Subject: Voltaren Gel Limit Policy 1728-H 06-2023

Drug

TOPICAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs)

diclofenac sodium topical gel 1%

VOLTAREN GEL (OTC)®  (diclofenac sodium topical gel 1%)

Policy:

FDA-APPROVED INDICATIONS
Diclofenac sodium topical gel, 1%
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
     •   Diclofenac sodium topical gel has not been evaluated for use on
          the spine, hip, or shoulder.

Voltaren Gel (OTC)
Voltaren Arthritis Pain is for the temporary relief of arthritis pain ONLY in the following areas:
     •   hand, wrist, elbow (upper body areas)
     •   foot, ankle, knee (lower body areas)
This product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no relief in 7 days, stop use.

INITIAL LIMIT QUANTITY
Drug	1 Month Limit*	3 Month Limit*
(diclofenac sodium topical gel, 1%)	300 grams / 25 days	900 grams / 75 days
Voltaren Gel (OTC)    (diclofenac sodium topical gel, 1%)	300 grams / 25 days	900 grams / 75 days
*The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Diclofenac sodium topical gel, 1% gel [package insert]. Durham, NC: Encube Ethicals, Inc.; February 2020.
2. Voltaren Gel (OTC) [package insert]. Warren, NJ: GSK Consumer Healthcare; 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed April 25, 2023.
4. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited 04/25/2023).

 

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 17, 2023