Diagnosis: Systemic Lupus Erythematosus
Treatment: Pharmacy/Prescription Drugs

Summary: This patient has a history of SLE (systemic lupus erythematosus) with features of RA (Rheumatoid Arthritis). She has an inflammatory arthritis with Raynaud's, for which she takes Procardia. She has positive antinuclear antibodies (ANA) and anti- deoxyribonucleic acid (DNA). She has used Enbrel, Imuran, sulfasalazine and Humira in the past. Xeljanz was stopped and Actemra was given. She is also on Rayos and Plaquenil. She had surgical closure of an atrial septal defect (ASD) in 2019. She stopped Rayos and began Acthar Gel twice a week in 2019. As of a visit in 2019, she was on Plaquenil, Actemra and Acthar Gel. She was noted to be doing much better and the plan is to increase Acthar to three times per week.

The insurer has denied coverage for Acthar injection 80 units every three days as not medically necessary. The denial was upheld.

Acthar works by stimulation of production of endogenous steroids, and therefore a similar pattern of toxicity would be expected. Using Acthar does not prevent possible corticosteroid toxicity, including in a patient who has already been on oral steroids. It also has probable other mechanisms of action, as well. The labeling is non-specific and provides no criteria that help determine a "selected" case. An UptoDate search finds no reference to the use of Acthar in the treatment of SLE or RA. Large trials that clarify the benefit/toxicity of Acthar, or that clarify when to use it are not found. Acthar injections 80 units every 3 days are not medically necessary for this patient. The labeling and literature do not provide guidelines as to when Acthar is appropriate, and risk/benefits are not clear. Treatment guidelines do not address its use. There is no basis for determining that Acthar is any better/safer than a dose of corticosteroids adjusted for disease activity. There is no documentation that supports the use of Acthar Gel as a standard of care in the treatment of SLE. The medical necessity is not substantiated.