Newly Approved Narcolepsy Product has a Price tag Exceeding $100K Annually
On August 15, 2019, the United States Food and Drug Administration (FDA) approved Harmony Biosciences’ Wakix® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. Harmony Biosciences has indicated they expect Wakix® to be commercially available in the U.S. in the fourth quarter of 2019 with an annual price tag of about $140,000. Wakix® is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the DEA.
Wakix® is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. Wakix ® is administered orally once daily in the morning upon wakening
Wakix® enters a competitive space joining, Modafinil (generic Provigil®), Armodafinil (generic Nuvigil®) as well as many generic stimulant medications. These products work by enhancing dopamine signaling creating wake-promoting actions. All alternative medications are controlled substances with a potential for abuse.
Alternative summary for Wakix® :
|Drug Name||Loss of Exclusivity||Estimated Annual Cost|
|Armodafinil||Generic for Nuvigil||$353|
|Modafinil||Generic for Provigil||$195|
|Generic Stimulant |
Based on the availability of various generic alternatives as initial therapy, it is advised to consider prior authorization criteria to ensure the appropriate use of Wakix ® . Possible PA for Narcolepsy would be:
- Diagnosis of narcolepsy
- Age ≥ 18 years
- Failure of at least one-month trial of multiple alternative medications
- Dose does not exceed 35.6 mg/day
Additional information can be found HERE