Rimegepant Medicine 08 June 2021 Extended indication Migraine Prevention Therapeutic value Possible benefit in ease of use Total cost € 31,500,000.00 Registration phase Registration application pending Product Active substance Rimegepant Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Headache Extended indication Migraine Prevention Current proprietary name Already available biosimilars / generics Proprietary name Nurtec Manufacturer Biohaven Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Calcitonin gene-related peptide (CGRP)-receptorantagonist. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date February 2021 Expected Registration March 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Actual primary completion datum fase 3 studie in december 2019. SPS: "Biohaven reports that scientific advice for rimegepant for acute and prophylaxis migraine treatment was received from the EMA CHMP in June and December 2018, respectively. Based on this feedback, it believes it has several potential pathways to approval, which it is pursuing. Biohaven plans to file in Europe in Q1 21" Therapeutic value Current treatment options Andere CGRP receptor antagonisten. Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn op dit moment drie andere CGRP antagonisten geregistreerd als profylactische behandeling voor migraine. Geen van die drie middelen kan oraal ingenomen worden. Dit geeft een grote meerwaarde in toediening. Duration of treatment Frequency of administration 1 times every 2 days Dosage per administration 75 mg References NCT03732638 Additional remarks Expected patient volume per year Patient volume < 21,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GVS-advies erenumab (Aimovig®) voor de behandeling van migraine, ZIN 2019 Additional remarks In 2016 waren er 266.400 personen met migraine bekend bij de huisarts. In het geneesmiddelen vergoedingssysteem advies voor erenumab (andere CGRP receptor antagonist) wordt de prevalente populatie die voor dat geneesmiddel in aanmerking komt geschat op ruim 21.000 patiënten. Aangezien er meerdere nieuwe behandelingen op de markt komen voor deze indicatie zullen deze geneesmiddelen de markt onderling verdelen. Expected cost per patient per year Cost € < 1,500.00 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 https://www.reuters.com/article/us-colucid-pharms-m-a-eli-lilly-idUSKBN1521O6 Additional remarks Op basis van de lijstprijs van concurrerende geneesmiddelen in de Verenigde Staten zal een prijs van €1.500 in de EU verwacht kunnen worden. De uiteindelijke prijs in Nederland zal mogelijk lager liggen. Potential total cost per year Total cost € 31,500,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Acute migraine References SPS Additional remarks Other information Additional remarks