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Peginterferon alfa-2a

Pegasys

Extended indication Extension of indication to include monotherapy in adults for the treatment of polycythaemia vera and
Therapeutic value Possible added value
Total cost 2,872,800.00
Registration phase Registered

Product

Active substance Peginterferon alfa-2a
Domain Hematology
Reason of inclusion Indication extension
Main indication Myeloproliferative disorders
Extended indication Extension of indication to include monotherapy in adults for the treatment of polycythaemia vera and as monotherapy in adults for the treatment of essential thrombocythaemia.
Proprietary name Pegasys
Manufacturer pharmaand
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2023
Expected Registration August 2024
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie juni 2024

Therapeutic value

Therapeutic value Possible added value
References Expertopinie
Additional remarks Er zijn diverse studies gedaan (gerandomiseerde studies met hydroxycarbamide en anagrelide). De verwachting is dat er meerwaarde is in zowel de eerste als in latere therapie lijnen bij polycythaemia vera en essentiële thrombocythaemie.

Expected patient volume per year

Patient volume

< 1,026

Market share is generally not included unless otherwise stated.
References https://www.kanker.nl/kankersoorten/polycythaemia-vera/algemeen/wat-is-polycythaemia-vera (1); https://www.kanker.nl/kankersoorten/essentiele-trombocytemie/algemeen/wat-is-essentiele-trombocytemie (2)
Additional remarks Polycythaemia vera komt naar schatting voor bij 2,3 van de 100.000 mensen (414) (1). Voor essentiële trombocytemie is dit 3,4 per 100.000 mensen (612) (2).

Expected cost per patient per year

Cost 2,800.00
References GIPdatabank
Additional remarks In 2023 werd er per patiënt €2.800 vergoed voor de reeds geregistreerde indicaties.

Potential total cost per year

Total cost

2,872,800.00

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.