Subject: Voltaren Gel Limit 1728-H 07-2022

Drug

TOPICAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs)

VOLTAREN GEL (RX AND OTC)  (diclofenac sodium topical gel 1%)

Policy:

FDA-approved Indications
Voltaren Gel
Voltaren 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.
Voltaren 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.

 

LIMIT CRITERIA
Drug	1 Month Limit*	3 Month Limit*
Voltaren Gel (RX and 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.

 

 

RATIONALE

Voltaren 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. Voltaren Gel has not been evaluated for use on the spine, hip, or shoulder.¹ Voltaren Gel (OTC) is used for the treatment of arthritis pain only in the following areas: hand, wrist, elbow (upper body areas) and foot, ankle, knee (lower body areas). ² Per the compendia, use of topical diclofenac sodium gel 1% is only indicated for use in osteoarthritis.^3,4

 

The proper amount of Voltaren Gel should be measured using the dosing card supplied in the drug product carton. The dosing card should be used for each application of drug product. The gel should be applied within the rectangular area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily. Do not apply more than 16 g daily to any single joint of the lower extremities. Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily. Do not apply more than 8 g daily to any single joint of the upper extremities. Total dose should not exceed 32 g per day, over all affected joints.¹

 

The dosing card should be used to measure a dose of Voltaren Gel (OTC). For each upper body area (hand, wrist, or elbow) 2 grams should be used. For each lower body area (foot, ankle, or knee) 4 grams should be used. Voltaren Gel (OTC) should be used 4 times every day but should not be used on more than 2 body areas at the same time.²

 

The initial quantity limit is set at a dose to treat a single joint up to 8 grams per day. Voltaren Gel (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube.¹ Voltaren Gel (OTC) is available in 50 gram, 100 gram and 150 gram tubes and as a carton containing 350 grams (two 150 gram tubes and one 50 gram tube).² It is the discretion of the dispensing pharmacy to fill quantities per package size up to the established quantity limits. The Voltaren Gel (OTC) 350 gram package size will only be available on post-limit.

 

If the patient is requesting more than the initial quantity limit, the claim will reject with a message indicating that a prior authorization is required.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Voltaren Gel [package insert]. Malvern, PA: Endo Pharmaceuticals, Inc.; September 2018.
2. Voltaren Gel (OTC) [package insert]. Warren, NJ: GSK Consumer Healthcare; 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed April 27, 2022.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed April 27, 2022.

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