Last Updated : January 26, 2023
Details
FilesGeneric 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:
- 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 open | March 26, 2021 |
| Call for patient/clinician input closed | May 21, 2021 |
| Clarification: - Patient input submission received from the Canadian Skin Patient Alliance (CSPA) & Eczéma Québec and the Eczema Society of Canada | |
| Submission received | April 26, 2021 |
| Submission accepted | May 10, 2021 |
| Review initiated | May 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 comment | April 06, 2022 |
| Deadline for sponsors comments | April 18, 2022 |
| CADTH responses on draft review report(s) provided to sponsor | May 12, 2022 |
| Expert committee meeting (initial) | May 25, 2022 |
| Draft recommendation issued to sponsor | July 12, 2022 |
| Draft recommendation posted for stakeholder feedback | July 21, 2022 |
| End of feedback period | August 05, 2022 |
| Final recommendation issued to sponsor and drug plans | August 19, 2022 |
| Final recommendation posted | September 08, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 02, 2022 |
| CADTH review report(s) posted | January 26, 2023 |
Files
Last Updated : January 26, 2023