For US Healthcare Professionals Only

Providing patient access support for OgivriTM

A team of dedicated patient access specialists is available to answer calls and address concerns or questions regarding:

Coding and billing

  • Provide information about applicable coding for OgivriTM (trastuzumab-dkst) and its administration
  • Ogivri has been assigned product specific billing code of Q5114.

Note: Coding information is provided for informational purposes only and the physician must determine the appropriate code for each patient and payer

Benefit investigation

  • Research patient-specific insurance coverage, coding, and billing requirements for OgivriTM and its administration
  • Verify patient cost-sharing requirements including deductible, co-pay, coinsurance, and out-of-pocket maximum, and amounts met to date
  • Determine payer access requirements (e.g., specialty pharmacy, in-office dispensing, etc.)
  • Prepare Summary of benefits that documents all findings

Prior authorization (PA)/reauthorization assistance and tracking

  • Check patient insurance plan enrollment status

Coverage/claim appeal assistance & tracking

  • Verify appeal requirements
  • Track status & resolution of appeals

Insurance coverage verification

  • Check patient insurance plan enrollment status

Patient Assistance

Patients without insurance coverage for OgivriTM who cannot afford their medication may be able to receive their medication free of charge Eligibility requirements apply based on residency, income, and other factors. Contact MYLAN ADVOCATE® for more information

Field Reimbursement Support

A reimbursement expert from your area can visit your practice or clinic for live educational programs on coverage and reimbursement information or to assist with questions related to OgivriTM access for patients

Alternate Coverage Identification

MYLAN ADVOCATE® can help identify other resources, such as state programs or third-party charitable foundations, that may be able to assist your patients

Other forms of patient support available from MYLAN ADVOCATE®

COMMERCIALLY INSURED PATIENTS MAY ACCESS OGIVRITM FOR A $0 CO-PAY*

CoPay Card
  • No income restrictions
  • Eligibility criteria apply;
  • See below for additional details
*The Co-Pay card is issued by Sunrise Banks N.A.,St. Paul, MN 55103, Member FDIC, pursuant to a license from Visa U.S.A. Inc.
Use of this card constitutes acceptance of the terms and conditions stated in the Cardholder Agreement. Card usage restrictions apply. See cardholder materials for details.

Experienced and caring MYLAN ADVOCATE® patient access specialists are available

Monday-Friday, 9:00 AM to 8:00 PM ET
Phone: 1 (833) 695-2623 Fax: 1 (833) 247-2756
Patient support services and resources are available 24 hours a day, 7 days a week, via the MYLAN ADVOCATE® portal at www.mylanadvocateportal.com

CO-PAY TERMS AND CONDITIONS

The Mylan Advocate® Co-Pay Assistance Program for Mylan’s OgivriTM (trastuzumab-dkst) for injection 150 mg/vial and/or 420 mg/vials open to both new and existing eligible patients who have commercial prescription drug insurance.

This co-pay assistance can be redeemed by patients or patient guardians who are residents of the U.S. or Puerto Rico and who are 18 years of age or older, subject to the full terms and conditions set forth on Mylan’s website as it may be updated from time to time - www.mylanadvocate.com. This co-pay assistance program can be used to reduce the amount of an eligible patient’s out-of-pocket expenses for Mylan’s OgivriTM (trastuzumab-dkst) for injection 150 mg/vial and/or 420 mg/vial up to the maximum aggregate amount set forth on Mylan’s website while this co-pay assistance program remains in effect (such aggregate amount includes dispenses of both OgivriTM (trastuzumab-dkst) for injection 150 mg/vial and 420 mg/vial).

This co-pay assistance program is not valid for uninsured patients or commercially insured patients without coverage for OgivriTM (trastuzumab-dkst) for injection 150 mg/vial and/or 420 mg/vial; not valid for patients who are covered in whole or in part by any state or federally funded healthcare program, including, but not limited to, any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare (regardless of whether OgivriTM (trastuzumab-dkst) for injection 150 mg/vial and/or 420 mg/vial is covered by such government program); not valid if the patient is Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; and not valid if the patient’s insurance plan is paying the entire cost of this prescription. This co-pay assistance program is void outside the U.S. or Puerto Rico or in any state or jurisdiction where prohibited by law, taxed or restricted. Absent a change in Massachusetts law, this co-pay assistance program will no longer be valid for Massachusetts residents as of January 1, 2020. Please see Mylan’s website for any updates.

Valid prescription required. Use of this co-pay assistance program must be consistent with the terms of any drug benefit provided by a commercial health insurer, health plan or private third-party payer. This co-pay assistance program may be changed or discontinued at any time without notice. This co-pay assistance program is not health insurance. The co-pay assistance program is not transferable, and the amount of the savings cannot exceed the patient’s out-of-pocket expenses. Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. The co-pay assistance is not redeemable for cash. No additional purchase is required. Data related to your use of this co-pay assistance program may be collected, analyzed and shared with Mylan for market research and other purposes related to assessing copay assistance programs. Data shared with Mylan will be aggregated and de-identified, meaning it will be combined with data related to other co-pay assistance program redemptions and will not identify you.

IMPORTANT SAFETY INFORMATION

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WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

  • Administration of 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.
  • Evaluate left ventricular function in all patients prior to and during treatment with Ogivri. Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function.

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

  • Administration of 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.
  • Evaluate left ventricular function in all patients prior to and during treatment with Ogivri. Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function.

Infusion Reactions; Pulmonary Toxicity

  • Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt Ogivri infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Ogivri for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

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.

Cardiomyopathy

  • Ogivri administration 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). Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
  • Evaluate left ventricular function in all patients prior to and during treatment with Ogivri
  • Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions

  • Ogivri administration can result in serious and fatal infusion reactions
  • Symptoms usually occur during or within 24 hours of Ogivri administration
  • Interrupt Ogivri infusion for dyspnea or clinically significant hypotension
  • Monitor patients until symptoms completely resolve
  • Discontinue Ogivri for 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 Ogivri 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 Ogivri
  • Advise pregnant women and females of reproductive potential that exposure to Ogivri during pregnancy or within 7 months prior to conception can result in fetal harm
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of Ogivri. 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 Ogivri treatment and any potential adverse effects on the breastfed child from Ogivri or from the underlying maternal condition

Pulmonary Toxicity

  • Ogivri administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic 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
  • Discontinue Ogivri in patients experiencing pulmonary 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 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 in metastatic gastric cancer are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

INDICATIONS

Adjuvant Breast Cancer

Ogivri™ 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

Select patients for therapy based on an FDA-approved companion diagnostic for Ogivri.

* 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 Breast Cancer

Ogivri is indicated:

  • 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

Select patients for therapy based on an FDA-approved companion diagnostic for Ogivri.

Metastatic Gastric Cancer

Ogivri is indicated, 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.

Select patients for therapy based on an FDA-approved companion diagnostic for Ogivri.