BioOncology Co-Pay Card Program

Co-payment support for your patients taking Herceptin

The following frequently asked questions provide an overview of the BioOncology Co-Pay Card Program and how it can help your patients.

How does the program work?

Your practice gives eligible patients a brochure with an enclosed BioOncology Co-Pay Card at the time the prescription is written.
Eligible patients can then activate the card by phone or on the Internet before the prescription is filled.
The patient presents the activated card, along with their prescription, to the pharmacist and their co-pay amount will be reduced accordingly.

Who is eligible?

Eligible

Covered by commercial insurance (non-governmental) AND
Co-pay for Herceptin over $100 AND
Live in Puerto Rico or the United States AND
Annual household income of $100,000 or less AND
Age 18 years or older

Not Eligible

Participating in Medicare D, Medicaid Medigap, VA, DoD, and Tricare (or any other federal- or state-funded benefit programs) OR
Uninsured OR
Currently residing in Massachusetts OR
Currently participating in the Genentech Access to Care Foundation

How much does the program cover if my patient is eligible?

Patient responsiblity	The first $100 per month of their Herceptin co-pay, plus any additional amount not covered by the program.
Program pays	No monthly limit; program pays 80% of remaining copay after the first $100.
Program limit	Up to $4000 in Herceptin co-pay support, which must be used within 1 year after patient activates their card.

How do I explain to patients how this program works?

Eligibility	Be sure to highlight the need for commercial insurance with a co-pay of over $100.
Program limits	Program pays up to 80% of the remaining copay after the first $100, up to $4000 per year. Patients must pay first $100 per month, plus amount not covered by program.
Getting started	Patient activates card, then presents the card, along with their prescription, to the pharmacist.

Where do I get BioOncology Co-Pay Cards?

Please speak with your Herceptin Sales Representative.

What about my Herceptin patients who are not eligible for this program?

We develop medicines for serious or life-threatening medical conditions and we believe they should be accessible to the patients who need them. At Herceptin Access Solutions, we are here to help find a way for you to get Herceptin to your patients, regardless of their ability to pay for it. If your patients have difficulty paying their co-pay for Herceptin, an Access Solutions specialist can refer them to an independent, nonprofit organization for financial assistance. Call us at 1-888-249-4918 weekdays, 6 AM to 5 PM PST or visit our Web site at www.HerceptinAccessSolutions.com for more information.

Adjuvant indications
Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature)^† breast cancer:
As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
With docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy

† High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic indications
Herceptin is indicated:
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Boxed WARNINGS and Additional Important Safety Information

Cardiotoxicity
Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF).
- The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens.
- Discontinue Herceptin treatment in patients receiving adjuvant therapy for breast cancer and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.
Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death.
- In one adjuvant clinical trial, cardiac ischemia or infarction occurred in the Herceptin-containing regimens.
- Herceptin can also cause asymptomatic decline in LVEF.
Cardiac Monitoring
Candidates for treatment with Herceptin should undergo a thorough baseline cardiac assessment, including history, physical examination, and an assessment of LVEF by echocardiogram or MUGA scan.
- Patients should undergo frequent monitoring for decreased left ventricular function during and after Herceptin treatment.
- More frequent monitoring should be employed if Herceptin is withheld in patients who develop significant left ventricular cardiac dysfunction.
Infusion reactions and Pulmonary Toxicity
Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported.
- In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.
- Patients should be monitored until signs and symptoms completely resolve.
- Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia.
- In postmarketing reports, serious and fatal infusion reactions have been reported. Discontinue Herceptin in all patients with severe or life-threatening infusion reactions.
Herceptin use can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis.
- Such events can occur as sequelae of infusion reactions.
- Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
Neutropenia
Exacerbation of chemotherapy-induced neutropenia has also occurred
- In controlled clinical trials, severe neutropenia and febrile neutropenia occurred more frequently in metastatic breast cancer patients receiving Herceptin with myelosuppressive chemotherapy compared to chemotherapy alone.
- The incidence of septic death was not significantly increased.
Pregnancy Category D
Herceptin can cause fetal harm when administered to a pregnant woman.
Post-marketing reports suggest that Herceptin use during pregnancy increases the risk of oligohydramnios during the second and third trimester.
Most Common Adverse Events
The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

Please see the Herceptin full Prescribing Information including Boxed WARNINGS and additional important safety information.

References:
1. Sliwkowski MX, Lofgren JA, Lewis GD, Hotaling TE, Fendly BM, Fox JA. Nonclinical studies addressing the mechanism of action of trastuzumab (Herceptin). Semin Oncol. 1999;26(suppl 12):60-70.
2. Yakes FM, Chinratanalab W, Ritter CA, et al. Herceptin-induced inhibition of phosphatidylinositol-3 kinase and AktIs required for antibody-mediated effects on p27, cyclin D1, and antitumor action. Cancer Res.2002; 62(14):4132-4141.
3. Arnould L, Gelly M, Penault-Llorca F, et al. Trastuzumab-based treatment of HER2+ breast cancer: an antibody-dependent cellular cytotoxicity mechanism? Br J Cancer.2006;94(2):259-267.
4. Bianco AR. Targeting c-erbB2 and other receptors of the c-erb B family: rationale and clinical applications. JChemother. 2004; 16 Suppl 4:52-54.