sodium zirconium cyclosilicate


Generic Name:
sodium zirconium cyclosilicate
Project Status:
Therapeutic Area:
Hyperkalemia, adults
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Project Line:
Reimbursement Review
Project Number:
Call for patient/clinician input closed:
NOC Status at Filing:
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:
Fee Schedule:
Schedule A
Hyperkalemia, adults
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. 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

- 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

- 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

- No redactions requested by the sponsor

Final CADTH review report(s) posted May 14, 2020