lemborexant

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Generic Name:
lemborexant
Project Status:
Complete
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
Performance Metric:
Achieved
Biosimilar:
No
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.
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 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/clinician input openJanuary 28, 2022
Call for patient/clinician input closedMarch 25, 2022
Clarification:

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

Submission receivedFebruary 28, 2022
Submission acceptedMarch 14, 2022
Review initiatedMarch 15, 2022
Draft CADTH review report(s) provided to sponsor for commentJune 10, 2022
Deadline for sponsors commentsJune 21, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 15, 2022
Expert committee meeting (initial)July 27, 2022
Draft recommendation issued to sponsorAugust 09, 2022
Draft recommendation posted for stakeholder feedbackAugust 18, 2022
End of feedback periodSeptember 02, 2022
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

Expert committee meetingDecember 21, 2022
Final recommendation issued to sponsor and drug plansJanuary 10, 2023
Final recommendation postedJanuary 26, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 24, 2023
CADTH review report(s) postedApril 19, 2023