PENNSAID (diclofenac)

PENNSAID (diclofenac)

SELF-ADMINISTRATION - TOPICAL

Indication for Prior Authorization:

• Treatment of the pain of osteoarthritis of the knee(s)

Coverage Criteria:

• Diagnosis of osteoarthritis of the knee(s), AND
• Patient is 18 years of age or older, AND
• Patient has tried and failed 2 preferred oral prescription nonsteroidal anti-inflammatory drugs (NSAIDs), AND
• Patient has tried and failed diclofenac 1% gel

Dosing:

• 1.5% solution: apply 40 drops to each affected knee 4 times daily
• 2% solution: apply 2 pump actuations to each affected knee twice daily

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following: 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Pennsaid® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery
• Pennsaid® is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• Cardiovascular Thrombotic Events (Black Box Warning): Avoid the use of Pennsaid® in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Pennsaid® is used in patients with a recent MI, monitor patients for signs of cardiac ischemia
• Gastrointestinal Bleeding, Ulceration, and Perforation (Black Box Warning): NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal
• Additional warnings for: hepatotoxicity, hypertension, heart failure and edema, renal toxicity and hyperkalemia, anaphylactic reactions, exacerbation of asthma related to aspirin sensitivity, serious skin reactions, premature closure of fetal ductus arteriosus, hematologic toxicity, masking of inflammation and fever, sun exposure, and eye exposure
• Do not use combination therapy with Pennsaid® and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations
• Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation
• Based on available data, diclofenac may be present in human milk
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 12/21/20- Annual Review, format updated
• 6/5/17- Annual Review

References: 

• Pennsaid [package insert]. Lake Forest (IL): Horizon Therapeutics USA, Inc.; 2020.