efinaconazole

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Generic Name:
efinaconazole
Project Status:
Complete
Therapeutic Area:
Onychomycosis
Manufacturer:
Bausch Health, Canada Inc.
Call for patient/clinician input open:
Brand Name:
Jublia
Project Line:
Reimbursement Review
Project Number:
SR0577-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule A
Indications:
Onychomycosis
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 July 04, 2018
Patient group input closed August 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 groups August 31, 2018
Patient group comments on input summary closed September 10, 2018
Submission received August 02, 2018
Submission accepted for review August 17, 2018
Review initiated August 24, 2018
Draft CADTH review report(s) sent to applicant November 08, 2018
Comments from applicant on draft CADTH review report(s) received November 19, 2018
Redaction requests from applicant on draft CADTH review report(s) received November 26, 2018
CADTH review team's comments on draft CADTH review report(s) sent to applicant January 04, 2019
Canadian Drug Expert Committee (CDEC) meeting January 16, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans January 29, 2019
Embargo period ended and validation of redacted CADTH review report(s) received March 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 agenda May 15, 2019
CDEC Final Recommendation issued to applicant and drug plans May 23, 2019
CDEC Final Recommendation posted May 27, 2019
Final CADTH review report(s) posted June 17, 2019