Atogepant Medicine 03 June 2025 Extended indication Acute treatment of migraine with or without aura in adults Therapeutic value No estimate possible yet Total cost € 89,670,000.00 Registration phase Positive CHMP opinion Product Active substance Atogepant Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Headache Extended indication Acute treatment of migraine with or without aura in adults Current proprietary name Already available biosimilars / generics Proprietary name Aquipta Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action CGRP-directed antibody Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date January 2026 Expected Registration June 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in april 2026. Therapeutic value Current treatment options Andere CGRP receptor antagonisten. Rimegepant is een vergelijkbaar oraal tablet, maar wordt niet vergoed. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment moeten de resultaten uit de trials nog afgewacht worden. Duration of treatment Frequency of administration Dosage per administration References NCT06241313 Additional remarks Expected patient volume per year Patient volume 4,200 - 10,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References RIVM. Volksgezondheid en Zorg Migraine 2020 Zorginstituut Nederland. Budgetimpactanalyse CGRP-remmers Aimovig, Ajovy en Emgality Stichting Farmaceutische Kengetallen, Pharmaceutisch weekblad jaargang 155, nr 48 (2020) Expert opinie. Additional remarks In 2019 waren er 279.900 personen met migraine bekend. In 2020 was bekend dat er 210.000 triptaan gebruikers waren in Nederland. De verwachting is dat atogepant gebruikt zal worden als laatste lijnsbehandeling na het falen op twee of meer triptanen. Op basis van contact met klinische experts is de verwachting dat 2 tot 5% van de triptaangebruikers falen op twee of meer triptanen, hetgeen neerkomt op 4.200 tot 10.500 patiënten. De definitie van falen op triptanen en falen op eerdere preventieve medicatie moeten echter beiden helder geformuleerd worden. Expected cost per patient per year Cost € 12,200.00 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 Drugs.com Additional remarks 30 tabletten van 30mg zijn in de Verenigde Staten $1,105. Dit komt omgerekend neer op €12.180 per jaar. De prijs in Nederland is echter nog niet bekend. Potential total cost per year Total cost € 89,670,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks