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Interstitial Lung Disease (ILD) - Ofev Prior Authorization (with Quantity Limit) Criteria - Medicare Part D
Medicare Utilization Management Policy
Version Date: 01/01/2025

Prior Authorization and Quantity Limit Criteria for Approval

Initial Evaluation

Ofev will be approved when ALL of the following are met: 

  1. ONE of the following:
    1. BOTH of the following:
      1. The patient has a diagnosis of idiopathic pulmonary fibrosis (IPF)
        AND 
      2. The patient has no known explanation for interstitial lung disease (ILD) or pulmonary fibrosis (e.g., radiation, drugs, metal dusts, sarcoidosis, or any connective tissue disease known to cause ILD)
        OR
    2. BOTH of the following:
      1. The patient has a diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD)
        AND
      2. The patient’s diagnosis has been confirmed on high-resolution computed tomography (HRCT) or chest radiography scans
        OR
    3. BOTH of the following:
      1. The patient has a diagnosis of chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype
        AND
      2. The patient’s diagnosis has been confirmed on high-resolution computed tomography (HRCT)
        AND
  2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pathologist, pulmonologist, radiologist, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
    AND
  3. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
    2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
        AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
        AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Ofev will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
    AND
  2. The patient has a diagnosis of ONE of the following:
    1. Idiopathic pulmonary fibrosis (IPF)
      OR
    2. Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
      OR
    3. Chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype
      AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pathologist, pulmonologist, radiologist, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
    AND
  4. The patient has had clinical benefit with the requested medication
    AND
  5. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
    2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
        AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
        AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months
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