estradiol and progesterone

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Generic Name:

Project Status:

Complete

Therapeutic Area:

Vasomotor symptoms associated with menopause

Manufacturer:

Knight Therapeutics Inc.

Brand Name:

Bijuva

Project Line:

Reimbursement Review

Project Number:

SR0697-000

NOC Status at Filing:

Post NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the treatment of moderate to severe vasomotor symptoms associated with menopause in women with intact uterus.

Submission Type:

Initial

Fee Schedule:

Schedule C

Tumour Type:

N/A

Indications:

For the treatment of moderate to severe vasomotor symptoms associated with menopause in women with intact uterus.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

February 10, 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
Milestones title	Date
Call for patient/clinician input open	02-Jun-21
Call for patient/clinician input closed	23-Jul-21
Clarification: - No patient input submission received
Submission received	30-Jun-21
Submission accepted	15-Jul-21
Review initiated	16-Jul-21
Draft CADTH review report(s) provided to sponsor for comment	07-Oct-21
Deadline for sponsors comments	19-Oct-21
CADTH review report(s) and responses to comments provided to sponsor	03-Dec-21
Expert committee meeting (initial)	15-Dec-21
Draft recommendation issued to sponsor	04-Jan-22
Draft recommendation posted for stakeholder feedback	13-Jan-22
End of feedback period	27-Jan-22
Final recommendation issued to sponsor and drug plans	10-Feb-22
Final recommendation posted	01-Mar-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	25-Feb-22
CADTH review report(s) posted	08-Apr-22

Last Updated : July 23, 2024