Version 3

Selinexor

Medicine

Extended indication Extension of indication for Nexpovio in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who ha
Therapeutic value No estimate possible yet
Total cost € 2,000,000.00
Registration phase Positive CHMP opinion

Product

Active substance Selinexor
Domain Hematology
Reason of inclusion Indication extension IND
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 remarks CRM1 nuclear export inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date May 2021
Expected Registration July 2022
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie ontvangen in mei 2022.

Therapeutic value

Therapeutic value No estimate possible yet

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

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 https://www.reuters.com/article/us-karyopharm-fda-idUSKCN1TY2FI.
Additional remarks 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

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information