FDA Grants OTC Status to Voltaren® 1% Gel

FDA, Medicare Set-Aside Blog, Medicare Set-Asides, Rx/Pharmacy on February 21, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last Friday, while many of us may have been focused on Valentine’s Day activities, the Food and Drug Administration (FDA) was busy granting over-the-counter status to three products which were previously available only by prescription. One of those products was Voltaren (diclofenac) 1% gel, which is manufactured by GSK. When the product makes its OTC debut, it will be marketed as Voltaren Arthritis Pain. Voltaren 1% gel was initially approved as a prescription drug product in 2007 but more recently, GSK filed an Rx-to-OTC switch application with the FDA.

We wrote about Rx-to-OTC switch applications in October, when we detailed the efforts that many states have undertaken to make naloxone available without a prescription. If you missed that blog, you can read it here. When the FDA reviews an Rx-to-OTC switch application, it considers many factors which ultimately help to determine whether or not the drug is safe and effective for use by the general public without seeking treatment by a health care professional.

The approval of a topical non-steroidal anti-inflammatory drug (NSAID) is not surprising considering that certain formulations of oral NSAIDs have already been approved for OTC use, e.g. ibuprofen 200mg (marketed as Motrin® and Advil®) and naproxen sodium 220mg (marketed as Aleve®). Other formulations of ibuprofen and naproxen continue to be available by prescription only. The same will be true for topical diclofenac, meaning that while Voltaren Arthritis Pain will be available on an over-the-counter basis, other formulations of topical diclofenac will continue to be available by prescription only. These formulations include Solaraze® 3% gel and Pennsaid® 2% solution.

Although Voltaren Arthritis Pain has been deemed to be safe and effective in the absence of ongoing medical treatment, it carries an adverse drug event profile that is similar to those of oral NSAIDs. These adverse events are well-known and include things such as gastrointestinal ulceration or bleeding, decreased clotting time, heart failure, heart attack and stroke. Due to these risks, the OTC product labeling will include a full accounting of precautions and warnings for patients. The OTC packing will also include a recommendation that patients not use the product for more than 21 days unless instructed to do so by a health care professional. You can read the full FDA press release here.

Voltaren gel is FDA approved for the treatment of joint pain due to osteoarthritis to joints amenable to topical treatment such as the hands and knees and is not approved for treatment of the spine, hip, or shoulder; therefore, historically, Voltaren gel has been a non-Medicare covered expense when being used for back, neck, hip, or shoulder pain.  However, since OTC products are non-Medicare covered, FDA’s approval of Voltaren Arthritis Pain presents a further cost saving opportunity within the Medicare Set-Aside (MSA). In certain clinical scenarios Voltaren Arthritis Pain may be considered a safe and effective alternative to other Medicare covered therapy.  Provided there is adequate documentation to support its use, it may be possible to exclude certain costs from the MSA. MEDVAL is uniquely positioned to provide a drug utilization assessment to identify cost-savings opportunities such as this. Please reach out to a member of our team to learn more.