Last Updated : November 19, 2018
Details
FilesGeneric Name:
lumacaftor/ivacaftor
Project Status:
Complete
Therapeutic Area:
Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older
Manufacturer:
Vertex Pharmaceuticals (Canada) Incorporated
Call for patient/clinician input open:
Brand Name:
Orkambi
Project Line:
Reimbursement Review
Project Number:
SR0559-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of cystic fibrosis (CF) in patients 6 years of age and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | January 24, 2018 |
| Patient group input closed | March 15, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | March 26, 2018 |
| Patient group comments on input summary closed | April 03, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | February 22, 2018 |
| Submission accepted for review | March 08, 2018 |
| Review initiated | March 09, 2018 |
| Draft CDR review report(s) sent to applicant | May 29, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 07, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 14, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | August 01, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 16, 2018 |
| Clarification:
- Request for Clarification received from CDR Participating Drug Plans |
|
| Drug plans' request for clarification placed on CDEC agenda | September 19, 2018 |
| Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans | September 26, 2018 |
| CDEC Final Recommendation posted | October 04, 2018 |
| Clarification:
- Target posting of CDEC Final Recommendation October 4, 2018 |
|
| Final CDR review report(s) posted | October 12, 2018 |
Files
Last Updated : November 19, 2018