Acalabrutinib Medicine 10 December 2019 Extended indication 1L CLL in combinatie met obinutuzumab Therapeutic value No judgement Total cost € 42,000,000.00 Registration phase Registration application pending Product Active substance Acalabrutinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication CLL Extended indication 1L CLL in combinatie met obinutuzumab Current proprietary name Already available biosimilars / generics Proprietary name Calquence Manufacturer AstraZeneca Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2019 Expected Registration November 2020 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie in Q4 2020. Therapeutic value Current treatment options Rituximab combined with idelalisib (IdR) or bendamustine (BR); ibrutinib; fludarabine cyclophosphamide rituximab (FCR); chlorambucil +/- rituximab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 mg References NCT02475681 Additional remarks Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Geschat wordt dat er jaarlijks zo'n 600 patiënten in de 1e lijn behandeld worden. Expected cost per patient per year Cost € 70,000.00 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. References Zie eerdere inschatting ibrutinib CLL in de Horizonscan. Additional remarks Prijs mogelijk in dezelfde range als ibrutinib: inschatting zo'n € 70.000. Potential total cost per year Total cost € 42,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Geen andere fase III studies naar andere indicaties op dit moment, wel lopen er vele fase II studies naar verschillende indicaties. References AdisInsight Additional remarks Other information Additional remarks