abrocitinib


( Last Updated : August 8, 2022)
Generic Name:
abrocitinib
Project Status:
Active
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

Details


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.
  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.

Key Milestones2

Call for patient/clinician input open26-Mar-21
Call for patient/clinician input closed21-May-21
Clarification:

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

Submission received26-Apr-21
Submission accepted10-May-21
Review initiated11-May-21
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 comment06-Apr-22
Deadline for sponsors comments18-Apr-22
CADTH responses on draft review report(s) provided to sponsor12-May-22
Expert committee meeting (initial)25-May-22
Draft recommendation issued to sponsor12-Jul-22
Draft recommendation posted for stakeholder feedback21-Jul-22
End of feedback period05-Aug-22
Final recommendation issued to sponsor and drug plans 
Final recommendation posted 
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 
CADTH review report(s) posted