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:

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:

August 10, 2023

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: Canada's Drug Agency 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 Canada's Drug Agency and CDEC acted in accordance with the Procedures for Canada's Drug Agency Reimbursement Reviews for the review of Vraylar.

The Panel’s decision was provided in a memorandum report to Canada's Drug Agency. Canada's Drug Agency 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
Clarification: - 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 Canada's Drug Agency review report(s) provided to sponsor for comment	03-Feb-22
Deadline for sponsors comments	14-Feb-22
Canada's Drug Agency 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
Clarification: - 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 Canada's Drug Agency review report(s)	24-Aug-22
Canada's Drug Agency review report(s) posted	12-Oct-22
Procedural review accepted	14-Oct-22
Procedural review concluded	16-Dec-22
Clarification: - Final recommendation upheld