Enspryng (satralizumab-mwge) — Blue Cross Blue Shield of Alabama

Initial criteria

• - The patient has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
• - The patient is anti-aquaporin-4 (AQP4) antibody positive (lab test required)
• - The diagnosis was confirmed by at least ONE of the following: • Optic neuritis • Acute myelitis • Area postrema syndrome (episode of otherwise unexplained hiccups or nausea and vomiting) • Acute brainstem syndrome • Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions • Symptomatic cerebral syndrome with NMOSD-typical brain lesions
• - The patient has had at least 1 discrete clinical attack of CNS symptoms
• - Alternative diagnoses (e.g., multiple sclerosis, ischemic optic neuropathy) have been ruled out
• - If the patient has an FDA labeled indication, then ONE of the following: • The patient’s age is within FDA labeling for the requested indication for the requested agent • There is support for using the requested agent for the patient’s age for the requested indication
• - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or has consulted with such a specialist
• - The prescriber has screened the patient for hepatitis B viral (HBV) infection AND BOTH of the following: • The patient does NOT have an active HBV infection • If the patient has had a previous HBV infection or is a carrier for HBV infection the prescriber has consulted with a gastroenterologist or a hepatologist before initiating and during treatment with the requested agent
• - The patient does NOT have active or untreated latent tuberculosis
• - The patient does NOT have any FDA labeled contraindications to Enspryng