Proper Billing of Nayzilam® and Valtoco® Nasal Sprays

A subset of patients who experience seizures due to epilepsy suffer from seizure clusters, despite being on maintenance epilepsy medications. Nayzilam® and Valtoco® are both FDA-approved 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 12 years and older and 6 years and older, respectively. Regardless, if your patient is prescribed Nayzilam® or Valtoco®, the perplexing billing opens the door for easy recoupments from PBMs.

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The first step to take when receiving either a Nayzilam® or Valtoco® prescription is to ensure it has clear directions and quantity prescribed.

Per the manufacturer product label, the initial dose of Nayzilam® is one spray into one nostril. If needed, and the directions support, an additional spray may be administered into the opposite nostril 10 minutes after the initial dose if the patient has not responded to the initial dose. For Valtoco®, the number of sprays per dose is dependent on the strength prescribed. According to the manufacturer product label, the initial dose for the 5 mg and 10 mg strengths is one spray into one nostril while the initial dose for the 15 mg and 20 mg strengths is two sprays – one spray into each nostril. If needed, and the directions support, a second dose may be administered at least 4 hours after the initial dose if the patient has not responded to the initial dose.

Also, it is necessary to know the maximum number of episodes the patient is allowed to treat per month to correctly calculate the days’ supply. FDA-approved directions recommend no more than two doses of Nayzilam® should be used to treat a single episode and it should not be used to treat more than one episode every three days with a maximum of five episodes per month. Similarly, FDA-approved directions recommend no more than two doses of Valtoco® should be used to treat a single episode and it should not be used to treat more than one episode every five days with a maximum of five episodes per month.

See the chart below and PAAS Tips for recommended billing guidance, in addition to other prescription components necessary to best protect your pharmacy from audit recoupments:

Drug Name NCPDP Billing Unit per Box Number of Sprays per Dose Number of Doses per Box Number of Sprays per Box Suggested Days’ Supply per Box
Nayzilam® 5 mg/spray 2 EA 1 dose = 1 spray 2 2 x 5 mg 3
Valtoco® 5 mg/spray 1 dose = 1 spray 2 x 5 mg 5
Valtoco® 10 mg/spray 1 dose = 1 spray 2 x 10 mg
Valtoco® 15 mg/2 sprays 1 dose = 2 sprays 4 x 7.5 mg
Valtoco® 20 mg/2 sprays 1 dose = 2 sprays 4 x 10 mg

PAAS Tips:

  • If any clarifications need to be made on the directions, be sure to include a full clinical note, complete with a date, name and title of person spoken with, what was communicated, and your initials
  • Ensure both the quantity and unit of measure is clear on the prescription as “2 boxes” and “2 EA” will lead to different billing outcomes
  • Notate the number of episodes the patient will be treating per month to ensure proper billing and use, paying particular attention to the refill intervals
  • Nayzilam® and Valtoco® are both C-IV and therefore require all aspects of a valid controlled substance prescription on the hard copy, such as patient address, physician address and physician DEA #

Meredith Thiede, PharmD
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