roflumilast

Details

Key Milestones2
Call for patient/clinician input open03-Apr-25
Call for patient/clinician input closed27-May-25
Submission received16-May-25
Submission accepted02-Jun-25
Review initiated03-Jun-25
Draft CADTH review report(s) provided to sponsor for comment04-Sep-25
Deadline for sponsors comments15-Sep-25
CDA-AMC review report(s) and responses to comments provided to sponsor09-Oct-25
Expert committee meeting (initial)22-Oct-25
Draft recommendation issued to sponsorNovember 03, 2025
To
November 05, 2025
Draft recommendation posted for stakeholder feedback13-Nov-25
End of feedback period27-Nov-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)22-Oct-25

trastuzumab deruxtecan

Details

Key Milestones2
Call for patient/clinician input openApril 02, 2025
Call for patient/clinician input closedMay 27, 2025
Submission receivedMay 15, 2025
Submission acceptedMay 30, 2025
Review initiatedJune 02, 2025
Draft CADTH review report(s) provided to sponsor for commentAugust 22, 2025
Deadline for sponsors commentsSeptember 03, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorSeptember 25, 2025
Expert committee meeting (initial)October 08, 2025
Draft recommendation issued to sponsorOctober 21, 2025
To
October 23, 2025
Draft recommendation posted for stakeholder feedbackOctober 30, 2025
End of feedback periodNovember 14, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 08, 2025

upadacitinib

Details

Key Milestones2
Call for patient/clinician input open31-Mar-25
Call for patient/clinician input closed27-May-25
Submission received16-May-25
Submission accepted02-Jun-25
Review initiated03-Jun-25
Clarification:

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

Draft CADTH review report(s) provided to sponsor for comment04-Sep-25
Deadline for sponsors comments15-Sep-25
CDA-AMC review report(s) and responses to comments provided to sponsor09-Oct-25
Expert committee meeting (initial)22-Oct-25
Draft recommendation issued to sponsorNovember 03, 2025
To
November 05, 2025
Draft recommendation posted for stakeholder feedback13-Nov-25
End of feedback period27-Nov-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)22-Oct-25

vanzacaftor, tezacaftor, deutivacaftor

Details

Key Milestones2
Call for patient/clinician input open27-Mar-25
Call for patient/clinician input closed20-May-25
Submission received09-May-25
Submission accepted26-May-25
Review initiated27-May-25
Draft CADTH review report(s) provided to sponsor for comment11-Aug-25
Deadline for sponsors comments20-Aug-25
CDA-AMC review report(s) and responses to comments provided to sponsor12-Sep-25
Expert committee meeting (initial)24-Sep-25
Draft recommendation issued to sponsorOctober 07, 2025
To
October 09, 2025
Draft recommendation posted for stakeholder feedback16-Oct-25
End of feedback period30-Oct-25

Pharmaceutical Reviews Update — Issue 55

Details

Program Updates

1. Methods Guide Update

Canada’s Drug Agency  (CDA-AMC) has published our first-ever guidance document on health technology assessment (HTA) methods used in the appraisal of clinical evidence for a drug submitted by a sponsor to our drug reimbursement review program.  

vorasidenib

Details

Key Milestones2
Call for patient/clinician input openMarch 19, 2025
Call for patient/clinician input closedMay 12, 2025
Submission receivedApril 30, 2025
Submission acceptedMay 14, 2025
Review initiatedMay 15, 2025
Draft CADTH review report(s) provided to sponsor for commentAugust 18, 2025
Deadline for sponsors commentsAugust 27, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorSeptember 25, 2025
Expert committee meeting (initial)October 08, 2025
Draft recommendation issued to sponsorOctober 21, 2025
To
October 23, 2025
Draft recommendation posted for stakeholder feedbackOctober 30, 2025
End of feedback periodNovember 14, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 08, 2025

darolutamide

Details

Key Milestones2
Call for patient/clinician input open13-Mar-25
Call for patient/clinician input closed06-May-25
Submission received28-Apr-25
Clarification:

Eligible for review through the PACES process

Submission accepted12-May-25
Review initiated13-May-25
Draft CADTH review report(s) provided to sponsor for comment03-Jul-25
Deadline for sponsors comments10-Jul-25
CDA-AMC review report(s) and responses to comments provided to sponsor25-Aug-25
Expert committee meeting (initial)05-Sep-25
Draft recommendation issued to sponsor12-Sep-25
Draft recommendation posted for stakeholder feedback18-Sep-25
End of feedback period03-Oct-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)05-Sep-25