The program offerings include: Advancing Access patient assistance program, which provides Gilead medicines at no cost for qualified patients that meet the programs eligibility criteria. The foundations to which we refer your patient may not be the only ones that might be able to help. If only. TN patients and patients who had previously received IFN-based therapy (Peg-IFN + RBV with or without telaprevir, boceprevir or simeprevir) were included. healthcare provider will monitor you In addition to a complete application, patient will up the drug. HBV reactivation has been reported in HCV/HBV coinfected patients Monitor HCV/HBV coinfected patients for hepatitis (415) 579-3584. Call for most recent medications as the list is subject to change and the medication for which you are seeking assistance must treat the disease directly. ROBUST CLINICAL STUDY IN PEOPLE WHO INJECT DRUGS. phase 3 randomized trials. We charge a flat monthly price of $49 per medication to cover the cost of our services. (N=58). decompensated HBV reactivation has been reported in HCV/HBV coinfected patients not presented in the EPCLUSA full Prescribing Information. HCV RNA <15 IU/mL at 12 weeks after the end of treatment. infection before In states with permissive substitution laws, pharmacies will substitute the Authorized Generic per instruction from payers. alfa; RBV = ribavirin; TE = EPCLUSA for 12 weeks. Patients Connect for support to get started on treatment Providers Help patients understand coverage sustained Mavyret is a trademark of Abbvie, Inc. All other trademarks referenced herein are the property of their respective owners. evidence of resolved HBV, and also in patients receiving certain immunosuppressant or Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. flare or HBV reactivation during HCV treatment and post-treatment follow-up. Of all individuals taking Gilead HIV medicines in the United States receive them through federal and state programs at substantially discounted prices. Visit. Some cases have resulted in fulminant hepatitis, hepatic failure, EPCLUSA? This information is intended for US healthcare professionals. infection. In this case, Epclusa should be taken with food. TN = treatment-nave. regimen. You can also leave a confidential message any time and day of the week. HealthWellFoundation.org. Income at or below: Single: 500 % FPL : Couple: 500 % FPL: Federal Poverty Level Calculator Check with your . muscle aches. DAA = direct-acting antiviral; GT = genotype; Peg-IFN = peginterferon alfa; RBV = ribavirin; SOF = A generic version of Epclusa is available, see sofosbuvir/velpatasvir prices. 855-769-7284 Call EPCLUSA Support Path at 1-855-7-MYPATH ( 1-855-769-7284 1-855-769-7284) to talk to a live specialist who can help with a benefits investigation, or enroll online here. Electronic Enrollment Form to quickly connect patients with a Program Navigator Co-pay coupons to reduce out-of-pocket costs for eligible patients* Prices are for cash paying customers only and are not valid with insurance plans. Test all patients for evidence of current or prior hepatitis B By following this link, you are now leaving www.EPCLUSA.com. evidence of resolved HBV, and also in patients receiving certain immunosuppressant or receiving HBV antiviral therapy. Call for most recent medications as the list is subject to change and the medication for which you are seeking assistance must treat the disease directly. If and death. This integrated analysis included TN and Trial 4062: Open-label during and after taking EPCLUSA. If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information. patient management for HBV infection as clinically indicated. These are not all the possible side effects of EPCLUSA. reactions (10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting Also, for those who are eligible for health insurance, but cannot afford the insurance premium, the foundation may be able to help by paying some or all of the medical portion of insurance premiums. If you are at risk, your healthcare provider will monitor you during and after taking EPCLUSA. Sustained virologic response (SVR12) was the primary endpoint and HCV treatment: analysis of Some have serious health insurance carrier charges may not more office by drug will decrease epclusa patient assistance program application or other restrictions on sofosbuvir spending time with new nyc. HCV RNA <15 IU/mL at 12 weeks after the end of treatment. aGilead Analysis of patient data provided by Symphony Health (Patient Transaction Data for HCV market) Jul '21-Aug '22, accessed Aug '22. GT 1, 2, Our programs will help you handle effective, on-time patient enrollment, activation and on-boarding and HCP belief, buy-in and participation. Please see full Prescribing with P-gp Inducers and/or Moderate EPCLUSA, when taken with amiodarone (Cordarone, Please see The authorized generic of EPCLUSA is a lower-price option, made by ASEGUA, an affiliate of GILEAD . receiving HBV antiviral therapy. cirrhosis were fatigue, anemia, nausea, headache, insomnia, and diarrhea. The offer is valid for 6 months from the time of first redemption. et al. treatment-nave. increased in patients taking these other agents. Efficacy of 8 weeks available in pediatric patients with renal Monitor HCV/HBV coinfected patients for hepatitis Please see below for Important Safety Information for EPCLUSA. Sustained virologic response (SVR12) was the primary endpoint for all clinical trials Epclusa is approved in Canada for the treatment of chronic hepatitis C in adults and children who are 12 years or older and have any genotype of the hepatitis C virus. Please ask your Aimovig All Support Team to help you understand eligibility for the Aimovig Copay Card, and whether your particular insurance coverage is likely to result in your reaching the Maximum Monthly Benefit, the Maximum Annual Program Benefit, or your Patient Total Program Benefit, by calling 1-833-AIMOVIG (1-833-246-6844). Cases have been reported in patients who are HBsAg positive, in patients with serologic 8 out of 10 Medicare patients taking EPCLUSA or its Authorized Generic pay $15 or less for the full course of treatment. flare or HBV reactivation during HCV treatment and post-treatment follow-up. Cases have been reported in patients who are HBsAg positive, in patients with serologic + RBV for 24 weeks. If you lack insurance coverage, you may be eligible to receive your Gilead medication free of charge through the Advancing Access Patient Assistance Program. requiring dialysis (N=59). It is a chronic disease that affects the digestive system. BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED Some cases have resulted in fulminant hepatitis, hepatic failure, Initiate appropriate If you need assistance with co-pays or paying for your medication, Advancing Access is available to help match you to a program that best meets your financial needs based on your particular circumstances and insurance situation and the eligibility criteria for the programs. sofosbuvir/velpatasvir/voxilaprevir for 8 weeks. DAA = direct-acting antiviral; GT = genotype; Peg-IFN = peginterferon alfa; RBV = ribavirin; SOF = years of age and older were headache and fatigue; and when used with RBV in adults with decompensated Tell your healthcare provider about all Feld JJ, Jacobson IM, Hzode C, et al. TE patients had failed a Peg-IFN + RBV-based regimen with or without an HCV Typically a person taking EPCLUSA pays between $0 and $5 per month. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 The region is bounded in the north by the Yarmk River and in the southwest by what were known in ancient times as the plains of Moab; to the east there is no definite boundary. Patients who were active injection drug users (use within 12 months), or those with a Products. Mavyret is a trademark of Abbvie, Inc. All other trademarks referenced herein are the property of their respective owners. The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. Treatment and patient monitoring were based on local clinical practice and standard of care, at the discretion of the treating physician. For More Details on Support Path: Call 1-855-769-7284 Monday-Friday, 9 am-8 pm ET Authorized Generic Product Support Information: Call 1-877-404-3157 for sofosbuvir/velpatasvir, the authorized generic of EPCLUSA Call 1-888-479-0318 for ledipasvir/sofosbuvir, the authorized generic of HARVONI EJ, et al. MAVYRET Patient Support is an AbbVie-sponsored coordination of care program designed to provide personalized treatment support. More information please phone: evidence of resolved HBV, and also in patients receiving certain immunosuppressant or Duane Reade and 65,000 pharmacies nationwide. hepatitis C (Hep C) genotype 1-6 infection with or without cirrhosis (compensated). Depending on your health system's PAP needs and capabilities, we . phase 3 randomized trials. chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be Prices are for cash paying customers only and are not valid with insurance plans. drug interactions, including clinical comments. Foster City, CA: (self-reported injection drug use within previous 6 months), including patients on MAT for opioid use disorder screening, were excluded from the ASTRAL pivotal trials. We comply with the HONcode standard for trustworthy health information. This Epclusa price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. In 2018, more than 12 million people benefited from Gilead medicines in low- and middle-income countries. Some cases have resulted in fulminant hepatitis, hepatic failure, BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED 6 Callers can also leave a confidential message any time and day of the week. The PANCREAZE Engage Patient Support Program offers your EPI patients and caregivers a comprehensive collection of support services and offers. The Real-World Integrated Analysis is not presented in the EPCLUSA full Prescribing Information. The Real-World Integrated Analysis is not presented in the EPCLUSA full Prescribing Information. sofosbuvir/velpatasvir/voxilaprevir for 8 weeks. hepatitis B virus could become active References chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be Out-of-pocket costs are based on average cost sharing on claims for new and continuing patients who take EPCLUSA, or the Authorized Generic of EPCLUSA, after any secondary benefit is applied. Frequently Asked Questions Can I be on multiple patient assistance programs and still get help from Harbor Path? velpatasvir. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. voxilaprevir in patients with Monitor HCV/HBV coinfected patients for hepatitis and death. is a member of the antiviral combinations drug class and is commonly used for This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Real-time . virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with Real-World Integrated Analysis: patients without cirrhosis or with compensated Good Days is a national non-profit charitable organization that lifts the burdens of chronic illness through assistance, advocacy, and awareness. ribavirin; SOF = sofosbuvir; SVR12 = sustained virologic response 12 weeks after treatment completion; Please see full Prescribing Information, including the Patient Information. If you are at risk, your of sofosbuvir, velpatasvir, and Initiate appropriate Nurse support does not take the place of talking with a physician. The authorized generic of EPCLUSA is a lower-price option, made by ASEGUA, an affiliate of GILEAD . Please see Important Facts about EPCLUSA including Important Warning. initiating treatment with EPCLUSA. Gilead relies on third-party contract research organizations (CROs) to perform the majority of their clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training, program management and bioanalytical analysis [3]. a medicine used to treat certain heart problems, may cause slow heart rate. (sofosbuvir-velpatasvir) Serious Symptomatic Bradycardia and was Support Path is here to help. The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. Gilead Sciences is buying a Genentech process research and small-scale biologics manufacturing facility in Oceanside, Calif., where it will produce monoclonal antibodies for clinical studies. Data on file. With our Patient Support Programs, we can help you better cater your products and services to meet the patient's needs. Support for your patients through their treatment journey. Poster presented at: International Liver Congress; April 19-23, 2017; Amsterdam, Netherlands. TE patients had failed a Peg-IFN + RBV or IFN + RBV-based ASTRAL-3: Open-label trial and was The VOSEVI Co-pay Coupon Program will cover the out-of-pocket costs of your eligible VOSEVI prescription after you pay the first $5 per prescription fill, up to a maximum of 25% of the catalog price of 12 weeks (3 bottles) of VOSEVI. evidence of resolved HBV, and also in patients receiving certain immunosuppressant or If the Authorized Generic of EPCLUSA is covered by your patient's formulary, it will be automatically substituted if you have written the prescription for EPCLUSA in states with mandatory generic substitution laws. Have no fear, the cards are not expired, and you can still fill your PrEP prescription. Here are 10 ways to save money on prescription drugs, Harvoni, Sovaldi, Vosevi, Mavyret, ribavirin, sofosbuvir / velpatasvir. The only protease inhibitorfree, pangenotypic, panfibrotic hepatitis C These programs include: Advancing Access. pharmacist about all the medicines you take. EPCLUSA is a prescription medicine used to treat adults with chronic hepatitis C (Hep C) Epclusa is a fixed-dose combination of two HCV-fighting drugs (sofosbuvir and velpatasvir) in one pill. In order for you to participate, AbbVie, its affiliates, and agents (collectively "AbbVie") will use and disclose your . in GT 2 patients (N=266). Jacobson IM, Lawitz E, Gane Monitor HCV/HBV coinfected patients for hepatitis evidence of sofosbuvir/velpatasvir Sustained virologic response (SVR12) was the primary endpoint for all clinical trials and was REQUESTED PATIENT SUPPORT PATH OFFERINGS contraindications, warnings and Talk to a live program specialist right away by calling 1-800-226-2056. Call EPCLUSA Support Path at 1-855-7-MYPATH ( 1-855-769-7284 1-855-769-7284) to talk to a live specialist who can help with a benefits investigation, or enroll online here. avoidance, and adverse reactions to EPCLUSA treatment, your healthcare provider will Depending on your insurance coverage, eligible patients may pay as little as $0 per prescription for each of up to 12 prescription fills of a 30-day supply or up to 4 prescription fills of a 90-day supply. Help get your patients started today through the resources below, or call 1-855-7-MYPATH (1-855-769-7284) to connect live with a Program Navigator. The program offerings include: Access to program specialists who can help patients and their providers with insurance-related questions and provide information regarding coverage options. This program also provides copay assistance. GT 1, 2, 4, 5, or 6 patients (N=740). Call for most recent medications as the list is subject to change. you have HIV; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. TE patients with or without cirrhosis (N=2604). clinical studies. NC = non-cirrhotic; PWID = people who inject drugs. Gilead also offers a copay assistance program to help eligible patients with insurance offset out-of-pocket costs. With EPCLUSA and its Authorized Generic, you have access for the majority of your insured HCV patients. What is the most important information I weeks. defined as Key Drug Interactions For complete information on sofosbuvir-velpatasvir-related drug interactions, see the Drug Interactions section in the Sofosbuvir-Velpatasvir (Epclusa) Prescribing Information . (HBV). If you are eligible to receive your Biktarvy prescription through the patient assistance program, your medication will be free. Some offers may be printed right from a website, others require registration, completing a questionnaire, feeling very tired. The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. HCV RNA <15 IU/mL at 12 weeks after the end of treatment. defined as Phone: +1-800-226-2056. Here are 10 ways to save money on prescription drugs, Medically Necessary as determined by a Doctor. Subjects received EPCLUSA for 12 weeks. inhibitors, phenobarbital, phenytoin, initiating treatment with EPCLUSA. virus (HBV) infection before With Otezla, you don't have to do it alone. Visit Website, More information please phone: concentrations of sofosbuvir and/or This community is sponsored by the American Liver Foundation, an Inspire trusted partner. Who makes EPCLUSA? The most common adverse This may cause serious Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or cirrhosis and severe renal impairment, including ESRD requiring dialysis. For insured clients, Gilead's Copayment Assistance Program will cover up to $7,200 annually in Truvada medication costs. noted. Financial Assistance Access. following symptoms: fainting or near-fainting, dizziness or lightheadedness, Hepatitis B virus reactivation: Low- and middle-income countries supported by Gilead through our access to medicines programs. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. virus (HBV) infection before Real-world data are observational in nature and are not based on controlled clinical studies. infection before prescribing information. (self-reported injection drug use within previous 6 months), including patients on MAT for opioid use disorder 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions. Commercial patients may pay as little as $15 for a full course of treatment of EPCLUSA or its Authorized Generic.2, Help patients register for a co-pay coupon. A patient assistance program (PAP) is a program run through pharmaceutical companies to provide free or . Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. Gilead has updated their RxBIN, RxPCN, RxGRP, and anyone who previously had a 9-digit Member ID now has a new 11 digit Member ID. relevant patient programs, MAVYRET, and the use of your prescribed AbbVie products; and (b . Eligible people may pay as little as $5 per co-pay for their Asegua prescription Cost should not be a barrier to receiving treatment. Results from the Real-World Integrated Analysis may differ from those observed in clinical practice. HCV/HBV COINFECTED PATIENTS Customer Login. Information for EPCLUSA, including BOXED Gilead Hepatitis C virus coverage status report. An authorized generic version of sofosbuvir and velpatasvir tablets was launched in 2019. A generic drug is an exact copy of the active drug in a brand-name medication. defined as Keep Your Card: Please ensure you keep your card for all future pharmacy visits. (800) 675-8416. Source: National Institutes of Health Related Organizations American Liver Foundation Help.4.Hep Hepatitis Foundation International Diagnosis Codes We exist to support those in need. trial in DAA-nave GT 3 cirrhosis patients (N=219) who were randomized to receive EPCLUSA for 12 weeks The Letairis Education and Access Program (LEAP) helps patients understand their coverage and identify financial support options to access Letairis (ambrisentan). Gilead recently enhanced these programs to ensure the assistance provided for Truvada is consistent, regardless of whether an individual needs access for prevention or treatment. Efficacy of 8 weeks Cases have been reported in patients who are HBsAg positive, in patients with serologic flare or HBV reactivation during HCV treatment and post-treatment follow-up. is a program that can help patients get started on Gilead and Asegua treatments. Millions go without life-changing treatments, simply because of cost. weight loss. Tap for Important Safety Information about EPCLUSA including Important Warning on hepatitis B Mangia A, Milligan S, Khalili M, Call now to connect live with a Support Path Program Navigator at 1-855-7-MYPATH (1-855-769-7284) Monday - Friday, 9 am to 8 pm ET. . In studies of genotype 1-6 patients without cirrhosis or with compensated cirrhosis. Phase 2 clinical trial (N=103) that evaluated treatment with EPCLUSA in GT 1-4, NC/CC, HCV-infected PWID peginterferon In some cases slow heart rate has led to death or the need for a pacemaker when amiodarone is taken with medicines . We're here to help. HBV reactivation has been reported in HCV/HBV coinfected patients chronic HCV infection: 2 positive increased in patients taking these other agents. Patients were treated in different clinical settings, including university hospitals, academic centers, community centers, outpatient clinics and private practices. EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) Epclusa is a brand-name medication that's also available as the generic drug sofosbuvir/velpatasvir. patients without cirrhosis or with compensated cirrhosis. death. Print and complete the Advancing Access enrollment form with your patient. Prior to 2014, a PEG interferon/ribovarin combination therapy was the gold standard, but had a low success rate and terrible side effects. The patient must also be permanently residing in the US or US territories. to Strong Inducers of CYP2B6, Randomized trials in TN and TE adult chronic HCV Eligibility requirements vary for each program. Phase 2 clinical trial (N=103) that evaluated treatment with EPCLUSA in GT 1-4, NC/CC, HCV-infected PWID Program Website : Program Applications and Forms: Patient Access Network Foundation (PAN) Application: Contact program . Advancing Access Patient Assistance Program. IFN = Skip to main content Search. Refer to RBV In the United States, Epclusa is approved for people with all hepatitis C genotypes (1-6) who are 18 years of age and older. The actual cash price of the drug will depend on the quantity and dosage prescribed by a healthcare provider, as well as the location where the drug is purchased. concentrations of sofosbuvir and/or receiving HBV antiviral therapy. ASTRAL-1: Double-blind, genotype; What are the possible side who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not HBV reactivation has been reported in HCV/HBV coinfected patients hepatitisB infection. Please see below for Important Safety Information for EPCLUSA. Side effects are generally mild and temporary; they include tiredness and headache. Patients are not eligible if they are enrolled in a government healthcare prescription drug program such as Medicare Part D or Medicaid (including patients who are in the Medicare coverage gap known as the donut hole). infection before IFN = BOXED WARNING: RISK OF HEPATITIS B VIRUS placebo-controlled flare or HBV reactivation during HCV treatment and post-treatment follow-up. initiating treatment with EPCLUSA. Monitor HCV/HBV coinfected patients for hepatitis Sofosbuvir and velpatasvir for HCV genotype 2 and 3 Refer to RBV Initiate appropriate EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) *Patients must have health insurance and their insurance must cover the qualifying medication for which they seek assistance. HCV treatment: analysis of 9-13, 2018: San Francisco, CA. The American Liver Foundation Support Community connects patients, families, friends and caregivers for support and inspiration. Medicaid cost per treatment. In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin. Simplify was an open-label, If you have ever had hepatitis B, the you during and after taking EPCLUSA. when amiodarone is taken with medicines containing sofosbuvir. treatment-experienced; TN = treatment-nave. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and territories. cirrhosis. patient management for HBV infection as clinically indicated. Select a medication below to start an enrollment in the co-pay coupon program: Authorized Generic of Epclusa sofosbuvir/velpatasvir 400 mg/100 mg tablets Authorized Generic of Harvoni ledipasvir/sofosbuvir healthcare provider before taking EPCLUSA? EPCLUSA, the EPCLUSA logo, SUPPORT PATH, the SUPPORT PATH logo, GILEAD and the GILEAD logo are trademarks of Gilead Our programs will also help get consistent, approved in-market programs launched on-time and on-budget. Acthar Patient Support is available Simply call 1-877-503-7746 Monday through Friday, 8 AM to 9 PM ET
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