leniolisib

Details

Key Milestones2
Call for patient/clinician input open07-Mar-24
Call for patient/clinician input closed30-Apr-24
Clarification:

- Patient input submission received from the Canadian Immunodficiencies Patient Organization (operating as Immunity Canada)

Submission received19-Apr-24
Submission accepted06-May-24
Review initiated07-May-24
Draft Canada's Drug Agency review report(s) provided to sponsor for comment22-Jul-24
Clarification:

- Submission temporarily suspended

ciltacabtagene autoleucel

Details

Key Milestones2
Call for patient/clinician input open06-Mar-24
Call for patient/clinician input closed30-Apr-24
Clarification:

- Patient input submission received from Myeloma Canada

Submission received18-Apr-24
Submission accepted03-May-24
Review initiated06-May-24
Draft CADTH review report(s) provided to sponsor for comment24-Jul-24
Deadline for sponsors comments02-Aug-24
CDA-AMC review report(s) and responses to comments provided to sponsor29-Aug-24
Expert committee meeting (initial)11-Sep-24
Draft recommendation issued to sponsor24-Sep-24
Draft recommendation posted for stakeholder feedback03-Oct-24
End of feedback period18-Oct-24
Final recommendation issued to sponsor and drug plans01-Nov-24
Final recommendation posted20-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Nov-24
CDA-AMC review report(s) posted31-Mar-25

alectinib

Details

Key Milestones2
Call for patient/clinician input open06-Mar-24
Call for patient/clinician input closed30-Apr-24
Clarification:

- Patient input submission received from Lung Cancer Canada and the Lung Health Foundation / Ontario Lung Association

Submission received18-Apr-24
Submission accepted03-May-24
Review initiated06-May-24
Draft CADTH review report(s) provided to sponsor for comment24-Jul-24
Deadline for sponsors comments02-Aug-24
CDA-AMC review report(s) and responses to comments provided to sponsor29-Aug-24
Expert committee meeting (initial)11-Sep-24
Draft recommendation issued to sponsor23-Sep-24
Draft recommendation posted for stakeholder feedback03-Oct-24
End of feedback period18-Oct-24
Final recommendation issued to sponsor and drug plans30-Oct-24
Final recommendation posted18-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)14-Nov-24
CDA-AMC review report(s) posted05-Mar-25

CADTH Pharmaceutical Reviews Update — Issue 44

Details

Program Updates

1.    Pilot Expert Committee Extension and Upcoming Call for Nominations

Canada's Drug Agency is pleased to announce a 1-year extension to the Formulary Management Expert Committee (FMEC), the new expert committee announced as a 1-year pilot in June 2023.

nab-paclitaxel

Details

Key Milestones2
Call for patient/clinician/industry input openFebruary 12, 2024
Call for patient/clinician/industry input closedApril 22, 2024
Submission receivedFebruary 12, 2024
Review initiatedFebruary 13, 2024
Expert committee meeting (initial)July 04, 2024
Draft recommendation posted for stakeholder feedbackAugust 01, 2024
End of feedback periodAugust 16, 2024
Final recommendation postedSeptember 24, 2024
Canada's Drug Agency review report(s) postedAugust 21, 2024

eplontersen

Details

Key Milestones2
Call for patient/clinician input openFebruary 27, 2024
Call for patient/clinician input closedApril 22, 2024
Clarification:

- Patient input submission received from Transthyretin Amyloidosis Canada (TAC)

Submission receivedApril 09, 2024
Submission acceptedApril 23, 2024
Review initiatedApril 24, 2024
Draft CADTH review report(s) provided to sponsor for commentJuly 10, 2024
Deadline for sponsors commentsJuly 19, 2024
CADTH review report(s) and responses to comments provided to sponsorAugust 16, 2024
Expert committee meeting (initial)August 28, 2024
Draft recommendation issued to sponsorSeptember 12, 2024
Draft recommendation posted for stakeholder feedbackSeptember 19, 2024
End of feedback periodOctober 04, 2024
Final recommendation issued to sponsor and drug plansOctober 21, 2024
Final recommendation postedNovember 06, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 04, 2024
CADTH review report(s) postedFebruary 18, 2025