Ibrutinib

Extended indication	Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation
Therapeutic value	No estimate possible yet
Total cost	1,338,064.00
Registration phase	No registration expected

Product

Active substance	Ibrutinib
Domain	Hematology
Reason of inclusion	Indication extension
Main indication	Aggressive non-Hodgkin?s lymphoma
Extended indication	Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation
Proprietary name	Imbruvica
Manufacturer	Janssen
Mechanism of action	Tyrosine kinase inhibitor
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase.

Registration

Registration route	Centralised (EMA)
Submission date	March 2022
Orphan drug	No
Registration phase	No registration expected
Additional remarks	Teruggetrokken door de fabrikant in december 2022.

Therapeutic value

Current treatment options	Rituximab-CHOP
Therapeutic value	No estimate possible yet
Substantiation	In de klinische studie zijn positieve resultaten behaald op PFS, maar er is geen OS winst behaald. Er wordt niet verwacht dat het een standaardbehandeling zal worden. De dosering is wat hoger dan bij patiënten met CLL.
Frequency of administration	1 times a day
Dosage per administration	560mg
References	NCT01776840

Expected patient volume per year

Patient volume	< 16 Market share is generally not included unless otherwise stated.
References	NKR; Fabrikant; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties)
Additional remarks	De incidentie van MCL in Nederland was in 2015, 187 patiënten waarvan 130 patiënten ouder zijn dan 65 jaar. Ongeveer 12% van de patiënten hiervan komt in aanmerking voor deze behandeling. Het geschatte aantal patiënten komt daarmee op 12% x 130 = 16 patiënten per jaar.

Patient volume

< 16

Market share is generally not included unless otherwise stated.

References

NKR; Fabrikant; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties)

Additional remarks

De incidentie van MCL in Nederland was in 2015, 187 patiënten waarvan 130 patiënten ouder zijn dan 65 jaar. Ongeveer 12% van de patiënten hiervan komt in aanmerking voor deze behandeling. Het geschatte aantal patiënten komt daarmee op 12% x 130 = 16 patiënten per jaar.

Expected cost per patient per year

Cost	83,629.00
References	G-standaard
Additional remarks	Lijstprijs (€57,28/tablet 140mg) x maximaal gebruik per jaar (4 tabletten/dag x 365 dagen) = €83.629.

Potential total cost per year

Total cost	1,338,064.00 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

1,338,064.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.