prasterone


( Last Updated : June 16, 2022)
Generic Name:
prasterone
Project Status:
Complete
Therapeutic Area:
Postmenopausal vulvovaginal atrophy
Manufacturer:
Lupin Pharma Canada Ltd.
Brand Name:
Intrarosa
Project Line:
Reimbursement Review
Project Number:
SR0707-000
NOC Status at Filing:
Post NOC

Details

Manufacturer Requested Reimbursement Criteria1:
Intrarosa (prasterone vaginal ovules) is indicated for treatment of postmenopausal vulvovaginal atrophy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Intrarosa (prasterone vaginal ovules) is indicated for treatment of postmenopausal vulvovaginal atrophy.
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 open02-Sep-21
Call for patient/clinician input closed25-Oct-21
Clarification:

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

Submission received01-Oct-21
Submission accepted18-Oct-21
Review initiated19-Oct-21
Draft CADTH review report(s) provided to sponsor for comment10-Jan-22
Deadline for sponsors comments19-Jan-22
CADTH review report(s) and responses to comments provided to sponsor10-Feb-22
Expert committee meeting (initial)23-Feb-22
Draft recommendation issued to sponsor07-Mar-22
Draft recommendation posted for stakeholder feedback17-Mar-22
End of feedback period31-Mar-22
Final recommendation issued to sponsor and drug plans14-Apr-22
Final recommendation posted03-May-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)29-Apr-22
CADTH review report(s) posted16-Jun-22

Files

Recommendation and Reasons

Clinical and Pharmacoeconomic combined Report

Stakeholder feedback on Draft Recommendation