tezepelumab

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Generic Name:
tezepelumab
Project Status:
Complete
Therapeutic Area:
Asthma
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Tezspire
Project Line:
Reimbursement Review
Project Number:
SR0731-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Tezepelumab is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Tezepelumab is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma.
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 openMarch 17, 2022
Call for patient/clinician input closedMay 06, 2022
Clarification:

- Patient input submission received from Asthma Canada and the Lung Health Foundation/The Ontario Lung Association

Submission receivedApril 14, 2022
Submission acceptedApril 29, 2022
Review initiatedMay 02, 2022
Draft CADTH review report(s) provided to sponsor for commentJuly 15, 2022
Deadline for sponsors commentsJuly 26, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 16, 2022
Expert committee meeting (initial)September 28, 2022
Draft recommendation issued to sponsorOctober 12, 2022
Draft recommendation posted for stakeholder feedbackOctober 20, 2022
End of feedback periodNovember 03, 2022
Final recommendation issued to sponsor and drug plansNovember 16, 2022
Final recommendation postedDecember 02, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 30, 2022
CADTH review report(s) postedFebruary 06, 2023