Terms and Conditions

The Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. Patients using Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government program (collectively, "Government Programs") to pay for their Genentech medicine are not eligible. The Program is not valid for Genentech medicines that are eligible to be reimbursed in their entirety by private insurance plans or other programs.

Under the Program, the patient may pay a co-pay. The final amount owed by a patient may be as little as $0 for the Genentech medicine (see Program specific details). The total patient out-of-pocket cost is dependent on the patient's health insurance plan. The Program assists with the cost of the Genentech medicine only. It does not assist with the cost of other medicines, procedures or office visit fees. After reaching the maximum annual Program benefit amount, the patient will be responsible for all remaining out-of-pocket expenses. The Program benefit amount cannot exceed the patient's out-of-pocket expenses for the cost associated with the Genentech medicine. The maximum Program benefit will reset every January 1st. The Program is not health insurance or a benefit plan. The patient's non-governmental insurance is the primary payer. The Program does not obligate the use of any specific medicine or provider. Patients receiving assistance from charitable free medicine programs (such as the Genentech Patient Foundation) or any other charitable organizations for the same expenses covered by the Program are not eligible. The Program benefit cannot be combined with any other rebate, free trial or a similar offer for the Genentech medicine. No party may seek reimbursement for all or any part of the benefit received through the Program.

The Program may be accepted by participating pharmacies, physicians' offices or hospitals. Once a patient is enrolled, the Program will honor claims with a date of service that precedes the Program enrollment date up to 180 days. Claims must be submitted within 365 days from the date of service unless otherwise indicated. Use of the Program must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physicians' offices and hospitals are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. Programs' benefits may not be sold, purchased, traded or offered for sale.

The patient or their guardian must be 18 years of age or older to receive Program assistance. The Program is only valid in the United States and U.S. Territories, is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. Eligible patients will be automatically re-enrolled in the Program on an annual basis. Eligible patients will be removed from the Program after 3 years of inactivity (e.g., no claims submitted in a 3-year timeframe). Program eligibility and automatic re-enrollment are contingent upon the patient's ability to meet all requirements set forth by the Program. Healthcare providers may not advertise or otherwise use the Program as a means of promoting their services or Genentech medicines to patients. The Program is intended for the patient. Only the patient using the Program may receive the funds made available through the Program. The Program is not intended for third parties who reduce the amount available to the patient or take a portion for their own purposes. Patients with health plans that redirect Genentech Program assistance intended for patient out-of-pocket costs may be subject to alternate Program benefit structures. Genentech reserves the right to rescind, revoke or amend the Program without notice at any time.

Indication and Important Safety Information

Indication

Esbriet® (pirfenidone) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Select Important Safety Information

Elevated liver enzymes and drug-induced liver injury (DILI): DILI has been observed with Esbriet. In the postmarketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. ALT, AST, and bilirubin elevations have occurred with Esbriet. Monitor ALT, AST, and bilirubin before and during treatment. Measure liver function promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Temporary dosage reduction or discontinuation may be required.

Photosensitivity reaction or rash: Photosensitivity and rash have been noted with Esbriet. Avoid exposure to sunlight and sunlamps, and concomitant medications known to cause photosensitivity. Wear sunscreen and protective clothing daily. Temporary dosage reduction or discontinuation may be required.

Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease (GERD), and abdominal pain have occurred with Esbriet. Temporary dosage reduction or discontinuation may be required.

Adverse reactions: The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, GERD, sinusitis, insomnia, weight decreased, and arthralgia.

Drug interactions: Moderate (e.g., ciprofloxacin) and strong (e.g., fluvoxamine) CYP1A2 inhibitors increase systemic exposure of Esbriet and may alter its adverse reaction profile. If discontinuation of strong CYP1A2 inhibitors and/or high-dose ciprofloxacin prior to starting Esbriet is not possible, dosage reduction of Esbriet is recommended.

Specific Populations:

Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. Esbriet is not recommended for use in patients with severe hepatic impairment.

Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. Esbriet is not recommended for use in patients with end-stage renal disease requiring dialysis.

Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of Esbriet.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.