durvalumab

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Generic Name:
durvalumab
Project Status:
Complete
Therapeutic Area:
Extensive-stage small cell lung cancer
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Imfinzi
Project Line:
Reimbursement Review
Project Number:
PC0234-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per Health Canada indication: in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
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 open03-Nov-20
Call for patient/clinician input closed24-Dec-20
Clarification:

- Patient input submission received from Lung Cancer Canada and Lung Health Foundation

Submission received01-Dec-20
Submission accepted15-Dec-20
Review initiated16-Dec-20
Draft CADTH review report(s) provided to sponsor for comment22-Mar-21
Deadline for sponsors comments31-Mar-21
CADTH responses on draft review report(s) provided to sponsor03-May-21
Expert committee meeting (initial)14-May-21
Draft recommendation issued to sponsor31-May-21
Draft recommendation posted for stakeholder feedback10-Jun-21
End of feedback period24-Jun-21
Final recommendation issued to sponsor and drug plans09-Jul-21
Final recommendation posted27-Jul-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)23-Jul-21
CADTH review report(s) posted09-Sep-21