Gefapixant Medicine 08 December 2020 Extended indication Adults with Unexplained and Refractory Chronic Cough Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Gefapixant Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Adults with Unexplained and Refractory Chronic Cough Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder Mechanism of action Receptor antagonist 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 Unknown ATMP No Submission date February 2021 Expected Registration March 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in maart 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Gefapixant is 52 weken onderzocht in de COUGH-1 en COUGH-2 studies. Hierin werd gefaxipant vergeleken met placebo en werd er een verbetering in de kwaliteit van leven geconstateerd. Er is nog geen vergelijking gedaan met andere geneesmiddelen. Duration of treatment Frequency of administration 2 times a day Dosage per administration 45mg References NCT03449134 Additional remarks - Codeine is not indicated for use in patients with RCC or UCC. - Codeine is not included and not recommended in the most recent European Respiratory Society guideline ‘Chronic Cough’ as a treatment option for RCC/UCC patients. - No Dutch guideline available. - Codeine has not been studied in RCC/UCC patients in any major trials. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Morice A. Chronic cough: epidemiology. Chron Respir Dis. 2008;5(1):43-7. Additional remarks Onder chronisch hoesten wordt verstaan dat het hoesten meer dan 8 weken aanhoudt. De prevalentie in de algemene bevolking wordt geschat op 12%. De drie voornaamste oorzaken van chronisch hoesten bij een niet-roker met een normale thoraxradiografie zijn astma, gastro-intestinale reflux (GER) en rhinosinusitis, echter bij een klein deel behandeling hiervoor niet afdoende en behoudt men chronische hoestklachten (RCC). Daarnaast kan er voor een klein aantal patiënten echter geen oorzaak gevonden worden en is er sprake van chronische onverklaarbare hoest (UCC). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks Codeine is not an appropriate comparator for gefapixant in this underserved patient population, where no current treatment option is registered for this UCC/RCC indication.