Forms and Documents

Tarceva Access Solutions Enrollment Forms

The Prescriber Service Form and PAN are required for enrollment in Tarceva Access SolutionsThe Prescriber Service Form replaces the Statement of Medical Necessity (SMN).

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 Tarceva

 

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 Tarceva

 

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.

 

Fax Cover Letter

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

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

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.