AccordCares® Patient Support Services

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A Guide to Getting Started on HERCESSI

Download this brochure to better understand HER2+ breast cancer, how HERCESSI may help, what benefits it could offer, and the possible side effects.

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Digital Support

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Medisafe Medication Management App Star icon Accord BioPharma is a proud partner

Ranked #1 by pharmacists and physicians in independent tests, this free app provides dosing reminders, so patients never need to worry about missing a dose.

Medication Management: Delivers personalized and real-time dosing assistance to help patients stay on track.

Access & Education: Provides helpful health information tailored to the patient’s condition or medication.

Caregiver Support: Allows the patient’s care network to stay connected throughout the treatment journey.

AccordCares co-pay and patient assistance programs

As part of Accord’s commitment to helping patients gain access to the medicines they need, AccordCares offers key support and resources to your eligible patients who may require financial assistance with their treatment.

Co-Pay Program
Co-Pay Program

REDUCE OUT-OF-POCKET EXPENSES

For your eligible patients with commercial insurance, the AccordCares Co-Pay Program can be used to reduce the amount of out-of-pocket expenses for HERCESSI.

Eligible patients may pay as little as:

$0 co-pay per HERCESSI treatment

Maximum benefit of $25,000 per calendar year for out-of-pocket expenses for HERCESSI including co-pays or co-insurance. Terms and Conditions may apply.

Patient Assistance Program
Patient Assistance Program

ASSIST YOUR UNINSURED PATIENTS

The AccordCares Patient Assistance Program is available
to your patients without insurance, or for those whose
insurance does not cover their medicine. To qualify, your
patient must meet certain income and eligibility
requirements.

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Other key offerings include:

  • Benefits investigation
  • Prior authorization
  • Billing and coding information
  • Alternate funding referral
Reach Out

An AccordCares associate can be reached Monday through Friday, 8 AM to 8 PM ET at:

PHONE: 1-866-258-7151

FAX: 1-855-558-6304

OR BY MAIL: PO Box 4485
Chesterfield, MO 63006

HCPs can visit the AccordCares site

Activate HCP Account

AccordCares Co-Pay Program for HERCESSITM Terms and Conditions

This program is not valid for patients who are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).

Program offer is not valid for cash-paying patients and the patients are responsible for any out-of-pocket costs for HERCESSI that exceed the annual maximum.

The program does not cover or provide support for supplies, procedures, or any physician-related service associated with HERCESSI.

To be eligible, the patient must have private insurance with coverage of HERCESSI.

This offer is not valid when the entire cost of their prescription drug is eligible to be reimbursed by their private insurance plans or other private health or pharmacy benefit programs.

The patient must deduct the value of this assistance from any reimbursement request submitted to their private insurance plan, either directly by the patient or on their behalf.

The patient is responsible for reporting use of the program to any private insurer, health plan, or other
third party who pays for or reimburses any part of the prescription filled using the program, as may be
required.

The patient should not use the program if their insurer or health plan prohibits use of manufacturer co-pay
assistance programs.

The patient must be 18 years of age or older to be eligible for this Co-Pay Program. This program is not
considered health insurance.

This program is not valid where prohibited by law. This program cannot be combined with any other savings,
free trial, or similar offer for the specified prescription. Valid prescription is required.

Accord BioPharma reserves the right to rescind, revoke, or amend this program without notice. This offer is not conditioned on any past, present, or future purchase, including refills. The program terms and offer will expire at the end of each calendar year.

AccordCares Patient Assistance Program for HERCESSI Terms and Conditions

AccordCares may ask for proof of income at any time for the purpose of audit/verification. If requested, the patient agrees to provide proof of income within 30 days of the request. Continuation in the program is conditioned upon timely verification of income.

In addition, the patient agrees to notify AccordCares promptly if their insurance situation changes.

The patient also agrees that Accord BioPharma may verify their eligibility for the AccordCares Program, and the patient understands that such verification may include contacting them or their healthcare provider for additional information and/or reviewing additional financial, insurance, and medical information.

The patient authorizes Accord BioPharma to use their demographic information to access reports on their individual credit history from consumer reporting agencies for the purposes of determining their income eligibility. The patient understands that, upon request, Accord BioPharma will tell them whether an individual consumer report was requested and the name and address of the agency that furnished it. The patient further understands and authorizes Accord BioPharma to use any consumer reports about them and information collected from them, along with other information they obtain from public and other sources, to estimate their income in conjunction with the AccordCares Patient Assistance Program eligibility determination process.

If the patient completed Section 3, they confirm their agreement with the conditions set forth in Section 3 and certify that the information they have set forth in Section 3, including the number of people in their household and their household income, are true and accurate to the best of their knowledge.

The patient further certifies that they will not seek reimbursement or credit for this prescription requested under the AccordCares Patient Assistance Program from any insurer, health plan, or government program, and if they are a member of a Medicare Part D plan, they will not seek to have this prescription, or any cost associated with it, counted as part of their out-of-pocket cost for prescription drugs.

The patient understands that any drugs provided under the AccordCares Patient Assistance Program shall not be sold, traded, bartered, or transferred.

The patient understands they must be a permanent resident of the U.S. or U.S. Territory (including Guam, Puerto Rico, and the Virgin Islands).

The patient understands that any program assistance provided by AccordCares will terminate if the program becomes aware of any fraud or if this medication is no longer prescribed for them.

The patient certifies that they cannot afford this medication.

The patient understands that completing the application does not ensure that they will qualify for this program. In order to qualify for the program, they must live in the United States, or a U.S. territory and they are being treated by a U.S. licensed doctor.

Accord BioPharma reserves the right to rescind, revoke or amend this program without notice.

    Connect with a HERCESSI Specialist

    Complete the form with your information to reach a HERCESSI Specialist.

    *Required fields.

    HERCESSITM (trastuzumab-strf) for injection, for intravenous use

    HERCESSI (trastuzumab-strf) is biosimilar to HERCEPTIN® (trastuzumab).

    BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION

    BOXED WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, AND PULMONARY TOXICITY

    See full prescribing information for complete boxed warning

    Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCESSI for cardiomyopathy.

    Infusion Reactions, Pulmonary Toxicity: Discontinue HERCESSI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

    Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception.

    Cardiomyopathy

    • Trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
    • Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF)
    • Discontinue HERCESSI treatment in patients receiving adjuvant therapy and withhold HERCESSI in patients with metastatic disease for clinically significant decrease in left ventricular function

    Cardiac Monitoring

    • Evaluate cardiac function prior to and during treatment. For adjuvant therapy, also evaluate cardiac function after completion of HERCESSI
    • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
    • Monitor frequently for decreased LVEF during and after HERCESSI treatment
    • Monitor more frequently if HERCESSI is withheld for significant left ventricular cardiac dysfunction

    Infusion Reactions

    • With trastuzumab products, serious and fatal infusion reactions have been reported
    • Symptoms usually occur during or within 24 hours of trastuzumab product administration
    • Interrupt HERCESSI infusion for dyspnea or clinically significant hypotension
    • Monitor patients until symptoms completely resolve
    • Discontinue HERCESSI for severe infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
    • 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

    Embryo-Fetal Toxicity

    • Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
    • Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCESSI
    • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCESSI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HERCESSI treatment and any potential adverse effects on the breastfed child from HERCESSI or from the underlying maternal condition

    Pulmonary Toxicity

    • Trastuzumab products 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

    Exacerbation of Chemotherapy-Induced Neutropenia

    • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

    Most Common Adverse Reactions

    • The most common adverse reactions associated with trastuzumab products in breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
    • The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

    To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Indications

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    Adjuvant Breast Cancer

    HERCESSITM (trastuzumab-strf) is indicated in adults 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
    • as part of a treatment regimen with docetaxel and carboplatin
    • as a single agent following multi-modality anthracycline-based therapy

    Metastatic Breast Cancer

    HERCESSI is indicated in adults:

    • in combination with paclitaxel for the 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

    Metastatic Gastric Cancer

    HERCESSI is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

    HERCESSITM (trastuzumab-strf) for injection is available as a single-dose vial for the 150 mg/vial strength and as a multiple-dose vial for the 420 mg/vial strength.

    Click here for full Prescribing Information, including Boxed Warnings.

    HERCEPTIN® (trastuzumab) is a registered trademark of Genentech USA, Inc.

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