pirfenidone — Blue Cross Blue Shield of Texas

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) AND 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 Esbriet with available generic equivalent, ONE of the following: A. The patient is currently being treated with and stable on the requested agent OR B. The patient has tried and had an inadequate response with the generic equivalent OR C. The patient has intolerance or hypersensitivity to the generic equivalent that is NOT expected to occur with the brand agent OR D. The patient has an FDA labeled contraindication to the generic equivalent that is NOT expected to occur with the brand agent OR E. The generic equivalent was discontinued due to lack of efficacy or adverse event OR F. The generic equivalent is expected to be ineffective or cause barriers to adherence, worsen a comorbid condition, or cause harm OR G. The generic equivalent is NOT in the best interest of the patient based on medical necessity OR H. The patient has tried another drug in the same pharmacologic class that was discontinued due to lack of effect or adverse event AND I. Support for use of brand agent over generic equivalent is documented
• 3. The prescriber is a specialist in the patient’s diagnosis area (e.g., pathologist, pulmonologist, radiologist, rheumatologist) or has consulted one
• 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 Esbriet with available generic equivalent, ONE of the brand-preference conditions A–H above is met and use is supported over generic equivalent
• 4. The prescriber is a specialist or has consulted a specialist in the patient’s diagnosis area
• 5. The patient will NOT be using the requested agent in combination with another agent in this program
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months