Subject: Pennsaid PA with Limit 787-C P06-2025

Drug

diclofenac sodium (brand unavailable)  (diclofenac sodium )

PENNSAID  (diclofenac sodium )

Policy:

Indications

FDA-approved Indications

Diclofenac Sodium Topical Solution 1.5%

Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

Pennsaid

Pennsaid is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Coverage Criteria

Osteoarthritis Pain of the Knee(s)

Authorization may be granted when the patient has osteoarthritis pain of the knee(s) when ONE of the following criteria is met:

• Treatment with the requested drug is necessary due to a concern about intolerance to oral nonsteroidal anti-inflammatory drugs (NSAIDs).
• Treatment with the requested drug is necessary due to a contraindication to oral NSAIDs.

Continuation of Therapy

Osteoarthritis Pain of the Knee(s)

Authorization may be granted when the patient has osteoarthritis pain of the knee(s) when ALL of the following criteria are met:

• The patient has achieved or maintained a positive clinical response to the requested drug.
• The patient has been re-evaluated periodically to determine if treatment is still necessary.

Quantity Limits Apply

Quantity Limit

The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

Drug	4 Week Limit	12 Week Limit
(diclofenac sodium topical solution 1.5%)	300 mL (2 bottles, 150 mL each) / 21 days	900 mL (6 bottles, 150 mL each) / 63 days
Pennsaid (diclofenac sodium topical solution 2%)	224 gm (2 bottles, 112 gm each) / 21 days	672 gm (6 bottles, 112 gm each) / 63 days

Duration of Approval (DOA)

• 787-C: Initial therapy DOA: 4 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Pennsaid [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; November 2024.
2. Diclofenac Sodium Topical Solution 1.5% [package insert]. Baton Rouge, LA: SOLA Pharmaceuticals, LLC; June 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed May 13, 2025.
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 05/13/2025).
5. Kolasinski SL, Neogi T, Hockberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip and Knee. Arthritic Care & Research 2020;72(2):149-162.
6. American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty) Evidence-Based Clinical Practice Guideline (3rd Edition). August 31, 2021

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 13, 2025