Access made simple

Two options to obtain Tarceva


Tarceva Access Solutions

Work with Genentech BioOncology Access Solutions

Genentech BioOncology Access Solutions—connecting your patients to their medicine. We are committed to helping all patients access our medicines, regardless of their ability to pay.

At Genentech, we develop medicines for serious or life-threatening medical conditions and we believe they should be accessible for the patients who need them. Genentech BioOncology Access Solutions helps resolve access and reimbursement issues for individual patients every day. Our dedicated Specialists help bring patient treatment and practice solutions together.

Our dedicated Specialists can:

  • Help confirm benefits and coverage and resolve any related issues
  • Refer underinsured patients for co-pay assistance
  • Provide free medicine to qualified uninsured patients through the Genentech® Access to Care Foundation (GATCF)
  • Individualize services to meet your patients’ specific needs

To get started, complete the Statement of Medical Necessity (SMN) and the Patient Authorization and Notice of Release of Information (PAN) via MyPatientSolutions.com or fax the completed forms to (888) 249-4919. The forms are available for download at Genentech-Access.com/Tarceva or contact your local representative for an SMN/PAN.

Visit Genentech-Access.com/Tarceva for more information on our programs. To speak live with one of our Specialists, call (888) 249-4918 from 6AM to 5PM PT, Monday through Friday.

The Access Solutions logo is a trademark of Genentech, Inc.


Specialty Pharmacy

Work with specialty pharmacies directly

You can also choose to work with authorized specialty pharmacies directly. Specialty pharmacies offer a comprehensive array of services in addition to product distribution, including:

  • In-depth experience with oral oncolytics
  • Reimbursement resources for complicated health plan paperwork and requirements
  • Support to help patients understand and successfully adhere to a complex therapy according to the physician’s treatment plan
  • The ability to manage special handling and shipping needs linked with specialty therapies

Check out the list of authorized specialty pharmacies ›

Assistance offerings for your patients

OFFERING HOW WE HELP
Genentech BioOncology Co-pay Card Genentech offers the BioOncology Co-pay Card to help qualified, commercially insured patients with the out-of-pocket costs associated with their Tarceva prescription. Qualified patients can pay $25 or less for their Tarceva co-pay.

Patients are eligible if they are covered by commercial insurance and are 18 years of age or older. They are not eligible if they are uninsured or participating in Medicare, Medicaid, Medigap, VA, DoD, or TRICARE. They are not eligible if they are covered by federally funded health insurance.
Referrals to co-pay assistance foundations If publicly or privately insured patients have difficulty paying for their Tarceva co-pay, co-insurance, or other out-of-pocket costs, Genentech BioOncology Access Solutions can refer them to a co-pay assistance foundation* supporting their disease state.
Genentech® Access to Care Foundation (GATCF) GATCF helps eligible patients who meet specific medical and financial criteria receive Tarceva free of charge. GATCF provides free medicine to eligible patients who are uninsured, rendered uninsured by payer denial or underinsured. To qualify, patients must meet specific financial and medical criteria.
The GATCF Extension for Medicare Part D Eligible patients with a Medicare Part D plan who do not qualify for support from a co-pay assistance foundation may receive Tarceva at no cost.
SureStart™ Eligible patients facing a coverage delay may receive up to 6 free 15-day shipments of Tarceva while awaiting an insurance coverage determination.
Tarceva Patient Support Program
6AM to 5PM PT, Monday through Friday
(877) TARCEVA
The Tarceva Patient Support Program is a free source of information and resources to help patients throughout their treatment. This program is not intended to replace the advice and guidance of a doctor.

*Genentech does not influence or control the operations of these co-pay assistance foundations, but Genentech BioOncology Access Solutions can assist patients in navigating the process of seeking co-pay assistance by making an appropriate referral based on a patient’s diagnosis and by assisting with the application process. We cannot guarantee co-pay assistance once a patient has been referred by Genentech BioOncology Access Solutions. The foundations to which we refer patients each have their own criteria for patient eligibility, including financial eligibility.
Patients must not have met the catastrophic coverage requirement and must meet the GATCF financial and medical criteria.

Visit Genentech-Access.com/Tarceva for more information on our programs. To speak live with one of our Specialists, call (888) 249-4918 from 6AM to 5PM PT, Monday through Friday.

Contact a representative

Indications

Metastatic 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

  • Interstitial Lung Disease (ILD): 
    • Cases of serious ILD, including fatal cases, can occur with Tarceva treatment. The overall incidence of ILD in approximately 32,000 Tarceva-treated patients in uncontrolled studies and studies with concurrent chemotherapy was approximately 1.1%. In patients with ILD, the onset of symptoms was between 5 days to more than 9 months (median 39 days) after initiating Tarceva therapy.
    • Withhold Tarceva for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, permanently discontinue Tarceva.
  • Renal Failure: 
    • Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with Tarceva treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration.
    • The pooled incidence of severe renal impairment in the 3 monotherapy lung cancer studies was 0.5% in the Tarceva arms and 0.8% in the control arms. The incidence of renal impairment in the pancreatic cancer study was 1.4% in the Tarceva plus gemcitabine arm and 0.4% in the control arm.
    • Withhold Tarceva in patients developing severe renal impairment until renal toxicity is resolved. Perform periodic monitoring of renal function and serum electrolytes during Tarceva treatment.
  • Hepatotoxicity With or Without Hepatic Impairment:
    • Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with Tarceva treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment.
      • Hepatic Toxicity: One Tarceva-treated patient experienced fatal hepatic failure and four additional patients experienced grade 3-4 liver test abnormalities. 
    • In clinical studies where patients with moderate to severe hepatic impairment were excluded, the pooled incidence of hepatic failure in the 3 monotherapy lung cancer studies was 0.4% in the Tarceva arms and 0% in the control arms. The incidence of hepatic failure in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0.4% in the control arm.
    • Perform periodic liver testing (transaminases, bilirubin, and alkaline phosphatase) during treatment with Tarceva. Increased frequency of monitoring of liver function is required for patients with pre-existing hepatic impairment or biliary obstruction.
    • Withhold Tarceva in patients without pre-existing hepatic impairment for total bilirubin >3 x ULN or transaminases >5 x ULN. Withhold Tarceva in patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline.
    • Discontinue Tarceva in patients whose abnormal liver tests meeting the above criteria do not improve significantly or resolve within 3 weeks.
  • Gastrointestinal Perforation:
    • Gastrointestinal perforation, including fatal cases, can occur with Tarceva treatment. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation.
    • The pooled incidence of gastrointestinal perforation in the 3 monotherapy lung cancer studies was 0.2% in the Tarceva arms and 0.1% in the control arms. The incidence of gastrointestinal perforation in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
    • Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
  • Bullous and Exfoliative Skin Disorders:
    • Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, can occur with Tarceva treatment.
    • The pooled incidence of bullous and exfoliative skin disorders in the 3 monotherapy lung cancer studies was 1.2% in the Tarceva arms and 0% in the control arms. The incidence of bullous and exfoliative skin disorders in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
    • Discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
  • Cerebrovascular Accident:
    • In the pancreatic carcinoma trial, 7 patients in the Tarceva plus gemcitabine group developed cerebrovascular accidents (incidence: 2.5%). One of these was hemorrhagic and was the only fatal event. In comparison, in the placebo plus gemcitabine group there were no cerebrovascular accidents. The pooled incidence of cerebrovascular accident in the 3 monotherapy lung cancer studies was 0.6% in the Tarceva arms and not higher than that observed in the control arms.
  • Microangiopathic Hemolytic Anemia With Thrombocytopenia:
    • The pooled incidence of microangiopathic hemolytic anemia with thrombocytopenia in the 3 monotherapy lung cancer studies was 0% in the Tarceva arms and 0.1% in the control arms. The incidence of microangiopathic hemolytic anemia with thrombocytopenia in the pancreatic cancer study was 1.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
  • Ocular Disorders:
    • Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur with Tarceva treatment and can lead to corneal perforation or ulceration.
    • The pooled incidence of ocular disorders in the 3 monotherapy lung cancer studies was 17.8% in the Tarceva arms and 4% in the control arms. The incidence of ocular disorders in the pancreatic cancer study was 12.8% in the Tarceva plus gemcitabine arm and 11.4% in the control arm.
    • Interrupt or discontinue Tarceva therapy if patients present with acute or worsening ocular disorders such as eye pain.
  • Hemorrhage in Patients Taking Warfarin:
    • Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when Tarceva and warfarin are administered concurrently.
    • Regularly monitor prothrombin time and INR during Tarceva treatment in patients taking warfarin or other coumarin-derivative anticoagulants.
  • Embryo-Fetal Toxicity:
    • Based on animal data and its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus.
    • Advise females of reproductive potential to use effective contraception during therapy and for one month after the last dose of Tarceva.

MOST COMMON ADVERSE REACTIONS

  • Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
    • Most frequent (≥30%) adverse reactions were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.
    • Most frequent Grade 3/4 (NCI-CTC Version 3.0) adverse reactions were rash (14%) and diarrhea (5%). In Tarceva-treated patients, the most frequently reported adverse reactions leading to dose modification were rash (13%), diarrhea (10%), and asthenia (3.6%). 
  • Advanced Pancreatic Cancer - Tarceva Administered Concurrently with Gemcitabine:
    • Fatigue, rash, nausea, anorexia, and diarrhea.
    • Grade 3/4 (NCI-CTC version 2.0) rash and diarrhea were each reported in 5% of patients. Rash and diarrhea each resulted in dose reductions in 2% of patients and discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.

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.

Please see the Tarceva full Prescribing Information for additional Important Safety Information.