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Newly Approved Narcolepsy Product has a Price tag Exceeding $100K Annually

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
Nuvigil Already Occurred $9,683
Armodafinil Generic for Nuvigil $353
Provigil Already Occurred $1678
Modafinil Generic for Provigil $195
Generic Stimulant
Medications
Already Occurred ~$100-$1000
Sunosi 2031 $8030
Xyrem 1/1/2023 $143,256
Wakix 2031 $138,335

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