pirfenidone — Blue Cross Blue Shield of Oklahoma

Preferred products

• pirfenidone

Initial criteria

• 1. ONE of the following:
• A. The patient has a diagnosis of idiopathic pulmonary fibrosis (IPF) AND ALL of the following:
• 1. Other known causes of interstitial lung disease (ILD) have been excluded (e.g., domestic and occupational environmental exposures, connective tissue diseases, drug toxicities, alternative diagnoses, etc) AND
• 2. ONE of the following:
• A. The patient had a high-resolution computed tomography (HRCT) scan with results showing a pattern for usual interstitial pneumonia (UIP) OR
• B. The patient had a surgical lung biopsy with pathology confirming UIP OR
• C. The patient had a HRCT scan with results showing a pattern for probable UIP AND a surgical lung biopsy with pathology indicating probable UIP OR
• B. The patient has another FDA labeled indication for the requested agent and route of administration AND
• 2. If the request is for one of the following brand agents with an available generic equivalent (listed below), then ONE of the following:
• A. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent [chart notes are required] OR
• B. The patient has tried and had an inadequate response with the generic equivalent [chart notes are required] OR
• C. The patient has an intolerance or hypersensitivity to the generic equivalent that is NOT expected to occur with the brand agent [chart notes are required] OR
• D. The patient has an FDA labeled contraindication to the generic equivalent that is NOT expected to occur with the brand agent [chart notes are required] OR
• E. The generic equivalent was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] OR
• F. The generic equivalent is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes are required] OR
• G. The generic equivalent is NOT in the best interest of the patient based on medical necessity [chart notes are required] OR
• H. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as the generic equivalent and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] AND
• I. There is support for the use of the requested brand agent over the generic equivalent
• 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 will NOT be using the requested agent in combination with another agent included in this prior authorization program AND
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. If the request is for one of the following brand agents with an available generic equivalent (listed below), then ONE of the following:
• A. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent [chart notes are required] OR
• B. The patient has tried and had an inadequate response with the generic equivalent [chart notes are required] OR
• C. The patient has an intolerance or hypersensitivity to the generic equivalent that is NOT expected to occur with the brand agent [chart notes are required] OR
• D. The patient has an FDA labeled contraindication to the generic equivalent that is NOT expected to occur with the brand agent [chart notes are required] OR
• E. The generic equivalent was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] OR
• F. The generic equivalent is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes are required] OR
• G. The generic equivalent is NOT in the best interest of the patient based on medical necessity [chart notes are required] OR
• H. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as the generic equivalent and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] AND
• I. There is support for the use of the requested brand agent over the generic equivalent
• 4. 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
• 5. The patient will NOT be using the requested agent in combination with another agent included in this prior authorization program AND
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months