Canada’s Drug Agency | Drugs, Health Technologies and Systems.

CADTH Pharmaceutical Reviews Update — Issue 37

Details

Canada's Drug Agency Program Updates 

1.  Implementation of GRADE in Canada's Drug Agency Reimbursement Reviews 

As part of an organization-wide initiative, Canada's Drug Agency is adopting the GRADE approach for communicating the level of certainty of a body of evidence within Canada's Drug Agency Reimbursement Reviews. Developed by an international working group, GRADE stands for Grading of Recommendations Assessment, Development, and Evaluation, and it is a widely adopted tool for rating the certainty in the evidence.  

Last Updated : May 25, 2023

Adult B-Cell Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and Positive

Details

Review Type: Rapid

 

Provisional Funding Algorithm
Draft Report Posted May 25, 2023
Stakeholder Feedback Deadline June 1, 2023
Final Report Posted  June 28, 2023
Last Updated : June 28, 2023

odevixibat

Details

Key Milestones2
Call for patient/clinician input open24-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from the Canadian Liver Foundation

Submission received23-Jun-23
Submission accepted10-Jul-23
Review initiated11-Jul-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment29-Sep-23
Deadline for sponsors comments12-Oct-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor09-Nov-23
Expert committee meeting (initial)22-Nov-23
Draft recommendation issued to sponsor04-Dec-23
Draft recommendation posted for stakeholder feedback14-Dec-23
End of feedback period10-Jan-24
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plans13-Feb-24
Final recommendation posted01-Mar-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)08-Feb-24
Canada's Drug Agency review report(s) posted10-May-24
Last Updated : May 10, 2024

inclisiran

Details

Key Milestones2
Call for patient/clinician input open24-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from Canadian Heart Patient Alliance and HeartLife Foundation

Submission received19-Sep-23
Submission accepted04-Oct-23
Review initiated05-Oct-23
Draft CADTH review report(s) provided to sponsor for comment20-Dec-23
Deadline for sponsors comments08-Jan-24
CADTH review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor13-Mar-24
Draft recommendation posted for stakeholder feedback21-Mar-24
End of feedback period08-Apr-24
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting26-Jun-24
Draft recommendation issued to sponsor11-Jul-24
Draft recommendation posted for stakeholder feedback18-Jul-24
End of feedback period01-Aug-24
Final recommendation issued to sponsor and drug plans15-Aug-24
Final recommendation posted03-Sep-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)29-Aug-24
CADTH review report(s) posted20-Dec-24
Last Updated : December 20, 2024

vutrisiran

Details

Key Milestones2
Call for patient/clinician input openMay 23, 2023
Call for patient/clinician input closedJuly 14, 2023
Clarification:

- Patient input submission received from TTR Amyloidosis Canada

Submission receivedJuly 04, 2023
Submission acceptedJuly 18, 2023
Review initiatedJuly 19, 2023
Draft CADTH review report(s) provided to sponsor for commentOctober 04, 2023
Deadline for sponsors commentsOctober 16, 2023
CADTH review report(s) and responses to comments provided to sponsorNovember 09, 2023
Expert committee meeting (initial)November 22, 2023
Draft recommendation issued to sponsorDecember 06, 2023
Draft recommendation posted for stakeholder feedbackDecember 21, 2023
End of feedback periodJanuary 12, 2024
Final recommendation postedFebruary 15, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 12, 2024
CADTH review report(s) postedApril 29, 2024
Last Updated : December 12, 2024

clascoterone

Details

Key Milestones2
Call for patient/clinician input open23-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from the Acne and Rosacea Society of Canada and Canadian Skin Patient Alliance

Submission received04-Jul-23
Submission accepted18-Jul-23
Review initiated19-Jul-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment04-Oct-23
Deadline for sponsors comments16-Oct-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor09-Nov-23
Clarification:

- Voluntarily withdrawn by the sponsor on 15 Nov 2023

Last Updated : November 17, 2023

elranatamab

Details

Key Milestones2
Call for patient/clinician input open05-Sep-23
Call for patient/clinician input closed30-Oct-23
Clarification:

- Patient input submission received from Myeloma Canada

Submission received09-Nov-23
Submission accepted24-Nov-23
Review initiated27-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment23-Feb-24
Deadline for sponsors comments05-Mar-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor28-Mar-24
Expert committee meeting (initial)10-Apr-24
Draft recommendation issued to sponsor23-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24
Final recommendation issued to sponsor and drug plans31-May-24
Final recommendation posted18-Jun-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)14-Jun-24
Canada's Drug Agency review report(s) posted07-Nov-24
Last Updated : November 12, 2024

ibrutinib

Details

Key Milestones2
Call for patient/clinician input openMay 09, 2023
Call for patient/clinician input closedJune 30, 2023
Clarification:

- Patient input submission received from Lymphoma Canada and Waldenstrom’s Macroglobulinemia Foundation of Canada (WMFC)

Submission receivedJune 20, 2023
Submission acceptedJuly 05, 2023
Review initiatedJuly 06, 2023
Draft Canada's Drug Agency review report(s) provided to sponsor for commentSeptember 20, 2023
Deadline for sponsors commentsSeptember 29, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorOctober 27, 2023
Expert committee meeting (initial)November 08, 2023
Draft recommendation issued to sponsorNovember 22, 2023
Draft recommendation posted for stakeholder feedbackNovember 30, 2023
End of feedback periodDecember 14, 2023
Final recommendation issued to sponsor and drug plansJanuary 05, 2024
Final recommendation postedJanuary 23, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)January 19, 2024
Canada's Drug Agency review report(s) postedApril 02, 2024
Last Updated : April 2, 2024

Non-Small Cell Lung Cancer without actionable oncogenic alterations

Details

Review Type: Panel

Last Updated : August 10, 2023

Biologics in Plaque Psoriasis

Details

Biologics require formulary management strategies to manage expenditures, due to a lack of or delay in biosimilar development and market approval. A Canada's Drug Agency Integrated Technology Review on biologics for plaque psoriasis (PsO) indicated that although several old-generation biologics used to treat PsO have lost exclusivity, they represent a significant portion of expenditures.

 

 

Key Milestones2
Posting of Draft Scope for stakeholder feedbackJune 22, 2023
End of feedback periodJuly 7, 2023
Posting of Draft Summary Report for stakeholder feedbackJuly 20, 2023
End of feedback periodAugust 3, 2023
Expert committee meeting (initial)August 24, 2023
Draft recommendation(s) posted for stakeholder feedbackSeptember 21, 2023
End of feedback periodOctober 6, 2023
Final recommendation(s) postedNovember 9, 2023
Last Updated : November 9, 2023