NAYZILAM (midazolam nasal spray)

Self-Administration - nasal

Indications for Prior Authorization:
  •  Indicated for the acute treatment 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 in patients with epilepsy 12 years of age and older
Coverage Criteria: 

For diagnosis of epilepsy

  • Dose does not exceed 5 mg.  One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose, AND
  • Patient is 12 years of age or older, AND
  • Diagnosis of partial or generalized epilepsy, AND
  • Prescribed by or in consultation with a neurologist, AND
  • Patient is experiencing stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures), AND
  • Patient is on a stable regimen of antiepileptic drugs, AND
  • Patient has tried and failed injectable midazolam for intranasal or buccal administration, or diazepam rectal gel
Reauthorization Criteria:

For diagnosis of epilepsy:

  • Dose does not exceed 5 mg.  One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose, AND
  • Member is responding positively to therapy
Coverage Duration:
  • Initial and reauthorization: 1 year, approvals are limited to 5 treatments per month
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Contraindications include acute narrow-angle glaucoma
  • Dosing:
    • Initial dose: Administer one spray (5 mg dose) into one nostril.
    • Second dose (if needed): One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose
      • A second dose of Nayzilam® should not be administered if the patient has trouble breathing or if there is excessive sedation that is uncharacteristic of the patient during a seizure cluster episode.
    • Maximum Dosage and Treatment Frequency: Do not use more than 2 doses (10 mg) of Nayzilam® to treat a single episode.
    • It is recommended that Nayzilam® be used to treat no more than one episode every three days and no more than 5 episodes per month
  • Controlled substance C-IV.
Policy Updates:
  • 11/16/2021 – Updated trial and failure criteria to include diazepam rectal gel
  • 2/18/2020 – New policy approved by P&T
References:
  • Diastat & Diastat AcuDial [package insert], Bridgewater, NJ: Bausch Health US, LLC; March 2021.
  • Glauser T, Ben-Menachem E, Bourgeois B, et al; for the ILAE subcommission of AED Guidelines. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2013;54(3):551-563.
  • Glauser T, Shinnar S, Gloss D, et al. Evidence-based guideline: treatment of convulsive status epilepticus in children and adults: report of the Guideline Committee of the American Epilepsy Society. Epilepsy Curr. 2016;16(1):48-61.
  • Hartman AL, Di Laura Devore C, Kang PB, et al. Rescue Medicine for Epilepsy in Education Settings. American Academy of Pediatrics January 2016; 137 (1): e20153876. 10.1542/peds.2015-3876.
  • McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, Martland T, Berry K, Collier J, Smith S, Choonara I. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomized controlled trial. Lancet. 2005;366(9481):205. Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK.
  • McKee HR, Abou-Khalil B. Outpatient pharmacotherapy and modes of administration for acute repetitive and prolonged seizures. CNS Drugs. 2015;29(1):55. Department of Neurology, University of Cincinnati, 222 Piedmont Avenue, Cincinnati, OH, 45219, USA.
  • Nayzilam [package insert]. Smyrna, GA: UCB, Inc.; February 2021.
  • Scott RC, Besag FM, Neville BG. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: a randomized trial. Lancet. 1999;353(9153):623. Wolfson Centre, Institute of Child Health, Great Ormond Street Hospital for Children NHS Trust, London, UK.
  • Talukdar B, Chakrabarty B. Efficacy of buccal midazolam compared to intravenous diazepam in controlling convulsions in children: a randomized controlled trial. Brain Dev. 2009;31(10):744. Epub 2008 Dec 27. Department of Pediatrics, Maulana Azad Medical College and Asssociated Chacha Nehru Bal Chikitsalaya (CNBC), Delhi-110031, India
  • Valtoco [package insert], San Diego, CA: Neurelis, Inc.; February 2021.

Last review date: November 16, 2021