Acalabrutinib Medicine 04 December 2025 Extended indication diffuse large B-cell lymphoma (based on study ESCALADE- ACE-LY-312)); Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL. Therapeutic value No estimate possible yet Total cost € 43,600,000.00 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 diffuse large B-cell lymphoma (based on study ESCALADE- ACE-LY-312)); Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL. 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 ATMP No Submission date May 2027 Expected Registration December 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options 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 https://www.astrazenecaclinicaltrials.com/study/D8227C00001/; NCT04529772 (ESCALADE) Additional remarks Expected patient volume per year Patient volume 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2022; Additional remarks De incidentie van DLBCL (en varianten) in Nederland in 2022 was 1.606 patiënten (1). Ongeveer 50% van de patiënten heeft het non-GCB subtype. Dit betekent dat er per jaar ongeveer 800 patiënten met DLBCL in aanmerking zouden kunnen komen voor behandeling met ibrutinib. Expected cost per patient per year Cost € 54,000.00 - 55,000.00 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 medicijnkosten Additional remarks Gemiddelde prijs per stuk € 74,78 excl. btw 100MG. Potential total cost per year Total cost € 43,600,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks