Nephrotic Syndrome denials in California external review

What the reviewers wrote

Where the denial was overturned

A 61-year-old male enrollee has requested authorization and coverage for Acthar, 80 mg subcutaneously, twice per week for treatment of the enrollee’s renal insufficiency status post right nephrectomy. Findings: The physician reviewer found that the cause of this patient’s nephrotic syndrome is not known with certainty because the patient has not had a kidney biopsy. However, it seems likely that this patient has FSGS secondary to hyperfiltration with a solitary kidney, in the setting of hypertension, despite being well controlled. This is a relatively common occurrence in patients with underlying renal risk factors, specifically hypertension, in patients who have a solitary kidney. Typically these patients do not respond to any immunosuppressive medications as it is not an immune-mediated process.

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Acthar Gel. The records provided for review document that this patient presents with a history of nephrotic syndrome (NS) with other morphologic changes and focal segmental glomerulosclerosis (FSGS). The patient was previously treated with prednisone without substantial response and Acthar Gel with good response. The patient’s provider has recommended retreatment with Acthar Gel. The U.S. Food and Drug Administration (FDA) has approved Acthar Gel for the treatment of patients with a diagnosis of NS.

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.

A 52-year-old male enrollee has requested Acthar gel for treatment of his nephrotic syndrome. Findings: The physician reviewer found that the medical literature supports use of Acthar gel therapy in patients with idiopathic nephrotic syndrome. However, Acthar gel is not recommended for treatment of patients with nephrotic syndrome occurring due to transplant glomerulopathy, recurrent, or de novo glomerulonephritis in renal allografts. The records do not indicate the patient’s native renal disease, whether the patient had nephrotic range proteinuria or nephrotic syndrome, or if the patient was treated with an ACE inhibitor. All told, the requested Acthar gel has not been demonstrated to be medically necessary for treatment of this patient’s medical condition.

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 nephrotic syndrome, then check the rights and deadlines that apply to your plan.