satralizumab-mwge — Blue Cross Blue Shield of Montana

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 requested indication OR there is support for using the requested agent for the patient’s age for the requested indication
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or has consulted with such a specialist
• Prescriber has screened the patient for hepatitis B viral (HBV) infection AND BOTH of the following: patient does NOT have an active HBV infection AND if the patient has had a 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 be using the requested agent in combination with rituximab, Soliris, Uplizna, or Ultomiris for the requested indication

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Prescriber is or has consulted with a specialist in the area of the patient’s diagnosis (e.g., neurologist)
• Patient does not have active hepatitis B infection AND if the patient has had a previous HBV infection or is a carrier, the 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 be using the requested agent in combination with rituximab, Soliris, Uplizna, or Ultomiris for the requested indication

Approval duration

12 months