Pirtobrutinib Medicine 07 December 2021 Extended indication Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Therapeutic value No estimate possible yet Total cost € 2,376,000.00 Registration phase Registered Product Active substance Pirtobrutinib Domain Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Current proprietary name Already available biosimilars / generics Proprietary name Jaypirca Manufacturer Eli Lilly Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Pirtobrutinib (LOXO-305) is een zeer selectieve, niet-covalente BTK-remmer van de volgende generatie (ncBTKi). Registration Registration route Centralised (EMA) Type of trajectory Conditional marketing authorisation Particularity Unknown ATMP No Submission date June 2022 Expected Registration June 2023 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie april 2023. Registratie per 30 oktober 2023. Therapeutic value Current treatment options R-CHOP/ R-DHAP, lenalidomide, ibrutinib, bortezomib of stamceltransplantatie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is een BTK-remmer met een ander aangrijpingspunt dan ibrutinib en acalabrutinib. Dit kan mogelijk een voordeel zijn. De BRUIN studie was een fase I/II met positieve resultaten. Er zijn nog geen data van de fase III pirtobrutinib versus SOC. Duration of treatment Median 8 month / months Frequency of administration 1 times a day Dosage per administration 200mg References Mato RA et al.Lancet 2021; 397: 892–901. Key Data Presented at ASH (American Society of Hematology) 2021 Annual Meeting (Michael L. Wang) Efficacy of Pirtobrutinib in Covalent BTK-Inhibitor Pre-Treated Relapsed / Refractory Mantle Cell Lymphoma: Additional Patients and Extended Follow-up from the Phase 1/2 BRUIN Study. ASH 2022. Additional remarks Van de 90 patiënten met MCL, was het mediane aantal eerdere behandelingen dat men kreeg 3 (IQR 2–4). Alle patiënten kregen eerder een BTK inhibitor. ORR = 58%. De fabrikant geeft aan dat de mediane behandelduur 8 maanden betreft. Expected patient volume per year Patient volume 33 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL (1) Additional remarks Incidentie betreft in totaal 225 patiënten in 2020 voor Mantle Cell Lymphoma (MCL) (1). Gezien de indicatie zal het een vergelijkbare plek krijgen als brexucabtagene autoleucel (Tecartus®). Dit betreffen 33 patiënten. Expected cost per patient per year Cost € 72,000.00 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 Fabrikant Additional remarks De prijs per 30 dagen betreft €9.000. Uitgaande van een mediane behandelduur van 8 maanden komt dit neer op €72.000 per patiënt per jaar. Potential total cost per year Total cost € 2,376,000.00 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 Chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL) - second-line or greater References SPS UK Additional remarks Other information Additional remarks