Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Rheumatoid arthritis
Treatment: Orencia intravenously (IV) 250 milligrams
The insurer denied: Orencia intravenously (IV) 250 milligrams
The denial is overturned

The patient is an adult female with rheumatoid arthritis (RA) and possible systemic lupus erythematosus (SLE) overlap. She failed treatment with the tumor necrosis factor (TNF) inhibitors Humira and Remicade and remains with severe active arthritis on methotrexate 20 milligrams weekly, hydroxychloroquine 200 milligrams daily and prednisone 7.5 milligrams daily. Weight is 104 pounds and body mass index (BMI) is 19. The patient also has a history of Crohn's disease and Clostridium difficile colitis with life-threatening colonic perforation requiring surgery.

The attending physician now wishes to prescribe Orencia 500 milligrams intravenously for the treatment of active rheumatoid arthritis (RA). The patient is not a candidate for self-injectable biologic therapy due to decreased manual dexterity with active arthritis. Orencia was denied for this patient because she has not failed all of the Plan-preferred formulary alternatives (i.e., Enbrel, Rinvoq, Xeljanz, Kevzara). Per attached documentation and the attending physician's appeal letter, Enbrel is contraindicated with a diagnosis of Crohn's disease and due to risk of precipitating a flare of systemic lupus erythematosus (SLE) she cannot take a tumor necrosis factor (TNF) inhibitor. The patient also already failed two other tumor necrosis factor (TNF) inhibitors, Humira and Remicade. Xeljanz, Rinvoq and Kevzara would be contraindicated with a history of colonic perforation. This appeal is for Orencia 500 milligrams intravenously for the treatment of active rheumatoid arthritis (RA).

The health plan should cover the proposed treatment with Orencia.

This patient with rheumatoid arthritis (RA) and possible systemic lupus erythematosus (SLE) overlap failed treatment with Humira and Remicade, and remains with severe active arthritis on methotrexate 20 milligrams weekly, hydroxychloroquine 200 milligrams daily and prednisone 7.5 milligrams daily. The attending physician now wishes to prescribe Orencia 500 milligrams intravenously for active rheumatoid arthritis (RA), which is Food and Drug Administration (FDA)-approved for the treatment of rheumatoid arthritis (RA). However, the patient has not tried or failed treatment with all of the Plan-preferred formulary alternatives (i.e., Enbrel, Rinvoq, Xeljanz, Kevzara).

Treatment with the tumor necrosis factor (TNF) inhibitor Enbrel is not appropriate for this patient who also has Crohn's disease, as Enbrel may lead to exacerbations of Crohn's disease. Furthermore, this patient has already failed treatment with the tumor necrosis factor (TNF) inhibitors Remicade and Humira, and tumor necrosis factor (TNF) inhibitors such as Enbrel could lead to exacerbation of systemic lupus erythematosus (SLE). Rinvoq, Xeljanz and Kevzara may all increase the risk of gastrointestinal perforation, and thus would be contraindicated in this patient with a history of Crohn's disease and Clostridium difficile colitis with life-threatening colonic perforation requiring surgery. Therefore, since this patient has contraindications to all of the remaining Plan-preferred formulary alternatives, treatment with intravenous Orencia is clinically appropriate and should be covered by the health plan.