Extended indication

Extension of indication in vulvar and vaginal atrophy (VVA) patients treated with ospemifene compare

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

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

Therapeutic value

No estimate possible yet

Dosage per administration

60 mg

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost

605.00

References
NHS Commissioning Statement
Additional comments
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.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.