Specialty Pharmacy Services

Pirfenidone (Esbriet)

Oral Capsule · Three Times Daily · With Meals

Pirfenidone (Esbriet) is a specialty medication prescribed for idiopathic pulmonary fibrosis. Accord Specialty Pharmacy provides pirfenidone with prior authorization support, copay assistance coordination, and doorstep delivery.

Drug at a Glance

  • Drug Class Antifibrotic
  • Generic Name Pirfenidone
  • Brand Name Esbriet®
  • Route Oral capsule or tablet, three times daily with meals
  • Manufacturer Legacy Pharma (brand Esbriet) / multiple generics

Clinically Reviewed By · Accord Clinical Team, PharmD, RPh

Pirfenidone (Esbriet) at a Glance

Feature Pirfenidone (Esbriet)
Generic Name Pirfenidone
Brand Name Esbriet®
Drug Class Antifibrotic
FDA Approved For Idiopathic Pulmonary Fibrosis (IPF)
FDA Approved (Year) 2014
Dosage Form Capsule or tablet, three times daily with meals
Available Generic Yes
Specialty Pharmacy Required Often required by insurance
Prior Authorization Frequently required
Copay Assistance Available Yes, for eligible commercially insured patients
Home Delivery Available through Accord Specialty Pharmacy

FDA-Approved Use

What Pirfenidone (Esbriet) Is Used For

Idiopathic Pulmonary Fibrosis

IPF

IPF is a chronic, progressive lung disease in which the tissue surrounding the air sacs in the lungs becomes scarred and stiff over time, making breathing increasingly difficult. The cause is not known ("idiopathic"). Pirfenidone has been shown in clinical trials to slow the rate of lung function decline in patients with IPF.1,2

  • Chronic, progressive scarring of lung tissue
  • Slows decline in lung function (FVC)
  • Currently the sole FDA-approved indication for pirfenidone

Your prescriber is the right person to determine whether pirfenidone is appropriate for your specific situation. Learn more about idiopathic pulmonary fibrosis from the National Heart, Lung, and Blood Institute ↗, or read about Pulmonology specialty pharmacy services →

What Is Pirfenidone (Esbriet)?

Pirfenidone (Esbriet) is one of two FDA-approved medications for idiopathic pulmonary fibrosis and has been shown to slow how quickly the disease progresses. It works through a combination of anti-inflammatory, antioxidant, and antifibrotic effects in the lungs — reducing the activity of growth factors and other signals involved in the scarring process.2

The precise mechanism by which pirfenidone slows lung fibrosis is not fully understood, but research has consistently demonstrated that it reduces TGF-beta and other profibrotic mediators that drive the progressive scarring characteristic of IPF. It does not reverse damage that has already occurred, but it can meaningfully slow the rate at which lung function declines over time.2

Pirfenidone is taken three times daily with meals. Taking it with food is important: it significantly reduces the likelihood of nausea and gastrointestinal side effects, which are among the most commonly reported.3 Accord manages the coordination between your prescriber, your insurance plan, and the manufacturer support programs that help make treatment accessible. Learn how Accord supports patients →

Pirfenidone Side Effects and What to Watch For

Like all specialty medications, pirfenidone can cause side effects. Most are manageable, and your prescriber will likely discuss what to expect before you start treatment.

Two side effects are worth knowing about specifically. Gastrointestinal effects — particularly nausea — are among the most frequently reported, and taking pirfenidone with food as directed can significantly reduce them. Photosensitivity is also a distinctive and common pirfenidone side effect: patients have a higher likelihood of experiencing sensitivity to sunlight, which can cause rash or skin reactions.3 Taking sun precautions during treatment is an active part of managing this medication well. If anything concerns you while taking pirfenidone, call Accord's pharmacy team at 1-855-222-6730.

Most Common

Gastrointestinal and General Effects3

  • Nausea — the most frequently reported side effect (about 36% of patients vs. 16% on placebo in clinical trials); taking pirfenidone with food helps reduce this
  • Rash (about 30% of patients vs. 10% on placebo) — distinct from the sun-related skin reactions described below
  • Diarrhea, indigestion, and abdominal pain
  • Fatigue and headache
  • Decreased appetite and weight loss
  • Vomiting and dizziness
Monitoring Required

Photosensitivity3

  • Pirfenidone increases sensitivity to sunlight (about 9% of patients vs. 1% on placebo) — this is among the most distinctive side effects of this medication
  • Use broad-spectrum sunscreen with SPF 50 or higher whenever outdoors, even on cloudy days
  • Wear protective clothing, a hat, and avoid direct sun exposure when possible
  • Report any skin rash or unusual skin reaction to your prescriber promptly — a dose adjustment may be needed
  • Avoid medications and products known to increase photosensitivity during treatment
Serious Warnings

Liver Toxicity3

  • Pirfenidone can cause elevations in liver enzymes — liver function tests (ALT, AST, and bilirubin) are checked before starting treatment, monthly for the first six months, and every three months after that
  • Symptoms that may indicate liver problems: yellowing of the skin or eyes (jaundice), dark urine, or pain in the upper right abdomen
  • Significant liver enzyme elevations are uncommon and are generally reversible with a dose adjustment or, if needed, stopping treatment
  • Report any of these symptoms to your prescriber or seek medical attention promptly

Esbriet vs. Ofev for IPF

Esbriet (pirfenidone) and Ofev (nintedanib) are both FDA-approved antifibrotic medications used for IPF. No head-to-head randomized trial has directly compared the two, but real-world and comparative studies give a general picture of how they differ.7 Your prescriber is the right person to decide which is appropriate for your situation.

Esbriet (Pirfenidone) Ofev (Nintedanib)
FDA-Approved For3 IPF only IPF, SSc-ILD, and progressive fibrosing ILD
Effect on Lung Function Decline7 Slows FVC decline; no significant efficacy difference found vs. nintedanib in comparative studies Slows FVC decline; no significant efficacy difference found vs. pirfenidone in comparative studies
Most Distinctive Side Effects7 Photosensitivity and skin rash, nausea Diarrhea (the primary reason for dose reduction), nausea, reduced appetite
Liver Monitoring7 Regular liver function monitoring required Regular liver function monitoring required
Dosing7 Tablet or capsule, three times daily with food Capsule, twice daily with food

These comparisons are based on published clinical studies. The choice between medications should be individualized by your treating specialist.

Accord dispenses both Esbriet and Ofev. Questions about which one fits your situation? Call 1-855-222-6730 and our pharmacists can help you think through what to ask your prescriber.

Prior Authorization for Pirfenidone (Esbriet)

Most insurance plans require prior authorization before covering pirfenidone. Prior authorization is a process where your prescriber submits clinical documentation to your insurance plan confirming that pirfenidone is medically necessary for your condition. For a specialty medication like pirfenidone, this typically includes documentation of your IPF diagnosis and may involve pulmonary function test results or imaging.

When Accord receives your referral, we contact your prescriber's office to gather what the insurance plan requires, submit the prior authorization request, and follow up proactively to keep things moving. If your plan issues a denial, we work alongside your prescriber to build a formal appeal with the additional clinical documentation needed to support your case. Information for prescribers →

Prior Authorization Process

1

Documentation

We request IPF diagnosis documentation, pulmonary function results, and imaging from your prescriber

2

PA Submission

Prior authorization submitted to your insurance plan with full clinical documentation

3

Plan Decision

Approval issued, or denial received — timelines vary by payer

4

Appeal if Denied

We build a formal appeal with your prescriber to support your case

Note on appeals: A denial is not necessarily final. Many initially denied requests for pirfenidone are approved on formal appeal. Our team manages this process alongside your prescriber at no additional burden to your care team.

Pirfenidone and Esbriet Cost: Financial Assistance Options

Pirfenidone cost and Esbriet cost vary significantly depending on your insurance plan, your deductible, and which assistance programs you qualify for. The list price of a specialty medication rarely reflects what patients actually pay. Our team works through all of that before your first fill.

Commercially Insured — Brand

Esbriet Co-pay Program (Legacy Pharma)

$5 as low as, per 30-day supply (up to $25,000/year)

Eligible commercially insured patients may pay as little as $5 per month for brand Esbriet, with up to $25,000 in program assistance per calendar year. Not available for patients with Medicare, Medicaid, or TRICARE coverage.4

Commercially Insured — Generic

Generic Pirfenidone

Lower cost option for eligible patients

Generic pirfenidone is FDA-approved and available through specialty pharmacies. It contains the same active ingredient as brand Esbriet. Manufacturer copay programs apply to brand Esbriet only and do not cover generic versions. Our team can help evaluate which option fits your coverage.5

Uninsured or Underinsured

Legacy Patient Program

$0 for eligible uninsured or underinsured patients

The Legacy Patient Program provides brand Esbriet free of charge to eligible patients who do not have insurance or who have financial concerns and meet income guidelines. Our team assists with the enrollment process.4

Medicare

Independent Foundation Grants

Varies by foundation and funding availability

The Legacy Pharma co-pay program is not available for Medicare patients. Independent patient assistance foundations may offer grants for pirfenidone costs depending on your situation. Our team can help identify what may apply to you.

Have questions about your specific coverage? Call 1-855-222-6730 or contact us online. Our team reviews your coverage and helps connect you to every program you may qualify for.

Getting Started

What to Expect with Accord

01

Referral Sent

Your prescriber sends a referral to Accord by fax or online referral form.

02

Insurance Verified

We confirm your coverage, benefits, and any cost-sharing requirements.

03

Prior Authorization

We submit clinical documentation and manage the PA process on your behalf.

04

Financial Assistance

We identify programs that may fit your situation and help connect you to the right resources.

05

Doorstep Delivery

Your medication ships directly to your door in states where Accord is licensed.

Have Questions About Pirfenidone?

Ask a Specialty Pharmacist

Common Questions About Pirfenidone (Esbriet)

Does Accord Specialty Pharmacy carry pirfenidone (Esbriet)?

Yes. Accord is a licensed specialty pharmacy that dispenses both brand Esbriet and generic pirfenidone. We manage prior authorization, financial assistance coordination, and doorstep delivery in states where Accord holds an active pharmacy license.

How do I transfer my pirfenidone prescription to Accord?

Your prescriber can send a referral directly to Accord using our referral form, or by faxing to 386-456-3000. You can also call us at 1-855-222-6730 and our team will walk you through the process.

How long does prior authorization take for pirfenidone?

Timelines vary by insurance plan and typically depend on the documentation your prescriber submits. Our team begins working on your prior authorization as soon as we receive your referral and follows up proactively. We keep both you and your prescriber updated throughout the process.

What if my insurance denies pirfenidone?

A denial is not necessarily the final word. Our team works with your prescriber to submit a formal appeal with the additional documentation needed to support your case. Many initially denied requests are approved on appeal.

Is there a generic version of Esbriet?

Yes — both generic pirfenidone and brand Esbriet are FDA-approved and available through specialty pharmacies.5 Call us at 1-855-222-6730 to discuss your options and which version makes the most sense for your coverage.

Esbriet vs. Ofev — what is the difference?

Both Esbriet (pirfenidone) and Ofev (nintedanib) are FDA-approved for IPF and have been shown to slow lung function decline. Current guidelines from the American Thoracic Society do not recommend one over the other — both are considered valid first-line options.6 See our full Esbriet vs. Ofev comparison for a side-by-side look at approved uses, side effects, and dosing. Your prescriber can discuss which is the better fit for your overall health picture. Accord dispenses both medications.

Pirfenidone vs. nintedanib — are they the same medication?

No. Pirfenidone (Esbriet) and nintedanib (Ofev) are two separate FDA-approved medications for IPF that work through different mechanisms. Both are antifibrotic drugs, but they target different pathways in the fibrosis process.2 Your prescriber is the right person to determine which is most appropriate for you.

Is Esbriet a chemotherapy drug?

No. Esbriet (pirfenidone) is an antifibrotic medication, not a chemotherapy drug. It works by reducing the signals that drive lung scarring in IPF — it does not target or kill cancer cells. Pirfenidone was developed specifically for the treatment of idiopathic pulmonary fibrosis.2

Does sun sensitivity from pirfenidone go away?

Photosensitivity is a known pirfenidone side effect that varies by patient. Taking protective measures — broad-spectrum sunscreen with SPF 50 or higher, protective clothing, and limiting direct sun exposure — helps most patients manage it effectively.3 If you are experiencing a skin reaction that concerns you, contact your prescriber. Our pharmacy team can also be reached at 1-855-222-6730 to discuss what you are experiencing.

For Patients

Ready to Get Started?

Our team coordinates everything — insurance verification, prior authorization, financial assistance, and delivery. Call us or ask your prescriber to send a referral, and we take it from there.

Call 1-855-222-6730

For Prescribers

Refer a Patient to Accord

Download the pirfenidone referral form, complete all sections, and fax to 386-456-3000. We confirm receipt within one business day and manage prior authorization on your behalf.

Download Referral Form
References (7)
  1. National Heart, Lung, and Blood Institute. What Is Idiopathic Pulmonary Fibrosis? U.S. Department of Health and Human Services. nhlbi.nih.gov
  2. Drugs.com. Esbriet (pirfenidone): Uses, Side Effects, Dosage. drugs.com
  3. Esbriet (pirfenidone) Prescribing Information. Genentech, Inc. DailyMed, U.S. National Library of Medicine. dailymed.nlm.nih.gov
  4. Legacy Pharma Inc. Esbriet Co-pay Program and Legacy Patient Program. esbriethcp.com
  5. Drugs.com. Generic Esbriet (pirfenidone) Availability. drugs.com
  6. Raghu G, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine, 2022. atsjournals.org
  7. Chianese M, et al. Pirfenidone and Nintedanib in Pulmonary Fibrosis: Lights and Shadows. Pharmaceuticals (Basel). 2024;17(6):709. pmc.ncbi.nlm.nih.gov
Refer a Patient