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sodium zirconium cyclosilicate

Last Updated: August 21, 2019
Result type: Reports
Project Number: SR0612-000
Product Line: Common Drug Review

Generic Name: sodium zirconium cyclosilicate

Brand Name: Lokelma

Manufacturer: AstraZeneca Canada Inc.

Indications: Hyperkalemia, adults

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

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 postedApril 04, 2019
Patient group input closedMay 27, 2019
Clarification:Patient input submission received from The Kidney Foundation of Canada

Patient input summary sent for review to patient input groupsJune 13, 2019
Patient group comments on input summary closedJune 20, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 16, 2019
Submission accepted for reviewMay 31, 2019
Review initiatedJune 03, 2019
Draft CADTH review report(s) sent to applicantAugust 20, 2019
Comments from applicant on draft CADTH review report(s) receivedAugust 29, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to applicant and drug plansOctober 28, 2019
To
October 30, 2019