Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Systemic Lupus Erythematous
Treatment: Acthar gel

The insurer denied coverage for Acthar gel.  The denial is reversed. 

An appeal indicated that the patient has been seen for several years for active systemic lupus erythematosus (SLE) and primary osteoarthritis. The patient is allergic to Benlysta and has active disease. Therefore, at this time the patient needs an alternative treatment. Previously Acthar gel was effective. 

The patient carries a diagnosed of SLE and is allergic to Benlysta. The package insert for Acthar indicates that the requested medication is approved for inflammatory diseases, which is what is afflicting this patient and hence is reasonable, appropriate and thus certified. The patient had previously responded to Acthar which is indicated for their condition of SLE. As such, the request for Acthar gel is considered medically necessary for this patient.

Per Ho-Mahler, N., Turner, B., Eaddy, M., Hanke, M. L., & Nelson, W. W. (2020), "Data from 54 patients with rheumatoid arthritis (RA), 30 patients with SLE, and 8 patients with dermatomyositis (DM)/polymyositis (PM) were analyzed. The most frequently reported reasons for initiating repository corticotropin injection (RCI) were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 Units twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician's impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of "improved," and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively."

Per Askanase, A. D., Zhao, E., Zhu, J., Bilyk, R., & Furie, R. A. (2020), "In the modified intention-to-treat population (RCI, n = 84; placebo, n = 85), the proportion of SLE Responder Index (SRI-4) responders at week 16 was not significantly different between groups (RCI, 47.6%; placebo, 43.5%; OR [95% confidence interval (CI)] 1.2 [0.6 to 2.2]; p = 0.5762). RCI treatment resulted in a reduction from baseline to week 16 in 28 swollen joint counts (SJC)/tender joint counts (TJC) and the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine. Post hoc analyses demonstrated a greater proportion of British Isles Lupus Assessment Group (BILAG) based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 >= 10 and CLASI-Activity >= 11. No new safety signals were identified."

Per Philbin, M., Niewoehner, J., & Wan, G. J. (2017), "Initiation of RCI therapy in patients with infantile spasms (IS), multiple sclerosis (MS), RA, SLE, or DM/PM has been associated with lower post-therapy healthcare utilization and medical costs, including decreases in hospitalizations, hospital length of stay, outpatient visits, and emergency department visits."                                                         

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Acthar gel is substantiated.