estradiol

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Generic Name:

estradiol

Project Status:

Complete

Therapeutic Area:

Dyspareunia

Manufacturer:

Knight Therapeutics Inc.

Brand Name:

Imvexxy

Project Line:

Reimbursement Review

Project Number:

SR0694-000

NOC Status at Filing:

Post NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy.

Submission Type:

Initial

Fee Schedule:

Schedule C

Tumour Type:

N/A

Indications:

For the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

January 20, 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 Milestones
Call for patient/clinician input open	26-May-21
Call for patient/clinician input closed	16-Jul-21
Clarification: - No patient input submission received
Submission received	23-Jun-21
Submission accepted	08-Jul-21
Review initiated	09-Jul-21
Draft CADTH review report(s) provided to sponsor for comment	23-Sep-21
Deadline for sponsors comments	04-Oct-21
CADTH review report(s) and responses to comments provided to sponsor	12-Nov-21
Expert committee meeting (initial)	24-Nov-21
Draft recommendation issued to sponsor	07-Dec-21
Draft recommendation posted for stakeholder feedback	16-Dec-21
End of feedback period	07-Jan-22
Final recommendation issued to sponsor and drug plans	20-Jan-22
Final recommendation posted	07-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	03-Feb-22
CADTH review report(s) posted	24-Feb-22

Last Updated : December 16, 2021