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Gefapixant

Extended indication Adults with Unexplained and Refractory Chronic Cough
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Gefapixant
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung other
Extended indication Adults with Unexplained and Refractory Chronic Cough
Manufacturer MSD
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2021
Expected Registration March 2022
Orphan drug No
Registration phase Registration application pending
Additional remarks Fabrikant verwacht registratie in maart 2022.

Therapeutic value

Current treatment options No current registered treatment option is available for adults with Unexplained Chronic Cough (UCC) and Refractory Chronic Cough (RCC).
Therapeutic value No estimate possible yet
Duration of treatment continuous
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

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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension No

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.