Last Updated : April 19, 2023
Details
FilesGeneric 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:
- 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 | January 28, 2022 |
|---|---|
| Call for patient/clinician input closed | March 25, 2022 |
| Clarification: - Patient input submission received from Menopause Chicks, Migraine Canada and Mood Disorders Society of Canada | |
| Submission received | February 28, 2022 |
| Submission accepted | March 14, 2022 |
| Review initiated | March 15, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 10, 2022 |
| Deadline for sponsors comments | June 21, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 15, 2022 |
| Expert committee meeting (initial) | July 27, 2022 |
| Draft recommendation issued to sponsor | August 09, 2022 |
| Draft recommendation posted for stakeholder feedback | August 18, 2022 |
| End of feedback period | September 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 meeting | December 21, 2022 |
| Final recommendation issued to sponsor and drug plans | January 10, 2023 |
| Final recommendation posted | January 26, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 24, 2023 |
| CADTH review report(s) posted | April 19, 2023 |
Files
Last Updated : April 19, 2023