OVERVIEW PROCESS SERVICES HARVONI. Simply on Your Side. Please see full Prescribing Information, including Patient Information.

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1 HARVONI Simply on Your Side. OVERVIEW PROCESS SERVICES

2 A breakthrough treatment with exceptional support Living with hepatitis C (Hep C) can come with a lot of uncertainty. But getting started with Hep C treatment and staying on track doesn t have to. HARVONI Support Path is here to help with live support before, during, and after treatment. OVERVIEW When I was ready, my Hep C Specialist and I chose HARVONI HARVONI is a breakthrough in Hep C therapy. In clinical trials, HARVONI was proven to cure 96 99% of adult patients with Hep C genotype 1 and no prior Hep C treatment with just 12 weeks of therapy.* Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed. The treatment regimen is one pill, once a day. It s that simple. And with HARVONI Support Path simply on your side, you will have the resources and support you may need. *In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without advanced liver disease (cirrhosis), 99% (210 out of 213) of those who received HARVONI once daily for 12 weeks were cured. In a separate study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 96% (208 out of 216) of those who received HARVONI once daily for 12 weeks were cured. What is HARVONI? HARVONI is a prescription medicine used to treat chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 4, 5 or 6 infection. It is not known if HARVONI is safe and effective in children under 18 years of age. What should I tell my healthcare provider before taking HARVONI? If you have: liver problems other than hepatitis C infection; severe kidney problems or are on dialysis; HIV, or any other medical condition; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. 3

3 OVERVIEW Support made simple HARVONI Support Path does more than help you get started on treatment. It helps you stay on track with your therapy too. It s here to make the process of getting support simpler for you. With just a call or click, you could be up and running. HARVONI Support Path is here to help by making these resources available to you: Live specialists to help you navigate insurance coverage and walk you through financial assistance options Nurses on call to answer any questions you may have about HARVONI Tips and tools that can help you get started and monitor your progress during treatment Financial Assistance This guide is designed to help you get started It contains useful information to help you access the support and resources you may need. With clearly tabbed sections, it s easy to learn more about: The HARVONI treatment process the steps you and your Hep C Specialist may go through to get started and stay on track with HARVONI All the ways HARVONI Support Path can help including live support for potential financial assistance and insurance navigation, and multiple tips and tools to monitor your progress Also included is a checklist to help you prepare for, and get the most from, your call with a HARVONI Support Path specialist. At the very end is a glossary that explains some of the more unfamiliar medical and insurance terms words and phrases highlighted in BLUE used throughout the brochure. Whether you are considering or have begun treatment with HARVONI, HARVONI Support Path is simply on your side. HARVONI Simply on Your Side. If you have questions during the prescription process, or at any time before, during, or after treatment, call your Hep C Specialist or HARVONI Support Path at MYPATH ( ) Live Support, Treatment Tips & Tools Insurance Support 5

4 Simply on your side throughout the HARVONI treatment process You are prescribed HARVONI HARVONI Treatment Process Results date With every step you take toward treating your Hep C, HARVONI Support Path is here to help you understand the treatment process and provide support along the way. Rx Insurance approval:* 3 4 weeks 12 weeks of treatment: Treatment duration is 12 weeks for most patients who have not had prior treatment Post-treatment follow-up: 3 months The diagram to the right shows the steps you and your Hep C Specialist may go through to get started with HARVONI. Please note that the diagram is only intended to show how the process typically works. Your individual experience may vary based on a number of other factors. This is when you find out if your insurance company approves your prescription and what your financial assistance options may be. HARVONI prescriptions are usually filled one month at a time. Some health plans may require blood tests at certain points to see how you re responding to treatment. HARVONI Support Path will be just a phone call away while you wait to see if you are cured. Please take your time and carefully read through this guide. It will help you understand the resources HARVONI Support Path can provide to help support your treatment. From explaining financial assistance options to navigating the insurance approval process to offering the extra help you may need to reach your treatment goals, you can call on HARVONI Support Path. * Insurance approval, also known as prior authorization, is a step that some insurance companies require before they decide if they are going to pay for your medicine. Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed. PROCESS What should I tell my healthcare provider before taking HARVONI? (continued) Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects. Tell your healthcare provider if you take any medicines containing tenofovir disoproxil fumarate (ATRIPLA, COMPLERA, STRIBILD, TRUVADA, VIREAD ). What are the possible side effects of HARVONI? HARVONI, when taken with amiodarone (Cordarone, Nexterone, Pacerone ), a medicine used to treat certain heart problems, may cause serious side effects, including slow heart rate. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems. The most common side effects of HARVONI include tiredness, headache and weakness. 7

5 Exploring your financial assistance options It was reassuring to learn I had options Some patients may need financial assistance to help reduce out-of-pocket costs that come with treatment. HARVONI Support Path specialists will work with you to understand your financial situation and evaluate potential assistance options for you, such as: PROCESS Co-pay Coupon Those who are eligible may pay no more than $5 per co-pay. Most people with private insurance are eligible for the co-pay coupon. You are not eligible if you are enrolled in a government healthcare prescription drug program such as Medicaid or Medicare Part D (including when you are in the coverage gap known as the donut hole ). If you are eligible, the HARVONI co-pay coupon program will cover the out-of-pocket costs of your HARVONI prescriptions up to a maximum of 25% of the catalog price of a 12-week regimen of HARVONI. Other Financial Assistance If you are enrolled in a government healthcare prescription drug program, do not have insurance, or have private insurance that does not cover HARVONI, other financial assistance may be available. HARVONI Support Path specialists can research and answer questions about potential alternate funding and patient assistance options. These may include independent third-party foundations, and local, county, state, and federal programs. Referral to a foundation or public program does not guarantee that you will receive financial assistance. Each organization has its own requirements and application process. To learn more, call MYPATH ( ) or visit HARVONI.com/support SERVICES 9

6 Get help navigating your insurance coverage The insurance approval process can be difficult and timeconsuming. HARVONI Support Path helps simplify the process with live specialists who can help you navigate insurance coverage issues. They can help even before you re prescribed HARVONI! A HARVONI Support Path specialist helped explain the insurance approval process They ll start by researching and making sure what your health insurance benefits are. This is called a benefits investigation. Then, they ll explain your medication coverage what type of plan you have, what is and isn t covered, and how much your deductible is, if you have one. They can do this for you before you get a prescription. SERVICES HARVONI Support Path specialists will also explain the insurance approval process (also known as prior authorization). Your insurance company needs to approve your prescription for HARVONI before you can receive your medication. This process can take 3 to 4 weeks. To learn more, call MYPATH ( ) or visit HARVONI.com/support If you don t get approved at first, don t be discouraged. Many prescriptions are denied for something as simple as missing information. HARVONI Support Path specialists can provide information about the appeals process and explore other options that may be available to you. Remember, HARVONI Support Path specialists are available to support you. After you re approved, it could take 2 more weeks to receive your medication. If you have any questions during this time or any other, don t hesitate to call a HARVONI Support Path specialist. 11

7 Extra help is here if you need it You never know when you may need a little extra help. So it s good to know that HARVONI Support Path will be there when you do to answer your questions. Knowing support was available made all the difference 24/7 Live Nurse Support is available (including holidays) to answer questions about HARVONI that you may have. Some commonly asked questions include:? What are the most common side effects??? Can I take HARVONI with other medicines? How will I know if it s working? A HARVONI Support Path specialist can provide ongoing support. They will explain the treatment delivery, which is usually through a specialty pharmacy, and the process for refilling your prescription. You ll usually be written a prescription with refills instead of a full course of therapy. We can send you reminders to request refills with plenty of time to spare. They will explain why your doctor may perform blood tests during treatment to see how you re progressing. To learn more, call MYPATH ( ) or visit HARVONI.com/support 13

8 HARVONI Support Path is here for you Whether you re thinking about treatment, making plans to speak to a specialist about HARVONI, exploring insurance coverage, or on treatment, look to HARVONI Support Path for resources to support you throughout the treatment process. Sign up to receive tips and tools delivered how and when you need them, including: Tips on managing your health Tools to help you get the most from partnering with your healthcare team Information on what to expect during the treatment process Motivational stories from other patients Tips Tools Information Motivational stories To sign up, visit HARVONI.com/support or call MYPATH ( ) 15

9 You re ready to call a HARVONI Support Path specialist It s helpful to know and understand your insurance coverage for your medication. Changing circumstances may affect your coverage, such as when you start a new job, enroll in a new healthcare plan during open enrollment, or start a new calendar year. That s why it s important to know your medication coverage with an investigation of your benefits before you begin treatment. Follow the checklist provided below. Information you ll need to provide when you call HARVONI Support Path Your name and address Name and address of your prescribing doctor Your Pharmacy Benefit Card Your Medical Benefit Card Steps to investigating your medication coverage Call HARVONI Support Path at MYPATH ( ) Inform the HARVONI Support Path specialist that you want to complete a benefits investigation Questions to ask during the follow-up phone call Does my insurance cover HARVONI? Yes / No Is my prescription drug coverage private or government sponsored? Do I have a deductible? Yes / No If yes, how much is it? Am I eligible for the co-pay coupon? Yes / No Am I eligible for foundation assistance? Yes / No What is my total out-of-pocket expense for this medication? If you are uninsured or learn from your benefits investigation that your insurance does not cover HARVONI, alternate funding and patient assistance options may be available. Please discuss these options with a HARVONI Support Path specialist. Call MYPATH ( ). Notes regarding my medication coverage: Provide the HARVONI Support Path specialist with the required information (noted above) Receiving the results of your investigation You will receive the results of your benefits investigation in a follow-up phone call from HARVONI Support Path within 24 to 48 hours Your prescribing doctor will receive a written benefits investigation summary via fax within 48 hours 17

10 Glossary of terms used in this brochure Here are some helpful definitions of terms used in this brochure. If they re not familiar, don t worry. Many of these terms can seem like a foreign language. If you still have questions, call one of our live support specialists. Catalog price: The cost of the medication to a company that distributes pharmaceutical and medical products. This is also known as the Wholesale Acquisition Cost (WAC). Co-pay: The amount you have to pay out-of-pocket to receive a medication. Donut hole : The donut hole refers to a gap in prescription drug coverage under Medicare Part D. Out-of-pocket costs: Expenses for medical care or prescriptions that aren t reimbursed or paid for by your insurance. Private insurance: Privately funded health insurance usually provided through an employer or paid for by an individual. It is not funded by the government (ie, Medicare, Medicaid). Specialty pharmacy: A pharmacy that provides medications that have special delivery, storage, or administration requirements, and delivers medicine directly to patients by U.S. mail or a delivery service. Insurance approval or prior authorization: A step that some insurance companies require before they decide if they are going to pay for your medicine. Medication coverage: Medication(s) that your health plan pays at least part of the cost for at some time during the year. Your health plan maintains a formulary, which is a list of the drugs the health plan provides. Open enrollment: The period of time during which individuals who are eligible to enroll in a qualified health plan can enroll in a plan. To learn more, call MYPATH ( ) or visit HARVONI.com/support HARVONI, the HARVONI logo, COMPLERA, STRIBILD, TRUVADA, VIREAD, SUPPORT PATH, the SUPPORT PATH logo, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners Gilead Sciences, Inc. All rights reserved. HVNC /15 19