Canada’s Drug Agency | Drugs, Health Technologies and Systems.

cerliponase alfa

Details

Key Milestones2
Call for patient input posted June 04, 2018
Patient group input closed July 24, 2018
Clarification:

- No patient input submission received
Submission received July 31, 2018
Submission accepted for review August 15, 2018
Review initiated August 16, 2018
Draft Canada's Drug Agency review report(s) sent to applicant November 14, 2018
Comments from applicant on draft Canada's Drug Agency review report(s) received November 23, 2018
Redaction requests from applicant on draft Canada's Drug Agency review report(s) received November 30, 2018
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant January 04, 2019
Canadian Drug Expert Committee (CDEC) meeting January 16, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans January 30, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received February 13, 2019
Clarification:

- Reconsideration requested

- Request for Clarification received from CDR Participating Drug Plans
Applicant's request for reconsideration placed on CDEC agenda April 10, 2019
Drug plans' request for clarification placed on CDEC agenda April 10, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans April 17, 2019
Clarification:

- Embargoed CDEC recommendation issued in accordance with Canada's Drug Agency Pharmaceutical Reviews Update - Issue 7
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received May 02, 2019
Clarification:

- Request for Clarification received from CDR Participating Drug Plans

- Drug plans' request for clarification placed on the May 15, 2019 CDEC agenda
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans May 23, 2019
CDEC Final Recommendation posted May 27, 2019
Final Canada's Drug Agency review report(s) posted June 28, 2019
Last Updated : June 28, 2019

dupilumab

Details

Key Milestones2
Call for patient input posted August 15, 2017
Patient group input closed October 04, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups November 16, 2017
Patient group comments on input summary closed November 21, 2017
Clarification:

- Patient input summary feedback received
Submission received October 27, 2017
Submission accepted for review November 10, 2017
Review initiated November 13, 2017
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted
Draft CDR review report(s) sent to applicant February 20, 2018
Comments from applicant on draft CDR review report(s) received March 01, 2018
Redaction requests from applicant on draft CDR review report(s) received March 08, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant March 29, 2018
Canadian Drug Expert Committee (CDEC) meeting April 11, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans April 24, 2018
Embargo period ended and validation of redacted CDR review report(s) received May 15, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested
Applicant's request for reconsideration placed on CDEC agenda June 20, 2018
CDEC Final Recommendation issued to applicant and drug plans June 27, 2018
CDEC Final Recommendation posted July 09, 2018
Final CDR review report(s) and patient input posted July 10, 2018
Last Updated : July 10, 2018

edaravone

Details

Key Milestones2

Call for patient input postedMay 25, 2018
Patient group input closedJuly 16, 2018
Clarification:

- Patient input submission received from the ALS Society of Canada

Patient input summary sent for review to patient input groupsJuly 31, 2018
Patient group comments on input summary closedAugust 08, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJuly 05, 2018
Submission accepted for reviewJuly 19, 2018
Review initiatedJuly 20, 2018
Draft Canada's Drug Agency review report(s) sent to applicantOctober 04, 2018
Comments from applicant on draft Canada's Drug Agency review report(s) receivedOctober 16, 2018
Redaction requests from applicant on draft Canada's Drug Agency review report(s) receivedOctober 23, 2018
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicantNovember 09, 2018
Canadian Drug Expert Committee (CDEC) meetingNovember 21, 2018
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plansDecember 05, 2018
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) receivedJanuary 24, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaMarch 20, 2019
CDEC Final Recommendation issued to applicant and drug plansMarch 27, 2019
CDEC Final Recommendation postedMarch 29, 2019
Final Canada's Drug Agency review report(s) and patient input postedApril 24, 2019
Last Updated : April 25, 2019

tofacitinib

Details

Key Milestones2
Call for patient input posted May 22, 2018
Patient group input closed July 11, 2018
Clarification:

- Patient input submission received from the Gastrointestinal Society
Patient input summary sent for review to patient input groups July 17, 2018
Patient group comments on input summary closed July 24, 2018
Clarification:

- Patient input summary feedback received
Submission received June 27, 2018
Submission accepted July 12, 2018
Review initiated July 13, 2018
Draft Canada's Drug Agency review report(s) sent to sponsor October 10, 2018
Comments from sponsor on draft Canada's Drug Agency review report(s) received October 19, 2018
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received October 26, 2018
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor November 09, 2018
Canadian Drug Expert Committee (CDEC) meeting November 21, 2018
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans December 04, 2018
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received December 18, 2018
Clarification:

- Reconsideration requested
Sponsor's request for reconsideration placed on CDEC agenda February 20, 2019
CDEC Final Recommendation issued to sponsor and drug plans February 27, 2019
CDEC Final Recommendation posted March 01, 2019
Final Canada's Drug Agency review report(s) and patient input posted March 21, 2019
Last Updated : March 10, 2021

sucroferric oxyhydroxide

Details

Key Milestones2
Call for patient input posted May 10, 2018
Patient group input closed June 29, 2018
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders
Patient input summary sent for review to patient input groups July 16, 2018
Patient group comments on input summary closed July 23, 2018
Clarification:

- Patient input summary feedback received
Submission received June 12, 2018
Submission accepted for review June 26, 2018
Review initiated July 09, 2018
Draft CDR review report(s) sent to applicant September 21, 2018
Comments from applicant on draft CDR review report(s) received October 02, 2018
Redaction requests from applicant on draft CDR review report(s) received October 10, 2018
Clarification:

- No redactions requested by theapplicant
CDR review team's comments on draft CDR review report(s) sent to applicant November 09, 2018
Canadian Drug Expert Committee (CDEC) meeting November 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans December 04, 2018
Embargo period ended and validation of redacted CDR review report(s) received December 18, 2018
CDEC Final Recommendation issued to applicant and drug plans January 02, 2019
CDEC Final Recommendation posted January 04, 2019
Final CDR review report(s) and patient input posted February 01, 2019
Last Updated : February 1, 2019

Lenvima for Renal Cell Carcinoma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 25, 2019

Lutathera for Gastroenteropancreatic neuroendocrine tumors – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : August 19, 2019

Folotyn for Peripheral T-Cell Lymphoma

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 22, 2019

Rivaroxaban

Details

Key Milestones2
Call for patient input posted April 25, 2018
Patient group input closed June 14, 2018
Clarification:

- Patient input submission received from Cardiac Health Foundation
Patient input summary sent for review to patient input groups June 20, 2018
Patient group comments on input summary closed June 27, 2018
Clarification:

- Patient input summary feedback received
Submission received May 24, 2018
Submission accepted for review June 07, 2018
Review initiated June 08, 2018
Draft CDR review report(s) sent to applicant August 23, 2018
Comments from applicant on draft CDR review report(s) received September 04, 2018
Redaction requests from applicant on draft CDR review report(s) received September 11, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant October 04, 2018
Canadian Drug Expert Committee (CDEC) meeting October 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received November 13, 2018
CDEC Final Recommendation issued to applicant and drug plans November 20, 2018
CDEC Final Recommendation posted November 22, 2018
Final CDR review report(s) and patient input posted January 03, 2019
Last Updated : January 3, 2019

Tagrisso for Non-Small Cell Lung Cancer (first line) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : January 21, 2019