Patient support for those prescribed ONIVYDE®.

Once the doctor has prescribed ONIVYDE® (irinotecan liposome injection), the Patient Access Specialists at IPSEN CARES® can provide applicable patient coverage information, as appropriate, between the parent, caregiver, doctor’s office, insurance company, and specialty pharmacy. By serving as a central point of contact, IPSEN CARES® can help patients get started on treatment and provide support throughout the process.

Program Enrollment

Patients must be enrolled to access all IPSEN CARES® support offerings.

Our Patient Access Specialists will check each patient’s pharmacy and medical benefits to determine if the drug is covered for the indication the treating physician has specified. If there are any restrictions, IPSEN CARES® will provide the information required by the insurance company that the doctor may need to complete. A summary of all the information collected will be sent back to the doctor’s office in a single document, called Benefit Verification Results. Benefit verifications are usually turned around within 4 business hours upon receipt of the completed enrollment form and patient authorization.

Health care providers (HCPs) can help patients enroll in three ways:

  1. Through our online provider portal
  2. By printing a downloadable PDF to be filled out and faxed
  3. By calling the Patient Access Specialists at IPSEN CARES® at (866) 435-5677

Patients and Health Care Providers can also call IPSEN CARES® at (866) 435-5677

Patient Authorization

Patients are required to sign the ONIVYDE® Patient Authorization form every 12 months to give the Patient Access Specialists at IPSEN CARES® permission to access the patient’s personal health information in order to help with getting started on treatment. The form can be signed and submitted online, or by downloadable PDF, which must be printed, filled out, signed, and faxed.

Help with Copays?

Check for copay coverage. Considering that some patients need financial assistance, our copay assistance programs may help eligible* patients with their treatment.

The ONIVYDE® Copay Program for eligible, commercially insured patients is available by enrolling in IPSEN CARES®. Here is the key information:

  • Patients pay $0 per order for ONIVYDE® up to a maximum annual benefit
  • Copay assistance may be provided with up to a maximum annual benefit of $20,000 for the program year
  • For patients who have government-provided insurance (eg, Medicare, Medicaid, TRICARE) IPSEN CARES® may be able to offer the contact information for independent nonprofit foundations that may be able to offer financial assistance
Parents/Caregivers, Download and Print
Copay Flashcard
*Patient Eligibility & Terms and Conditions: Patients who are eligible to participate (i.e. prescriptions or coverage could be paid in part or in full) in any state or federally funded programs, including, but not limited to, Medicare or Medicaid, VA, DOD, or TRICARE (collectively, “Government Programs”) are not eligible for copay assistance through IPSEN CARES®. Patients residing in Massachusetts, Minnesota, Michigan, or Rhode Island can only receive assistance with the cost of Ipsen products but not the cost of related medical services (injection). Patients receiving free starter therapy through the IPSEN CARES® program are not eligible for the copay assistance program while they are waiting for insurance prescription coverage to begin. Patients receiving assistance through another assistance program or foundation, free trial, or other similar offer or program, also are not eligible for the copay assistance program during current enrollment year.For patients with commercial insurance who are not considered to be cash-pay patients, the maximum copay benefit amount per prescription is an amount equal to the difference between the annual maximum copay benefit of $20,000 and the total amount of co-pay benefit provided to the patient in the Onivyde® Copay Program for the 2018 calendar year. For cash-pay patients, the maximum copay benefit amount per prescription is $1,666.66, subject to the annual maximum of $20,000 in total. “Cash-pay” patients are defined for purposes of this program as patients without insurance coverage or who have commercial insurance that does not cover Onivyde®. Medicare Part D enrollees who are in the prescription drug coverage gap (the “donut hole”) are not considered cash-pay patients, and are not eligible for the copay benefit.Patient pays any amount greater than the maximum copay savings amount per prescription. Patient or guardian is responsible for reporting receipt of copay savings benefit to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled through the program, as may be required. Additionally, patients may not submit any benefit provided by this program for reimbursement through a Flexible Spending Account, Health Savings Account, or Health Reimbursement Account. Ipsen reserves the right to rescind, revoke, or amend these offers without notice at any time. Ipsen and/or Triplefin LLC, are not responsible for any transactions processed under this program where Medicaid, Medicare, or Medigap payment in part or full has been applied. Cash-paying patients are eligible to participate. Data related to your participation may be collected, analyzed, and shared with Ipsen for market research and other purposes related to assessing the program. Data shared with Ipsen will be de-identified, meaning it will not identify you. Void outside of the United States and its territories or where prohibited by law, taxed, or restricted. This program is not health insurance. No other purchase is necessary. Offer expires December 31, 2018.

BELOW IS ANOTHER WAY WE CAN PROVIDE ASSISTANCE

Free Medication

Uninsured patients may be eligible for free medication through our Patient Assistance Program. To qualify, patients must be: 1) uninsured, 2) US residents, and 3) meet income criteria.

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Important Safety Information for ONIVYDE® (irinotecan liposome injection)

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ONIVYDE can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include fever and infection associated with a low white blood cell count (neutropenic fever, neutropenic sepsis); diarrhea; lung problems (interstitial lung disease, a group of diseases which cause inflammation of the lung tissues leading to scarring); and reactions during administration of ONIVYDE (including anaphylactic reactions). The most common side effects which were seen in people with pancreatic cancer treated with ONIVYDE include: diarrhea, feeling tired, vomiting, nausea, loss of appetite, inflammation in the mouth, fever, and dehydration. When taking ONIVYDE, you may also have abnormal blood test results. The most common blood cell count change seen in ONIVYDE-treated pancreatic cancer patients is a reduction in the number of white blood cells, specifically lower lymphocytes and neutrophils (types of white blood cells), which are important for fighting infections.

Before you receive ONIVYDE, your healthcare provider will give you medications to decrease the potential for allergic reactions to infusion of ONIVYDE. You will also receive anti-nausea medicine to decrease nausea and vomiting, and, possibly, a medicine to decrease immediate diarrhea, called an anti-cholinergic.

What is ONIVYDE used for?

ONIVYDE is a prescription medicine used to treat pancreatic cancer which has spread to other parts of the body. ONIVYDE can be used in patients who have already received gemcitabine treatment for their pancreatic cancer. ONIVYDE is given in combination with 2 other medicines, fluorouracil (also known as 5-FU) and leucovorin (which is often abbreviated as LV), and is not given alone.

When should ONIVYDE not be given?

You should not receive ONIVYDE if:

  • you have had a severe allergic reaction to ONIVYDE or irinotecan HCl,
  • your white blood cell count is low (neutrophil white blood cell count below the level of 1,500 cells/mm3),
  • you have a fever and your neutrophil white blood cell count is low (also called neutropenic fever), or
  • you have a problem in your bowel that prevents food, fluids or gas from moving through your intestines.
Serious side effects may occur while taking ONIVYDE. Call or see your healthcare provider right away if you develop any of the following or if these get worse.
Serious side effects may include:
  • Infections (particularly if your white blood cells are low). Symptoms of infection may include fever, chills, dizziness, or shortness of breath. Blood cell counts will be monitored periodically by your healthcare provider during treatment.
  • Diarrhea. Symptoms of severe diarrhea may include persistent diarrhea; discolored stools (black, green or bloody); or symptoms of dehydration such as lightheadedness, dizziness, or faintness. Your healthcare provider may treat diarrhea with anti-diarrhea medicines (loperamide or atropine).
  • Lung problems (interstitial lung disease). Symptoms of interstitial lung disease include new onset of cough or difficulty breathing and fever.
  • Allergic reaction (hypersensitivity). Seek immediate medical attention for signs of severe reaction such as chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips when receiving or during the 24 hours after receiving ONIVYDE.
Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment with ONIVYDE. Your healthcare provider may also need to delay or completely stop treatment with ONIVYDE, if you have severe side effects.

  • The most frequent side effects resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and infection caused by low white blood cells (neutropenic sepsis).
  • The most frequent side effects requiring dose reductions of ONIVYDE were neutropenia, diarrhea, nausea, and low red blood cell count (anemia).
  • The most frequent side effects requiring dose interruption or delays of ONIVYDE were neutropenia, diarrhea, fatigue, vomiting, and low platelet counts called thrombocytopenia (platelets are important for clotting to stop bleeding).
Tell your healthcare provider about all the medicines you take, including:
  • prescriptions
  • over-the-counter medicines
  • vitamins
  • herbal supplements
Pregnancy and Nursing:

If you are a female, tell your healthcare provider if you are pregnant or plan to become pregnant. ONIVYDE can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 1 month after the last dose of ONIVYDE. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment with ONIVYDE. Before receiving ONIVYDE, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if ONIVYDE passes into your breast milk. Do not breastfeed during treatment with ONIVYDE and for at least 1 month after the last dose of ONIVYDE.

If you are a man, you should not father a child during your treatment with ONIVYDE. ONIVYDE can harm the unborn baby of your partner. You should use an effective method of birth control during and for at least 4 months after the last dose of ONIVYDE.

Click here for Full Prescribing Information, including Boxed Warning.

These are not all the possible side effects of ONIVYDE.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. To learn more, talk to your healthcare provider. You can ask your doctor or pharmacist for information about ONIVYDE that is written for health professionals, and it can be found at ONIVYDE.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Need immediate assistance?Call (866) 435-5677.

Our Patient Access Specialists are available Monday-Friday, from 8:00 AM to 8:00 PM ET (5:00 AM to 5:00 PM PT).

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