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

Performance Metric:

Achieved

Biosimilar:

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:

July 27, 2021

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	03-Nov-20
Call for patient/clinician input closed	24-Dec-20
Clarification: - Patient input submission received from Lung Cancer Canada and Lung Health Foundation
Submission received	01-Dec-20
Submission accepted	15-Dec-20
Review initiated	16-Dec-20
Draft CADTH review report(s) provided to sponsor for comment	22-Mar-21
Deadline for sponsors comments	31-Mar-21
CADTH responses on draft review report(s) provided to sponsor	03-May-21
Expert committee meeting (initial)	14-May-21
Draft recommendation issued to sponsor	31-May-21
Draft recommendation posted for stakeholder feedback	10-Jun-21
End of feedback period	24-Jun-21
Final recommendation issued to sponsor and drug plans	09-Jul-21
Final recommendation posted	27-Jul-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	23-Jul-21
CADTH review report(s) posted	09-Sep-21