satralizumab-mwge — Blue Cross Blue Shield of Texas

Initial criteria

• Diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
• Patient is anti-aquaporin-4 (AQP4) antibody positive (lab test required)
• Diagnosis confirmed by at least ONE of the following: optic neuritis OR acute myelitis OR area postrema syndrome (episode of otherwise unexplained hiccups or nausea and vomiting) OR acute brainstem syndrome OR symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions OR symptomatic cerebral syndrome with NMOSD-typical brain lesions
• 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: patient’s age is within FDA labeling for the indication OR there is support for using the requested agent for the patient’s age
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or has consulted with a specialist
• Prescriber has screened for hepatitis B viral (HBV) infection AND BOTH of the following: patient does NOT have active HBV infection AND if patient has previous HBV infection or is a carrier, prescriber has consulted with a gastroenterologist or hepatologist before initiating and during treatment
• Patient does NOT have active or untreated latent tuberculosis
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Patient will NOT use the agent in combination with rituximab, Soliris, Uplizna, or Ultomiris for the requested indication

Reauthorization criteria

• Patient previously approved for the requested agent through plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or has consulted with a specialist
• Patient does not have active hepatitis B infection; if patient has had previous HBV infection or is a carrier, prescriber continues to consult with a gastroenterologist or hepatologist during treatment
• Patient does NOT have active or untreated latent tuberculosis
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Patient will NOT use the agent in combination with rituximab, Soliris, Uplizna, or Ultomiris for the requested indication

Approval duration

12 months