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

atogepant

Details

Key Milestones2
Call for patient/clinician input openOctober 30, 2023
Call for patient/clinician input closedDecember 22, 2023
Clarification:

- Patient input submission received from the Canadian Migraine Society and Migraine Canada

Submission receivedDecember 21, 2023
Submission acceptedJanuary 12, 2024
Review initiatedJanuary 15, 2024
Draft CADTH review report(s) provided to sponsor for commentApril 02, 2024
Deadline for sponsors commentsApril 11, 2024
CADTH review report(s) and responses to comments provided to sponsorMay 09, 2024
Expert committee meeting (initial)May 22, 2024
Draft recommendation issued to sponsorJune 04, 2024
Draft recommendation posted for stakeholder feedbackJune 13, 2024
End of feedback periodJune 27, 2024
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plansJuly 15, 2024
Final recommendation postedJuly 31, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 29, 2024
CADTH review report(s) postedDecember 13, 2024
Last Updated : December 16, 2024

pembrolizumab

Details

Key Milestones2
Call for patient/clinician input open26-Oct-23
Call for patient/clinician input closed15-Dec-23
Clarification:

- Patient input submission received from CCRAN collectively with CCSN & GI Society

Submission received07-Dec-23
Submission accepted21-Dec-23
Review initiated22-Dec-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment18-Mar-24
Deadline for sponsors comments27-Mar-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor25-Apr-24
Expert committee meeting (initial)08-May-24
Draft recommendation issued to sponsor22-May-24
Draft recommendation posted for stakeholder feedback30-May-24
End of feedback period13-Jun-24
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plans11-Jul-24
Final recommendation posted29-Jul-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)25-Jul-24
Canada's Drug Agency review report(s) posted21-Nov-24
Last Updated : November 21, 2024

abemaciclib

Details

Key Milestones2
Call for patient/clinician input open24-Oct-23
Call for patient/clinician input closed15-Dec-23
Clarification:

- Patient input submission received from the Canadian Breast Cancer Network and Rethink Breast Cancer

Submission received09-Feb-24
Submission accepted26-Feb-24
Review initiated27-Feb-24
Draft CADTH review report(s) provided to sponsor for comment27-May-24
Clarification:

- Submission temporarily suspended

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

Draft CADTH review report(s) provided to sponsor for comment02-Jul-24
Deadline for sponsors comments11-Jul-24
CADTH review report(s) and responses to comments provided to sponsor01-Aug-24
Expert committee meeting (initial)14-Aug-24
Draft recommendation issued to sponsor23-Aug-24
Draft recommendation posted for stakeholder feedback05-Sep-24
End of feedback period19-Sep-24
Final recommendation issued to sponsor and drug plans03-Oct-24
Final recommendation posted22-Oct-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Oct-24
CADTH review report(s) posted07-Feb-25
Last Updated : February 7, 2025

ravulizumab

Details

Key Milestones2
Call for patient/clinician input open13-Jul-23
Call for patient/clinician input closed01-Sep-23
Clarification:

- Patient input submission received from MS Canada and The Sumaira Foundation

Submission received29-Aug-23
Submission accepted13-Sep-23
Review initiated14-Sep-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment30-Nov-23
Deadline for sponsors comments11-Dec-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor12-Jan-24
Expert committee meeting (initial)24-Jan-24
Draft recommendation issued to sponsor07-Feb-24
Draft recommendation posted for stakeholder feedback15-Feb-24
End of feedback period01-Mar-24
Final recommendation issued to sponsor and drug plans13-Mar-24
Final recommendation posted02-Apr-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)28-Mar-24
Canada's Drug Agency review report(s) posted14-Jun-24
Last Updated : June 14, 2024

Sodium-Glucose Cotransporter 2 Inhibitors in Type 2 Diabetes Mellitus

Details

The class of sodium-glucose cotransporter-2 (SGLT2) inhibitors is an integral part of the management of type 2 diabetes mellitus. Evidence informing the place in therapy of SGLT2 inhibitors has matured since Canada's Drug Agency last assessed this drug class. Public drug programs have requested a review to assess the optimal use of SGLT2 inhibitors after a trial of metformin. 

Key Milestones
Posting of Draft Scope for stakeholder feedbackSeptember 14, 2023
End of feedback periodSeptember 28, 2023
Posting of Draft Summary Report for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 2, 2023
Expert committee meeting (initial)November 30, 2023
Draft recommendation(s) posted for stakeholder feedbackJanuary 4, 2024
End of feedback periodJanuary 25, 2024
Final recommendation(s) postedMarch 7, 2024
Last Updated : March 7, 2024

pembrolizumab

Details

Key Milestones2
Call for patient/clinician input open11-Oct-23
Call for patient/clinician input closed01-Dec-23
Clarification:

- Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada

Submission received22-Nov-23
Submission accepted06-Dec-23
Review initiated07-Dec-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment29-Feb-24
Deadline for sponsors comments11-Mar-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor25-Apr-24
Expert committee meeting (initial)08-May-24
Draft recommendation issued to sponsor21-May-24
Draft recommendation posted for stakeholder feedback30-May-24
End of feedback period13-Jun-24
Final recommendation issued to sponsor and drug plans26-Jun-24
Final recommendation posted15-Jul-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)11-Jul-24
Canada's Drug Agency review report(s) posted08-Nov-24
Last Updated : November 12, 2024

infliximab

Details

Key Milestones2
Call for patient/clinician input open22-Aug-23
Call for patient/clinician input closed17-Oct-23
Clarification:

- Patient input submission received from the Gastrointestinal Society

Submission received04-Oct-23
Submission accepted19-Oct-23
Review initiated20-Oct-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment11-Jan-24
Deadline for sponsors comments22-Jan-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor11-Mar-24
Draft recommendation posted for stakeholder feedback21-Mar-24
End of feedback period08-Apr-24
Final recommendation issued to sponsor and drug plans22-Apr-24
Final recommendation posted09-May-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)07-May-24
Canada's Drug Agency review report(s) posted28-Aug-24
Last Updated : September 3, 2024

evolocumab

Details

Key Milestones2
Call for patient/clinician input openOctober 03, 2023
Call for patient/clinician input closedNovember 27, 2023
Clarification:

- No patient input submission received

Submission receivedNovember 29, 2023
Submission acceptedDecember 13, 2023
Review initiatedDecember 14, 2023
Draft CADTH review report(s) provided to sponsor for commentMarch 07, 2024
Deadline for sponsors commentsMarch 19, 2024
CADTH review report(s) and responses to comments provided to sponsorApril 12, 2024
Expert committee meeting (initial)April 24, 2024
Draft recommendation issued to sponsorMay 07, 2024
Draft recommendation posted for stakeholder feedbackMay 16, 2024
End of feedback periodMay 31, 2024
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plansAugust 08, 2024
Final recommendation postedAugust 26, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)August 22, 2024
CADTH review report(s) postedDecember 11, 2024
Last Updated : December 11, 2024

relugolix

Details

Key Milestones2
Call for patient/clinician input open29-Sep-23
Call for patient/clinician input closed27-Nov-23
Clarification:

- Patient input submission received from The Androgen Deprivation Therapy Education Program, the Canadian Cancer Society and PROCURE - CANCER PROSTATE

Submission received14-Nov-23
Submission accepted28-Nov-23
Review initiated29-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment23-Feb-24
Deadline for sponsors comments05-Mar-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor28-Mar-24
Expert committee meeting (initial)10-Apr-24
Draft recommendation issued to sponsor23-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plans22-Jul-24
Final recommendation posted08-Aug-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)13-Jun-24
Canada's Drug Agency review report(s) posted29-Oct-24
Last Updated : October 29, 2024

epcoritamab

Details

Key Milestones2
Call for patient/clinician input open29-Sep-23
Call for patient/clinician input closed27-Nov-23
Clarification:

- Patient input submission received from Lymphoma Canada and the Leukemia & Lymphoma Society of Canada

Submission received14-Nov-23
Clarification:

Eligible for consideration as a time-limited recommendation

Submission accepted28-Nov-23
Review initiated29-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment23-Feb-24
Deadline for sponsors comments05-Mar-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor28-Mar-24
Expert committee meeting (initial)10-Apr-24
Draft recommendation issued to sponsor24-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24
Final recommendation issued to sponsor and drug plans31-May-24
Final recommendation posted18-Jun-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)14-Jun-24
Canada's Drug Agency review report(s) posted30-Oct-24
Last Updated : October 31, 2024