nivolumab

Details

Files

Generic Name:

nivolumab

Project Status:

Complete

Therapeutic Area:

Hodgkin lymphoma

Manufacturer:

N/A

Call for patient/clinician input open:

November 21, 2024

Brand Name:

N/A

Project Line:

Reimbursement Review

Project Number:

PX0376-000

Call for patient/clinician input closed:

January 17, 2025

Biosimilar:

Submission Type:

Non-sponsored Submission

Submission Complexity:

Standard Review

Fee Schedule:

Pending

Indications:

With doxorubicin, vinblastine and dacarbazine (AVD) in previously untreated stage III or IV Hodgkin Lymphoma.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Key Milestones²
Milestones title	Date
Submission received	November 27, 2024
Expert committee meeting (initial)	May 15, 2025
Draft recommendation posted for stakeholder feedback	June 05, 2025
End of feedback period	June 19, 2025
Clarification: - Reconsideration: minor revisions requested by drug programs - Request for reconsideration accepted
CDA-AMC review report(s) posted	August 05, 2025