Iga Nephropathy denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The enrollee has requested authorization and coverage for Acthar 80 units/ml.Madan and colleagues conducted a retrospective case series to examine Acthar gel (adrenocorticotropic hormone, ACTH) in patients with varied-etiology nephrotic syndrome (NS). They concluded that Acthar gel may meet an important treatment need in patients with treatment-resistant NS in response to first-line therapies, patients unable to tolerate first-line therapies, and in patients with advanced disease. Chakraborty and colleagues performed a systematic review to analyze the published literature on ACTH therapy in various NS etiologies, including IgA nephropathy (IgAN), to determine its efficacy. They concluded that ACTH showed benefits in proteinuria reduction across all etiologies of NS.

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Acthar Gel 400 units/5 mL vial. The records document that this patient presents with a diagnosis of IgA nephropathy. The patient has been treated with steroids, which the provider has recommended tapering, and switching to Acthar Gel. The U.S. Food and Drug Administration (FDA) has approved Acthar Gel for the treatment of patients with nephrotic syndrome (NS). Although Acthar Gel is not recommended for the treatment of patients with NS as first-line therapy, it is indicated as second-line therapy when initial treatment has failed or is not well tolerated.

Where the denial was upheld

Nature of Statutory Criteria/ Case Summary: The enrollee has requested authorization and coverage for the medication, H.P Acthar Gel. The enrollee has a history of steroid induced diabetes mellitus type 2, and systemic lupus erythematosus (SLE). Her nephrologist is requesting approval of HP Acthar Gel due to worsening proteinuria, now in the nephrotic range. She has had previous unsuccessful treatments including steroids, CellCept, Plaquenil, and cyclosporine. Her physician indicates a renal biopsy showed immunoglobulin A (IgA) nephropathy. Current treatments are not managing her symptoms so her physician has prescribed Acthar with a goal of managing proteinuria with nephrotic syndrome. A kidney biopsy done showed focal segmental glomerulosclerosis associated with lgA nephropathy and/or prior lupus nephritis.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tavenos (avacopan) 10 mg capsule. In this case, the patient has failed conventional therapy and is at high risk for ongoing graft loss. Mortality after allograft failure is quite high. Uffing and colleagues note that the graft loss is higher in patients with recurrence of IgA nephropathy after kidney transplantation. While not approved by the U.S. Food and Drug Administration (FDA), studies in current medical literature show promising results on the use of avacopan for IgA nephropathy.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving iga nephropathy, then check the rights and deadlines that apply to your plan.