Rydapt for Acute Myeloid Leukemia – 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.

glecaprevir pibrentasvir

Details

Key Milestones2

Call for patient input posted May 11, 2017
Patient group input closed June 30, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups July 19, 2017
Patient group comments on input summary closed July 26, 2017
Clarification:

- Patient input summary feedback received

Submission received June 09, 2017
Submission accepted for review June 23, 2017
Review initiated June 26, 2017
Draft CDR review report(s) sent to applicant September 28, 2017
Comments from applicant on draft CDR review report(s) received October 10, 2017
Redaction requests from applicant on draft CDR review report(s) received October 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant December 01, 2017
Canadian Drug Expert Committee (CDEC) meeting December 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans January 02, 2018
Embargo period ended and validation of redacted CDR review report(s) received January 16, 2018
CDEC Final Recommendation issued to applicant and drug plans January 23, 2018
CDEC Final Recommendation posted January 25, 2018
Final CDR review report(s) and patient input posted February 08, 2018

migalastat

Details

Key Milestones2

Call for patient input posted3May 05, 2017
Patient group input closed3June 26, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJuly 21, 2017
Patient group comments on input summary closedJuly 28, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJune 09, 2017
Submission accepted for reviewJune 23, 2017
Review initiatedJuly 05, 2017
Clarification:

- Submission temporarily suspended pending receipt of information

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

Draft CDR review report(s) sent to applicantOctober 23, 2017
Comments from applicant on draft CDR review report(s) receivedNovember 01, 2017
Redaction requests from applicant on draft CDR review report(s) receivedNovember 08, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantDecember 01, 2017
Canadian Drug Expert Committee (CDEC) meetingDecember 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 03, 2018
Embargo4 period ended and validation of redacted CDR review report(s) receivedJanuary 17, 2018
CDEC Final Recommendation issued to applicant and drug plansJanuary 24, 2018
CDEC Final Recommendation posted5January 26, 2018
Final CDR review report(s) and patient input posted5February 05, 2018

insulin degludec

Details

Key Milestones2

Call for patient input posted3 May 02, 2017
Patient group input closed3 June 21, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups July 25, 2017
Patient group comments on input summary closed August 01, 2017
Clarification:

- Patient input summary feedback received

Submission received May 31, 2017
Submission accepted for review June 14, 2017
Review initiated June 15, 2017
Draft CDR review report(s) sent to applicant September 01, 2017
Comments from applicant on draft CDR review report(s) received September 13, 2017
Redaction requests from applicant on draft CDR review report(s) received September 20, 2017
Clarification:

- No redaction requests from applicant received

CDR review team's comments on draft CDR review report(s) sent to applicant October 05, 2017
Canadian Drug Expert Committee (CDEC) meeting October 18, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 30, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received November 13, 2017
CDEC Final Recommendation issued to applicant and drug plans November 20, 2017
CDEC Final Recommendation posted5 November 22, 2017
Final CDR review report(s) and patient input posted5 December 15, 2017

lixisenatide

Details

Key Milestones2

Call for patient input posted3 April 26, 2017
Patient group input closed3 June 15, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups June 20, 2017
Patient group comments on input summary closed June 27, 2017
Clarification:

- No patient input summary feedback received

Submission received May 29, 2017
Submission accepted for review June 12, 2017
Review initiated June 13, 2017
Draft CDR review report(s) sent to applicant September 05, 2017
Comments from applicant on draft CDR review report(s) received September 14, 2017
Redaction requests from applicant on draft CDR review report(s) received September 21, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant October 05, 2017
Canadian Drug Expert Committee (CDEC) meeting October 18, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 31, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received November 14, 2017
CDEC Final Recommendation issued to applicant and drug plans November 21, 2017
CDEC Final Recommendation posted5 November 23, 2017
Final CDR review report(s) and patient input posted5 December 21, 2017

RFA: Inlyta for Metastatic Renal Cell Carcinoma

Details

Note: The pCODR Provincial Advisory Group, PAG, has submitted a Request for Advice for the Final Recommendation for this drug and indication originally posted on March 7, 2013. The original axitinib (Inlyta) pCODR review can be found  on the Inlyta for metastatic renal cell carcinoma (mRCC) details page: /inlyta-metastatic-renal-cell-carcinoma-mrcc-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.

ocrelizumab

Details

Key Milestones2

Call for patient input posted3 April 18, 2017
Patient group input closed3 June 07, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups June 15, 2017
Patient group comments on input summary closed June 22, 2017
Clarification:

- Patient input submission received

Submission received May 16, 2017
Submission accepted for review May 31, 2017
Review initiated June 01, 2017
Draft CDR review report(s) sent to applicant August 21, 2017
Comments from applicant on draft CDR review report(s) received August 30, 2017
Redaction requests from applicant on draft CDR review report(s) received September 07, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant October 05, 2017
Canadian Drug Expert Committee (CDEC) meeting October 18, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 31, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received November 14, 2017
CDEC Final Recommendation issued to applicant and drug plans November 21, 2017
CDEC Final Recommendation posted5 November 23, 2017
Final CDR review report(s) and patient input posted5 December 15, 2017

abobotulinumtoxinA

Details

Key Milestones2

Call for patient input posted3 March 17, 2017
Patient group input closed3 May 08, 2017
Clarification:

-Patient input submission received

Patient input summary sent for review to patient input groups May 15, 2017
Patient group comments on input summary closed May 23, 2017
Clarification:

-Patient input summary feedback received

Submission received April 24, 2017
Submission accepted for review May 08, 2017
Review initiated May 09, 2017
Draft CDR review report(s) sent to applicant July 31, 2017
Comments from applicant on draft CDR review report(s) received August 10, 2017
Redaction requests from applicant on draft CDR review report(s) received August 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant September 08, 2017
Canadian Drug Expert Committee (CDEC) meeting September 20, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 02, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received October 17, 2017
CDEC Final Recommendation issued to applicant and drug plans October 24, 2017
CDEC Final Recommendation posted5 October 26, 2017
Final CDR review report(s) and patient input posted5 November 16, 2017

Onivyde for Metastatic Pancreatic 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.

Tafinlar & Mekinist in combo for Non-Small Cell Lung 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.