prasterone

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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

Performance Metric:

Achieved

Biosimilar:

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:

April 14, 2022

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones²
Call for patient/clinician input open	02-Sep-21
Call for patient/clinician input closed	25-Oct-21
Clarification: - Patient input submission received from the Women's Health Coalition of Alberta Society
Submission received	01-Oct-21
Submission accepted	18-Oct-21
Review initiated	19-Oct-21
Draft CADTH review report(s) provided to sponsor for comment	10-Jan-22
Deadline for sponsors comments	19-Jan-22
CADTH review report(s) and responses to comments provided to sponsor	10-Feb-22
Expert committee meeting (initial)	23-Feb-22
Draft recommendation issued to sponsor	07-Mar-22
Draft recommendation posted for stakeholder feedback	17-Mar-22
End of feedback period	31-Mar-22
Final recommendation issued to sponsor and drug plans	14-Apr-22
Final recommendation posted	03-May-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	29-Apr-22
CADTH review report(s) posted	16-Jun-22

Last Updated : June 16, 2022