abrocitinib

Details

Files
Generic Name:
abrocitinib
Project Status:
Complete
Therapeutic Area:
Atopic dermatitis, moderate to severe
Manufacturer:
Pfizer Canada ULC
Brand Name:
Cibinqo
Project Line:
Reimbursement Review
Project Number:
SR0686-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Cibinqo (abrocitinib) is indicated for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable. CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 openMarch 26, 2021
Call for patient/clinician input closedMay 21, 2021
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance (CSPA) & Eczéma Québec and the Eczema Society of Canada

Submission receivedApril 26, 2021
Submission acceptedMay 10, 2021
Review initiatedMay 11, 2021
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) provided to sponsor for commentApril 06, 2022
Deadline for sponsors commentsApril 18, 2022
CADTH responses on draft review report(s) provided to sponsorMay 12, 2022
Expert committee meeting (initial)May 25, 2022
Draft recommendation issued to sponsorJuly 12, 2022
Draft recommendation posted for stakeholder feedbackJuly 21, 2022
End of feedback periodAugust 05, 2022
Final recommendation issued to sponsor and drug plansAugust 19, 2022
Final recommendation postedSeptember 08, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 02, 2022
CADTH review report(s) postedJanuary 26, 2023