Pirtobrutinib

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	Positive CHMP opinion

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.
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

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
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	33 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.

Patient volume

33

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	2,376,000.00 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.

Total cost

2,376,000.00

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.

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.