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Last Updated: June 10, 2019
Result type: Reports
Project Number: SR0586-000
Product Line: Reimbursement Review

Generic Name: isavuconazole

Brand Name: Cresemba

Manufacturer: AVIR Pharma Inc.

Therapeutic Area: Treatment of invasive aspergillosis and mucormycosis

Indications: Treatment of invasive aspergillosis and mucormycosis

Manufacturer Requested Reimbursement Criteria1: For use in adults for the treatment of: Invasive aspergillosis Invasive mucormycosis

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: May 15, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 postedOctober 04, 2018
Patient group input closedNovember 23, 2018

- No patient input submission received

Submission receivedNovember 02, 2018
Submission accepted for reviewNovember 16, 2018
Review initiatedNovember 22, 2018
Draft CADTH review report(s) sent to applicantFebruary 12, 2019
Comments from applicant on draft CADTH review report(s) receivedFebruary 22, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedMarch 05, 2019

- Extension requested by applicant

- Request granted

CADTH review team's comments on draft CADTH review report(s) sent to applicantMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansApril 24, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMay 08, 2019
CDEC Final Recommendation issued to applicant and drug plansMay 15, 2019
CDEC Final Recommendation postedMay 17, 2019
Final CADTH review report(s) postedJune 10, 2019