sodium zirconium cyclosilicate

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Generic 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
Performance Metric:
Achieved
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:
  1. 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 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