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

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

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

1 year (including a 4-week period for repeat pulmonary function tests, if needed)