cariprazine

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Generic Name:
cariprazine
Project Status:
Complete
Therapeutic Area:
Schizophrenia
Manufacturer:
Allergan (an AbbVie Company).
Brand Name:
Vraylar
Project Line:
Reimbursement Review
Project Number:
SR0708-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the acute and long-term maintenance of schizophrenia in adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 open01-Oct-21
Call for patient/clinician input closed22-Nov-21

Clarification:

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

Submission received29-Oct-21
Submission accepted12-Nov-21
Review initiated15-Nov-21
Draft CADTH review report(s) provided to sponsor for comment03-Feb-22
Deadline for sponsors comments14-Feb-22
CADTH review report(s) and responses to comments provided to sponsor11-Mar-22
Expert committee meeting (initial)23-Mar-22
Draft recommendation issued to sponsor27-Apr-22
Draft recommendation posted for stakeholder feedback05-May-22
End of feedback period19-May-22

Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting27-Jul-22
Final recommendation issued to sponsor and drug plans10-Aug-22
Final recommendation posted26-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)24-Aug-22
CADTH review report(s) posted12-Oct-22
Procedural review accepted14-Oct-22
Procedural review concluded16-Dec-22

Clarification:

- Final recommendation upheld