Nayzilam®

Drug - Nayzilam® (midazolam nasal spray) [UCB, Inc.] 

February 2020

Therapeutic area - Anticonvulsants, Other

Initial approval criteria

• Patient is 12 years of age or older AND
• Patient has a diagnosis of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern AND
• Patient is prescribed Nayzilam by or in consultation with a neurologist AND
• Prescriber attests that patient is adherent to a stable regimen of antiepileptic drugs (AEDs) (e.g., lamotrigine, topiramate, oxcarbazepine, etc.) AND
• Prescriber provides documentation to substantiate the following:
  • A comprehensive medication review is conducted to ensure that patient’s concomitant use of opioid is identified AND
  • If patient is on concomitant opioid, provide a clinical rationale for the determination that Nayzilam is the best option for the patient after careful consideration of other alternatives AND
  • Instructions have been provided to the patient and caregiver on ALL of the following:
    • How to identify seizure cluster AND
    • How to use Nayzilam including providing Nayzilam training kit AND
    • How to discard used and unused Nayzilam AND
    • Side effects of Nayzilam including impaired mental alertness and memory problems AND
    • Signs and symptoms of respiratory depression and sedation, if patient is on concomitant opioid; and how to respond to these medical emergencies AND
    • Methods to contact prescriber between visits AND
  • If patient has been prescribed Diastat gel previously and is now being prescribed Nayzilam, provide a clinical rationale for the switch. Factors such as preference and convenience will not be considered OR
  • If patient has not been prescribed Diastat gel previously, provide a clinical rationale for choosing Nayzilam nasal spray over Diastat gel. Factors such as preference and convenience will not be considered
• Initial approval will be for 3 months

Renewal criteria

• Patient continues to meet the above criteria AND
• Prescriber provides clinical rationale for requesting quantities exceeding limits below
• Renewal approval will be for 6 months

Quantity limits

• Initial approval: 10 single-dose nasal spray units per 30 days. Requests for extra units used for training, testing or priming, etc. will not be considered.
• Renewal approval: 4 single-dose nasal spray units per 30 days. Requests for extra units used for training, testing or priming, etc. will not be considered.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411