isavuconazole

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Generic Name:

isavuconazole

Project Status:

Complete

Therapeutic Area:

Treatment of invasive aspergillosis and mucormycosis

Manufacturer:

AVIR Pharma Inc.

Call for patient/clinician input open:

October 4, 2018

Brand Name:

Cresemba

Project Line:

Reimbursement Review

Project Number:

SR0586-000

Call for patient/clinician input closed:

November 23, 2018

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For use in adults for the treatment of: Invasive aspergillosis Invasive mucormycosis

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Treatment of invasive aspergillosis and mucormycosis

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

May 15, 2019

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	October 04, 2018
Patient group input closed	November 23, 2018
Clarification: - No patient input submission received
Submission received	November 02, 2018
Submission accepted for review	November 16, 2018
Review initiated	November 22, 2018
Draft CADTH review report(s) sent to applicant	February 12, 2019
Comments from applicant on draft CADTH review report(s) received	February 22, 2019
Redaction requests from applicant on draft CADTH review report(s) received	March 05, 2019
Clarification: - Extension requested by applicant - Request granted
CADTH review team's comments on draft CADTH review report(s) sent to applicant	March 29, 2019
Canadian Drug Expert Committee (CDEC) meeting	April 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans	April 24, 2019
Embargo period ended and validation of redacted CADTH review report(s) received	May 08, 2019
CDEC Final Recommendation issued to applicant and drug plans	May 15, 2019
CDEC Final Recommendation posted	May 17, 2019
Final CADTH review report(s) posted	June 10, 2019