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sodium zirconium cyclosilicate

Last Updated: March 25, 2020
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 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: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: March 25, 2020

Recommendation Type: Do not reimburse

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 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 -
Redaction requests from sponsor on draft CADTH review report(s) received -
Redacted CADTH review report(s) sent to sponsor and drug plans -
Validation of redacted CADTH review report(s) received -
Final CADTH review report(s) posted -