niraparib abiraterone acetate

Details

Key Milestones2
Call for patient/clinician input openApril 21, 2023
Call for patient/clinician input closedJune 19, 2023
Clarification:

- Patient input submission received from Canadian Cancer Survivor Network

Submission receivedJune 14, 2023
Submission acceptedJune 28, 2023
Review initiatedJune 29, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentSeptember 14, 2023
Deadline for sponsors commentsSeptember 25, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorOctober 27, 2023
Expert committee meeting (initial)November 08, 2023
Clarification:

Recommendation deferred to December 6, 2023 pERC meeting due to additional clarification needed by committee

Draft recommendation issued to sponsorDecember 18, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansFebruary 01, 2024
Final recommendation postedFebruary 20, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)February 15, 2024
Canada's Drug Agency review report(s) postedApril 29, 2024

tralokinumab

Details

Key Milestones2
Call for patient/clinician input openApril 21, 2023
Call for patient/clinician input closedJune 19, 2023
Clarification:

- Patient input submission received from Eczema Society of Canada and Eczéma Québec & Canadian Skin Patient Alliance

Submission receivedJune 05, 2023
Submission acceptedJune 19, 2023
Review initiatedJune 20, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentSeptember 05, 2023
Deadline for sponsors commentsSeptember 14, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorOctober 13, 2023
Expert committee meeting (initial)October 25, 2023
Draft recommendation issued to sponsorNovember 07, 2023
Draft recommendation posted for stakeholder feedbackNovember 16, 2023
End of feedback periodNovember 30, 2023
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingApril 24, 2024
Final recommendation issued to sponsor and drug plansMay 08, 2024
Final recommendation postedMay 27, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)May 23, 2024
Canada's Drug Agency review report(s) postedSeptember 17, 2024

Triple Negative Breast Cancer

eltrombopag

Details

Key Milestones2
Call for patient/clinician input openApril 17, 2023
Call for patient/clinician input closedJune 12, 2023
Clarification:

- Patient input submission received from Aplastic Anemia & Myelodysplasia Association of Canada (AAMAC)

Call for industry input openApril 17, 2023
Call for industry input closedJune 12, 2023
Submission receivedApril 13, 2023
Review initiatedMay 24, 2023
Expert committee meeting (initial)October 17, 2023
Draft recommendation posted for stakeholder feedbackNovember 09, 2023
End of feedback periodNovember 24, 2023
Final recommendation postedDecember 20, 2023
Canada's Drug Agency review report(s) postedOctober 23, 2023

CADTH Pharmaceutical Reviews Update — Issue 36

CADTH Pharmaceutical Reviews Update — Issue 35

Details

See Pharmaceutical Reviews Update ― Issue 35 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

  • Canada's Drug Agency consultation on time-limited reimbursement recommendations

  • Revised timing for issuing the call for patient and clinician Input

  • important reminders about the sponsor summary of clinical evidence template

  • instructions for inviting Canada's Drug Agency to attend Health Canada meetings

elexacaftor/tezacaftor/ivacaftor and ivacaftor

Details

Key Milestones2
Call for patient/clinician input openMarch 28, 2023
Call for patient/clinician input closedMay 23, 2023
Clarification:

- Patient input submission received from Cystic Fibrosis Canada

Submission receivedMay 10, 2023
Submission acceptedMay 25, 2023
Review initiatedMay 26, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentAugust 10, 2023
Deadline for sponsors commentsAugust 21, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 18, 2023
Draft recommendation posted for stakeholder feedbackOctober 26, 2023
End of feedback periodNovember 09, 2023
Final recommendation issued to sponsor and drug plansNovember 24, 2023
Final recommendation postedDecember 12, 2023
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)December 08, 2023
Canada's Drug Agency review report(s) postedFebruary 09, 2024

secukinumab

Details

Key Milestones2
Call for patient/clinician input openMarch 28, 2023
Call for patient/clinician input closedMay 23, 2023
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance (CSPA), HS Heroes, and Hidradenitis & Me Support Group

Submission receivedMay 10, 2023
Submission acceptedMay 25, 2023
Review initiatedMay 26, 2023
Draft CADTH review report(s) provided to sponsor for commentAugust 10, 2023
Deadline for sponsors commentsAugust 21, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Clarification:

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

Draft recommendation issued to sponsorAugust 07, 2024
Clarification:

- Submission temporarily suspended

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

Draft recommendation posted for stakeholder feedbackAugust 15, 2024
End of feedback periodAugust 29, 2024
Final recommendation issued to sponsor and drug plansSeptember 12, 2024
Final recommendation postedOctober 01, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 26, 2024
CADTH review report(s) postedJanuary 17, 2025