pitolisant hydrochloride


Generic Name:
pitolisant hydrochloride
Project Status:
Therapeutic Area:
Paladin Labs Inc.
Brand Name:
Project Line:
Reimbursement Review
Project Number:
NOC Status at Filing:
Post NOC
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:
Fee Schedule:
Schedule A
​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:
  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/clinician input openNovember 10, 2021
Call for patient/clinician input closedJanuary 07, 2022

- Patient input submission received from Wake Up Narcolepsy, Inc.

Submission receivedDecember 08, 2021
Submission acceptedJanuary 25, 2022

- Submission was not accepted for review on 22 Dec 2021

Review initiatedJanuary 26, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 09, 2022
Deadline for sponsors commentsMay 18, 2022
CADTH review report(s) and responses to comments provided to sponsorJune 10, 2022
Expert committee meeting (initial)June 22, 2022
Draft recommendation issued to sponsorJuly 06, 2022
Draft recommendation posted for stakeholder feedbackJuly 21, 2022
End of feedback periodAugust 05, 2022

- Reconsideration: major revisions requested by sponsor

Expert committee meetingNovember 23, 2022
Final recommendation issued to sponsor and drug plansDecember 06, 2022
Final recommendation postedDecember 22, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 20, 2022
CADTH review report(s) postedFebruary 22, 2023