Tafasitamab

Extended indication	Extension of indication to include the treatment of nighttime sleep disturbances in adults with Smith Magenis Syndrome (SMS)
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Tasimelteon
Domain	Neurological disorders
Reason of inclusion	Indication extension
Main indication	Sleep disorders
Extended indication	Extension of indication to include the treatment of nighttime sleep disturbances in adults with Smith Magenis Syndrome (SMS)
Proprietary name	Hetlioz
Manufacturer	Vanda
Mechanism of action	Receptor agonist
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Extramural (GVS)
Additional remarks	Melatoninereceptoragonist

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	October 2024
Expected Registration	September 2025
Orphan drug	Yes
Registration phase	Registration application pending
Additional remarks	Verwachte registratie op basis van gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value	No estimate possible yet
Frequency of administration	1 times a day
Dosage per administration	20 mg
References	NCT02231008 (VP-VEC-162-2401)

There is currently nothing known about the expected patient volume.

Cost	400.00
References	GoodRx
Additional remarks	In de Verenigde Staten is de prijs voor tasimelteon ongeveer $14.000 voor 30 capsules van 20mg en dus $467 per capsule. In principe is de dosering 1 capsule. Prijs per patiënt per jaar dus sterk afhankelijk van de duur van de behandeling. Tasimelteon wordt op dit moment niet vergoed in Nederland.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.