Limited coverage criteria – pirfenidone

267 mg capsule

267 mg/801 mg tablet

Initial

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

For whom a diagnosis of IPF is confirmed by a respirologist with expertise in IPF and who have had a high-resolution CT scan within the previous 24 months

AND

In whom all other causes of restrictive lung disease are excluded (e.g., collagen vascular disorder or hypersensitivity pneumonitis)

AND

Who are under the care of a respirologist with expertise in IPF

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: 7 months (including a 4-week period for repeat pulmonary function tests, if needed)

First renewal

Prescribed by a respirologist with expertise in IPF

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

Prescribed by a respirologist with expertise in IPF

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)