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

inclisiran

Details

Key Milestones2
Call for patient/clinician input open24-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from Canadian Heart Patient Alliance and HeartLife Foundation

Submission received19-Sep-23
Submission accepted04-Oct-23
Review initiated05-Oct-23
Draft CADTH review report(s) provided to sponsor for comment20-Dec-23
Deadline for sponsors comments08-Jan-24
CADTH review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor13-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 CADTH review report(s)29-Aug-24
CADTH review report(s) posted20-Dec-24
Last Updated : December 20, 2024

nivolumab

Details

Key Milestones2
Call for patient/clinician input open25-Sep-23
Call for patient/clinician input closed21-Nov-23
Clarification:

- Patient input submission received from Melanoma Canada, and Save Your Skin Foundation

Submission received06-Nov-23
Submission accepted21-Nov-23
Review initiated22-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment15-Feb-24
Deadline for sponsors comments27-Feb-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 sponsor22-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24
Final recommendation issued to sponsor and drug plans29-May-24
Final recommendation posted14-Jun-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)12-Jun-24
Canada's Drug Agency review report(s) posted26-Sep-24
Last Updated : September 26, 2024

lebrikizumab

Details

Key Milestones2
Call for patient/clinician input openSeptember 20, 2023
Call for patient/clinician input closedNovember 14, 2023
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance, Eczema Society of Canada and Eczéma Québec

Submission receivedNovember 01, 2023
Submission acceptedNovember 16, 2023
Review initiatedNovember 17, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 08, 2024
Deadline for sponsors commentsFebruary 20, 2024
CADTH review report(s) and responses to comments provided to sponsorMarch 14, 2024
Expert committee meeting (initial)March 27, 2024
Draft recommendation issued to sponsorJuly 08, 2024
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation posted for stakeholder feedbackJuly 18, 2024
End of feedback periodAugust 01, 2024
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingSeptember 25, 2024
Final recommendation issued to sponsor and drug plansOctober 09, 2024
Final recommendation postedNovember 15, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 24, 2024
CADTH review report(s) postedFebruary 11, 2025
Last Updated : February 11, 2025

letermovir

Details

Key Milestones2
Call for patient/clinician input open15-Sep-23
Call for patient/clinician input closed14-Nov-23
Clarification:

- No patient input submission received

Submission received30-Oct-23
Submission accepted14-Nov-23
Review initiated15-Nov-23
Draft CADTH review report(s) provided to sponsor for comment08-Feb-24
Clarification:

- Voluntarily withdrawn by the sponsor on 14-May-2024

Deadline for sponsors comments20-Feb-24
Clarification:

- Submission temporarily suspended

- Temporary suspension of the review has been lifted

Last Updated : April 30, 2025

ruxolitinib

Details

Key Milestones2
Call for patient/clinician input open14-Sep-23
Call for patient/clinician input closed21-Nov-23
Submission received27-Oct-23
Submission accepted17-Nov-23
Clarification:

- Submission was not accepted for review on 10 Nov 2023

Review initiated20-Nov-23
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted on 28 Aug 2024

Draft CADTH review report(s) provided to sponsor for comment16-Oct-24
Deadline for sponsors comments25-Oct-24
CDA-AMC review report(s) and responses to comments provided to sponsor15-Nov-24
Expert committee meeting (initial)27-Nov-24
Draft recommendation issued to sponsor11-Dec-24
Draft recommendation posted for stakeholder feedback19-Dec-24
End of feedback period10-Jan-25
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target CDEC reconsideration meeting date to be determined

Expert committee meeting23-Apr-25
Final recommendation issued to sponsor and drug plans06-May-25
Final recommendation posted23-May-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)21-May-25
CDA-AMC review report(s) posted-
Last Updated : May 23, 2025

Prostate Cancer

Details

Review Type: Rapid
 

Provisional Funding Algorithm
Draft Report Posted: September 14, 2023
Stakeholder Feedback Deadline: September 21, 2023
Final Report Posted: October 27, 2023
Last Updated : October 27, 2023

dostarlimab

Details

Key Milestones2
Call for patient/clinician input openSeptember 05, 2023
Call for patient/clinician input closedOctober 30, 2023
Clarification:

- No patient input submission received

Submission receivedOctober 18, 2023
Submission acceptedNovember 01, 2023
Review initiatedNovember 02, 2023
Draft CADTH review report(s) provided to sponsor for commentJanuary 29, 2024
Deadline for sponsors commentsFebruary 07, 2024
CADTH review report(s) and responses to comments provided to sponsorMarch 01, 2024
Expert committee meeting (initial)March 13, 2024
Draft recommendation issued to sponsorMarch 27, 2024
Draft recommendation posted for stakeholder feedbackApril 04, 2024
End of feedback periodApril 18, 2024
Final recommendation issued to sponsor and drug plansMay 03, 2024
Final recommendation postedMay 22, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 17, 2024
CADTH review report(s) postedJuly 24, 2024
Last Updated : January 29, 2025

insulin icodec

Details

Key Milestones2
Call for patient/clinician input open06-Sep-23
Call for patient/clinician input closed30-Oct-23
Clarification:

- Patient input submission received from Diabetes Canada

Submission received18-Oct-23
Submission accepted01-Nov-23
Review initiated02-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment01-Feb-24
Deadline for sponsors comments12-Feb-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor14-Mar-24
Expert committee meeting (initial)27-Mar-24
Draft recommendation issued to sponsor11-Apr-24
Draft recommendation posted for stakeholder feedback18-Apr-24
End of feedback period03-May-24
Final recommendation issued to sponsor and drug plans17-May-24
Final recommendation posted05-Jun-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)03-Jun-24
Canada's Drug Agency review report(s) posted27-Sep-24
Last Updated : October 3, 2024

bimekizumab

Details

Key Milestones2
Call for patient/clinician input open30-Aug-23
Call for patient/clinician input closed24-Oct-23
Clarification:

- Patient input submission received from Arthritis Consumer Experts, Canadian Spondyloarthritis Association (CSA),Canadian Arthritis Patient Alliance (CAPA),Arthritis Society Canada (ASC) and Creaky Joints (CJ)

Submission received19-Oct-23
Submission accepted02-Nov-23
Review initiated03-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment30-Jan-24
Deadline for sponsors comments08-Feb-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor14-Mar-24
Expert committee meeting (initial)27-Mar-24
Draft recommendation issued to sponsor10-Apr-24
Draft recommendation posted for stakeholder feedback18-Apr-24
End of feedback period03-May-24
Final recommendation issued to sponsor and drug plans16-May-24
Final recommendation posted04-Jun-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)31-May-24
Canada's Drug Agency review report(s) posted10-Oct-24
Last Updated : October 10, 2024

risperidone

Details

Key Milestones2
Call for patient/clinician input openAugust 30, 2023
Call for patient/clinician input closedOctober 24, 2023
Clarification:

- No patient input submission received

Submission receivedOctober 13, 2023
Submission acceptedOctober 27, 2023
Review initiatedOctober 30, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 01, 2024
Deadline for sponsors commentsFebruary 12, 2024
CDA-AMC review report(s) and responses to comments provided to sponsorMarch 14, 2024
Clarification:

- Submission temporarily suspended

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

Expert committee meeting (initial)June 25, 2025
Draft recommendation issued to sponsorJuly 09, 2025
Draft recommendation posted for stakeholder feedbackJuly 17, 2025
End of feedback periodJuly 31, 2025
Final recommendation issued to sponsor and drug plansAugust 14, 2025
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)August 28, 2025
CDA-AMC review report(s) posted-
Last Updated : August 5, 2025