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
- 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 | 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 |