Clinical overview
Diclofenac is a nonsteroidal anti-inflammatory drug, often referred to as an NSAID, used to help reduce pain and inflammation. It is available in several formulations, including oral tablets, topical gels and topical solutions. In workers’ compensation and auto no-fault claims, topical diclofenac may be considered when localized musculoskeletal pain is part of the accepted condition and a topical therapy is clinically appropriate.
Diclofenac works by inhibiting cyclooxygenase, or COX, enzymes. This reduces production of prostaglandins, which are substances involved in pain and inflammation. As a topical product, diclofenac is applied to the skin over the affected area, which may help limit systemic exposure compared with oral NSAID therapy.
Topical diclofenac products are available in different strengths and dosage forms. Common pain-related topical formulations include diclofenac sodium topical gel 1% and diclofenac topical solution 1.5%. Diclofenac sodium gel 3% is a dermatologic product approved for actinic keratosis.
As with other NSAIDs, diclofenac products carry safety considerations, including cardiovascular and gastrointestinal risks. Product labeling should be reviewed, and treatment decisions should be made by the prescriber based on the patient’s clinical status, medical history, and treatment goals.
Diclofenac 1% gel compared with diclofenac 3% gel
Although diclofenac 1% gel and diclofenac 3% gel sound similar, they are not interchangeable. The two products differ in FDA-approved indication, typical use, evidence for pain management and cost. These differences are important for claims professionals, payers and clinical reviewers because the strength prescribed may affect whether the product aligns with the claim’s accepted condition and applicable formulary guidance.
Diclofenac 1% gel (Voltaren®)
Diclofenac 1% gel is commonly associated with musculoskeletal pain management and became available over the counter in 2020. It is a common anti-inflammatory used for arthritis pain in the knee, ankle, foot, hand, wrist and elbow, which are frequently accepted conditions in Optum Workers’ Compensation and Auto No-Fault claims data. The average wholesale price (AWP) for 100 grams is approximately $20.
Diclofenac 3% gel (formerly Solaraze®)
Diclofenac 3% gel is FDA-approved for actinic keratosis, a precancerous skin condition affecting sun-exposed areas such as the face, ears and scalp. It is not indicated for joint pain, and there is no evidence supporting off-label use of diclofenac 3% gel for pain. Diclofenac 3% gel is a prescription-only product. The AWP for 100 grams is approximately $112.
Official Disability Guidelines and formulary considerations
The Official Disability Guidelines (ODG) formulary lists diclofenac sodium, with Voltaren® as an example brand name, as a Y drug and generally recommends topical diclofenac for osteoarthritis of indicated joints. Diclofenac 1% gel aligns with these guidelines as the preferred Y product.
Some ODG resources, including the NDC Crosswalk and subscription website, list some diclofenac 3% gel national drug codes as Y drugs. However, the ODG confirmed that it lists diclofenac generally as a Y drug but does not yet break out individual topical strengths separately. ODG also clarified that diclofenac 3% gel is FDA-approved only for actinic keratosis and that commonly used preparations for musculoskeletal pain are typically 1% topical formulations.
Optum Workers’ Comp and Auto No-Fault position
Optum Workers’ Comp and Auto No-Fault considers diclofenac 1% gel to be the topical diclofenac product that aligns with ODG Y drug positioning for indicated musculoskeletal pain uses. Diclofenac 3% gel is not the preferred product for pain management. When diclofenac 3% gel is prescribed for pain, including neck or back pain, it should be reviewed as off-label use and considered an N drug for formulary purposes.
If you have any questions, please contact your clinical liaison or Ask-a-Pharmacist at 1-866-742-7676.