ulipristal acetate

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Generic Name:
ulipristal acetate
Project Status:
Complete
Therapeutic Area:
Uterine fibroids (signs and symptoms)
Manufacturer:
Allergan Inc.
Call for patient/clinician input open:
Brand Name:
Fibristal
Project Line:
Reimbursement Review
Project Number:
SF0609-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Request For Advice
Indications:
Uterine fibroids (signs and symptoms)
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones1

Call for patient input posted March 29, 2019
Patient group input closed May 21, 2019
Clarification:

- Patient input submission received from CANFib (Canadian Women with Fibroids Incorporated) and the Women’s Health Initiative Network

Patient input summary sent for review to patient input groups May 14, 2019
Patient group comments on input summary closed May 21, 2019
Clarification:

- Patient input summary feedback received

Request for Advice received March 28, 2019
Manufacturer informed of request for advice March 28, 2019
Manufacturer information or comments due April 11, 2019
Request for Advice initiated April 12, 2019
Draft CDR Request for Advice report sent to manufacturer May 09, 2019
Comments from manufacturer on draft CDR Request for Advice report received May 21, 2019
Redaction requests from manufacturer on draft CDR Request for Advice report received May 28, 2019
Canadian Drug Expert Committee (CDEC) meeting June 19, 2019
CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plans July 03, 2019
Embargo period ended and validation of redacted CDR Request for Advice report received July 17, 2019
CDEC Final Recommendation issued to manufacturer and drug plans July 24, 2019
CDEC Final Recommendation posted July 30, 2019
Final CDR review report(s) posted August 01, 2019