Diagnosis: Ankylosing Spondylitis Treatment: Humira (dosed once weekly), Pre-service The insurer denied the Humira (dosed once weekly), Pre-service The denial is upheld. The patient is a female with ankylosing spondylitis (AS). She failed treatment with various non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate, sulfasalazine, Enbrel, and steroids. She has been treated with Humira, 40 milligrams, every other week for several years, in combination with Plaquenil, 200 milligrams, twice daily, for Sjogren's syndrome overlap. The patient reports that Humira efficacy now wanes after day #8, and she has persistent tenosynovitis. The attending physician (AP) suggested increasing Humira to weekly dosing versus switching Humira to secukinumab (Cosentyx), and the patient preferred weekly Humira dosing. Weekly Humira dosing was denied as off-label dosing for ankylosing spondylitis. The appeal is for Humira, 40 milligrams, weekly, for the treatment of ankylosing spondylitis. No, the proposed treatment with Humira is not medically necessary. Humira is Food and Drug Administration (FDA) approved for the treatment of ankylosing spondylitis at a dose of 40 milligrams every other week. It is not Food and Drug Administration (FDA)-approved for this indication at a dose of 40 milligrams weekly, as requested for this patient. The physician refers to a published long-term extension of the ATLAS trial (referenced below), which followed 53 patients who received benefit from open label extension weekly Humira dosing for at least one year, and did not have an increased risk of side effects. However, this study was not designed to compare weekly versus every other week dosing of Humira for ankylosing spondylitis. Furthermore, there are other standard of care biologic therapies that may be used for this patient within Food and Drug Administration (FDA)-prescribing guidelines. The physician offered to treat this patient with one such option, secukinumab (Cosentyx). Treatment with Humira, 40 milligrams, weekly, for ankylosing spondylitis is not in accordance with standard of care in the rheumatology community or clinically appropriate, and is therefore not medically necessary for this patient.
1) van der Heijde D, Schiff MH, Sieper J, Kivitz AJ, Wong RL, Kupper H, Dijkmans BA, Mease PJ, Davis JC Jr; ATLAS Study Group. Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial. Ann Rheum Dis. 2009 Jun;68(6):922-9. doi: 10.1136/ard.2007.087270. Epub 2008 Aug 13. PMID: 18701556; PMCID: PMC2674550. 2) Yu DT and Avan Tubergen A. Treatment of axial spondyloarthritis (ankylosing spondylitis and nonradiographic axial spondyloarthritis) in adults. www.UpToDate.com. Updated 11/20/2020. 3) Humira FDA prescribing guidelines.