Pharmaceutical Reviews Update — Issue 52

Details

Program Updates 

1. Updates to the Pharmacoeconomic Submission Process and Submission Requirements 

Making Our Economic Model Change Logs More Transparent to Our Partners 

Transparency is essential in economic modelling to make complex analyses more understandable, reliable, and actionable. We are taking a new step to increase the transparency around how we handle economic models that are submitted by a drug sponsor as part of a drug reimbursement review.

Dupilumab

Details

Key Milestones2
Call for patient/clinician input open30-Oct-24
Call for patient/clinician input closed20-Dec-24
Submission received11-Dec-24
Submission accepted02-Jan-25
Review initiated03-Jan-25
Draft CADTH review report(s) provided to sponsor for comment09-Apr-25
Deadline for sponsors comments22-Apr-25
CDA-AMC review report(s) and responses to comments provided to sponsor15-May-25
Expert committee meeting (initial)28-May-25
Draft recommendation issued to sponsorJune 09, 2025
To
June 11, 2025
Draft recommendation posted for stakeholder feedback19-Jun-25
End of feedback period04-Jul-25

Anaplastic Lymphoma Kinase (ALK) -Positive Non-small Cell Lung Cancer (NSCLC)

daridorexant

Details

Key Milestones2
Call for patient/clinician input openOctober 24, 2024
Call for patient/clinician input closedDecember 20, 2024
Submission receivedDecember 05, 2024
Submission acceptedDecember 19, 2024
Review initiatedDecember 20, 2024
Draft CADTH review report(s) provided to sponsor for commentMarch 24, 2025
Deadline for sponsors commentsApril 02, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorMay 15, 2025
Expert committee meeting (initial)May 28, 2025
Draft recommendation issued to sponsorJune 09, 2025
To
June 11, 2025
Draft recommendation posted for stakeholder feedbackJune 19, 2025
End of feedback periodJuly 04, 2025

cipaglucosidase alfa with miglustat

Details

Key Milestones2
Call for patient/clinician input open23-Oct-24
Call for patient/clinician input closed13-Dec-24
Submission received29-Nov-24
Submission accepted13-Dec-24
Review initiated16-Dec-24
Draft CADTH review report(s) provided to sponsor for comment09-Apr-25
Deadline for sponsors comments22-Apr-25
CDA-AMC review report(s) and responses to comments provided to sponsor15-May-25
Expert committee meeting (initial)28-May-25
Draft recommendation issued to sponsorJune 09, 2025
To
June 11, 2025
Draft recommendation posted for stakeholder feedback19-Jun-25
End of feedback period04-Jul-25

bimekizumab

Details

Key Milestones2
Call for patient/clinician input open06-Sep-24
Call for patient/clinician input closed04-Nov-24
Submission received18-Oct-24
Submission accepted01-Nov-24
Review initiated04-Nov-24
Draft CADTH review report(s) provided to sponsor for comment06-Feb-25
Deadline for sponsors comments18-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 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-

regorafenib

Details

Key Milestones2
Submission received18-Oct-24
Review initiated21-Oct-24
Expert committee meeting (initial)20-Mar-25
Draft recommendation posted for stakeholder feedback11-Apr-25
End of feedback period29-Apr-25
Final recommendation posted-
CDA-AMC review report(s) posted-