The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse pitolisant (Ozawade®) from the basic healthcare package. This is a reassessment of an earlier advice from 2022. Pitolisant can be used in certain patients with sleep apnoea. This medicinal product is already included in the Medicine Reimbursement System (GVS) for the treatment of narcolepsy. If the Minister adopts our advice, these reimbursement conditions will be expanded. Only then will this medicinal product also be reimbursed for patients with sleep apnoea. However, we do recommend additional conditions for reimbursement.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advisory report to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Pitolisant is intended for certain people with sleep apnoea
Pitolisant is the active substance. The brand name is Ozawade®. The medicinal product is a tablet that is ingested.
The medicinal product can be used for people with obstructive sleep apnoea. Some people frequently stop breathing while sleeping. These breath stops are called apnoea. The apnoea can occur because the muscles relax during sleep. Obstructive means that the tongue and soft parts in the throat block the airway. Patients often wake up from their sleep, take in less oxygen and experience sleep deprivation. This causes a patient to be tired, sleepy or less concentrated during the day.
Pitolisant is already being reimbursed for certain patients with narcolepsy. People with narcolepsy are very sleepy during the day and may experience sudden sleep attacks. The marketing authorisation holder now also applies for reimbursement for patients with obstructive sleep apnoea. It is a reassessment of the medicine, because in 2022 the National Health Care Institute ruled that it was unclear whether the medicinal product is actually effective. The marketing authorisation holder has now provided additional study data.
National Health Care Institute advice on the reimbursement of pitolisant (Ozawade®)
The National Health Care Institute advises the Minister of VWS to expand the conditions of pitolisant (Ozawade®) and thus to also reimburse the medicinal product for certain patients with sleep apnoea from the basic healthcare package.
For more information on the GVS and lists 1A, 1B and 2, see the page on ‘Reimbursement of outpatient medicines’.
Conditions for reimbursement of pitolisant (Ozawade®)
Only for the treatment of excessive daytime sleepiness (EDS) and the improvement of the degree of wakefulness in a patient
- with narcolepsy or
- diagnosed with obstructive sleep apnoea (OSA), and
- with residual symptoms of excessive daytime sleepiness (EDS) requiring treatment to improve the degree of wakefulness and
- receiving optimal OSA therapy, and
- for whom other causes for EDS are excluded.
The initial prescription must be prescribed at an SVNL-accredited sleep centre and by a specialist physician with specific expertise in sleep-wake disorders. Twelve months after the start of the pitolisant treatment, the SVNL-accredited sleep centre must assess whether it is appropriate to continue the use of pitolisant.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Minister of VWS asks the National Health Care Institute to make an assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Pitolisant is an extramural medicinal product. ‘Extramural’ means medicines for home use that can be obtained at the pharmacy with a prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.