GVS advice to not include pitolisant (Ozawade®)
The National Health Care Institute has completed its assessment whether pitolisant (Ozawade®) can be included in the Medicine Reimbursement System (GVS). Pitolisant (Ozawade®) is used for the treatment of adult patients with narcolepsy. The National Health Care Institute advises the Minister to not include pitolisant (Ozawade®) because it does not meet the established medical science and medical practice.
Registered indication
Pitolisant with the brand name Ozawade® is registered to increase wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP), or who do not tolerate this therapy. One example of primary therapy is continuous positive airway pressure (CPAP).
Ozawade® is available as film-coated tablets of 4.5 mg and 18 mg.
The National Health Care Institute's advice
The National Health Care Institute has concluded that pitolisant, to increase wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP), or who do not tolerate this therapy, does not meet the established medical science and medical practice. For that reason, the National Health Care Institute advises the Minister that pitolisant should not be included in the Medicine Reimbursement System for this indication.
Given that pitolisant under the brand name (Wakix®) is already included in the GVS, the National Health Care Institute recommends that the following List 2 conditions are applied to pitolisant:
- Only for an insured person with narcolepsy.