Pitolisant Medicine 09 January 2018 Extended indication Excessive daytime sleepiness in moderate to severe obstructive sleep apnoea syndrome. Therapeutic value Possible added value Total cost Registration phase Withdrawn Product Active substance Pitolisant Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Sleep disorders Extended indication Excessive daytime sleepiness in moderate to severe obstructive sleep apnoea syndrome. Current proprietary name Already available biosimilars / generics Proprietary name Wakix Manufacturer Bioprojet Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Slaapcentra Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Betreft een indicatie-uitbreiding. Wakix is al geregistreerd voor indicatie 'narcolepsy with or without cataplexy'. Inmiddels zijn studies stopgezet (bron SPS). Therapeutic value Current treatment options Modefanil Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Middelen die overmatige slaperigheid kunnen behandelen en niet tot verslaving/gewenning leiden (zoals bij amphetamine varianten) of tot minder ernstige bijwerkingen leiden zijn potentieel klinisch veel waard. Of het effect op korte termijn ook behouden blijft op langere termijn is nog onduidelijk. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.nhg.org/standaarden/volledig/nhg-standaard-slaapproblemen-en-slaapmiddelen Additional remarks NHG: prevalentie tussen de 0,45 en 4% voor mannen; bij vrouwen is de prevalentie lager. (https://www.nhg.org/standaarden/volledig/nhg-standaard-slaapproblemen-en-slaapmiddelen). Dat betekent dus 76.500-680.000 patiënten. Maximaal aantal patiënten daarom geschat op 350.000. Expected cost per patient per year Cost € 4,000.00 - 9,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Prescribing Outlook 2017 Additional remarks Verwachting is dat het meerkosten gaat opleveren. Prescribing Outlook 2017: 'Pitolisant costs £310 to £620 per month (€360-720).' Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks