Selinexor

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.
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 remarks	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 remarks	158 incidente patiënten per jaar. Mogelijk zal het voor een kleine restgroep worden ingezet, maximaal 50 patiënten.

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
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 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

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.