Pharmacy Prior Authorization Criteria

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.

Criteria

Brand Esbriet, Generic pirfenidone, Ofev

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 surgical lung biopsy, 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 a lung biopsy, both HRCT and surgical lung biopsy pattern revealing IPF or probable IPF
AND
• For brand Esbriet capsules and tablets, trial and failure or intolerance to generic pirfenidone
AND
• Prescribed by or in consultation with a pulmonologist

Ofev

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
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: [5-6]
• 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 surgical lung biopsy, the presence of idiopathic interstitial pneumonia (e.g., fibrotic nonspecific interstitial pneumonia [NSIP], usual interstitial pneumonia [UIP] and centrilobular fibrosis) pattern on high-resolution computed tomography (HRCT) revealing SSc-ILD or probable SSc-ILD
OR
• In patients subjected to a lung biopsy, both HRCT and surgical lung biopsy pattern revealing SSc-ILD or probable SSc-ILD
AND
• Prescribed by or in consultation with a pulmonologist

Ofev

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
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 one of the following:
• Decline of forced vital capacity (FVC)
• Worsening of respiratory symptoms
• Increased extent of fibrosis seen on imaging
AND
• Prescribed by or in consultation with a pulmonologist

Brand Esbriet, Generic pirfenidone

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy
AND
• For brand Esbriet capsules and tablets, trial and failure or intolerance to generic pirfenidone

Ofev

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

• Patient demonstrates positive clinical response to therapy

P & T Revisions

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

References

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, Collard HR, Egan JJ, et al. Official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J of Respir Crit Care Med. 2011;183:788-824.
4. Raghu G, Rochwerg B, Zhang Y, et al. An Official ATS/ERS/JRS/ALAT clinical practice guideline: treatment of idiopathic pulmonary fibrosis, an update of the 2011 clinical practice guideline. Am J Respir Crit Care Med. 2015;192(2):e3-e19.
5. Fischer A, Swigris JJ, Groshong SD, et al. Clinically significant interstitial lung disease in limited scleroderma: histopathology, clinical features, and survival. Chest 2008; 134:601.
6. UptoDate [internet database]. Waltham, MA. UpToDate, Inc. Clinical manifestations, evaluation, and diagnosis of interstitial lung disease in systemic sclerosis (scleroderma). Available by subscription at: https://www.uptodate.com. Accessed November 18, 2020.
7. Pirfenidone Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, New Jersey. March 2023.

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Revision History

• 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.

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