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

guselkumab

Details

Key Milestones2
Call for patient/clinician input openSeptember 05, 2024
Call for patient/clinician input closedOctober 28, 2024
Submission receivedOctober 21, 2024
Submission acceptedNovember 04, 2024
Review initiatedNovember 05, 2024
Draft CADTH review report(s) provided to sponsor for commentFebruary 07, 2025
Deadline for sponsors commentsFebruary 19, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorMarch 13, 2025
Expert committee meeting (initial)March 26, 2025
Draft recommendation issued to sponsor-
Clarification:

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

Draft recommendation posted for stakeholder feedback-
End of feedback period-
Last Updated : April 14, 2025

trametinib

Details

Key Milestones2
Submission received06-Sep-24
Review initiated09-Sep-24
Expert committee meeting (initial)30-Jan-25
Draft recommendation posted for stakeholder feedback20-Feb-25
End of feedback period06-Mar-25
Final recommendation posted01-Apr-25
CDA-AMC review report(s) posted13-Mar-25
Last Updated : April 3, 2025

ruxolitinib

Details

Key Milestones2
Call for patient/clinician input open05-Sep-24
Call for patient/clinician input closed28-Oct-24
Submission received17-Oct-24
Submission accepted31-Oct-24
Review initiated01-Nov-24
Draft CADTH review report(s) provided to sponsor for comment31-Jan-25
Deadline for sponsors comments11-Feb-25
CDA-AMC review report(s) and responses to comments provided to sponsor13-Mar-25
Expert committee meeting (initial)26-Mar-25
Draft recommendation issued to sponsor08-Apr-25
Draft recommendation posted for stakeholder feedback17-Apr-25
End of feedback period05-May-25
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting23-Jul-25
Last Updated : July 24, 2025

durvalumab, tremelimumab

Details

Key Milestones2
Call for patient/clinician input open05-Sep-24
Call for patient/clinician input closed28-Oct-24
Submission received17-Oct-24
Submission accepted31-Oct-24
Review initiated01-Nov-24
Draft CADTH review report(s) provided to sponsor for comment23-Jan-25
Deadline for sponsors comments04-Feb-25
CDA-AMC review report(s) and responses to comments provided to sponsor28-Feb-25
Expert committee meeting (initial)12-Mar-25
Draft recommendation issued to sponsor24-Apr-25
Draft recommendation posted for stakeholder feedback01-May-25
End of feedback period15-May-25
Final recommendation issued to sponsor and drug plans30-May-25
Final recommendation posted17-Jun-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)13-Jun-25
CDA-AMC review report(s) posted-
Last Updated : June 20, 2025

durvalumab, carboplatin, paclitaxel

Details

Key Milestones2
Call for patient/clinician input openSeptember 04, 2024
Call for patient/clinician input closedOctober 28, 2024
Submission receivedOctober 16, 2024
Submission acceptedOctober 30, 2024
Review initiatedOctober 31, 2024
Draft CADTH review report(s) provided to sponsor for commentJanuary 22, 2025
Deadline for sponsors commentsFebruary 03, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorFebruary 28, 2025
Expert committee meeting (initial)March 12, 2025
Draft recommendation issued to sponsorMarch 26, 2025
Draft recommendation posted for stakeholder feedbackApril 03, 2025
End of feedback periodApril 17, 2025
Clarification:

- Reconsideration: major revisions requested by sponsor

- Request for reconsideration not accepted

.
Final recommendation issued to sponsor and drug plansMay 05, 2025
Final recommendation postedMay 22, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 20, 2025
CDA-AMC review report(s) posted-
Last Updated : May 22, 2025

durvalumab, olaparib, carboplatin, paclitaxel

Details

Key Milestones2
Call for patient/clinician input openSeptember 04, 2024
Call for patient/clinician input closedOctober 28, 2024
Submission receivedOctober 16, 2024
Submission acceptedOctober 30, 2024
Review initiatedOctober 31, 2024
Clarification:

- Submission temporarily suspended

- Voluntarily withdrawn by the sponsor on 29 Jan 2025

Last Updated : January 30, 2025

Cladribine and Natalizumab for Relapsing-Remitting Multiple Sclerosis

Details

Multiple sclerosis (MS) is a chronic autoimmune disease with the following clinical manifestations: demyelination, inflammation, neuronal loss, and gliosis (scarring). Relapsing-remitting multiple sclerosis (RRMS) is the most common type of the disease, with a subgroup of patients who have a more aggressive disease course — manifesting with a rapid accumulation of physical or cognitive deficits — which is referred to as highly active RR  MS.

Key Milestones
Call for patient/clinician/industry input open29-Aug-24
Call for patient/clinician/industry input closed13-Sep-24
Review initiated29-Aug-24
Expert committee meeting (initial)30-Jan-25
Draft recommendation posted for stakeholder feedback20-Feb-25
Draft report posted for stakeholder feedback20-Feb-25
End of feedback period06-Mar-25
Final recommendation posted28-Mar-25
Review report(s) posted  23-Apr-25
Last Updated : May 12, 2025

HR positive, HER2 negative breast cancer

Details

Review Type: Rapid

Provisional Funding Algorithm
Draft Report Posted : 31-Oct-2024
Stakeholder Feedback Deadline : 7-Nov-2024
Final Report Posted: 10-Dec-2024
Last Updated : December 10, 2024

semaglutide

Details

Key Milestones2
Call for patient/clinician input open17-Oct-24
Call for patient/clinician input closed06-Dec-24
Submission received27-Nov-24
Submission accepted11-Dec-24
Review initiated12-Dec-24
Draft CADTH review report(s) provided to sponsor for comment06-Mar-25
Deadline for sponsors comments18-Mar-25
CDA-AMC review report(s) and responses to comments provided to sponsor09-Apr-25
Expert committee meeting (initial)23-Apr-25
Draft recommendation issued to sponsor06-May-25
Draft recommendation posted for stakeholder feedback22-May-25
End of feedback period05-Jun-25
Final recommendation issued to sponsor and drug plans17-Jun-25
Final recommendation posted04-Jul-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)02-Jul-25
CDA-AMC review report(s) posted-
Last Updated : July 23, 2025