Esbriet — Blue Cross Blue Shield of New Mexico
Idiopathic pulmonary fibrosis (IPF)
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., domestic and occupational environmental exposures, connective tissue diseases, drug toxicities, alternative diagnoses)
- • ONE of the following HRCT or biopsy findings:
- – High-resolution computed tomography (HRCT) scan showing a pattern for usual interstitial pneumonia (UIP) OR
- – Surgical lung biopsy with pathology confirming UIP OR
- – HRCT scan showing probable UIP AND surgical lung biopsy indicating probable UIP
- OR
- The patient has another FDA labeled indication for the requested agent and route of administration
- AND if the request is for a brand agent with an available generic equivalent:
- • ONE of the following:
- – Patient currently treated and stable on requested brand (chart notes required) OR
- – Tried and had inadequate response with generic equivalent OR
- – Intolerance or hypersensitivity to generic equivalent that is NOT expected to occur with brand OR
- – FDA labeled contraindication to generic equivalent that is NOT expected to occur with brand OR
- – Generic discontinued due to lack of efficacy, diminished effect, or adverse event OR
- – Generic expected to be ineffective or create adherence barrier or worsen comorbid condition OR
- – Generic NOT in best interest of the patient based on medical necessity OR
- – Tried another drug in same class discontinued due to ineffectiveness, diminished effect, or adverse event AND support exists for brand use over generic
- • Brand–generic pair: Esbriet – pirfenidone
- Prescriber is a specialist in the area of the diagnosis (e.g., pulmonologist, rheumatologist, radiologist, pathologist) OR consulted with specialist
- Patient will NOT use the requested agent in combination with another agent in this PA program
- No FDA labeled contraindications to the requested agent
Reauthorization criteria
- Prior approval for the requested agent through plan’s PA process
- Documented clinical benefit with the requested agent
- If brand with generic equivalent, same brand vs. generic criteria as initial apply
- Prescriber is a specialist in the diagnosis area or has consulted one
- Not used in combination with another agent in the PA program
- No FDA labeled contraindications to requested agent
Approval duration
12 months