pirfenidone — Blue Cross Blue Shield of Montana

Initial criteria

• Diagnosis of idiopathic pulmonary fibrosis (IPF) AND all of the following: other known causes of interstitial lung disease (ILD) have been excluded (e.g., environmental exposures, connective tissue disease, drug toxicity, alternative diagnoses)
• ONE of the following diagnostic criteria: high-resolution CT scan showing usual interstitial pneumonia (UIP) pattern OR surgical lung biopsy confirming UIP OR HRCT showing probable UIP pattern AND surgical lung biopsy showing probable UIP
• OR patient has another FDA labeled indication for the requested agent and route of administration
• If brand agent requested with available generic equivalent, ONE of the following: currently treated and stable on requested agent OR inadequate response to generic equivalent OR intolerance/hypersensitivity to generic equivalent not expected to occur with brand OR FDA labeled contraindication to generic equivalent not expected to occur with brand OR generic equivalent discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event OR generic equivalent expected to be ineffective or cause significant barriers or harm OR generic equivalent is not in the best interest of patient OR patient tried another agent in same class discontinued due to lack of efficacy/effectiveness/adverse event AND support for use of requested brand over generic equivalent
• Prescriber is a specialist in or has consulted a specialist in the patient’s diagnosis area (pathologist, pulmonologist, radiologist, rheumatologist)
• Patient will NOT be using another agent included in this prior authorization program concurrently
• Patient does NOT have any FDA labeled contraindication to requested agent

Reauthorization criteria

• Patient previously approved for requested agent through plan prior authorization process
• Patient has experienced clinical benefit with requested agent
• If brand agent requested with available generic equivalent, meets one of the same brand/generic exception conditions as initial evaluation
• Prescriber is a specialist in or has consulted a specialist in the patient’s diagnosis area
• Patient will NOT be using another agent included in this prior authorization program concurrently
• Patient does NOT have any FDA labeled contraindication to requested agent

Approval duration

12 months