Peginterferon alfa-2a Medicine 04 June 2024 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. Therapeutic value Possible added value Total cost € 2,872,800.00 Registration phase Registered and reimbursed Product Active substance Peginterferon alfa-2a Domain Hematology Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Pegasys Manufacturer Pharmaand Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2023 Expected Registration August 2024 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie juni 2024. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 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. Maximum patient volume for sluice 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 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. 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks