Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Sjorgen's syndrome. 
Treatment: Otrexup 15 milligram (mg)/0.4 milliliter (ml) SC (subcutaneous) SOAJ (solution auto-injector). 

The insurer denied coverage for Otrexup 15 milligram (mg)/0.4 milliliter (ml) SC SOAJ. 
The denial is overturned. 

This is a female patient. In the documentation given for review it shows she is with the diagnoses of Sjogren and uveitis. It was noted the patient failed oral methotrexate and is doing well on Otrexup. The treating provider has requested continuation of therapy, which is the topic of this review. 

Uveitis is a serious disease that can lead to serious complications and eventually blindness if not treated appropriately. It is recommended to continue same treatment if it is working. Methotrexate is well known to work in these cases, better than the preferred alternatives. 

Otrexup 15 milligram (mg)/0.4 milliliter (ml) subcutaneous (SC) SOAJ is considered medically necessary for this patient. 

Treatment aims at eliminating inflammation and pain with steroids and topical cycloplegics. Any additional therapies depend on associated processes. For example, anti-viral medications are necessary in herpetic uveitis, while Bactrim can be used in toxoplasmic chorioretinitis. Antimetabolite, biologics, and other immunosuppressive medications (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine, adalimumab, and infliximab) are often necessary for chronic, non-infectious cases, especially in cases associated with systemic inflammatory diseases. However, these agents should only be prescribed by providers specifically trained in their use and attuned to their side effect profile." (Duplechain, A. et al. 2021). 

"Uveitis is one of the major causes of vision loss and is estimated to cause approximately 10% of blindness in developed countries. Immunosuppressive therapy is the main treatment for non-infectious uveitis; local or systemic corticosteroids are the first-line treatment. However, prolonged corticosteroid uses leads to severe ocular (such as cataracts or intraocular elevation) and systemic (such as diabetes mellitus, gastrointestinal complications, or osteoporosis) side effects (3). Thus, corticosteroid-sparing agents should be considered when patients require ongoing treatment and are unable to taper to 10 mg/day of systemic corticosteroids. 

Methotrexate (MTX) is a commonly used antimetabolite for ocular inflammation. Although MTX is administered as a first-line corticosteroid-sparing agent in countries, such as the United States or European countries" (Harada, Y. et al. 2021). 

"Uveitis, a group of diseases characterized by sight-threatening intraocular inflammation, is the fifth most common cause of severe vision loss in high-income nations and was estimated to be responsible for 10% to 15% of all blindness cases in the United States in epidemiology studies conducted in the 1990s. (1,2)  Uveitis can be associated with a systemic disease or be eye limited and affects people of all ages, which may lead to greater years of vision loss than other age-related diseases. 

The standard first-line treatment for noninfectious uveitis is corticosteroids (topical, systemic, injections, and implants). However, corticosteroid therapy has local and systemic adverse effects making its long-term use undesirable. Timely management of uveitis is critical to prevent permanent vision loss, and multidisciplinary collaboration is often required given the need for corticosteroid-sparing immunosuppression." (Rathinam, S. R. et al. 2019). 

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

The insurer's denial of coverage for the Otrexup 15 milligram (mg)/0.4 milliliter (ml) SC SOAJ is overturned. Medical Necessity is substantiated.