Wakix®

Drug - Wakix® (pitolisant) [Harmony Biosciences, LLC.]

August 2026

Therapeutic Area - Narcolepsy

Initial approval criteria

Universal criteria

  • Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
  • Patient must not be receiving treatment with sedative hypnotic agents (e.g., zolpidem, eszopiclone, zaleplon, benzodiazepines, barbiturates) AND
  • Patient will not use drugs that prolong the QT interval (e.g., quinidine, procainamide, disopyramide, amiodarone, sotalol, ziprasidone, chlorpromazine, thioridazine, moxifloxacin) concomitantly AND
  • Patient will not use histamine-1 (H1) receptor antagonists (e.g., pheniramine maleate, diphenhydramine, promethazine, imipramine, clomipramine, mirtazapine) concomitantly AND
  • Patient is not receiving concomitant solriamfetol, oxybate products (Xyrem and Xywav), modafinil, or armodafinil AND
  • Patient does not have a history of prolonged QTc interval (e.g., QTc interval > 450 milliseconds) AND
  • Wakix will not be used in patients with severe hepatic impairment (Child-Pugh C) AND
  • Patient does not have end stage renal disease (ESRD) (e.g., eGFR < 15 mL/minute/1.73 m2); AND
  • Wakix is prescribed by or in consultation with a sleep specialist physician or a neurologist

AND

Excessive daytime sleepiness (EDS) with narcolepsy

  • Patient has been evaluated using polysomnography and a multiple sleep latency test; AND
  • Prescriber attests that a diagnosis of narcolepsy has been confirmed; AND
  • If patient is over 18 years of age, a 3-month trial of amphetamine or methylphenidate AND a 3-month trial of modafinil or armodafinil, unless contraindicated
  • If patient is under 18 years age, a 3-month trial of amphetamine or methylphenidate AND a 3-month trial of brand Xyrem (or generic if patient has previously tried generic); AND
  • Baseline daytime sleepiness as measured by a validated scale (e.g., Epworth Sleepiness Scale, Stanford Sleepiness Scale, Karolinska Sleepiness Scale, Cleveland Adolescent Sleepiness Questionnaire, or a Visual Analog Scale)

OR

Cataplexy with narcolepsy

  • Patient has been evaluated using polysomnography and a multiple sleep latency test; AND
  • Prescriber attests that a diagnosis of narcolepsy has been confirmed; AND
  • A 3-month trial of amphetamine or methylphenidate AND a 3-month trial of brand Xyrem (or generic if patient has previously tried generic sodium oxybate); AND
  • Baseline frequency of cataplexy attacks

AND

  • Initial approval is for 3 months

Renewal criteria

  • Patient must continue to meet above criteria AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., abnormal behavior, abnormal dreams or nightmares, anhedonia, anxiety, bipolar disorder, depression or depressed mood, nausea, QT prolongation, sleep disorder, suicide attempt or suicidal ideation)
  • For Cataplexy: reduced frequency of cataplexy attacks from pre-treatment baseline
  • For Excessive Daytime Sleepiness: Response to therapy with a reduction in excessive daytime sleepiness from pre-treatment baseline as measured by a validated scale (e.g., Epworth Sleepiness Scale, Stanford Sleepiness Scale, Karolinska Sleepiness Scale, Cleveland Adolescent Sleepiness Questionnaire, or a Visual Analog Scale)

Quantity limits

  • Quantity limits pursuant to the FDA-approved label will apply

Questions

Provider Call Center: (844) 575-7887