Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Lupus Nephritis
Treatment: Voclosporin
The insurer denied the voclosporin.
The denial is upheld.

The patient is a female with systemic lupus erythematosus (SLE) and a history of Class III/V lupus nephritis. Her SLE had been stable on mycophenolate mofetil (MMF) 1.5 g (grams) daily and hydroxychloroquine (HCQ) 400 mg (milligrams) daily.

At her recent office visit, the patient had been lost to follow up while out of the country. She stopped taking MMF and self-decreased HCQ to 200 mg daily. In that setting, she had a lupus nephritis flare, which was formally diagnosed with increased creatinine (1.79) and 3+ (plus) proteinuria per report. She also presented with arthralgias, oral ulcers, lymphopenia and anemia.

The patient was treated with pulse-dose steroids followed by a prednisone taper down to 10 mg daily, and MMF 1.5 g daily was resumed. A repeat kidney biopsy was not performed. She had GI (gastrointestinal) intolerance to MMF, so the provider switched to Myfortic 720 mg twice daily, resumed HCQ 400 mg daily and continued prednisone 10 mg daily.

Per the provider's appeal, the patient has a creatinine of 1.49 and around 2 g proteinuria in the setting of therapeutic MMF levels. The provider wishes to add voclosporin to current therapy, and asserts that voclosporin would more likely lead to complete renal response as opposed to plan-preferred Benlysta. The appeal is for voclosporin for the treatment of recurrent SLE nephritis.

No, the requested addition of voclosporin for the treatment of SLE nephritis is not medically necessary over the health plan's preferred alternative, Benlysta.

This patient with SLE and SLE nephritis experienced a flare of these conditions in the setting of stopping her treatment with MMF and decreasing HCQ when lost to rheumatology follow up while out of the country. She was noted to have an increased creatinine of 1.79 and 3+ proteinuria per report, in addition to arthralgias, oral ulcers, lymphopenia and anemia, consistent with active SLE. She was treated with pulse-dose steroids followed by a prednisone taper down to 10 mg daily, and MMF 1.5 g daily was resumed. A repeat kidney biopsy was not performed.

Per the provider appeal letter, the patient presently has a creatinine of 1.49 and around 2 g proteinuria in the setting of therapeutic MMF levels, which is evidenced to be an improvement. In the absence of a repeat kidney biopsy and report of current urine sediment, it is unclear whether these findings represent chronic kidney disease versus persistent active SLE nephritis despite ongoing treatment. Standard of care for such a patient is to continue current treatment with monitoring, along with consideration of a repeat kidney biopsy prior to escalation of therapy.

If escalation of therapy for SLE nephritis is indeed required, there are no head to head comparative clinical trials suggesting that the requested voclosporin would be more efficacious than plan-preferred Benlysta for this patient. Of note, this patient had symptoms of active extra-renal SLE with her flare, which would be expected to respond to Benlysta and not voclosporin. Furthermore, voclosporin requires close clinical monitoring of blood pressure and renal function, which may not be ideal for a patient who has previously been lost to clinical follow up. Therefore, the proposed addition of voclosporin for the treatment of SLE nephritis is not medically necessary over the health plan's preferred alternative, Benlysta, for this specific patient.

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