CADTH Pharmaceutical Reviews Update — Issue 4

Darzalex in combo with Bortezomib, Melphalan and Prednisone for Multiple Myeloma (newly diagnosed) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Zytiga for Prostate Cancer – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Revlimid (in combo) bortezomib + dexamethasone for newly diagnosed Multiple Myeloma – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

baricitinib

Details

Key Milestones2

Call for patient input postedNovember 22, 2018
Patient group input closedJanuary 18, 2019
Clarification:

- Patient input submission received from Arthritis Consumer Experts and The Arthritis Society & Canadian Arthritis Patient Alliance

Patient input summary sent for review to patient input groupsFebruary 20, 2019
Patient group comments on input summary closedFebruary 27, 2019
Clarification:

- Patient input summary feedback received

Submission receivedDecember 20, 2018
Submission accepted for reviewJanuary 18, 2019
Clarification:

- Submission was not accepted for review on 11 Jan 2019

- Revised category 1 requirements received on 11 Jan 2019

Review initiatedJanuary 30, 2019
Clarification:

- Submission temporarily suspended pending receipt of information

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

Draft Canada's Drug Agency review report(s) sent to sponsorApril 29, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) receivedMay 08, 2019
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) receivedMay 15, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsorJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plansJuly 02, 2019
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) receivedJuly 26, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

CDEC Final Recommendation issued to sponsor and drug plansAugust 02, 2019
CDEC Final Recommendation postedAugust 07, 2019
Final Canada's Drug Agency review report(s) postedSeptember 10, 2019

Ogivri for Early Breast Cancer / Metastatic Breast Cancer / Metastatic Gastric Cancer Biosimilar – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Keytruda for Melanoma Adjuvant Treatment – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Brigatinib (Alunbrig) for Non-Small Cell Lung Cancer (NSCLC) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Abemaciclib for advanced or metastatic Breast Cancer – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.