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

iptacopan

Details

Key Milestones2
Call for patient/clinician input open04-Jul-24
Call for patient/clinician input closed23-Aug-24
Submission received15-Aug-24
Submission accepted29-Aug-24
Review initiated30-Aug-24
Draft CADTH review report(s) provided to sponsor for comment28-Nov-24
Deadline for sponsors comments09-Dec-24
CDA-AMC review report(s) and responses to comments provided to sponsor10-Jan-25
Expert committee meeting (initial)22-Jan-25
Draft recommendation issued to sponsor04-Feb-25
Draft recommendation posted for stakeholder feedback13-Feb-25
End of feedback period28-Feb-25
Final recommendation issued to sponsor and drug plans12-Mar-25
Final recommendation posted31-Mar-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)27-Mar-25
CDA-AMC review report(s) posted-

tarlatamab

Details

Key Milestones2
Call for patient/clinician input openJuly 03, 2024
Call for patient/clinician input closedAugust 23, 2024
Submission receivedAugust 14, 2024
Submission acceptedAugust 28, 2024
Review initiatedAugust 29, 2024
Draft CADTH review report(s) provided to sponsor for commentNovember 15, 2024
Deadline for sponsors commentsNovember 26, 2024
CDA-AMC review report(s) and responses to comments provided to sponsorDecember 19, 2024
Expert committee meeting (initial)January 08, 2025
Draft recommendation issued to sponsorJanuary 21, 2025
Draft recommendation posted for stakeholder feedbackJanuary 30, 2025
End of feedback periodFebruary 13, 2025
Final recommendation issued to sponsor and drug plansFebruary 28, 2025
Final recommendation postedMarch 19, 2025
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 17, 2025
CDA-AMC review report(s) posted-

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

Pharmaceutical Reviews Update — Issue 48

Details

Program Updates

1. Expanding Our Scientific Advice Services for Canada’s Life Sciences Sector

Canada’s Drug Agency is launching a new 1-year learning period in our Scientific Advice program that will expand the type of guidance we offer to drug manufacturers to include those that are seeking advice after a “do not reimburse” recommendation is made for their product.