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For Patients and Caregivers

Practice Forms and Documents

Find the enrollment forms you'll need to help patients enroll in the Genentech Patient Foundation. There are also tips for composing a letter of medical necessity and appeal letter.

To learn more about the resources available to help your practice, including information on benefits investigations and prior authorizations, go to Helpful Resources for Your Practice.

Quick Links

Esbriet Prescription Form
Genentech Patient Foundation Enrollment Forms
Tips for Composing Letters of Medical Necessity and Appeal

Esbriet Prescription Form

Complete this form and send it directly to the patient's specialty pharmacy to prescribe Esbriet.

Download the Esbriet Prescription Form

Genentech Patient Foundation Enrollment Forms

The Genentech Patient Foundation provides free Esbriet to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.

The following forms are needed for applying for assistance from the Genentech Patient Foundation. Learn more about the Genentech Patient Foundation and other resources programs.

Prescriber Foundation Form

Includes patient, insurance and prescription information. Page two must be completed and submitted by the prescriber.

Download the Prescriber Foundation Form

Patient Consent Form

This form is signed and dated by your patient, giving written permission for the Genentech Patient Foundation to discuss their health information with you and the patient's health insurance plan.

Download the Patient Consent Form
Download Formulario de Consentimiento del Paciente

Tips for Composing Letters of Medical Necessity and Appeal

Letter of Medical Necessity

This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference.

Tips for drafting a letter of medical necessity

Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference.

Tips for drafting an appeal letter

Appeals

Use the links below to find additional information to enclose in your letter of medical necessity or appeal letter:

FDA approval letter
Esbriet Prescribing Information
Sample Coding: Idiopathic Pulmonary Fibrosis (IPF)
NEXT: Financial Assistance Options

Important Safety Information and Indication

Indication

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

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. Patients treated with Esbriet had a higher incidence of ALT and/or AST elevations of ≥3x ULN (3.7%) compared with placebo patients (0.8%). Increases in ALT and AST ≥3x ULN were reversible with dose modification or treatment discontinuation.

Conduct liver function tests (ALT, AST, and bilirubin) prior to the initiation of therapy with Esbriet, monthly for the first 6 months, every 3 months thereafter, and as clinically indicated. 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. Dosage modification or interruption may be necessary for liver enzyme elevations.

Photosensitivity reaction or rash: Patients treated with Esbriet had a higher incidence of photosensitivity reactions (9%) vs placebo (1%). Patients should avoid or minimize exposure to sunlight and sunlamps, regularly use sunscreen (SPF 50 or higher), wear clothing that protects against sun exposure, and avoid concomitant medications that cause photosensitivity. Dosage reduction or discontinuation may be necessary.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the use of Esbriet in the post-marketing setting. If signs or symptoms of SCAR occur, interrupt Esbriet treatment until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, permanently discontinue Esbriet.

Gastrointestinal (GI) disorders: Patients treated with Esbriet had a higher incidence of nausea, diarrhea, dyspepsia, vomiting, gastroesophageal reflux disease (GERD), and abdominal pain. GI events required dose reduction or interruption in 18.5% of 2403 mg/day Esbriet-treated patients, compared with 5.8% of placebo patients; 2.2% of 2403 mg/day Esbriet-treated patients discontinued treatment due to a GI event, vs 1.0% of placebo patients. The most common (>2%) GI events leading to dosage reduction or interruption were nausea, diarrhea, vomiting, and dyspepsia. Dosage modification may be necessary.

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

Drug Interactions:

CYP1A2 inhibitors: Concomitant use of Esbriet and strong CYP1A2 inhibitors (e.g., fluvoxamine) is not recommended, as CYP1A2 inhibitors increase systemic exposure of Esbriet. If discontinuation of the CYP1A2 inhibitor prior to starting Esbriet is not possible, dosage reduction of Esbriet is recommended. Monitor for adverse reactions and consider discontinuation of Esbriet.

Concomitant use of ciprofloxacin (a moderate CYP1A2 inhibitor) at the dosage of 750 mg BID and Esbriet are not recommended. If this dose of ciprofloxacin cannot be avoided, dosage reductions of Esbriet are recommended, and patients should be monitored.

Moderate or strong inhibitors of both CYP1A2 and other CYP isoenzymes involved in the metabolism of Esbriet should be avoided during treatment.

CYP1A2 inducers: Concomitant use of Esbriet and strong CYP1A2 inducers should be avoided, as CYP1A2 inducers may decrease the exposure and efficacy of Esbriet.

Specific Populations:

Mild to moderate hepatic impairment: Esbriet should be used with caution in patients with Child Pugh Class A and B. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed.

Severe hepatic impairment: Esbriet is not recommended for patients with Child Pugh Class C. Esbriet has not been studied in this patient population.

Mild (CLcr 50–80 mL/min), moderate (CLcr 30–50 mL/min), or severe (CLcr<30 mL/min) renal impairment: Esbriet should be used with caution. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed.

End-stage renal disease requiring dialysis: Esbriet is not recommended. Esbriet has not been studied in this patient population.

Smokers: Smoking causes decreased exposure to Esbriet which may affect efficacy. Instruct patients to stop smoking prior to treatment and to avoid smoking when on 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.

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      Data on file. Genentech, Inc. 2022.

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    • Glassberg MK, Nathan SD, Lin C-Y, et al. Cardiovascular risks, bleeding risks, and clinical events from 3 phase III trials of pirfenidone in patients with idiopathic pulmonary fibrosis. Adv Ther. 2019;36(10):2910-2926.

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