Last Updated : May 14, 2020
Details
FilesGeneric Name:
sodium zirconium cyclosilicate
Project Status:
Complete
Therapeutic Area:
Hyperkalemia, adults
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Lokelma
Project Line:
Reimbursement Review
Project Number:
SR0612-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Corrective treatment of hyperkalemia in adult patients (10 g administered three times per day, for 48 hours but up to 72 hours as needed), in line with the anticipated Health Canada approved indication. Maintenance treatment of hyperkalemia in adult CKD patients with an eGFR of 30 ml/min/1.73m2, that have had at least 2 HK events and are sub-optimally managed on RAASi (5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hyperkalemia, adults
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | April 04, 2019 |
| Patient group input closed | May 27, 2019 |
| Clarification:Patient input submission received from The Kidney Foundation of Canada
|
|
| Patient input summary sent for review to patient input groups | June 13, 2019 |
| Patient group comments on input summary closed | June 20, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 16, 2019 |
| Submission accepted | May 31, 2019 |
| Review initiated | June 03, 2019 |
| Draft CADTH review report(s) sent to sponsor | August 20, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | August 29, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | October 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | October 16, 2019 |
| CDEC recommendation sent to sponsor and drug plans | October 29, 2019 |
| Embargo period ended | December 10, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | March 18, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | March 25, 2020 |
| CDEC Final Recommendation posted | March 27, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | April 08, 2020 |
| Clarification:
- No redactions requested by the sponsor |
|
| Final CADTH review report(s) posted | May 14, 2020 |
Files
Last Updated : May 14, 2020