Last Updated : June 18, 2019
Details
FilesGeneric 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:
- 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 |
Files
Last Updated : June 18, 2019