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

cabozantinib

Details

Key Milestones2
Call for patient/clinician input openJanuary 19, 2023
Call for patient/clinician input closedMarch 13, 2023
Submission receivedFebruary 17, 2023
Submission acceptedApril 14, 2023
Review initiatedApril 21, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentJuly 17, 2023
Deadline for sponsors commentsJuly 26, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorAugust 31, 2023
Expert committee meeting (initial)September 13, 2023
Draft recommendation issued to sponsorSeptember 25, 2023
Draft recommendation posted for stakeholder feedbackOctober 05, 2023
End of feedback periodOctober 20, 2023
Final recommendation issued to sponsor and drug plansNovember 03, 2023
Final recommendation postedNovember 27, 2023
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)November 20, 2023
Canada's Drug Agency review report(s) postedFebruary 14, 2024
Last Updated : February 15, 2024

setmelanotide

Details

Key Milestones2
Call for patient/clinician input open09-Jan-23
Call for patient/clinician input closed06-Mar-23
Clarification:

- Patient input submission received from the Bardet Biedl Syndrome Foundation

Submission received07-Mar-23
Submission accepted22-Mar-23
Review initiated23-Mar-23
Draft CADTH review report(s) provided to sponsor for comment06-Jul-23
Deadline for sponsors comments17-Jul-23
CADTH review report(s) and responses to comments provided to sponsor11-Aug-23
Expert committee meeting (initial)23-Aug-23
Draft recommendation issued to sponsor07-Sep-23
Draft recommendation posted for stakeholder feedback14-Sep-23
End of feedback period28-Sep-23
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plans16-Oct-23
Final recommendation posted01-Nov-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)30-Oct-23
CADTH review report(s) posted22-Dec-23
Last Updated : December 12, 2024

cenobamate

Details

Key Milestones2
Call for patient/clinician input open05-Jan-23
Call for patient/clinician input closed27-Feb-23
Clarification:

- Patient input submission received from the Canadian Epilepsy Alliance, Epilepsy Association of Calgary, Epilepsy Toronto and Epilepsy South Central Ontario

Submission received07-Feb-23
Submission accepted22-Feb-23
Review initiated23-Feb-23
Draft CADTH review report(s) provided to sponsor for comment11-May-23
Deadline for sponsors comments23-May-23
CADTH review report(s) and responses to comments provided to sponsor16-Jun-23
Expert committee meeting (initial)28-Jun-23
Draft recommendation issued to sponsor13-Jul-23
Draft recommendation posted for stakeholder feedback20-Jul-23
End of feedback period03-Aug-23
Final recommendation issued to sponsor and drug plans17-Aug-23
Final recommendation posted11-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)31-Aug-23
CADTH review report(s) posted29-Nov-23
Last Updated : December 12, 2024

roflumilast

Details

Key Milestones2
Call for patient/clinician input open04-Jan-23
Call for patient/clinician input closed27-Feb-23
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance (CSPA), Canadian Psoriasis Network (CPN) and Canadian Association of Psoriasis Patients (CAPP)

Submission received02-Feb-23
Submission accepted-
Review initiated17-Feb-23
Draft CADTH review report(s) provided to sponsor for comment09-May-23
Deadline for sponsors comments18-May-23
CADTH review report(s) and responses to comments provided to sponsor16-Jun-23
Expert committee meeting (initial)28-Jun-23
Draft recommendation issued to sponsor11-Jul-23
Draft recommendation posted for stakeholder feedback20-Jul-23
End of feedback period03-Aug-23
Final recommendation posted01-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)30-Aug-23
CADTH review report(s) posted01-Nov-23
Last Updated : December 12, 2024

pembrolizumab

Details

Key Milestones2
Call for patient/clinician input openNovember 10, 2021
Call for patient/clinician input closedJanuary 07, 2022
Clarification:

- Patient input submission received from Colorectal Cancer Resource & Action Network (CCRAN), in collaboration with Canadian Cancer Society (CCS) and Canadian Cancer Survivor Network (CCSN).

Submission receivedDecember 15, 2021
Submission acceptedJanuary 07, 2022
Clarification:

- Submission was not accepted for review on 6 Jan '22

Review initiatedJanuary 10, 2022
Draft Canada's Drug Agency review report(s) provided to sponsor for commentMarch 29, 2022
Deadline for sponsors commentsApril 07, 2022
Canada's Drug Agency review report(s) and responses to comments provided to sponsorApril 29, 2022
Expert committee meeting (initial)May 11, 2022
Draft recommendation issued to sponsorMay 25, 2022
Draft recommendation posted for stakeholder feedbackJune 02, 2022
End of feedback periodJune 16, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingDecember 07, 2022
Draft recommendation issued to sponsorDecember 21, 2022
Draft recommendation posted for stakeholder feedbackJanuary 05, 2023
End of feedback periodJanuary 19, 2023
Final recommendation issued to sponsor and drug plansFebruary 03, 2023
Final recommendation postedFebruary 22, 2023
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)February 17, 2023
Canada's Drug Agency review report(s) postedApril 25, 2023
Last Updated : April 25, 2023

belzutifan

Details

Key Milestones2
Call for patient/clinician input open16-Dec-22
Call for patient/clinician input closed21-Feb-23
Clarification:

- Patient input submission received from The Canadian VHL Alliance with: The Canadian Organization for Rare Disorders, Kidney Cancer Canada, Pancreatic Cancer Canada, and the Canadian Neuroendocrine Tumour Society

Submission received23-Jan-23
Submission accepted07-Feb-23
Review initiated08-Feb-23
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft Canada's Drug Agency review report(s) provided to sponsor for comment15-May-23
Deadline for sponsors comments26-May-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor29-Jun-23
Expert committee meeting (initial)12-Jul-23
Draft recommendation issued to sponsor26-Jul-23
Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)18-Sep-23
Canada's Drug Agency review report(s) posted15-Nov-23
Last Updated : November 16, 2023

zanubrutinib

Details

Key Milestones2
Call for patient/clinician input open15-Dec-22
Call for patient/clinician input closed13-Feb-23
Clarification:

- Patient input submission received from Lymphoma Canada.

Submission received20-Jan-23
Submission accepted06-Feb-23
Review initiated07-Feb-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment25-Apr-23
Deadline for sponsors comments05-May-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor29-Jun-23
Expert committee meeting (initial)12-Jul-23
Draft recommendation issued to sponsor24-Jul-23
Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)18-Sep-23
Canada's Drug Agency review report(s) posted29-Nov-23
Last Updated : November 29, 2023

Metastatic Urothelial Carcinoma

Details

Review Type: Rapid

Provisional Funding Algorithm
Draft Report Posted: November 24, 2022
Stakeholder Feedback Deadline: December 1, 2022
Final Report Posted: January 11, 2023
Last Updated : January 11, 2023

Hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer

Details

Review Type: Panel

Last Updated : March 8, 2023

tisagenlecleucel

Details

Key Milestones2
Call for patient/clinician input open21-Nov-22
Call for patient/clinician input closed20-Jan-23
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received01-Feb-23
Submission accepted15-Feb-23
Review initiated16-Feb-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment05-May-23
Deadline for sponsors comments16-May-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor29-Jun-23
Expert committee meeting (initial)12-Jul-23
Draft recommendation issued to sponsor25-Jul-23
Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)18-Sep-23
Canada's Drug Agency review report(s) posted01-Nov-23
Last Updated : April 30, 2024