Arthritis medication – topical nonsteroidal anti-inflammatory drug (NSAID) Voltaren® (diclofenac gel) – to be sold over-the-counter

February 28, 2020 · Clinical Connection team

Voltaren Gel 1% (diclofenac sodium topical gel) ― a common medication in workers’ compensation and auto no-fault ― will soon transition from prescription (Rx) to over-the-counter (OTC) status, according to the U.S. Food and Drug Administration (FDA).

Voltaren availability
With the switch to OTC, Voltaren Gel 1%, first approved by the FDA in 2007, will no longer be available by prescription. Voltaren Arthritis Pain, marketed by GlaxoSmithKline (GSK), will be offered in the same prescription strength and is expected to be on retail pharmacy shelves in spring 2020. The cost has not yet been published.

Generic diclofenac sodium topical gel 1% - currently marketed by a number of manufacturers – is available by prescription. At this time, it is uncertain if the availability of generic diclofenac topical gel 1% will be affected by this change in the branded product.

Usage information:
Voltaren Arthritis Pain is intended to be used for the temporary relief of joint pain in the hand, wrist, elbow, foot, ankle or knee due to osteoarthritis, which increases with age and is often self-diagnosed. Pain, swelling, stiffness and difficulty moving a joint, are common symptoms of arthritis.

Voltaren Arthritis Pain may take up to seven days to work; therefore, it is not intended to be used for immediate pain relief. If this medication is needed for more than 21 days or if pain has not improved in seven days, patients should stop taking the medication and talk with their prescribers.

The OTC formulation will have the same safety warnings as the Rx formulation, including but not limited to risk of heart attack, heart failure, stroke, severe stomach bleeding, as well as kidney and liver damage.

Impact on workers’ compensation and auto no-fault

In our book of business, diclofenac sodium topical gel (Voltaren^® Gel) has been ranked in the top 25 medications as a percentage of total number of prescriptions and generic spend for the past few years.

As a reminder, an OTC formulation is allowed and can be dispensed at the pharmacy if the Rx formulation is allowed on the formulary. To encourage use of the OTC formulation, prescribers should mark “OTC” on the front of the prescription.

Because GSK expects Voltaren Arthritis Pain to be available without a prescription in the spring 2020, claimants who are currently using Voltaren Gel 1% should talk to their prescribers so therapy is not interrupted.To learn more about Voltaren Arthritis Pain, click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

U.S. Food and Drug Administration (FDA). News Release. FDA approves three drugs for nonprescription use through Rx-to-OTC switch process. February 14, 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-three-drugs-nonprescription-use-through-rx-otc-switch-process.
GSK Press Release. FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States. February 17, 2020. Available at: https://us.gsk.com/en-us/media/press-releases/fda-approves-gsk-s-voltaren-arthritis-pain-for-over-the-counter-use-in-the-united-states/.