Extended indication Ceprotin is indicated for prophylaxis and treatment of purpura fulminans, coumarin‑induced skin necr
Therapeutic value No estimate possible yet
Total cost 80,384.00
Registration phase Positive CHMP opinion

Product

Active substance Proteïne C
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Antithrombotic medications
Extended indication Ceprotin is indicated for prophylaxis and treatment of purpura fulminans, coumarin‑induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency.
Proprietary name Ceprotin
Manufacturer Takeda
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2022
Expected Registration January 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in november 2022

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment continuous
Dosage per administration 200 ie/kg

Expected patient volume per year

Patient volume

< 5

Market share is generally not included unless otherwise stated.

References A Minford et al. Diagnosis and management of severe congenital protein C deficiency (SCPCD): Communication from the SSC of the ISTH. Thromb Haemost. 2022 (1);
Additional comments Ernstige proteïne C deficiëntie komt voor bij 1 op de 4 miljoen(1), maar mogelijk ligt het aantal nog lager vanwege vroege vruchtdood in de algehele populatie. Deze patiënten met ernstige proteïne C deficiëntie hebben risico op purpura fulminans.

Expected cost per patient per year

Cost 16,076.80
References medicijnkosten.nl, CBS
Additional comments De gemiddelde prijs per verpakking excl. btw (500IE + SOLV 5ML) is €1.024. Uitgaande van een behandelduur van een jaar 200 IE/kg per 48 uur zou dat bij een gemiddeld gewicht van 78,5 neerkomen op 16076,80

Potential total cost per year

Total cost

80,384.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.