FDA Approves New Treatments for nr-axSpA, But Coverage May Be Tricky

by Jane Anderson

The FDA's approval of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.'s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.'s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis (nr-axSpA) offers providers new options for patients who are intolerant of non-steroidal anti-inflammatory medications (NSAIDs) and other therapies.

Axial spondyloarthritis (axSpA), an inflammatory arthritis of the spine, was reclassified into two categories. In the more commonly known ankylosing spondylitis (AS), also called radiographic axial spondyloarthritis (r-axSpA), damage to the spine is visible on an X-ray. In the earlier-stage form of the disease, non-radiographic axial spondyloarthritis (nr-axSpA), joint deterioration is not yet evident on an X-ray.

"It's possible that with the emerging trend of biologics gaining expanded indications to treat non-radiographic axial spondyloarthritis, payers will respond by choosing a preferred agent from the three [biologics] approved," says Mesfin Tegenu, R.Ph., president of PerformRx. "However, expanded indications for biologics in the treatment of non-radiographic axial spondyloarthritis, being a less advanced form of ankylosing spondyloarthritis, might cause no changes to formularies."

Nicole Kjesbo, Pharm.D., principal clinical program pharmacist at Prime Therapeutics LLC, says that although Taltz and Cosentyx provide a new mechanism of action to treat nr-axSpA, "at this time, their FDA approvals for this indication will not change the course of therapy, as they were already recommended for off-label use by guidelines."

The two newly approved biologics are listed in clinical guidelines as third-line treatments, behind NSAIDs and tumor necrosis factor inhibitors (TNFis), Kjesbo says, and according to the guidelines, "TNFis are recommended over Taltz or Cosentyx."

"NSAIDs are most commonly used for axial SpA (AS and nr-axSpA), and in many patients this is the only drug ever needed," Tegenu says. "Most NSAIDs are available generically."

"Second-line therapy is any tumor necrosis factor inhibitor (TNFi)," adds Tegenu. And Kjesbo explains that "TNFi treatment is recommended over treatment with Taltz, Cosentyx or [Pfizer Inc.’s] Xeljanz/XR (tofacitinib)."

Only one other drug was previously labeled to treat nr-axSpA: UCB's TNFi, Cimzia (certolizumab pegol). In patients who try and fail or have contraindications to NSAIDs and to TNFis, the two IL-17A inhibitors — Taltz and Cosentyx — are indicated for AS, Tegenu says.

From RADAR on Drug Benefits