Last Updated : February 22, 2023
Details
FilesGeneric Name:
pitolisant hydrochloride
Project Status:
Complete
Therapeutic Area:
Narcolepsy
Manufacturer:
Paladin Labs Inc.
Brand Name:
Wakix
Project Line:
Reimbursement Review
Project Number:
SR0715-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Paladin Labs Inc. is requesting for Wakix (pitolisant hydrochloride tablets) to be reimbursed for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Wakix (pitolisant hydrochloride tablets) is indicated for the
treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients
with narcolepsy.
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.
| Call for patient/clinician input open | November 10, 2021 |
|---|---|
| Call for patient/clinician input closed | January 07, 2022 |
| Clarification: - Patient input submission received from Wake Up Narcolepsy, Inc. | |
| Submission received | December 08, 2021 |
| Submission accepted | January 25, 2022 |
| Clarification: - Submission was not accepted for review on 22 Dec 2021 | |
| Review initiated | January 26, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 09, 2022 |
| Deadline for sponsors comments | May 18, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | June 10, 2022 |
| Expert committee meeting (initial) | June 22, 2022 |
| Draft recommendation issued to sponsor | July 06, 2022 |
| Draft recommendation posted for stakeholder feedback | July 21, 2022 |
| End of feedback period | August 05, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | November 23, 2022 |
| Final recommendation issued to sponsor and drug plans | December 06, 2022 |
| Final recommendation posted | December 22, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 20, 2022 |
| CADTH review report(s) posted | February 22, 2023 |
Files
Last Updated : February 22, 2023