Diagnosis: Myasthenia Gravis
Treatment: Eculizumab, 10 milligrams
The insurer denied Eculizumab, 10 milligrams.
The determination is overturned.

This is a female patient who has a listed diagnosis of myasthenia gravis. The records indicate that the patient has previously failed prednisone, mycophenolate, thymectomy and intravenous immunoglobulin and persists with intermittent dysphagia and dyspnea. Eculizumab is requested and under review for medical necessity.

Yes. Eculizumab, 10 milligrams (mg) is medically necessary for this patient.

The patient remains disabled due to myasthenia gravis, despite multiple treatment failures. Eculizumab is proven, Food and Drug Administration (FDA) approved, and may be lifesaving. There is insufficient evidence from high-quality peer-reviewed literature, large, well-designed, blinded, randomized trials to support the long-term superiority of the remaining alternatives, over Eculizumab. It should be noted that the criteria requires high scores of Myasthenia Gravis-Activities of Daily Living (MG-ADL); however, such scores are neither required by the manufacturer or by the FDA.