cariprazine

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Generic Name:
cariprazine
Project Status:
Complete
Therapeutic Area:
Bipolar Disorder
Manufacturer:
Allergan (an AbbVie company)
Brand Name:
Vraylar
Project Line:
Reimbursement Review
Project Number:
SR0718-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As monotherapy for: Bipolar Mania: acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and Bipolar Depression: acute treatment of depressive episodes associated with bipolar I disorder in adults
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Cariprazine is indicated as monotherapy for: Bipolar Mania: acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and Bipolar Depression: acute treatment of depressive episodes associated with bipolar I disorder in adults
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 openDecember 23, 2021
Call for patient/clinician input closedFebruary 18, 2022
Clarification:

- Patient input submission received from the Institute for Advancements in Mental Health and Mood Disorders Society of Canada

Submission receivedJanuary 28, 2022
Submission acceptedFebruary 11, 2022
Review initiatedFebruary 16, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 05, 2022
Deadline for sponsors commentsMay 16, 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 05, 2022
Draft recommendation posted for stakeholder feedbackJuly 14, 2022
End of feedback periodJuly 28, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingOctober 26, 2022
Final recommendation issued to sponsor and drug plansNovember 09, 2022
Final recommendation postedNovember 25, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 25, 2022
CADTH review report(s) postedFebruary 08, 2023