WHA

Interstitial Lung Disease (ILD) Agents

Indications for Prior Authorization

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

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.

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

Criteria

Brand Esbriet, Generic pirfenidone*, Ofev

For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039 *If patient meets criteria above, please approve at GPI-10 level and with a MSC Y. For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

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]
    • Exclusion of other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity)
      • 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
  • One of the following (applies to Brand Esbriet and Ofev only):
    • For brand Esbriet capsules and tablets, trial and failure or intolerance to generic pirfenidone
      • OR
    • For Ofev, one of the following:
      • Trial and failure, contraindication or intolerance to generic pirfenidone
        • 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

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Initial Authorization)

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

  • Diagnosis of idiopathic pulmonary fibrosis (IPF) as documented by both of the following: [3]
    • Exclusion of other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity)
      • 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
  • One of the following:
    • Trial and inadequate response, contraindication or intolerance to generic pirfenidone
      • OR
    • Patient will be continuing therapy with Ofev (defined as no more than a 45-day gap in therapy) in combination with Jascayd
      • 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

Prior Authorization (Reauthorization)

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

  • Patient demonstrates positive clinical response to therapy (e.g., reduction in decline of forced vital capacity (FVC))
Ofev

For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039

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
    • Exclusion of other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity)
    AND
  • Prescribed by or in consultation with a pulmonologist
Ofev

For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039

Prior Authorization

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

  • Diagnosis of chronic fibrosing interstitial lung disease
    • AND
  • Patient has a high-resolution computed tomography (HRCT) showing at least 10% of lung volume with 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)
    • Radiologic evidence of disease progression
    AND
  • Prescribed by or in consultation with a pulmonologist

  • Guideline ID
    GL-458217

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Nov 4, 2014

P & T Revisions

2025-12-10, 2025-11-04, 2025-05-01, 2025-04-30, 2025-03-25, 2024-11-04, 2023-10-27, 2023-10-25, 2023-01-31, 2022-10-31, 2022-08-31, 2022-06-01, 2021-09-27, 2021-05-19, 2020-11-19, 2020-05-15, 2019-10-14

  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. October 2025
  • 2025-12-10: Addition of criteria for Jascayd for the indication of IPF with an embedded step through generic pirfenidone. Addition of step through generic pirfenidone to Ofev IPF criteria. Addition of operational note for generic pirfenidone: *If patient meets criteria above, please approve at GPI-10 level and with a MSC Y. Added IL statute operational note.
  • 2025-11-04: Annual review: Updated diagnosis language to align with updated references.
  • 2025-05-01: Approval length updated to "Approved- no reauthorization required"
  • 2025-04-30: Removing reauthorization requirement as part of extended reauthorization program.
  • 2025-03-25: Removing reauthorization requirement as part of extended reauthorization program.
  • 2024-11-04: Annual review: No criteria changes. Updated references.
  • 2023-10-27: Annual review: No criteria changes. Updated indications, references.
  • 2023-10-25: Added trial requirement for Brand Esbriet through it's generic and updated reauth language
  • 2023-01-31: Added generic Esbriet (pirfenidone) 267mg capsule to guideline
  • 2022-10-31: Annual review: No criteria changes. Updated references.
  • 2022-08-31: Additional GPI added for generic pirfenidone
  • 2022-06-01: Added generic pirfenidone. Updated references.
  • 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-11-19: Annual Review: criteria and references updated
  • 2020-05-15: Program Update
  • 2019-10-14: Added new indication for Ofev. Removed ICD codes from IPF criteria. Changed guideline name to Interstitial Lung Disease (ILD) Agents.