FDA Says Multiple Gel-One Injections Are Safe

The FDA says multiple injections of Gel-One Cross-linked Hyaluronate, made by Zimmer Biomet Holdings, Inc., are safe.

The early December expanded safety announcement by the company said the FDA agreed the single-injection product is safe for use in repeat treatments administered in the physician office setting. Gel-One, according to the company, is indicated for knee osteoarthritis patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, such as acetaminophen. Hyaluronic acid (HA) is typically the last remaining step before the big, $30, 000-$40, 000 knee replacement surgery.

The company claims the product is the first low-volume viscosupplement available in a single-injection formulation for the treatment of osteoarthritis of the knee. Hyaluronic acid supplements the natural HA of the knee, which provides lubrication to the joint. Gel-One requires only a single 3 mL injection to complete the treatment course. The expanded safety claim from the FDA will enable physicians to safely utilize repeat treatment courses, if required, to provide continued pain relief for patients.

A few years ago, a senior Zimmer scientist told OTW that the company sees itself moving into the joint preservation business. In the current announcement, David Nolan, group president of the company’s biologics, extremities, sports medicine, surgical, trauma, and foot and ankle division, said the expanded safety claim, “is an exciting development for our growing portfolio of joint preservation treatments, as well as the millions of patients who can benefit from this simple, in-office solution for chronic knee pain. By enabling physicians to administer Gel-One Hyaluronate over multiple treatment cycles, we can offer patients a new option for longer-term osteoarthritis management.”

Payer Challenges

While the clinical evidence of HA has passed FDA muster, payers have been balking at paying for the procedure triggered by a May 2013 change in clinical practice guidelines from the American Academy of Orthopaedic Surgeons (AAOS). AAOS said it “cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee.”

While a vast majority of payers are still paying for HA, a number of them have started to make doctors and their office staff jump through new pre-authorization hoops. Medicare Utilization and Payment data found that in 2012, Medicare Part B reimbursed for 1.2 million injections of HA for 423, 669 Medicare patients by 12, 761 physicians or other clinicians.