WHA
 

Interstitial Lung Disease (ILD) Agents - PA, NF

Indications for Prior Authorization

Ofev (nintedanib)
  • For diagnosis of Idiopathic Pulmonary Fibrosis
    Indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF).

  • For diagnosis of Systemic Sclerosis-associated Interstitial Lung Disease
    Indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

  • For diagnosis of Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Progressive Phenotype
    Indicated for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Esbriet (pirfenidone)
  • For diagnosis of Idiopathic Pulmonary Fibrosis
    Indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Jascayd (nerandomilast)
  • For diagnosis of Idiopathic Pulmonary Fibrosis
    Indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients.

  • For diagnosis of Progressive Pulmonary Fibrosis
    Indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.

Criteria

Brand Ofev, generic nintedanib, generic pirfenidone

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Idiopathic Pulmonary Fibrosis (IPF)

  • Diagnosis of idiopathic pulmonary fibrosis (IPF) as documented by both of the following: [3]
    • Other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been ruled out
      • AND
    • One of the following:
      • In patients not subjected to histopathology (e.g., surgical lung biopsy, bronchoalveolar lavage ± transbronchial lung cryobiopsy), the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) revealing IPF or probable IPF
        • OR
      • In patients subjected to histopathology (e.g., surgical lung biopsy, bronchoalveolar lavage ± transbronchial lung cryobiopsy), both HRCT and histopathology findings align with a diagnosis of IPF
    AND
  • Prescribed by or in consultation with a pulmonologist
Brand Ofev, generic nintedanib

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

  • Diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) as documented by the following: [4]
    • Diagnosis of systemic sclerosis
      • AND
    • Radiologic evidence of interstitial lung disease (ILD) (e.g., reticulation, traction bronchiectasis, interstitial lung abnormalities, other patterns of interstitial pneumonias)
      • AND
    • Other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been ruled out
    AND
  • Prescribed by or in consultation with one of the following:
    • Pulmonologist
    • Rheumatologist
Brand Ofev, generic nintedanib

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Progressive Phenotype, Progressive Pulmonary Fibrosis (PPF)

  • Diagnosis of one of the following:
    • chronic fibrosing interstitial lung disease
    • progressive pulmonary fibrosis (PPF)
    AND
  • Patient does not have idiopathic pulmonary fibrosis
    • AND
  • Patient has a high-resolution computed tomography (HRCT) showing fibrotic features
    • AND
  • Disease has a progressive phenotype as observed by two of the following: [3]
    • Worsening of respiratory symptoms
    • Physiological evidence of disease progression (e.g., decline in forced vital capacity (FVC), decline in diffusing capacity of the lungs for carbon monoxide)
    • Radiological evidence of disease progression
    AND
  • Prescribed by or in consultation with one of the following:
    • Pulmonologist
    • Rheumatologist
Jascayd

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Idiopathic Pulmonary Fibrosis (IPF)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of idiopathic pulmonary fibrosis (IPF) as documented by both of the following: [3]
    • Other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been ruled out
      • AND
    • One of the following:
      • In patients not subjected to histopathology (e.g., surgical lung biopsy, bronchoalveolar lavage ± transbronchial lung cryobiopsy), the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) revealing IPF or probable IPF
        • OR
      • In patients subjected to histopathology (e.g., surgical lung biopsy, bronchoalveolar lavage ± transbronchial lung cryobiopsy), both HRCT and histopathology findings align with a diagnosis of IPF
    AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
    • Trial and inadequate response, contraindication or intolerance to both of the following:
      • generic pirfenidone
      • generic nintedanib
      OR
    • Jascayd will be used as add-on therapy in combination with one of the following:
      • generic pirfenidone
      • generic nintedanib
      OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
    AND
  • Prescribed by or in consultation with a pulmonologist
Jascayd

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Progressive Phenotype, Progressive Pulmonary Fibrosis (PPF)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of one of the following:
    • chronic fibrosing interstitial lung disease
    • progressive pulmonary fibrosis (PPF)
    AND
  • Patient does not have idiopathic pulmonary fibrosis
    • AND
  • Submission of medical records (e.g., chart notes) confirming patient has a high-resolution computed tomography (HRCT) showing fibrotic features [A]
    • AND
  • Submission of medical records (e.g., chart notes) confirming disease is progressive as defined by any two of the following: [3]
    • Worsening of respiratory symptoms
    • Physiological evidence of disease progression (e.g., decline in forced vital capacity (FVC), decline in diffusing capacity of the lungs for carbon monoxide)
    • Radiological evidence of disease progression
    AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
    • Trial and inadequate response, contraindication or intolerance to generic nintedanib
      • OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy
    AND
  • Prescribed by or in consultation with one of the following:
    • Pulmonologist
    • Rheumatologist

  • Guideline ID
    GL-709187

  • Formulary
    ehb

  • Effective date
    Sep 1, 2026

  • P&T approval date

P & T Revisions

1970-01-01, 2026-07-28, 2026-07-17, 2026-04-28

  1. Esbriet prescribing information. Genentech, Inc. South San Francisco, CA. February 2023
  2. Ofev prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. June 2024.
  3. Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2022;205(9):e18-e47. doi:10.1164/rccm.202202-0399STevidence-based guidelines for diagnosis and management. Am J of Respir Crit Care Med. 2011;183:788-824.
  4. Hossain T, Montesi SB, Volkmann ER, et al. Summary for Clinicians: Clinical Practice Guideline for the Treatment of Systemic Sclerosis-associated Interstitial Lung Disease: Evidence-based Recommendations. Ann Am Thorac Soc. 2024;21(1):12-16. doi:10.1513/AnnalsATS.202309-760CME
  5. Pirfenidone Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, New Jersey. March 2023.
  6. Jascayd Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. December 2025
  1. In the pivotal trial for Jascayd for PPF, FIBRONEER-ILD, patients with PPF were enrolled if they had relevant fibrosis defined as greater than 10% fibrotic features on HRCT and signs of progression.
  • 2026-07-28: Update to Jascayd NF criteria to include a step through both generic products if using for monotherapy or a single step through generic products if using for combination therapy. Generic pirfenidone also added to relevant criteria buckets to align with addition to EHB formulary.
  • 2026-07-17: Update to verbiage for exclusion of other known causes of ILD throughout guideline with no clinical intent. No other changes.
  • 2026-04-28: New standalone GL for EHB created mirroring commercial standard with covered products only.