Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Scleritis and Uveitis.
Treatment: Humira to treat Non-infectious Refractory Scleritis.
The insurer denied coverage for Humira to treat Non-infectious Refractory Scleritis.
The denial is overturned.

This is a female patient with a history of refractory right-sided anterior scleritis. The patient presented to the rheumatologist's office for a follow-up visit for a scleritis flare up. The patient was being treated with 25 milligrams (mg) of subcutaneous (SC) methotrexate a week. The physician recommended continuing 25 mg of SC methotrexate once a week and 10 mg of prednisone a day until the patient receives 2 doses of Humira. The physician recommended administering SC Humira every other week to the patient.

The insurer has denied coverage for Humira to treat Non-infectious Refractory Scleritis, as not medically necessary. The insurer states that Humira is only covered if the patient has rheumatoid arthritis, Crohn's disease, plaque psoriasis, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, hidradenitis suppurativa, Behcet's disease, pyoderma gangrenosum, or uveitis. 

The patient is Human Leukocyte Antigen (HLA)- B51 positive without other signs of Behcet's Disease. The patient was treated with methotrexate but did not respond to treatment. Many of these patients fail topical treatments. These patients often needed systemic glucocorticoids, antimetabolites, and immunosuppressive agents. If the patient fails these treatments then tumor necrosis factor (TNF) inhibitors like Humira are an option. Evidence-based research supports the use of Humira to treat non-infectious refractory scleritis. 

The physician discusses two papers submitted with the appeal: "Long-Term Efficacy and Tolerability of anti-TNF Inhibitors in the Treatment of Non-Infectious Ocular Inflammation: An 8-Year Prospective Surveillance Study" (Sharma et al., 2018); and "Biologic Therapy in Refractory Cases of Uveitis and Scleritis: An Analysis of 18 cases from a Tertiary Care Center in South India" (Sadhu et al., 2020). 

Based on the review of the medical record, the patient has had episcleritis and more recently developed uveitis. These may be Behcet's Disease manifesting as eye complaints only, given the presence of HLA-B51. Given the presence of uveitis, the patient meets the Food and Drug Administration (FDA) approved indication for Humira use. And the articles provided for review support its use for refractory scleritis, despite no FDA-indication.  Humira is an appropriate choice here, given that this patient has both scleritis and uveitis. The use of Humira is also supported by Up to Date, who notes that Humira is a major option in disease resistant to other medications such as antimetabolites. 

Humira to treat Non-infectious Refractory Scleritis is considered medically necessary for this patient.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The medical necessity for Humira to treat Non-infectious Refractory Scleritis is substantiated. The insurer's denial should be overturned.