Tarceva Coverage

Benefits Investigations

Tarceva Access Solutions can conduct a benefits investigation (BI) to help you determine if Tarceva 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

Both the Prescriber Service Form and the Patient Consent Form must be received before Tarceva Access Solutions can begin helping your patient.

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 and Astellas Pharma US make no representation or guarantee concerning coverage or reimbursement for any service or item.

Prior Authorization

Tarceva Access Solutions can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. Both the Prescriber Service Form and the Patient Consent Form must be received before Tarceva Access Solutions can begin helping your patient.

If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or Tarceva 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 and Astellas Pharma US make no representation or guarantee concerning coverage or reimbursement for any service or item.

Important Safety Information & Indication

Indications

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Tarceva is indicated for:

  • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Limitations of use:

  • Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.

Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Important Safety Information

  • WARNINGS AND PRECAUTIONS:
    • Cases of serious interstitial lung disease (ILD), including fatal cases, have been reported.
    • Hepatic failure, hepatorenal syndrome, and severe acute renal failure (all including fatal cases) and renal insufficiency have been reported.
    • Gastrointestinal perforation (including fatal cases) has been reported.
    • Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, have been reported.
    • In the pooled incidences in the 3 monotherapy lung studies and the pancreatic carcinoma trial, serious adverse reactions, including fatal cases, such as cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia were reported.
    • Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur and can lead to corneal perforation or ulceration.
    • Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when Tarceva and warfarin are used concurrently.
    • Embryo-fetal toxicity. Women should be advised to avoid pregnancy or breastfeeding.
  • MOST COMMON ADVERSE REACTIONS:
    • Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
      • Diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.
    • Metastatic NSCLC – Maintenance Treatment:
      • Rash and diarrhea.
    • Metastatic NSCLC – Second/Third-line Treatment:
      • Rash and diarrhea.
    • Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
      • Fatigue, rash, nausea, anorexia, and diarrhea.

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

For additional Important Safety Information, please see full Prescribing Information.