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ulipristal acetate

Last Updated: January 16, 2018
Result type: Reports
Project Number: SF0528-000
Product Line: Common Drug Review

Generic Name: ulipristal acetate

Brand Name: Fibristal

Manufacturer: Allergan Inc.

Indications: Uterine fibroids (signs and symptoms)

Submission Type: Request For Advice

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: November 22, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Key Milestones1

Call for patient input posted2June 21, 2017
Patient group input closed2July 26, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsAugust 17, 2017
Patient group comments on input summary closedAugust 24, 2017
Clarification:

- Patient input summary feedback received

Request for Advice receivedJune 21, 2017
Manufacturer informed of request for adviceJune 21, 2017
Manufacturer information or comments dueJuly 06, 2017
Request for Advice initiatedJune 26, 2017
Draft CDR Request for Advice report sent to applicantAugust 30, 2017
Comments from applicant on draft CDR Request for Advice report receivedSeptember 11, 2017
Redaction requests from applicant on draft CDR Request for Advice report receivedSeptember 18, 2017
CDR review team's comments on draft CDR Request for Advice report sent to applicantOctober 05, 2017
Canadian Drug Expert Committee (CDEC) meeting3October 18, 2017
CDEC recommendation & redacted CDR Request for Advice report sent to applicant and drug plansNovember 01, 2017
Embargo4 period ended and validation of redacted CDR Request for Advice report receivedNovember 15, 2017
CDEC Final Recommendation issued to applicant and drug plansNovember 22, 2017
CDEC Final Recommendation posted5November 24, 2017
Final CDR Request for Advice report and patient input posted5December 15, 2017
  1. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding CDR process and targeted time frames for key milestones.
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. 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.

Tags

gynecology/obstetrics, ulipristal; Esmya; Fibristal; Uterine; fibroid; fibroids