CADTH | Evidence Driven
CADTH | Evidence Driven

ospemifene

Details

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Generic Name:
ospemifene
Project Status:
Complete
Therapeutic Area:
Dyspareunia, vaginal dryness
Manufacturer:
Duchesnay Inc.
Brand Name:
Osphena
Project Line:
Reimbursement Review
Project Number:
SR0709-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Osphena is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Osphena is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open21-Sep-21
Call for patient/clinician input closed12-Nov-21
Clarification:

- Patient input submission received from the Women's Health Coalition of Alberta Society

Submission received26-Oct-21
Submission accepted09-Nov-21
Review initiated10-Nov-21
Draft CADTH review report(s) provided to sponsor for comment01-Feb-22
Deadline for sponsors comments10-Feb-22
CADTH review report(s) and responses to comments provided to sponsor11-Mar-22
Expert committee meeting (initial)23-Mar-22
Draft recommendation issued to sponsor06-Apr-22
Draft recommendation posted for stakeholder feedback14-Apr-22
End of feedback period29-Apr-22
Final recommendation issued to sponsor and drug plans13-May-22
Final recommendation posted01-Jun-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)02-Jun-22
CADTH review report(s) posted11-Aug-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : August 11, 2022