Esbriet — Blue Cross Blue Shield of Illinois
other FDA labeled indication for requested agent and route of administration
Initial criteria
- Diagnosis of idiopathic pulmonary fibrosis (IPF) AND other known causes of interstitial lung disease (ILD) have been excluded (e.g., environmental exposures, connective tissue diseases, drug toxicities, alternative diagnoses, etc)
- AND ONE of the following: high-resolution computed tomography (HRCT) scan showing pattern for usual interstitial pneumonia (UIP); OR surgical lung biopsy with pathology confirming UIP; OR HRCT scan showing probable UIP AND surgical lung biopsy with pathology indicating probable UIP
- OR patient has another FDA labeled indication for the requested agent and route of administration
- If request is for a brand agent with an available generic equivalent, then ONE of the following: patient is currently being treated and stable; OR tried and had inadequate response with generic; OR intolerance/hypersensitivity to generic not expected with brand; OR FDA labeled contraindication to generic not expected with brand; OR generic discontinued due to lack of efficacy, diminished effect, or adverse event; OR generic expected to be ineffective based on clinical characteristics, adherence barriers, comorbidity worsening, or adverse effects; OR generic not in best interest based on medical necessity; OR patient tried another drug in same pharmacologic class or mechanism of action discontinued due to lack of efficacy or adverse event AND support for brand agent over generic
- Prescriber is a specialist in the patient’s diagnosis area (e.g., pathologist, pulmonologist, radiologist, rheumatologist) or has consulted with one
- Patient will NOT use requested agent in combination with another agent in this program
- Patient does NOT have FDA labeled contraindications to requested agent
Reauthorization criteria
- Patient previously approved for requested agent through plan's Prior Authorization process
- Patient has had clinical benefit with requested agent
- If request is for brand with generic equivalent, then ONE of: patient stable on brand; OR inadequate response to generic; OR intolerance/hypersensitivity to generic; OR FDA labeled contraindication to generic; OR generic discontinued due to lack of efficacy or adverse event; OR generic expected to be ineffective, cause adherence barrier, worsen comorbid condition, or cause adverse reaction; OR generic not in best interest based on medical necessity; OR tried another drug in same class/mechanism discontinued due to lack of efficacy or adverse event AND support for brand agent over generic
- Prescriber is a specialist in patient’s diagnosis area or has consulted with one
- Patient will NOT use requested agent in combination with another agent in program
- Patient does NOT have FDA labeled contraindications
Approval duration
12 months