estradiol

Details

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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
Biosimilar:
No
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:
  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 Milestones

Call for patient/clinician input open26-May-21
Call for patient/clinician input closed16-Jul-21
Clarification:

- No patient input submission received

Submission received23-Jun-21
Submission accepted08-Jul-21
Review initiated09-Jul-21
Draft CADTH review report(s) provided to sponsor for comment23-Sep-21
Deadline for sponsors comments04-Oct-21
CADTH review report(s) and responses to comments provided to sponsor12-Nov-21
Expert committee meeting (initial)24-Nov-21
Draft recommendation issued to sponsor07-Dec-21
Draft recommendation posted for stakeholder feedback16-Dec-21
End of feedback period07-Jan-22
Final recommendation issued to sponsor and drug plans20-Jan-22
Final recommendation posted07-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)03-Feb-22
CADTH review report(s) posted24-Feb-22