Acalabrutinib Medicine 07 December 2022 Extended indication Mantle cell lymphoma (MCL), 1L. Therapeutic value No estimate possible yet Total cost € 13,923,396.00 Registration phase Clinical trials Product Active substance Acalabrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Mantle cell lymphoma (MCL), 1L. Current proprietary name Already available biosimilars / generics Proprietary name Calquence Manufacturer AstraZeneca Portfolio holder AstraZeneca 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 2024 Expected Registration 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Rituximab-CHOP Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 100mg References NCT02972840 (ECHO) Additional remarks Expected patient volume per year Patient volume < 222 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL Additional remarks Incidentie betreft in totaal 222 patiënten in 2020 voor Mantle Cell Lymphoma (MCL). Expected cost per patient per year Cost € 62,718.00 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 Z-Index 2022; ZIN pakketadvies acalabrutinib 2022 Additional remarks De apotheekinkoopprijs (AIP) van acalabrutinib is €4.811,27 voor 56 capsules met 100 gram acalabrutinib (Z-Index). De aanbevolen dagelijkse dosering is 200mg (2 capsules) waarmee de kosten op €171,83 per dag komen. De kosten voor behandeling met acalabrutinib komen daarmee op €62.718 per jaar. Potential total cost per year Total cost € 13,923,396.00 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 Zie andere indicatie op de Horizonscan Geneesmiddelen. Daarnaast ook in fase 3: Relapsed or refractory chronic lymphocytic leukaemia (CLL) in high-risk patients References SPS UK Additional remarks Other information Additional remarks