Acalabrutinib Medicine 03 December 2024 Extended indication Acalabrutinib monotherapy for second line or later treatment of relapsed or refractory mantle cell lymphoma in adults and elderly Therapeutic value No estimate possible yet Total cost € 15,491,346.00 Registration phase Registration application pending Product Active substance Acalabrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Acalabrutinib monotherapy for second line or later treatment of relapsed or refractory mantle cell lymphoma in adults and elderly 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 Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2024 Expected Registration July 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van EMA-indiening in september 2024 en een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. Therapeutic value Current treatment options Rituximab-CHOP of BR 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 100 mg References NCT02213926 (ACE-LY-004) (1); Wang et al. Lancet. 2017 (2). Additional remarks Expected patient volume per year Patient volume < 247 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1) Additional remarks In 2022 waren er 247 patiënten gediagnosticeerd met mantelcellymfoom (1). 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 van acalabrutinib is €4.811,27 voor 56 tabletten met 100mg 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 € 15,491,346.00 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