Forms and Documents

We've made enrollment simpler, faster and more intuitive with some key changes to our forms. The Prescriber Service Form and the Patient Consent Form are required for enrollment in Genentech Access Solutions. These forms replace the Statement of Medical Necessity (SMN) and the Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation (PAN).

 

Esbriet Access Solutions Enrollment Forms

 

Other Important Documents

Considerations for Composing a 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. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for Esbriet

 

Considerations for Composing a Sample Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for Esbriet

 

Enrolling in the Genentech Patient Foundation

The Genentech Patient Foundation gives free medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.

 

Esbriet Recertification Reminder Program Enrollment Form

Complete this form to enroll your patients in the Esbriet Recertification Reminder Program to help avoid potential gaps in their Esbriet therapy due to health insurance plan recertification requirements.

 

Fax Cover Letter

Use this cover sheet when faxing documents to Esbriet Access Solutions.

Important Safety Information & Indication

Indication

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

Select Important Safety Information

Elevated liver enzymes: ALT, AST, and bilirubin elevations have occurred with Esbriet. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations 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 reductions or discontinuations may be required.

Gastrointestinal disorders: Nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease (GERD), and abdominal pain have occurred with Esbriet. Temporary dosage reductions or discontinuations 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 reductions of Esbriet are 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. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional important safety information at esbriet.com.