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
- 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 | - |