tenofovir alafenamide

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Generic Name:
tenofovir alafenamide
Project Status:
Complete
Therapeutic Area:
Hepatitis B, chronic
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Vemlidy
Project Line:
Reimbursement Review
Project Number:
SR0537-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hepatitis B, chronic
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input posted August 30, 2017
Patient group input closed October 20, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups November 02, 2017
Patient group comments on input summary closed November 09, 2017
Clarification:

- Patient input summary feedback received

Submission received September 28, 2017
Submission accepted for review October 13, 2017
Review initiated October 16, 2017
Draft CDR review report(s) sent to applicant January 04, 2018
Comments from applicant on draft CDR review report(s) received January 15, 2018
Redaction requests from applicant on draft CDR review report(s) received January 22, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant February 08, 2018
Canadian Drug Expert Committee (CDEC) meeting February 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans March 05, 2018
Embargo period ended and validation of redacted CDR review report(s) received March 19, 2018
CDEC Final Recommendation issued to applicant and drug plans March 26, 2018
CDEC Final Recommendation posted March 28, 2018
Final CDR review report(s) and patient input posted April 24, 2018