Subject: Pennsaid PA with Limit 787-C 07-2022

Drug

diclofenac sodium topical solution 1.5%

PENNSAID  (diclofenac sodium topical solution 2%)

Policy:

FDA-approved Indications
Diclofenac Sodium Topical Solution 1.5%
Diclofenac sodium topical solution 1.5% 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
The requested drug will be covered with prior authorization when the following criteria are met:
      •     The patient has osteoarthritis pain of the knee(s)
      AND
      •     Treatment with the requested drug is necessary due to
             concern about intolerance to oral nonsteroidal anti-
             inflammatory drugs (NSAIDs)
             OR
      •     Treatment with the requested drug is necessary due to a
             contraindication to oral nonsteroidal anti-inflammatory drugs
             (NSAIDs) 

Quantity Limits apply.

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

 
RATIONALE
The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Pennsaid (diclofenac sodium topical solution 2%) is indicated for the treatment of the pain of osteoarthritis of the knee(s).¹ Diclofenac sodium topical solution 1.5% is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).²

According to the American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip and Knee, topical NSAIDs are strongly recommended for patients with knee OA. In keeping with the principle that medications with the least systemic exposure (i.e., local therapy) are preferable, topical NSAIDs should be considered prior to use of oral NSAIDs; however, oral NSAIDs remain the mainstay of pharmacologic management of OA and are the initial oral medication of choice in the treatment of OA, regardless of anatomic location. Treatment decisions should take the personal beliefs and preferences of the patient, as well as the patient’s medical status into consideration. Which interventions and the order in which interventions are used will vary among patients.⁵ The American Academy of Orthopaedic Surgeons guidelines recommend oral or topical nonsteroid anti-inflammatory drugs (NSAIDs) for patients with osteoarthritis of the knee.⁶ Therefore, diclofenac sodium topical solution will be covered for patients who have osteoarthritis pain of the knee(s) and treatment with the requested drug is necessary due to concern about intolerance or a contraindication to oral non-steroidal anti-inflammatory drugs (NSAIDs).

The recommended dose of Pennsaid (diclofenac sodium topical solution 2%) is 40 milligrams of diclofenac sodium (2 pump actuations) on each painful knee 2 times a day (each pump actuation delivers 20 milligrams of diclofenac sodium in 1 gram of solution).¹ The recommended dose of diclofenac sodium topical solution 1.5% is 40 drops per knee 4 times a day (40 drops is approximately 1.2 milliliters).² 

Pennsaid (diclofenac sodium topical solution 2%) is available as a bottle containing 112 grams.¹ Diclofenac sodium topical solution 1.5% is available as a bottle containing 150 milliliters.² For each of these products, the quantity limit of 2 bottles is sufficient to treat both knees at the maximum FDA labeled dosing for 28 days.^1-2

Place of Service:

Outpatient

The above policy is based on the following references:

1. Pennsaid [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; January 2022.
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, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed May 12, 2022.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed May 12, 2022.
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 10, 2022