criteria below are met.

Diclofenac 1% gel - default limits: Retail maximum 500 grams per 28 days (5 x 100 g tubes); Home delivery maximum 1500 grams per 84 days (15 tubes).500 g/28 days

See overrides for multi-joint treatment

Diclofenac 1% gel - override: If the patient is treating the pain of osteoarthritis in multiple joints and requires more than 16 grams per day, approve 900 grams (9 tubes) per 28 days at retail and 2700 grams (27 tubes) per 84 days at home delivery.900 g/28 days

Override applies when criteria met; approvals for 1 year

Diclofenac 1.5% solution: Retail maximum 150 mL per 28 days (1 x 150 mL); Home delivery maximum 450 mL per 84 days (3 bottles). If treating signs and symptoms of osteoarthritis in both knees, approve 300 mL (2 bottles) per 28 days and 900 mL (6 bottles) per 84 days at home delivery.150 mL/28 days (standard); 300 mL/28 days for both knees

Approvals for 1 year

Diclofenac 2% solution (Pennsaid): Retail maximum 112 grams per 28 days (1 bottle); Home delivery maximum 336 grams per 84 days (3 bottles). If treating the pain of osteoarthritis in both knees, approve 224 grams (2 bottles) per 28 days and 672 grams (6 bottles) per 84 days at home delivery.112 g/28 days (standard); 224 g/28 days for both knees

Approvals for 1 year

Diclofenac 3% gel: Retail maximum 100 grams per 28 days (1 tube); Home delivery maximum 300 grams per 84 days (3 tubes). If treating more than three 5 cm x 5 cm actinic keratosis lesions, approve 100 grams per 28 days and 300 grams per 84 days for every three lesions; round up to the nearest multiple of three to determine the override quantity.100 g/28 days per up-to-3 lesions; scale by 3-lesion increments

Round up to determine override quantity; approvals for 1 year

No overrides are recommended for use in compounded formulations. Requests for quantities above the stated retail or home-delivery maximums should not be approved for compounded topical diclofenac preparations.

Provider Actions, Documentation, and Denial Triggers

Documentation Required

Documentation to Support Overrides

Providers must submit supporting clinical documentation when requesting overrides or exceptions to the Drug Quantity Management limits. Documentation should include the specific diagnosis, sites/joints being treated, daily quantity required with rationale (e.g., treating multiple joints or bilateral knee osteoarthritis), prior therapy and response, and any pertinent clinical measurements or notes that justify quantities above the listed maximums. Medical directors will review each request on its own merits and may exercise clinical judgment.

All approvals are valid for 1 year from the approval date.
If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria; submit documentation to support meeting those criteria.
Examples of documentation: progress notes, treatment plans specifying affected joints, dosing calculations showing grams/mL per day, prior authorization history, and records of inadequate response or intolerance to alternative therapies.

Denial Risk

Denial Triggers and Quantity Limit Enforcement

When the Drug Quantity Management rule is not met at point of service, coverage may be denied unless the required documentation demonstrates that an exception criterion is met (for example: multiple-joint osteoarthritis requiring >16 g/day of 1% gel, bilateral knee osteoarthritis requiring increased bottles of solution). Denials may occur for lack of sufficient clinical detail, missing documentation, or failure to meet the specific exception criteria described in the policy.

All approvals issued for exceptions are valid for 1 year.
Point-of-service quantity limits apply (retail per 28 days and home delivery per 84 days) unless an exception is approved.
Denial triggers include: insufficient or absent supporting documentation; request does not meet listed exception criteria; quantities exceed approved limits without documented justification.

Label Dosing Guidance (Per-Product)

Label dosing guidance

Diclofenac 1% gel per-joint dosingLower extremity: 4 g per affected foot/ankle/knee QID (do not exceed 16 g/day per single lower-extremity joint); Upper extremity: 2 g per affected hand/wrist/elbow QID (do not exceed 8 g/day per single upper-extremity joint). Total dose should not exceed 32 g/day.

Diclofenac 1.5% solution per-knee dosing40 drops (≈1.2 mL) per knee applied to clean, dry skin QID; ≈135 mL needed to treat one knee for 28 days (≈270 mL for two knees).

Diclofenac 2% solution (Pennsaid) per-knee dosing40 mg (2 pump actuations) applied to each painful knee BID; each gram contains 20 mg, so 112 g needed to treat one knee for 28 days (≈224 g for two knees).

Diclofenac 3% gel per-lesion dosingApply 0.5 g to each 5 cm x 5 cm actinic keratosis lesion twice daily; recommended duration 60–90 days (≈84 g needed to treat three lesions twice daily for 28 days).

Practical dosing limits from labelingUse the supplied dosing card for 1% gel (2 g and 4 g marks) to measure per-joint doses; do not exceed labeled per-joint and total daily maximums.

Retail and Home-Delivery Quantity Limits (per 28 days)

Diclofenac sodium 1% topical gel (100 g tube) — 500 grams

Retail maximum (per 28 days)500 grams (5 x 100 g tubes)

Home delivery maximum (per 84 days)1,500 grams (15 x 100 g tubes)

Related formulationDiclofenac sodium 1% topical gel (100 g tube) — generic (Voltaren® generic)

Diclofenac sodium 1% topical gel (100 g tube) — 1500 grams

Override retail maximum (when criteria met)Approve up to 900 grams per 28 days for multi-joint osteoarthritis requiring >16 g/day per joint (approval duration 1 year)

Override home delivery maximumApprove up to 2,700 grams per 84 days when override criteria are met (corresponds to 900 g/28 days)

ContextOverride applies only when medically necessary criteria are met for treatment of multiple joints.

Diclofenac sodium 1.5% topical solution (150 mL bottle) — 150 mL

Retail maximum (per 28 days)150 mL (1 x 150 mL bottle)

Home delivery maximum (per 84 days)450 mL (3 x 150 mL bottles)

Both-knees considerationIf treating both knees, approve 300 mL per 28 days (2 bottles) and 900 mL per 84 days when criteria met.

Diclofenac sodium 1.5% topical solution (150 mL bottle) — 450 mL

Home delivery maximum (per 84 days)450 mL (3 x 150 mL bottles)

Retail standard150 mL per 28 days; overrides available for bilateral knee treatment (see criteria).

ContextApprovals for overrides provided for 1 year when medically necessary criteria are met.

Diclofenac sodium 2% topical solution (112 g bottle, Pennsaid) — 112 grams

Retail maximum (per 28 days)112 grams (1 x 112 g bottle)

Home delivery maximum (per 84 days)336 grams (3 x 112 g bottles)

Per-knee dosing note112 g treats one knee for 28 days at labeled dosing (224 g for two knees).

Diclofenac sodium 2% topical solution (112 g bottle, Pennsaid) — 336 grams

Home delivery maximum (per 84 days)336 grams (3 x 112 g bottles)

Bilateral knee overrideIf treating both knees, approve 224 g per 28 days and 672 g per 84 days when criteria are met.

ContextApprovals for medically necessary overrides valid for 1 year.

Diclofenac sodium 3% topical gel (100 g tube) — 100 grams

Retail maximum (per 28 days)100 grams (1 x 100 g tube)

Home delivery maximum (per 84 days)300 grams (3 x 100 g tubes)

Per-lesion dosing noteLabeling: 0.5 g per 5 cm x 5 cm lesion BID; ≈84 g needed to treat three lesions twice daily for 28 days.

Diclofenac sodium 3% topical gel (100 g tube) — 300 grams