Extended indication Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory
Therapeutic value No estimate possible yet
Total cost 2,376,000.00
Registration phase Positive CHMP opinion


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.
Proprietary name Jaypirca
Manufacturer Eli Lilly
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Pirtobrutinib (LOXO-305) is een zeer selectieve, niet-covalente BTK-remmer van de volgende generatie (ncBTKi).


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2022
Expected Registration June 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie april 2023

Therapeutic value

Current treatment options R-CHOP/ R-DHAP, lenalidomide, ibrutinib, bortezomib of stamceltransplantatie.
Therapeutic value No estimate possible yet
Substantiation Het is een BTK-remmer met een ander aangrijpingspunt dan ibrutinib en acalabrutinib. Dit kan mogelijk een voordeel zijn. De fase 3 studie loopt nog.
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


Market share is generally not included unless otherwise stated.

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
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


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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL) - second-line or greater
References SPS UK

Other information

There is currently no futher information available.