Extended indication Extension of indication for Nexpovio in combination with bortezomib and dexamethasone for the treatm
Therapeutic value No estimate possible yet
Total cost 2,000,000.00
Registration phase Registration application pending

Product

Active substance Selinexor
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Multiple Myeloma
Extended indication Extension of indication for Nexpovio in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Proprietary name Nexpovio
Manufacturer Karyopharm
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Coated tablet
Budgetting framework Intermural (MSZ)
Additional comments CRM1 nuclear export inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date May 2021
Expected Registration March 2022
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Triple or quadruple therapie heeft de voorkeur, niet deze combinatie. Aangezien de meeste patiënten bortezomib en dexamethason al in een eerdere lijn hebben ontvangen zak het slechts voor een kleine restgroep ingezet worden als het beschikbaar komt.
Duration of treatment Average 13.93 month / months
References Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. The Lancet. 2020

Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.

References BIA van Darzalex voor de indicatie DarBorDex
Additional comments 158 incidente patiënten per jaar. Mogelijk zal het voor een kleine restgroep worden ingezet, maximaal 50 patiënten.

Expected cost per patient per year

Cost 40,000.00
References https://www.reuters.com/article/us-karyopharm-fda-idUSKCN1TY2FI.
Additional comments In de Verenigde Staten is de lijstprijs per maand bepaald op $22.000 (ongeveer €20.000). De mediane behandelduur is 9 weken wat neerkomt op ongeveer €40.000.

Potential total cost per year

Total cost

2,000,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.