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Sotatercept

Winrevair

Extended indication Treatment of pulmonary arterial hypertension.
Therapeutic value Possible added value
Total cost 119,595,000.00
Registration phase Registered

Product

Active substance Sotatercept
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung diseases other
Extended indication Treatment of pulmonary arterial hypertension.
Proprietary name Winrevair
Manufacturer MSD
Portfolio holder MSD
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Particularity New medicine with Priority Medicines (PRIME)
ATMP No
Submission date October 2023
Expected Registration August 2024
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie juni 2024

Therapeutic value

Therapeutic value Possible added value
Substantiation Sotatercept zal volgens experts een mogelijke meerwaarde kunnen gaan hebben in de behandeling van PAH. Bij studie patiënten of patiënten in het Early Access programma worden goede resultaten gezien. Daarnaast zijn de resultaten uit de fase 3 studie indrukwekkend te noemen, zeker in vergelijking met de resultaten van veel andere medicamenten binnen deze indicatie.
Frequency of administration 1 times every 3 weeks
Dosage per administration 0,7 mg/kg
References NCT04576988 (STELLAR)
Additional remarks Sotatercept start met een dosering van 0,3mg/kg en een streefdosis van 0,7mg/kg subcutaan (SC). Toegediend elke 21 dagen, plus PAH-therapie als achtergrondbehandeling.

Expected patient volume per year

Patient volume

255 - 884

Market share is generally not included unless otherwise stated.
References ntvg.nl
Additional remarks De prevalentie van PAH in Nederland is ongeveer 15 tot 52 per 1 miljoen inwoners.

Expected cost per patient per year

Cost < 210,000.00
References ICER
Additional remarks ICER schat de lijstprijs van Winrevair op ongeveer $240.000 per jaar. Dit is ongeveer €210.000.

Potential total cost per year

Total cost

119,595,000.00

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 No
References fabrikant

Other information

There is currently no futher information available.