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.
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.
Sure Start™ 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

Advanced Non-Small Cell Lung Cancer (NSCLC)

Tarceva is indicated for:

  • The first-line treatment of patients with metastatic 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.
  • The maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
  • The treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Limitations of use:

  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.
  • Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution.

Advanced 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

CONTRAINDICATIONS

None

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 and/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 value 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.
  • Myocardial Infarction (MI)/Ischemia:
    • In the pancreatic carcinoma trial, 6 patients (incidence 2.1%) in the Tarceva plus gemcitabine group developed myocardial infarction/ischemia. One of these patients died due to myocardial infarction. In comparison, 3 patients in the placebo/gemcitabine group developed myocardial infarction (incidence 1.1%), and one died due to myocardial infarction. The pooled incidence of myocardial infarction/ischemia in the 3 monotherapy lung cancer studies was 0.2% in the Tarceva arms and 0.4% in the control arms.
  • Cerebrovascular Accident:
    • In the pancreatic carcinoma trial, 7 patients in the Tarceva plus gemcitabine group developed cerebrovascular accident (incidence 2.5%). One of these was hemorrhagic and was the only fatal event. In comparison, in the placebo/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 0.9% 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:
    • Tarceva is pregnancy category D. Based on its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. If Tarceva is used during pregnancy, or if the patient becomes pregnant while taking Tarceva, the patient should be apprised of the potential hazard to a fetus.
    • Advise females of reproductive potential to use highly effective contraception during therapy and for at least 2 weeks after the last dose of Tarceva. Advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking 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.
    • 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 NSCLC – Maintenance Treatment:
    • Rash and diarrhea.
    • Grade 3/4 (NCI-CTC Version 3.0) adverse reactions were rash (9%) and diarrhea (2%). Rash and diarrhea resulted in dose reductions or interruption (5% and 3%, respectively) and discontinuation (1% and 0.5%, respectively) of Tarceva-treated patients.
  • Advanced NSCLC – Second/Third-Line Treatment:
    • Rash and diarrhea.
    • Grade 3/4 (NCI-CTC Version 2.0) adverse reactions were rash (9%) and diarrhea (6%). Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients. 
  • Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
    • Fatigue, rash, nausea, anorexia, and diarrhea. 
    • Grade 3/4 (NCI-CTC Version 2.0) adverse reactions were rash (5%) and diarrhea (5%). 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.