Extended indication Tezepelumab monotherapy for treatment of Eosinophilic oesophagitis in adolescents, adults and elderly with previously documented standard of care trea
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tezepelumab
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Other chronic immune diseases
Extended indication Tezepelumab monotherapy for treatment of Eosinophilic oesophagitis in adolescents, adults and elderly with previously documented standard of care treatment.
Proprietary name Tezspire
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Immunosuppression
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2026
Expected Registration October 2027
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Frequency of administration 1 times every 4 weeks
Dosage per administration 210mg tot 420mg
References NCT05583227 (CROSSING)
Additional remarks Tezepelumab 210mg om de vier weken en tezepelumab 420mg om de vier weken, subcutaan (SC) toegediend met behulp van een voorgevulde spuit met hulpstukken (APFS), versus placebo bij volwassen en adolescente deelnemers met EoE.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

References mednet.nl
Additional remarks Eosinofiele oesofagitis (EoE) is een chronische, progressieve inflammatoire aandoening, waarmee ongeveer 4.000 patiënten in Nederland gediagnosticeerd zijn.

Expected cost per patient per year

Cost < 14,000.00

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 medicijnkosten.nl
Additional remarks De lijstprijs van tezepelumab is €1.266,97 (incl. BTW) voor 210mg. Een jaarbehandeling is ongeveer €14.000 (exclusief BTW).

Potential total cost per year

Off label use

Off label use No

Indication extension

Other information