Ospemifene

Extended indication	Extension of indication in vulvar and vaginal atrophy (VVA) patients treated with ospemifene compared to 1)patients newly prescribed SERMs for oestrogen- deficiency conditions or breast cancer prevention. 2) the incidence in untreated VVA patients.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Ospemifene
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Other metabolism and Endocrinology
Extended indication	Extension of indication in vulvar and vaginal atrophy (VVA) patients treated with ospemifene compared to 1)patients newly prescribed SERMs for oestrogen- deficiency conditions or breast cancer prevention. 2) the incidence in untreated VVA patients.
Proprietary name	Senshio
Manufacturer	Shionogi
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Extramural (GVS)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	June 2021
Expected Registration	April 2022
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
Dosage per administration	60 mg

There is currently nothing known about the expected patient volume.

Cost	605.00
References	NHS Commissioning Statement
Additional remarks	De jaarlijkse kosten in het VK zijn door de NHS berekend als £514.68 per jaar. Omgerekend naar euro zou dit betekenen op jaarbasis €604,58 per patiënt.

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.