Product Details

Ofev

Nintedanib
100 mg
Capsule


DIN/PIN/NPN

02443066

Manufacturer

Boehringer-Ingelheim (Canada) Ltd./Ltee

Formulary Listing Date

2019-06-28  

Unit Price

28.4168

Amount MOH Pays

28.4168

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EX09

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Respirology Therapies

Nintedanib

  • Brand(s): Ofev
  • Dosage Form/Strength: 100 mg,150 mg capsules
  • Updated: April 29, 2022

Initial approval criteria: 

For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF): 

  1. Diagnosis confirmed by a respirologist and a high-resolution CT scan. 

  2. All other causes of restrictive lung disease (e.g., collagen vascular disorder or hypersensitivity pneumonitis) should be excluded.

  3. Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted.

  4. Patient is under the care of a physician with experience in IPF. 

Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests) 

Initial renewal criteria (at 6 months): 

Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% from initiation of therapy until renewal (initial 6-month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. 

Initial Renewal Duration: 6 Months 

Second and subsequent renewals (at 12 months and thereafter): 

Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% within any 12-month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. 

Approval period: 12 months 

Documentation/information required: 

  • If high-resolution CT scan is not available, lung biopsy may be provided to support the diagnosis of IPF as applicable and available 

  • Full pulmonary function test results. 

Second Renewal Duration: 12 Months

Exclusion Criteria: 

Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will not be funded.

Initiation Criteria:

For the treatment of chronic fibrosing interstitial lung disease with a progressive phenotype (PF-ILD) in patients meeting all of the following criteria: 

  1. Has a confirmed diagnosis by a specialist in interstitial lung diseases. Provide a copy of the consultation note. 

  2. Has a forced vital capacity (FVC) greater than or equal to 45% of predicted.

  3. Requests must come from or in consultation with a specialist with experience in managing interstitial lung diseases. 

Initial requests should contain the following information: 

  • Pulmonary function test results. 

  • A high-resolution computed tomography (HRCT) scan, if available. 

  • A consultation note from a specialist in interstitial lung diseases.

Exclusion Criteria: 

Nintedanib will not be funded as combination therapy with pirfenidone.

Renewal Criteria: 

Renewals will be considered in patients who have not experienced an absolute decline in percent predicted forced vital capacity of greater than or equal to 10% over the preceding year of treatment with nintedanib. 

Duration of approval of initials and renewal: 12 months 

Approved Dosage: up to 150 mg orally every 12 hours

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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