lemborexant


( Last Updated : September 12, 2022)
Generic Name:
lemborexant
Project Status:
Active
Therapeutic Area:
Insomnia
Manufacturer:
Eisai Limited
Call for patient/clinician input open:
Brand Name:
Dayvigo
Project Line:
Reimbursement Review
Project Number:
SR0716-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Eisai Limited is requesting coverage for lemborexant consistent with its Health Canada approved indication: The treatment of Insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Dayvigo (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  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 Milestones

Call for patient/clinician input open 28-Jan-22
Call for patient/clinician input closed 25-Mar-22
Clarification:

- Patient input submission received from Menopause Chicks, Migraine Canada and Mood Disorders Society of Canada

Submission received 28-Feb-22
Submission accepted 14-Mar-22
Review initiated 15-Mar-22
Draft CADTH review report(s) provided to sponsor for comment 10-Jun-22
Deadline for sponsors comments 21-Jun-22
CADTH review report(s) and responses to comments provided to sponsor 15-Jul-22
Expert committee meeting (initial) 27-Jul-22
Draft recommendation issued to sponsor 09-Aug-22
Draft recommendation posted for stakeholder feedback 18-Aug-22
End of feedback period 02-Sep-22
Clarification:

Deadline for patient groups and clinician groups to provide feedback on the draft recommendations is 06-Sep-2022

- Reconsideration: major revisions requested by sponsor

- Target CDEC reconsideration meeting date to be determine