( Last Updated : February 2, 2023)
Generic Name:
Project Status:
Therapeutic Area:
Allergan (an AbbVie Company).
Brand Name:
Project Line:
Reimbursement Review
Project Number:
NOC Status at Filing:


Manufacturer Requested Reimbursement Criteria1:
For the acute and long-term maintenance of schizophrenia in adults.
Submission Type:
Fee Schedule:
Schedule A
For the treatment of schizophrenia 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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Procedural review: CADTH accepted a procedural review request from AbbVie Canada for the SR0708-000 Vraylar Canadian Drug Expert Committee (CDEC) final recommendation.

Status: Concluded. 

Description: This matter was concluded following adjudication by a Procedural Review Panel (the “panel”). In its decision, the panel found that CADTH and CDEC acted in accordance with the Procedures for CADTH Reimbursement Reviews for the review of Vraylar.  

The Panel’s decision was provided in a memorandum report to CADTH. CADTH has prepared a response to address the findings of the procedural review

Outcome: The CDEC Final Recommendation of Do Not Reimburse is upheld for Vraylar. 

Key Milestones2

Call for patient/clinician input open 01-Oct-21
Call for patient/clinician input closed 22-Nov-21

- Patient input submission received from Institute for Advancements in Mental Health

Submission received 29-Oct-21
Submission accepted 12-Nov-21
Review initiated 15-Nov-21
Draft CADTH review report(s) provided to sponsor for comment 03-Feb-22
Deadline for sponsors comments 14-Feb-22
CADTH review report(s) and responses to comments provided to sponsor 11-Mar-22
Expert committee meeting (initial) 23-Mar-22
Draft recommendation issued to sponsor 27-Apr-22
Draft recommendation posted for stakeholder feedback 05-May-22
End of feedback period 19-May-22

- Reconsideration: major revisions requested by sponsor

Expert committee meeting 27-Jul-22
Final recommendation issued to sponsor and drug plans 10-Aug-22
Final recommendation posted 26-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 24-Aug-22
CADTH review report(s) posted 12-Oct-22
Procedural review accepted 14-Oct-22
Procedural review concluded 16-Dec-22

- Final recommendation upheld