Focal Segmental Glomerulosclerosis denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: This patient is a 43-year-old female who underwent renal transplant in 1992 due to focal segmental glomerulosclerosis (FSGS). She is on now on dialysis and requires a second renal transplant. A live donor is available; however the patient is highly sensitized and had a positive crossmatch with the potential donor. The patient’s transplant specialist recommends desensitization with IVIG and Rituxan prior to transplant, and indicates that plasmapheresis may also be required. The provider’s request for authorization of the desensitization protocols was denied by the Health Plan citing the experimental nature of the therapies.The proposed therapies are considered to be the standard of care and are not investigational.

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Acthar 80 unit/ml gel.The U.S. Food and Drug Administration (FDA) has approved Acthar gel for the treatment of patients with nephrotic syndrome. The authors of a study found that Acthar gel “showed benefits in proteinuria reduction across all etiologies of nephrotic syndrome.” Acthar gel is not considered a first-line therapy for patients with nephrotic syndrome. A further review of medical literature reveals that the advantage of Acthar gel is the lack of the side effects of steroids. It has been determined that Acthar gel meets an important treatment need in patients with treatment-resistant NS, as well as in patients unable to tolerate first-line therapies.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Acthar Gel. The U.S. Food and Drug Administration (FDA) approves the use of Acthar Gel for the treatment of nephrotic syndrome. However, secondary focal segmental glomerulosclerosis (FSGS) is not amenable to immunosuppressive therapy and treatment would consist of treating the underlying cause, that is, the condition that has caused the secondary condition. In this clinical setting, the requested medication is not likely to be more beneficial for the treatment of this patient than standard management consisting of treating the primary condition that has caused the patient’s secondary complication.

Findings: The physician reviewer found that a patient has requested authorization and coverage for Cortrophin Gel. Limited clinical data support the efficacy of Acthar in the treatment of focal segmental glomerulosclerosis (FSGS). While some patients who are resistant to or unable to tolerate therapy with calcineurin inhibitors or steroids may benefit from Acthar gel, larger clinical trials are needed to assess its efficacy in this setting. Per the medical records, the patient has not tried and failed therapy with calcineurin inhibitors or steroids. Given that current medical literature does not support the use of Acthar gel in the treatment of FSGS, the requested medication is not medically indicated. Therefore, Cortrophin Gel is not medically necessary for the treatment of this patient.

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 focal segmental glomerulosclerosis, then check the rights and deadlines that apply to your plan.