WHA

VALTOCO (diazepam 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 6 years of age and older
Coverage Criteria:

For diagnosis of epilepsy:

  • Dose does not exceed 0.2 mg/kg (6-11 years of age) or 0.3 mg/kg (12 years of age and older), and dose does not exceed 2 doses per single episode (not to exceed 1 episode every 5 days or 5 episodes per month), AND
  • Patient is 6 years of age or older, AND
  • Diagnosis of partial or generalized epilepsy, AND
  • Prescribed by or in consultation with a neurologist, AND
  • Member is experiencing stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures), AND
  • Currently 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 0.2 mg/kg (6-11 years of age) or 0.3 mg/kg (12 years of age and older), and dose does not exceed 2 doses per single episode (not to exceed 1 episode every 5 days or 5 episodes per month), 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:
  • A second dose, when required, may be administered after at least 4 hours after the initial dose. If the second dose is to be administered, use a new blister pack of Valtoco®.
  • It is recommended that Valtoco® be used to treat no more than one episode every five days and no more than five episodes per month.
  • Contraindicated in patients with acute narrow angle glaucoma.
  • Controlled substance C-IV.
Policy Updates:
  • 11/16/2021 – 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