estradiol and progesterone

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Generic Name:
estradiol and progesterone
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:
No
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:
  1. 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 open02-Jun-21
Call for patient/clinician input closed23-Jul-21
Clarification:

- No patient input submission received

Submission received30-Jun-21
Submission accepted15-Jul-21
Review initiated16-Jul-21
Draft CADTH review report(s) provided to sponsor for comment07-Oct-21
Deadline for sponsors comments19-Oct-21
CADTH review report(s) and responses to comments provided to sponsor03-Dec-21
Expert committee meeting (initial)15-Dec-21
Draft recommendation issued to sponsor04-Jan-22
Draft recommendation posted for stakeholder feedback13-Jan-22
End of feedback period27-Jan-22
Final recommendation issued to sponsor and drug plans10-Feb-22
Final recommendation posted01-Mar-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)25-Feb-22
CADTH review report(s) posted08-Apr-22