Last Updated : October 20, 2022
Details
FilesGeneric Name:
upadacitinib
Project Status:
Complete
Therapeutic Area:
atopic dermatitis
Manufacturer:
AbbVie
Brand Name:
Rinvoq
Project Line:
Reimbursement Review
Project Number:
SR0685-000
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 aged 12 years and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and/or who are refractory to or ineligible for systemic immunosuppressant therapies (i.e., due to contraindications, intolerance, or need for long-term treatment).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
RINVOQ is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable.RINVOQ can be used with or without topical corticosteroids.
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 | 15-Mar-21 |
| Call for patient/clinician input closed | 07-May-21 |
| Clarification: - Patient input submission received from the Canadian Skin Patient Alliance (CSPA) & Eczéma Québec and the Eczema Society of Canada | |
| Submission received | 13-Apr-21 |
| Submission accepted | 27-Apr-21 |
| Review initiated | 28-Apr-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 28-Jul-21 |
| Deadline for sponsors comments | 09-Aug-21 |
| CADTH responses on draft review report(s) provided to sponsor | 10-Feb-22 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Expert committee meeting (initial) | 23-Feb-22 |
| Draft recommendation issued to sponsor | 09-Mar-22 |
| Draft recommendation posted for stakeholder feedback | 17-Mar-22 |
| End of feedback period | 31-Mar-22 |
| Clarification: - Reconsideration: major revisions requested by drug programs | |
| Expert committee meeting | 25-May-22 |
| Final recommendation issued to sponsor and drug plans | 08-Jun-22 |
| Final recommendation posted | 24-Jun-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 22-Jun-22 |
| CADTH review report(s) posted | 20-Oct-22 |
Files
Last Updated : October 20, 2022