Generic name |
pirfenidone |
|
---|---|---|
Strength |
capsule: 267 mg tablet: 267 mg and 801 mg |
|
Form |
capsule and tablet |
Special Authority criteria |
Approval period |
---|---|
Initial For the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients:
AND
AND
Notes: For patients diagnosed with IPF, mild to moderate disease is defined as a forced vital capacity (FVC) greater than or equal to 50% of predicted. Practitioners who are requesting initial coverage for treating patients with IPF must also submit a copy of the diagnostic report from a high-resolution CT scan performed within the previous 24 months. Exclusion: Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will be not be funded. |
Initial approval: 7 months (including a 4-week period for repeat pulmonary function tests, if needed) |
First renewal
AND Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% from initiation therapy until renewal. 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. |
First renewal: 7 months (including a 4-week period for repeat pulmonary function tests, if needed) |
Second and subsequent renewals
AND 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 experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. |
Second and subsequent renewals: 1 year (including a 4-week period for repeat pulmonary function tests, if needed) |