Generic Name: ulipristal acetate
Brand Name: Fibristal
Manufacturer: Allergan Inc.
Indications: Uterine fibroids (signs and symptoms)
Submission Type: Request For Advice
Project Status: Complete
Date Recommendation Issued: November 22, 2017
Recommendation Type: Reimburse with clinical criteria and/or conditions
|Call for patient input posted2||June 21, 2017|
|Patient group input closed2||July 26, 2017|
- Patient input submission received
|Patient input summary sent for review to patient input groups||August 17, 2017|
|Patient group comments on input summary closed||August 24, 2017|
- Patient input summary feedback received
|Request for Advice received||June 21, 2017|
|Manufacturer informed of request for advice||June 21, 2017|
|Manufacturer information or comments due||July 06, 2017|
|Request for Advice initiated||June 26, 2017|
|Draft CDR Request for Advice report sent to applicant||August 30, 2017|
|Comments from applicant on draft CDR Request for Advice report received||September 11, 2017|
|Redaction requests from applicant on draft CDR Request for Advice report received||September 18, 2017|
|CDR review team's comments on draft CDR Request for Advice report sent to applicant||October 05, 2017|
|Canadian Drug Expert Committee (CDEC) meeting3||October 18, 2017|
|CDEC recommendation & redacted CDR Request for Advice report sent to applicant and drug plans||November 01, 2017|
|Embargo4 period ended and validation of redacted CDR Request for Advice report received||November 15, 2017|
|CDEC Final Recommendation issued to applicant and drug plans||November 22, 2017|
|CDEC Final Recommendation posted5||November 24, 2017|
|Final CDR Request for Advice report and patient input posted5||December 15, 2017|
- Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding CDR process and targeted time frames for key milestones.
- The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
- A request for advice may result in a revised CDEC recommendation that would supersede a previous CEDAC or CDEC Final Recommendation, or a CDEC Record of Advice document containing additional context and/or clarifications regarding a previous CEDAC or CDEC Final Recommendation.
- The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation. The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
- The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
- The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.
gynecology/obstetrics, ulipristal; Esmya; Fibristal; Uterine; fibroid; fibroids