pirfenidone — Blue Cross Blue Shield of Kansas

Initial criteria

• 1. ONE of the following:
• A. The patient has a diagnosis of idiopathic pulmonary fibrosis (IPF) AND ALL of the following:
• 1. Other known causes of interstitial lung disease (ILD) have been excluded (e.g., domestic and occupational environmental exposures, connective tissue diseases, drug toxicities, alternative diagnoses, etc)
• 2. ONE of the following:
• A. The patient had a high-resolution computed tomography (HRCT) scan with results showing a pattern for usual interstitial pneumonia (UIP) OR
• B. The patient had a surgical lung biopsy with pathology confirming UIP OR
• C. The patient had a HRCT scan with results showing a pattern for probable UIP AND a surgical lung biopsy with pathology indicating probable UIP
• OR
• B. The patient has another FDA labeled indication for the requested agent and route of administration
• 2. If the request is for a brand agent with an available generic equivalent, then ONE of the following:
• A. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent OR
• B. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent OR
• C. There is clinical support for the use of the requested brand agent over the generic equivalent
• 3. The prescriber is a specialist in the area of the patient's diagnosis (e.g., pathologist, pulmonologist, radiologist, rheumatologist) or has consulted with a specialist
• 4. The patient will NOT be using the requested agent in combination with another agent included in this prior authorization program
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. The patient has had clinical benefit with the requested agent
• 3. If the request is for a brand agent with an available generic equivalent, then ONE of the following:
• A. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent OR
• B. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent OR
• C. There is clinical support for the use of the requested brand agent over the generic equivalent
• 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pathologist, pulmonologist, radiologist, rheumatologist) or has consulted with a specialist
• 5. The patient will NOT be using the requested agent in combination with another agent included in this prior authorization program
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months