Subject: Voltaren Gel Limit 1728-H P06-2024_R

Drug

diclofenac sodium (all other brands)  (diclofenac sodium )

VOLTAREN GEL (OTC)  (diclofenac sodium )

Policy:

Indications

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

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.

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

Place of Service:

Outpatient

The above policy is based on the following references:

1. Diclofenac sodium topical gel, 1% gel [package insert]. Warren, NJ: Cipla USA, Inc.; December 2022.
2. Voltaren Gel (OTC) [package insert]. Warren, NJ: Haleon US Holdings LLC; March 2024.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed May 13, 2024.
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited 05/13/2024).

 

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 19, 2024