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Riociguat

Adempas

Extended indication Adempas is indicated for the treatment of PAH in paediatric patients aged 6 to less than 18 years wi
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Riociguat
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Lung diseases other
Extended indication Adempas is indicated for the treatment of PAH in paediatric patients aged 6 to less than 18 years with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists (see section 5.1).
Proprietary name Adempas
Manufacturer MSD
Mechanism of action Vasodilator
Route of administration Oral
Therapeutical formulation Coated tablet
Budgetting framework Extramural (GVS)
Additional remarks Dit betreft een aanpassing aan het pediatrische label van patiënten jonger dan 18 jaar en ≥ 50 kg naar jonger dan 18 jaar en ouder dan 6 jaar.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2024
Expected Registration June 2025
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in april 2025.

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment Maximal 24 week / weeks
Frequency of administration 3 times a day
Dosage per administration 1.0 - 2,5 mg
References NCT02562235
Additional remarks Tot 2,5 mg driemaal daags (titratie tussen 1,0 mg en 2,5 mg) gedurende maximaal 8 weken tijdens de individuele dosistitratiefase (IDT), en gevolgd door de laatste dosis toegediend in de IDT-fase gedurende maximaal 16 weken tijdens de onderhoudsfase.

Expected patient volume per year

Additional remarks Deze aanpassing aan het label zal een zeer gering effect hebben op het patiëntvolume.

Expected cost per patient per year

Cost < 13,733.00
References Medicijnkosten.nl (1).
Additional remarks Een tablet Adempas 2,5 mg kost €29,70 (incl. BTW) (1). Een behandeling driemaal daags 2,5 mg voor 24 weken kost €13.733 (excl. BTW).

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.