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efinaconazole

Last Updated: May 23, 2019
Result type: Reports
Project Number: SR0577-000
Product Line: Common Drug Review

Generic Name: efinaconazole

Brand Name: Jublia

Manufacturer: Bausch Health, Canada Inc.

Indications: Onychomycosis

Manufacturer Requested Reimbursement Criteria1: For the topical treatment of mild to moderate onychomycosis (tinea unguium) of toenails without lunula involvement due to Trichophyton rubrum and Trichophyton mentagrophytes in immunocompetent adult patients.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

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 postedJuly 04, 2018
Patient group input closedAugust 23, 2018
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance in collaboration with Wounds Canada

Patient input summary sent for review to patient input groupsAugust 31, 2018
Patient group comments on input summary closedSeptember 10, 2018
Submission receivedAugust 02, 2018
Submission accepted for reviewAugust 17, 2018
Review initiatedAugust 24, 2018
Draft CADTH review report(s) sent to applicantNovember 08, 2018
Comments from applicant on draft CADTH review report(s) receivedNovember 19, 2018
Redaction requests from applicant on draft CADTH review report(s) receivedNovember 26, 2018
CADTH review team's comments on draft CADTH review report(s) sent to applicantJanuary 04, 2019
Canadian Drug Expert Committee (CDEC) meetingJanuary 16, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansJanuary 29, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMarch 13, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaMay 15, 2019
CDEC Final Recommendation issued to applicant and drug plansMay 23, 2019
CDEC Final Recommendation posted-