GVS advice solriamfetol (Sunosi®) for the treatment of narcolepsy or obstructive sleep apnoea
The National Health Care Institute has completed its assessment whether the medicinal product solriamfetol (Sunosi®) can be included in the Medicine Reimbursement System (GVS). Solriamfetol is indicated for the treatment of narcolepsy or obstructive sleep apnoea. The National Health Care Institute advises the Minister to include solriamfetol (Sunosi®) in the GVS with reimbursement conditions as described below.
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Indication for which reimbursement is requested
Solriamfetol (Sunosi®) is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy) or obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).
Solriamfetol is available as 75 mg and 150 mg film-coated tablets. For narcolepsy, the recommended starting dose is 75 mg once daily, upon awakening; a starting dose of 150 mg may be considered. For OSA, the recommended starting dose is 37.5 mg once daily upon awakening. Depending on clinical response, the dose can be titrated, with a recommended maximum daily dose of 150 mg once daily.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to place solriamfetol (Sunosi®) on List 1A of the Health Insurance Regulation in a newly to be formed cluster with pitolisant (Wakix®). The standard dose is 150 mg per day for solriamfetol and 18 mg per day for pitolisant. The National Health Care Institute recommends that the following reimbursement condition be included for solriamfetol.