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

burosumab

Details

Key Milestones2
Call for patient input posted January 24, 2019
Patient group input closed March 15, 2019
Clarification:

- Patient input submission received from Canadian Organization for Rare Disorders
Patient input summary sent for review to patient input groups August 22, 2019
Patient group comments on input summary closed August 29, 2019
Clarification:

- Patient input summary feedback received
Submission received July 23, 2019
Submission accepted August 07, 2019
Review initiated August 08, 2019
Draft Canada's Drug Agency review report(s) sent to sponsor October 25, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) received November 05, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor November 29, 2019
Canadian Drug Expert Committee (CDEC) meeting December 11, 2019
CDEC recommendation sent to sponsor and drug plans December 23, 2019
Embargo period ended February 11, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested
Sponsor's request for reconsideration placed on CDEC agenda May 20, 2020
CDEC Final Recommendation & Canada's Drug Agency review report(s) issued to sponsor and drug plans May 27, 2020
CDEC Final Recommendation posted May 29, 2020
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received June 10, 2020
Redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans June 12, 2020
Validation of redacted Canada's Drug Agency review report(s) received June 19, 2020
Final Canada's Drug Agency review report(s) posted July 10, 2020
Last Updated : July 14, 2020

inotersen

Details

Key Milestones2
Call for patient input posted January 24, 2019
Patient group input closed March 15, 2019
Clarification:

- Patient input submission received from Hereditary Amyloidosis Canada
Patient input summary sent for review to patient input groups March 21, 2019
Patient group comments on input summary closed March 28, 2019
Clarification:

- No patient input summary feedback received
Submission received February 22, 2019
Submission accepted March 08, 2019
Review initiated March 11, 2019
Clarification:

- Selected for participation in Canada's Drug Agency/INESSS Clinical Engagement Pilot
Draft Canada's Drug Agency review report(s) sent to sponsor June 04, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) received June 13, 2019
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received June 20, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor July 05, 2019
Canadian Drug Expert Committee (CDEC) meeting July 17, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans July 31, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received September 13, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested
Sponsor's request for reconsideration placed on CDEC agenda November 20, 2019
CDEC recommendation sent to sponsor and drug plans November 27, 2019
Embargo period ended December 11, 2019
CDEC Final Recommendation issued to sponsor and drug plans December 18, 2019
CDEC Final Recommendation posted December 20, 2019
Final Canada's Drug Agency review report(s) posted January 10, 2020
Last Updated : January 13, 2020

dolutegravir / lamivudine

Details

Key Milestones2
Call for patient input posted January 23, 2019
Patient group input closed March 14, 2019
Clarification:

- Patient input submission received from the Canadian Treatment Action Council (CTAC)
Patient input summary sent for review to patient input groups March 21, 2019
Patient group comments on input summary closed March 28, 2019
Clarification:

- Patient input summary feedback received
Submission received February 21, 2019
Submission accepted for review March 07, 2019
Review initiated March 08, 2019
Draft Canada's Drug Agency review report(s) sent to sponsor May 23, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) received June 03, 2019
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received June 10, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor July 05, 2019
Canadian Drug Expert Committee (CDEC) meeting July 17, 2019
Clarification:

CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans September 09, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received September 23, 2019
CDEC Final Recommendation issued to sponsor and drug plans September 30, 2019
CDEC Final Recommendation posted October 02, 2019
Final Canada's Drug Agency review report(s) posted October 23, 2019
Last Updated : October 23, 2019

Keytruda Metastatic Urothelial Carcinoma (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 : October 21, 2019

Keytruda for Squamous NSCLC – 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 20, 2020

halobetasol propionate and tazarotene

Details

Key Milestones2

Call for patient input postedJanuary 07, 2019
Submission receivedFebruary 04, 2019
Clarification:

- Voluntarily withdrawn by the manufacturer on 2019-Feb-19

Last Updated : June 19, 2019

Lenvima for Hepatocellular 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 : August 13, 2019

insulin degludec + liraglutide

Details

Key Milestones2
Call for patient input posted January 02, 2019
Patient group input closed February 21, 2019
Clarification:

- Patient input submission received from Diabetes Canada and Type 2 Diabetes Experience Exchange
Patient input summary sent for review to patient input groups February 27, 2019
Patient group comments on input summary closed March 06, 2019
Clarification:

- Patient input summary feedback received
Submission received January 30, 2019
Submission accepted February 13, 2019
Review initiated February 14, 2019
Draft Canada's Drug Agency review report(s) sent to sponsor May 03, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) received May 14, 2019
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received May 22, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor September 06, 2019
Canadian Drug Expert Committee (CDEC) meeting September 18, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans October 02, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received October 17, 2019
CDEC Final Recommendation issued to sponsor and drug plans October 24, 2019
CDEC Final Recommendation posted October 28, 2019
Final Canada's Drug Agency review report(s) posted December 05, 2019
Last Updated : June 18, 2020

patisiran

Details

Key Milestones2

Call for patient input postedDecember 20, 2018
Patient group input closedFebruary 15, 2019
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groupsFebruary 26, 2019
Patient group comments on input summary closedMarch 05, 2019
Clarification:

- No patient input summary feedback received

Submission receivedJanuary 25, 2019
Submission accepted for reviewFebruary 08, 2019
Review initiatedFebruary 11, 2019
Clarification:

- Selected for participation in Canada's Drug Agency/INESSS Clinical Engagement Pilot

Draft Canada's Drug Agency review report(s) sent to sponsorMay 02, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) receivedMay 13, 2019
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) receivedMay 21, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsorJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plansJuly 04, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) receivedJuly 18, 2019
CDEC Final Recommendation issued to sponsor and drug plansJuly 25, 2019
CDEC Final Recommendation postedJuly 29, 2019
Final Canada's Drug Agency review report(s) postedAugust 27, 2019
Last Updated : September 6, 2019

Trifluridine and Tipiracil (Lonsurf) for Metastatic Colorectal Cancer Resubmission – 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 : December 19, 2019