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nintedanib

Last Updated: March 1, 2021
Result type: Reports
Project Number: SR0654-000
Product Line: Reimbursement Review

Generic Name: nintedanib

Brand Name: Ofev

Manufacturer: Boehringer Ingelheim (Canada) Ltd.

Therapeutic Area: chronic fibrosing interstitial lung diseases

Indications: Treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD)

Manufacturer Requested Reimbursement Criteria1: As per the Health Canada approved indication for progressive fibrosing-ILD (PF-ILD).

Submission Type: Initial

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Date Recommendation Issued: February 24, 2021

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 input open June 25, 2020
Call for patient input closed August 17, 2020
Clarification:

- Patient input submission received from British Columbia Lung Association & Lung Groups, Canadian Pulmonary Fibrosis Foundation and The Ontario Lung Association / Lung Health Foundation

Submission received July 24, 2020
Submission accepted August 13, 2020
Clarification:

- Submission was not accepted for review on 10 Aug 2020

Review initiated August 14, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment November 10, 2020
Deadline for sponsors comments November 19, 2020
CADTH responses on draft review report(s) provided to sponsor January 08, 2021
Expert committee meeting (initial) January 20, 2021
Draft recommendation issued to sponsor February 01, 2021
End of embargo period February 16, 2021
Final recommendation issued to sponsor and drug plans February 24, 2021
Final recommendation posted February 26, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) March 10, 2021
CADTH review report(s) posted -