Wakix®
Drug - Wakix® (pitolisant) [Harmony Biosciences, LLC.]
April 2020
Therapeutic area - Narcolepsy
Initial approval criteria
- Patient is ≥ 18 years old AND
- Patient has an International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of narcolepsy 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) AND
- Patient does not have cataplexy AND
- A mean sleep latency of ≤ 8 minutes AND ≥ 2 sleep onset REM periods (SOREMPs) are found on a mean sleep latency test (MSLT) performed according to standard techniques (A SOREMP [within 15 minutes of sleep onset] on the preceding nocturnal polysomnogram may replace one of the SOREMPs on the MSLT) AND
- The hypersomnolence and/or MSLT findings are not better explained by other causes such as insufficient sleep, obstructive sleep apnea, delayed sleep phase disorder, or the effect of medication or substances or their withdrawal AND
- Patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for ≥ 3 months 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, sodium oxybate or armodafinil AND
- Patient must have tried and failed a 3-month trial of maximum tolerated dose of modafinil AND
- Patient does not have a history of prolonged QTc interval (e.g., QTc interval > 450 milliseconds) AND
- Therapy 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)
- Initial approval is for 3 months
Renewal criteria
- Patient must continue to meet the initial approval criteria AND
- Patient reports documented 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) 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)
- Renewal approval is for 3 months
Quantity limits
- All tablet strengths: 68 tablets per 34 days
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
