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

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.

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.

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.