Idiopathic Pulmonary Fibrosis - Pirfenidone Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization and Quantity Limit Criteria for Approval

Initial Evaluation

Pirfenidone 267 mg and 801 mg tablets and Pirfenidone 267 mg capsules will be approved when ALL of the following are met:

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)
   AND 
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pathologist, pulmonologist, radiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND 
4. 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

Pirfenidone 267 mg and 801 mg tablets and Pirfenidone 267 mg capsules 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 idiopathic pulmonary fibrosis (IPF)
   AND 
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pathologist, pulmonologist, radiologist) 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: Updated: 01/01/2025 
      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