maralixibat

Details

Key Milestones2
Call for patient/clinician input openMarch 23, 2023
Call for patient/clinician input closedMay 15, 2023
Clarification:

- Patient input submission received from Alagille Syndrome Alliance and Canadian Liver Foundation

Submission receivedMay 05, 2023
Submission acceptedMay 19, 2023
Review initiatedMay 23, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentAugust 04, 2023
Deadline for sponsors commentsAugust 16, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 12, 2023
Draft recommendation posted for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 02, 2023
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingFebruary 28, 2024
Draft recommendation issued to sponsorMarch 11, 2024
Draft recommendation posted for stakeholder feedbackMarch 21, 2024
End of feedback periodApril 08, 2024
Final recommendation issued to sponsor and drug plansApril 22, 2024
Final recommendation postedMay 09, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)May 07, 2024
Canada's Drug Agency review report(s) postedSeptember 20, 2024

efgartigimod alfa

Details

Key Milestones2
Call for patient/clinician input open21-Mar-23
Call for patient/clinician input closed15-May-23
Clarification:

- Patient input submission received from Muscular Dystrophy Canada

Submission received10-May-23
Submission accepted25-May-23
Review initiated26-May-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment14-Aug-23
Deadline for sponsors comments23-Aug-23
Clarification:

- Submission temporarily suspended September 6, 2023

- Submission lifted September 12, 2023

Canada's Drug Agency review report(s) and responses to comments provided to sponsor13-Oct-23
Expert committee meeting (initial)25-Oct-23
Draft recommendation issued to sponsor08-Nov-23
Draft recommendation posted for stakeholder feedback16-Nov-23
End of feedback period30-Nov-23
Final recommendation issued to sponsor and drug plans14-Dec-23
Final recommendation posted09-Jan-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)05-Jan-24
Canada's Drug Agency review report(s) posted04-Apr-24

upadacitinib

Details

Key Milestones2
Call for patient/clinician input open16-Mar-23
Call for patient/clinician input closed09-May-23
Clarification:

- Patient input submission received from Crohn’s and Colitis Canada and Gastrointestinal Society

Submission received05-Jun-23
Submission accepted19-Jun-23
Review initiated20-Jun-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment05-Sep-23
Deadline for sponsors comments14-Sep-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor13-Oct-23
Expert committee meeting (initial)25-Oct-23
Draft recommendation issued to sponsor06-Nov-23
Draft recommendation posted for stakeholder feedback16-Nov-23
End of feedback period30-Nov-23
Final recommendation issued to sponsor and drug plans14-Dec-23
Final recommendation posted09-Jan-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)05-Jan-24
Canada's Drug Agency review report(s) posted14-Mar-24

evinacumab

Details

Key Milestones2
Call for patient/clinician input openMarch 16, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

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

Submission receivedMay 10, 2023
Submission acceptedMay 25, 2023
Review initiatedMay 26, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentAugust 10, 2023
Deadline for sponsors commentsAugust 21, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 11, 2023
Draft recommendation posted for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 02, 2023
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Final recommendation postedJanuary 31, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)January 29, 2024
Canada's Drug Agency review report(s) postedApril 17, 2024

olaparib

Details

Key Milestones2
Call for patient/clinician input openMarch 15, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from Canadian Cancer Society and Canadian Cancer Survivor Network

Submission receivedMay 19, 2023
Submission acceptedJune 05, 2023
Clarification:

- Submission temporarily suspended

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

Review initiatedJune 06, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentOctober 13, 2023
Deadline for sponsors commentsOctober 24, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorNovember 24, 2023
Expert committee meeting (initial)December 06, 2023
Draft recommendation issued to sponsorDecember 19, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansJanuary 31, 2024
Final recommendation postedFebruary 16, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)February 14, 2024
Canada's Drug Agency review report(s) postedApril 25, 2024

somapacitan

Details

Key Milestones2
Call for patient/clinician input open15-Mar-23
Call for patient/clinician input closed09-May-23
Clarification:

- Patient input submission received from The MAGIC Foundation

Submission received27-Apr-23
Submission accepted12-May-23
Review initiated15-May-23
Draft CADTH review report(s) provided to sponsor for comment28-Jul-23
Deadline for sponsors comments09-Aug-23
CADTH review report(s) and responses to comments provided to sponsor15-Sep-23
Expert committee meeting (initial)27-Sep-23
Draft recommendation issued to sponsor11-Oct-23
Draft recommendation posted for stakeholder feedback19-Oct-23
End of feedback period02-Nov-23
Final recommendation issued to sponsor and drug plans17-Nov-23
Final recommendation posted05-Dec-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)01-Dec-23
CADTH review report(s) posted30-Jan-24

calaspargase pegol

Details

Key Milestones2
Call for patient/clinician input openMarch 14, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from eukemia & Lymphoma Society of Canada

Submission receivedMay 12, 2023
Submission acceptedMay 29, 2023
Review initiatedMay 30, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentAugust 29, 2023
Deadline for sponsors commentsSeptember 08, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorSeptember 27, 2023
Expert committee meeting (initial)October 11, 2023
Draft recommendation issued to sponsorNovember 23, 2023
Draft recommendation posted for stakeholder feedbackNovember 30, 2023
End of feedback periodDecember 14, 2023
Final recommendation issued to sponsor and drug plansJanuary 04, 2024
Final recommendation postedJanuary 22, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)January 18, 2024
Canada's Drug Agency review report(s) postedApril 02, 2024

ibrutinib

Details

Key Milestones2
Call for patient/clinician input openMarch 09, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedApril 21, 2023
Submission acceptedMay 08, 2023
Review initiatedMay 09, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentJuly 24, 2023
Deadline for sponsors commentsAugust 02, 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 26, 2023
Draft recommendation posted for stakeholder feedbackOctober 05, 2023
End of feedback periodOctober 20, 2023
Final recommendation issued to sponsor and drug plansNovember 02, 2023
Final recommendation postedNovember 22, 2023
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)November 17, 2023
Canada's Drug Agency review report(s) postedFebruary 09, 2024

brentuximab vedotin

Details

Key Milestones2
Call for patient/clinician input open08-Mar-23
Call for patient/clinician input closed02-May-23
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received12-Apr-23
Submission accepted26-Apr-23
Review initiated27-Apr-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment19-Jul-23
Deadline for sponsors comments28-Jul-23
Clarification:

- Submission was voluntarily withdrawn by sponsor on 23-Oct-23

bevacizumab and lomustine

Details

Key Milestones2
Call for patient/clinician input openMarch 06, 2023
Call for patient/clinician input closedMay 02, 2023
Clarification:

- No patient input submission received

Call for industry input openMarch 06, 2023
Call for industry input closedMay 02, 2023
Submission receivedMarch 02, 2023
Review initiatedMarch 06, 2023
Expert committee meeting (initial)October 17, 2023
Draft recommendation posted for stakeholder feedbackNovember 09, 2023
End of feedback periodNovember 24, 2023
Final recommendation postedDecember 20, 2023
Canada's Drug Agency review report(s) postedOctober 30, 2023