Esbriet Coverage
Benefits Investigations
Esbriet Access Solutions can conduct a benefits investigation
(BI) to help you determine if a Genentech medicine is covered, if
prior authorizations (PAs) are required, which specialty pharmacy (SP)
the health insurance plan prefers and if patient assistance might be
needed.
Potential outcomes of a BI:
- Treatment is covered
- PA is required
- Treatment is denied
A BI may be initiated once the SMN and PAN are submitted to Esbriet
Access Solutions.
These can be downloaded from Forms and Documents or submitted online via My Patient Solutions.
The completion and submission of coverage- or reimbursement-related
documentation are the responsibility of the patient and health care
provider. Genentech makes no representation or guarantee concerning
coverage or reimbursement for any service or item.
Prior Authorization
Esbriet Access Solutions can help you identify if a prior
authorization (PA) is necessary and offer resources as you obtain it
for your patient. PA support may be provided once the SMN and PAN are
submitted to Esbriet Access Solutions.
If your patient’s request for a PA is not granted, your Respiratory Field Reimbursement Manager (FRM) or Esbriet Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.
The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.
Esbriet Start Now Program
With the Esbriet Start Now Program, eligible patients taking Esbriet may receive free medicine while awaiting an insurance coverage determination.
If you think your patient qualifies for the Esbriet Start Now
Program, submit the completed SMN and PAN to Esbriet Access
Solutions.
Eligible patients can receive a free supply of Esbriet for up to 30
days. Once coverage has been determined, the patient no longer
qualifies for the Esbriet Start Now Program.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
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.