Pharmaceutical Reviews Update — Issue 49

Details

Program Updates

1. Working Toward Target Zero: Expanding Our Rolling Review Pilot Process

Canada’s Drug Agency is taking a new step to improve the timeliness of patient access to new drugs. The action supports our ambitious Target Zero campaign — an initiative that aims to achieve zero days between Health Canada’s regulatory approval of a drug and our reimbursement recommendation to participating public drug plans. 

nivolumab ipilimumab

Details

Key Milestones2
Call for patient/clinician/industry input open 11-Jul-24
Call for patient/clinician/industry input closed 30-Aug-24
Submission received04-Jul-24
Review initiated05-Jul-24
Expert committee meeting (initial)21-Nov-24
Draft recommendation posted for stakeholder feedback12-Dec-24
End of feedback period03-Jan-25
Final recommendation posted04-Feb-25
CADTH review report(s) posted29-Jan-25

dostarlimab

Details

Key Milestones2
Call for patient/clinician input open04-Jul-24
Call for patient/clinician input closed30-Aug-24
Submission received15-Aug-24
Submission accepted29-Aug-24
Review initiated30-Aug-24
Draft CADTH review report(s) provided to sponsor for comment18-Nov-24
Deadline for sponsors comments27-Nov-24
CDA-AMC review report(s) and responses to comments provided to sponsor19-Dec-24
Expert committee meeting (initial)08-Jan-25
Draft recommendation issued to sponsor29-Apr-25
Clarification:

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

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Draft recommendation posted for stakeholder feedback08-May-25
End of feedback period23-May-25
Final recommendation issued to sponsor and drug plans06-Jun-25
Final recommendation posted24-Jun-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)20-Jun-25
CDA-AMC review report(s) posted-

iptacopan

Details

Key Milestones2
Call for patient/clinician input openJuly 04, 2024
Call for patient/clinician input closedAugust 23, 2024
Submission receivedAugust 15, 2024
Submission acceptedAugust 29, 2024
Review initiatedAugust 30, 2024
Draft CADTH review report(s) provided to sponsor for commentNovember 28, 2024
Deadline for sponsors commentsDecember 09, 2024
CDA-AMC review report(s) and responses to comments provided to sponsorJanuary 10, 2025
Expert committee meeting (initial)January 22, 2025
Draft recommendation issued to sponsorFebruary 04, 2025
Draft recommendation posted for stakeholder feedbackFebruary 13, 2025
End of feedback periodFebruary 28, 2025
Final recommendation issued to sponsor and drug plansMarch 12, 2025
Final recommendation postedMarch 31, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 27, 2025
CDA-AMC review report(s) postedJuly 24, 2025

tarlatamab

Details

Key Milestones2
Call for patient/clinician input open03-Jul-24
Call for patient/clinician input closed23-Aug-24
Submission received14-Aug-24
Submission accepted28-Aug-24
Review initiated29-Aug-24
Draft CADTH review report(s) provided to sponsor for comment15-Nov-24
Deadline for sponsors comments26-Nov-24
CDA-AMC review report(s) and responses to comments provided to sponsor19-Dec-24
Expert committee meeting (initial)08-Jan-25
Draft recommendation issued to sponsor21-Jan-25
Draft recommendation posted for stakeholder feedback30-Jan-25
End of feedback period13-Feb-25
Final recommendation issued to sponsor and drug plans28-Feb-25
Final recommendation posted19-Mar-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)17-Mar-25
CDA-AMC review report(s) posted27-Jun-25

teriflunomide

Details

Key Milestones2
Submission received11-Jul-24
Review initiated12-Jul-24
Expert committee meeting (initial)21-Nov-24
Draft recommendation posted for stakeholder feedback12-Dec-24
End of feedback period03-Jan-25
Final recommendation posted04-Feb-25
CADTH review report(s) posted29-Jan-25

dimethyl fumarate

Details

Key Milestones2
Submission received11-Jul-24
Review initiated12-Jul-24
Expert committee meeting (initial)21-Nov-24
Draft recommendation posted for stakeholder feedback12-Dec-24
End of feedback period03-Jan-25
Final recommendation posted04-Feb-25
CADTH review report(s) posted29-Jan-25