Product Details
Ofev
Nintedanib150 mg
Capsule
DIN/PIN/NPN
02443074
Manufacturer
Boehringer-Ingelheim (Canada) Ltd./Ltee
Formulary Listing Date
2019-06-28
Unit Price
56.8336
Amount MOH Pays
56.8336
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L01EX09
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Respirology Therapies | Nintedanib
Initial approval criteria: For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (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:
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:
Initial requests should contain the following information:
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: |