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
Proprietary name Nurtec
Manufacturer Biohaven
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Calcitonin gene-related peptide (CGRP)-receptorantagonist.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date February 2021
Expected Registration March 2022
Orphan drug No
Registration phase Registration application pending
Additional comments 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
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.
Frequency of administration 1 times every 2 days
Dosage per administration 75 mg
References NCT03732638

Expected patient volume per year

Patient volume

< 21,000

Market share is generally not included unless otherwise stated.

References GVS-advies erenumab (Aimovig®) voor de behandeling van migraine, ZIN 2019
Additional comments 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
References https://www.reuters.com/article/us-colucid-pharms-m-a-eli-lilly-idUSKBN1521O6
Additional comments 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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Acute migraine
References SPS

Other information

There is currently no futher information available.