Wakix (pitolisant) — Highmark
narcolepsy without cataplexy
Preferred products
- generic modafinil
- generic CNS stimulant (e.g., methylphenidate, dextroamphetamine)
Initial criteria
- age ≥ 6 years
- Diagnosis of narcolepsy (ICD-10: G47.419, G47.21, G47.429)
- Prescriber provides one of the following diagnostic confirmations: (1) Multiple sleep latency test (MSLT) with mean sleep latency ≤ 8 minutes and ≥ 2 sleep-onset rapid eye movement periods (SOREMPs); OR (2) Polysomnography and MSLT demonstrating mean sleep latency ≤ 8 minutes, ≥ 1 SOREMP on MSLT, and ≥ 1 SOREMP on polysomnography; OR (3) Documented hypocretin-1 deficiency with cerebrospinal fluid hypocretin-1 < 110 pg/mL or < 1/3 normal value based on laboratory reference range
- Prescriber provides documentation of baseline data showing excessive daytime sleepiness (EDS) via Epworth Sleepiness Scale (ESS) OR Maintenance of Wakefulness Test (MWT)
- If age ≥ 18 years and narcolepsy with cataplexy: documentation of baseline number of cataplexy episodes AND therapeutic failure, contraindication, or intolerance to a plan-preferred generic CNS stimulant (e.g., dextroamphetamine)
- If age ≥ 18 years and narcolepsy without cataplexy: therapeutic failure, contraindication, or intolerance to both generic modafinil AND a generic CNS stimulant (e.g., methylphenidate, dextroamphetamine)
- If age < 18 years and narcolepsy: therapeutic failure, contraindication, or intolerance to one of the following plan-preferred products: generic modafinil OR a generic CNS stimulant (e.g., methylphenidate, dextroamphetamine)
Reauthorization criteria
- Prescriber attests that member experienced a decrease in cataplexy episodes with narcolepsy compared to baseline OR
- Prescriber attests that member experienced decreased daytime sleepiness with narcolepsy as evidenced by improvement on Epworth Sleepiness Scale (ESS) or Maintenance of Wakefulness Test (MWT) compared to baseline
Approval duration
12 months