pitolisant hydrochloride


( Last Updated : August 11, 2022)
Generic Name:
pitolisant hydrochloride
Project Status:
Active
Therapeutic Area:
Narcolepsy
Manufacturer:
Paladin Labs Inc.
Call for patient/clinician input open:
Brand Name:
Wakix
Project Line:
Reimbursement Review
Project Number:
SR0715-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details

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:
Pending
Indications:
Wakix (pitolisant hydrochloride tablets) is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
  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 open10-Nov-21
Call for patient/clinician input closed07-Jan-22
Clarification:

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

Submission received08-Dec-21
Submission accepted25-Jan-22
Clarification:

- Submission was not accepted for review on 22 Dec 2021

Review initiated26-Jan-22
Draft CADTH review report(s) provided to sponsor for comment09-May-22
Deadline for sponsors comments18-May-22
CADTH review report(s) and responses to comments provided to sponsor10-Jun-22
Expert committee meeting (initial)22-Jun-22
Draft recommendation issued to sponsor06-Jul-22
Draft recommendation posted for stakeholder feedback21-Jul-22
End of feedback period05-Aug-22
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target CDEC reconsideration meeting date to be determined