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 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-

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

Details

Review Type: Rapid

Provisional Funding Algorithm

Draft Report Posted: 28-Nov-2024
Feedback Deadline: 5-Dec-2024
Final Report Posted : 21-Jan-2025

daridorexant

Details

Key Milestones2
Call for patient/clinician input open24-Oct-24
Call for patient/clinician input closed20-Dec-24
Submission received05-Dec-24
Submission accepted19-Dec-24
Review initiated20-Dec-24
Draft CADTH review report(s) provided to sponsor for comment24-Mar-25
Deadline for sponsors comments02-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 sponsor10-Jun-25
Draft recommendation posted for stakeholder feedback19-Jun-25
End of feedback period04-Jul-25
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target CDEC reconsideration meeting date to be determined

.

cipaglucosidase alfa with miglustat

Details

Key Milestones2
Call for patient/clinician input openOctober 23, 2024
Call for patient/clinician input closedDecember 13, 2024
Submission receivedNovember 29, 2024
Submission acceptedDecember 13, 2024
Review initiatedDecember 16, 2024
Draft CADTH review report(s) provided to sponsor for commentApril 09, 2025
Deadline for sponsors commentsApril 22, 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
Draft recommendation posted for stakeholder feedbackJune 19, 2025
End of feedback periodJuly 04, 2025
Final recommendation issued to sponsor and drug plansJuly 21, 2025
Final recommendation postedAugust 07, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)August 05, 2025
CDA-AMC review report(s) posted-

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-