Acalabrutinib Medicine 03 December 2024 Extended indication Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor. Therapeutic value No estimate possible yet Total cost € 15,511,600.00 Registration phase Registered Product Active substance Acalabrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor. 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 September 2024 Expected Registration May 2025 Orphan drug Yes Registration phase Registered Reimbursement Reimbursement request pending Medicine sluice Broadly excluded Additional remarks Zorginstituut Nederland beoordeelt of acalabrutinib (Calquence®) vergoed kan worden voor deze indicatie. Het advies wordt mei 2026 verwacht. Therapeutic value Current treatment options Ibrutinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Bij MCL zijn de 3 BTKi niet rechtstreeks vergeleken. De internationale richtlijn, noemt bij recidief ibrutinib en acalabrutinib, die in Europa goedkeuring hebben. De voorkeur gaat uit naar acalabrutinib of zanubrutinib, die minder AF, hypertensie en bloedingscomplicaties hebben, zoals is gevonden bij andere ziektebeelden. De meerwaarde ten aanzien van cardiale toxiciteit moet afgeleid worden uit de CLL studie: AF bij acalabrutinib 9,4%, bij ibrutinib 16% (3). Er zijn geen data over een verschil in progressievrije Overleving. Duration of treatment Frequency of administration 2 times a day Dosage per administration 100mg References NCT02213926 (ACE-LY-004) (1); Wang et al. Lancet. 2017 (2). Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. John C. Byrd, MD. Journal of Clinical Oncology (3). 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 € < 62,800.00 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 Z-Index 2024; ZIN pakketadvies acalabrutinib 2022 Additional remarks De apotheekinkoopprijs van acalabrutinib is €4.811,27 voor 56 tabletten met 100gr acalabrutinib (Z-Index). De aanbevolen dagelijkse dosering is 200mg (2 tabletten) 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 € 15,511,600.00 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