Last Updated : February 8, 2023
Details
FilesGeneric 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
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:
- 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 open | December 23, 2021 |
| Call for patient/clinician input closed | February 18, 2022 |
| Clarification: - Patient input submission received from the Institute for Advancements in Mental Health and Mood Disorders Society of Canada | |
| Submission received | January 28, 2022 |
| Submission accepted | February 11, 2022 |
| Review initiated | February 16, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 05, 2022 |
| Deadline for sponsors comments | May 16, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | June 10, 2022 |
| Expert committee meeting (initial) | June 22, 2022 |
| Draft recommendation issued to sponsor | July 05, 2022 |
| Draft recommendation posted for stakeholder feedback | July 14, 2022 |
| End of feedback period | July 28, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | October 26, 2022 |
| Final recommendation issued to sponsor and drug plans | November 09, 2022 |
| Final recommendation posted | November 25, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 25, 2022 |
| CADTH review report(s) posted | February 08, 2023 |
Files
Last Updated : February 8, 2023