YOUR GUIDE TO PATIENT SUPPORT SERVICES

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Stella Potter
6 years ago
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1 YOUR GUIDE TO PATIENT SUPPORT SERVICES Please see Important Safety Information About ONIVYDE (irinotecan liposome injection) on pages 6 7.

2 WHAT IS PROVYDE (ONIVYDE ACCESS SERVICES)? PROVYDE is a team of individuals established by Ipsen who can help you and your loved ones as you consider treatment with ONIVYDE (irinotecan liposome injection). HOW DO I GET STARTED? When you or your doctor submits the all-in-one Start Form, PROVYDE can assist you in a number of ways, including: Understanding your insurance coverage Researching available financial assistance options, and Providing useful information on additional support, including transportation assistance HOW WILL I KNOW IF MY INSURANCE COVERS TREATMENT WITH ONIVYDE? Coverage for ONIVYDE will vary by plan and by patient. PROVYDE can evaluate if your specific plan covers ONIVYDE and how much you will owe. $? WHAT FINANCIAL ASSISTANCE PROGRAMS DOES PROVYDE OFFER? PROVYDE can help you assess your eligibility for one of the 3 programs available: Free Drug Program Copay assistance - $0 copay program for commercially insured patients - Referrals to independent, nonprofit organizations 2 To determine your eligibility for financial assistance or for any other questions, please talk to your HCP or contact PROVYDE at , 8am 8p m ET, Monday Friday.

3 ? HOW DO I KNOW IF I M ELIGIBLE FOR ASSISTANCE? PROVYDE manages the free drug and $0 copay programs. See the table below for eligibility criteria. ELIGIBILITY CRITERIA Free Drug Program $0 Commercial Copay Program Uninsured/functionally uninsured* Commercially insured patients You are prescribed ONIVYDE for an FDA-approved indication You are prescribed ONIVYDE for an FDA-approved indication Treated in the US (including US territories) Treated in the US (including US territories) Meet income criteria * Functionally uninsured patients are those who may be enrolled in a health plan but do not have coverage for ONIVYDE. The commercial copay program is not available to patients covered by government-sponsored insurance such as Medicare and Medicaid. Please see Important Safety Information About ONIVYDE on pages

4 IF I HAVE COMMERCIAL INSURANCE COVERAGE, CAN I GET HELP WITH MY COPAY? The $0 copay program helps individuals pay for their eligible out-of-pocket drug expenses, including copays, co-insurance, and deductibles. PROVYDE can help you and your doctor through the application process. $ IF I HAVE MEDICARE OR MEDICAID, CAN I GET HELP WITH MY COPAY? PROVYDE can refer you to an independent, nonprofit organization and help you and your doctor through the application process. IF I HAVE NO INSURANCE COVERAGE, CAN I STILL GET TREATMENT? If you do not have health insurance coverage or enough insurance to pay for ONIVYDE (irinotecan liposome injection), you may qualify for the Free Drug Program. PROVYDE can help you and your doctor through the application process. $ + WHAT OTHER TYPE OF ASSISTANCE IS AVAILABLE? The nonprofit organizations also provide travel assistance for qualified patients. The assistance can be applied to a wide range of transportation needs, eg, public transportation to and from your doctor s appointments (including subway, bus, train, and taxi), gas, parking, tolls, etc. 4

5 ADDITIONAL SUPPORT FOR YOU AND YOUR CAREGIVER PROVYDE can refer you and your caregiver to independent, nonprofit organizations that offer a range of resources to both patients and caregivers, such as: Counseling Free support groups Education workshops led by experts in oncology Free booklets and fact sheets with information about the latest cancer treatments, managing side effects, and coping with cancer NOTES Please see Important Safety Information About ONIVYDE on pages

6 IMPORTANT SAFETY INFORMATION ABOUT ONIVYDE (IRINOTECAN LIPOSOME INJECTION) 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 antinausea 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/mm 3 ), 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). 6

7 IMPORTANT SAFETY INFORMATION ABOUT ONIVYDE (IRINOTECAN LIPOSOME INJECTION) CONT D 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. 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 fda.gov/medwatch or call FDA Please see Important Safety Information About ONIVYDE on pages

8 FIND ANSWERS TO THE FOLLOWING QUESTIONS INSIDE THIS BROCHURE: What is PROVYDE (ONIVYDE Access Services)? How do I get started? How will I know if my insurance covers treatment with ONIVYDE (irinotecan liposome injection)? What financial assistance programs does PROVYDE offer? How do I know if I m eligible for assistance? If I have commercial insurance coverage, can I get help with my copay? If I have Medicare or Medicaid, can I get help with my copay? If I have no insurance coverage, can I still get treatment? What other type of assistance is available? To learn more about PROVYDE, visit ONIVYDE.com. ONIVYDE is a registered trademark of Ipsen Biopharm Ltd. Please see Important Safety Information About ONIVYDE on pages Ipsen Biopharmaceuticals, Inc. All rights reserved. April 2017 ONV-US Hours: 8am 8pm ET, Monday Friday Phone: 844-ONIVYDE ( ) Fax: Mail: PO Box 4133, Gaithersburg, MD

INFORMATION ABOUT THERAPY WITH ONIVYDE (irinotecan liposome injection)

INFORMATION ABOUT THERAPY WITH ONIVYDE (irinotecan liposome injection) ONIVYDE is a prescription medicine used to treat pancreatic cancer, which has spread to other parts of the body. ONIVYDE can be used