Diagnosis: Lupus Nephrititis.
Treatment: Voclosporine, Pre-service.

The insurer denied the Voclosporine, Pre-service.
The denial is upheld.

The patient is a female diagnosed with lupus. She failed treatment with methotrexate and Plaquenil, and started treatment with CellCept due to a vasculitis rash. She later presented with mononeuritis and proteinuria > [greater than] 1 g (grams), with kidney biopsy demonstrating Class IV active lupus nephritis. At that point, she was treated with cyclophosphamide and tapering steroids. She resumed CellCept 3 g (grams) daily, and had improvement in proteinuria from 6.9 g (grams) to 1.6 g (grams) on spot urine protein to creatinine ratio. She has been inconsistent with taking CellCept.

At the patient's office visit, she was doing well, but due to persistent proteinuria over 1 g (grams) daily, the provider wished to add treatment with Voclosporin. Per the provider's appeal note, this patient started treatment with manufacturer samples of Voclosporin and demonstrated decreased proteinuria after one month. No primary data documenting this decrease in proteinuria are provided.

Voclosporin was denied coverage for this patient, because Benlysta is the preferred formulary alternative. The provider prefers continuation of Voclosporin over treatment with Benlysta because in clinical trials, Benlysta showed lower clinical responses. The appeal is for Voclosporin for the treatment of lupus nephritis.

No, the requested Voclosporin is not medically necessary.

Both Voclosporin and Benlysta are FDA (United States Food and Drug Administration)-approved for the treatment of lupus nephritis in combination with CellCept. This lupus patient was diagnosed with active Class IV nephritis on kidney biopsy, and was treated with cyclophosphamide and steroids, followed by maximally dosed CellCept 3g (grams) daily. At her office visit, she was clinically doing well, but due to persistent proteinuria over 1 g (grams) daily, the provider wished to add treatment with Voclosporin. Per the provider's appeal note, this patient started treatment with manufacturer samples of Voclosporin and demonstrated decreased proteinuria after one month. No primary data documenting this decreased proteinuria are provided.

The efficacy and safety of Benlysta was evaluated in a phase III multicenter trial that randomly assigned 448 patients with biopsy-proven, active class III, IV, or V lupus nephritis to receive Benlysta or placebo, in addition to standard therapy. At week 104, the rate of complete renal response was higher in the Benlysta group compared with the placebo group (30 versus 20 percent; OR [odds ratio] 1.7, 95% CI [confidence interval] 1.1-2.7). In addition, a post-hoc analysis of this trial found that the higher rate of complete response with Benlysta plus standard therapy was limited to individuals whose baseline UPCR (urine protein/creatinine ratio) was < [greater than] 3 g (grams) daily. Per attached documentation, this patient had proteinuria of 1.6 g (grams) daily, so Benlysta could be considered appropriate for her.

The efficacy and safety of Voclosporin was evaluated in a phase III, multicenter, randomized controlled trial of 357 patients (61 percent with focal or diffuse lupus nephritis, 14 percent with lupus membranous nephropathy, and 25 percent with both). At 52 weeks, the rate of complete renal response was higher among patients treated with Voclosporin compared with placebo (41 versus 23 percent; odds ratio [OR] 2.65, 95% CI [confidence interval] 1.644.27).

There are no randomized head-to-head trials directly comparing Benlysta to Voclosporin as add-on treatment to CellCept for persistent proteinuria in lupus nephritis. Based upon the available data, the formulary alternative Benlysta would be an appropriate alternative to voclosporin for this specific patient. Therefore, preferential treatment with Voclosporin instead of the formulary alternative Benlysta is not clinically appropriate or in accordance with standard or care, and thus not medically necessary for this specific patient.

Yes, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.