upadacitinib


( Last Updated : June 24, 2022)
Generic Name:
upadacitinib
Project Status:
Active
Therapeutic Area:
atopic dermatitis
Manufacturer:
AbbVie
Brand Name:
Rinvoq
Project Line:
Reimbursement Review
Project Number:
SR0685-000
NOC Status at Filing:
Pre NOC

Details


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:
  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 open15-Mar-21
Call for patient/clinician input closed07-May-21
Clarification:

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

Submission received13-Apr-21
Submission accepted27-Apr-21
Review initiated28-Apr-21
Draft CADTH review report(s) provided to sponsor for comment28-Jul-21
Deadline for sponsors comments09-Aug-21
CADTH responses on draft review report(s) provided to sponsor10-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 sponsor09-Mar-22
Draft recommendation posted for stakeholder feedback17-Mar-22
End of feedback period31-Mar-22
Clarification:

- Reconsideration: major revisions requested by drug programs

Expert committee meeting25-May-22
Final recommendation issued to sponsor and drug plans08-Jun-22
Final recommendation posted24-Jun-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)22-Jun-22
CADTH review report(s) posted