New York State Hepatitis C Coalition. Ending the Hepatitis C Epidemic in New York 2015 Policy Recommendations. Hepatitis C in New York the Facts

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1 New York State Hepatitis C Coalition Ending the Hepatitis C Epidemic in New York 2015 Policy Recommendations Hepatitis C in New York the Facts Hepatitis C virus (HCV) infection is the leading cause of serious liver disease in the United States. Untreated HCV can lead to cirrhosis, liver cancer or liver transplantation. It also increases the risk for heart disease, bone loss and difficulties with memory and concentration. Although the most serious consequences of HCV may take decades to manifest, earlier- stage liver disease may cause chronic pain, fatigue, and other symptoms that impact individuals quality of life. 1 At least 215,000 New Yorkers have chronic HCV infection, with half unaware of their status. 2 Among those who have been diagnosed, many lack consistent care or access to curative treatment, a fact that drives increasing HCV- related mortality. End- stage liver disease from HCV is a leading cause of death among PLWH. 3 Recent research from NYC has shown that on average people with HCV die 20 years earlier than uninfected people, and people who are coinfected with HCV and HIV die more than 25 years earlier. 4 Injection drug use is the leading risk factor for HCV; indeed new local outbreaks among young people have been identified alongside an increase in heroin use both across New York 5 and nationally. 6 Transmission among young injectors is a particular concern, with studies showing incidence of 10-35% per year. 7 Also of concern is the sharp rise in HCV infection among HIV- positive gay and bisexual men and other men who have sex with men (MSM); in the year 2000, 7% of HCV reports among people with HIV were MSM, while this percentage had tripled to 24% by the year As many as 30% of all people living with HIV (PLWH) in New York are HCV co- infected. 9 Nationally, an estimated 3.2 million people are living with chronic HCV, which now kills more people in the United States each year than AIDS. 10 Both in New York and the rest of the country, HCV- related mortality has risen steadily during the past decade. 11 With the recent FDA approval of a game- changing new generation of all- oral, highly effective, and easy to tolerate HCV drugs, we are finally at a moment where the epidemic can be controlled and eventually eradicated with the tools we have available. New York has already made important progress in responding to the epidemic. In 2013, the state passed the nation s first birth cohort- based HCV testing law for people born between 1

2 ( ), a strategy that CDC scientists have found identifies five times as many cases as previously used strategies. 12 The Department of Health s innovative Hepatitis C Care and Treatment Initiative has offered modest funding to 13 programs statewide to build capacity at hospitals and clinics. New York s more than 20 year history of support for syringe exchange and related harm reduction services, and its role in originating and expanding opioid agonist therapy for the treatment of opioid dependence, have influenced HIV, hepatitis, and drug services worldwide. Meanwhile, alongside the largest state- level HCV epidemic, New York has some of the most skilled medical providers, prevention specialists, researchers, and public health officials in the nation. But more can and must be done to leverage the therapeutic advances against HCV, and reduce transmission, morbidity, and mortality. New York has underinvested in HCV for decades, devoting a tiny fraction of funding for HCV compared to the smaller HIV epidemic, and placed severe restrictions on coverage for new HCV medications through Medicaid, which has led to treatment rationing. Underinvestment and withholding treatment for HIV/AIDS would be unacceptable and it should not be acceptable for HCV. Nationally, direct costs associated with HCV are expected to more than double to $85 billion a year within the next two decades, and to avoid following this projected trend NYS must act now to scale up its cost reduction strategies and HCV prevention efforts. New York must act now: long term costs associated with HCV can be significantly reduced by investing in HCV prevention, surveillance, and care and treatment infrastructure. The New York State Hepatitis C Coalition a group representing dozens of community- based health organizations recommends that Governor Cuomo and the New York State Legislature take the following actions: 1. Invest in scaling up prevention, care, and treatment infrastructure to end New York s Hepatitis C epidemic by increasing funding to $20 million. In December 2014, a group of 18 organizations now affiliated with the NYS Hepatitis C Coalition submitted a budget proposal to Governor Cuomo and legislative leadership, calling for a new $20 million investment in HCV prevention, care, and treatment. New funding would be phased in over a few years, with approximately half of the total peak funding intended as a short- term investment in care and treatment capacity that could be scaled back in the future. The proposal seeks to address critical gaps in the availability of HCV services, and is broken out into two major areas as follows: A. Build HCV care and treatment infrastructure and support local HCV surveillance. Despite the scale of the epidemic, state appropriations for the Department of Health s viral hepatitis programs have been flat- funded at less than $1.2 million for the past 5 years. As the 2

3 epidemic, and HCV- related mortality, continues to grow, there is an urgent need to support capacity building to augment the currently limited care and treatment workforce, and to build and link local HCV surveillance programs with these services, to inform resource allocation and health policy. New York State should increase funding for the Department of Health Viral Hepatitis programs to $12 million per year, which will allow an expansion of grant programs aimed at building the provider base, establishing or increasing local surveillance efforts, and improving access to testing, linkage to care, and care and treatment services, among other priorities. A significant proportion of the proposed appropriation would be time- limited: as care and treatment systems are scaled up, the need for front- end investment in capacity building will diminish. B. Fill gaps in HCV prevention services coverage by doubling state harm reduction funding from approximately $8 million to $16 Million, phased in over three years. Syringe exchange and wraparound services have been remarkably successful not only at reducing HIV and HCV incidence in New York, but in serving as a platform for engaging and linking individuals into care who are not typically reached or well- served by the medical system. Under the Affordable Care Act and NYS Medicaid Redesign system reforms, harm reduction services are essential for reaching a high need population and improving health while reducing costs. Comprehensive harm reduction services are more important now than ever, given increases in heroin and prescription opioid use, overdose deaths, and the hepatitis C epidemic, yet funding has been stagnant for years. New funds should be prioritized to fill geographic gaps based on indicators such as overdose, hepatitis C incidence, and drug- related hospitalization and drug treatment admissions. We propose increasing New York State funding for harm reduction services over a three year period, from the current approximately $8 million per year to $12 million, $14 million, and $16 million. 2. Fully Legalize Syringe Possession and Reform the Expanded Syringe Access Program (S Rivera/A Gottfried). Harm reduction programs, including syringe exchange and wraparound services, are the first meaningful point of contact many people who use drugs have with the healthcare system. These programs provide a step toward positive changes in their health and wellbeing often leading to less dangerous drug use or engagement in drug treatment. Harm reduction organizations in NYS are credited with reducing HIV and HCV transmission and overdose deaths, linking people to healthcare, including drug treatment, and saving the state many millions of dollars. Amid the increase in heroin and other injection drug use, now is the time to make sure that laws and other policies do not create barriers to these essential harm reduction services. First, 3

4 New York should repeal the criminal law on syringe possession: despite more than 20 years of legal syringe access programs, thousands of New Yorkers are still being arrested for syringe possession based on an outmoded, unnecessary law, a situation which creates fear and undermines service delivery. Second, the Expanded Syringe Access Program (ESAP) which allows nonprescription pharmacy syringe sales should be reformed to remove the limit of 10 syringes per transaction and allow basic program advertising subject to regulation. This proposal is a key recommendation of the Governor s Ending the AIDS Epidemic Task Force. A bill to enact the proposal was introduced in the legislature in January (S Rivera / A Gottfried), and the Governor s executive budget includes the ESAP provisions and a limited and inadequate approach to reforming the criminal law. The Governor and legislature should adopt the full syringe access reform proposal as part of the state budget Article VII health legislation. 3. Eliminate Medicaid coverage restrictions on new direct- acting anti- HCV drugs. The New York State Medicaid Drug Utilization Review Board (DURB) recently adopted guidelines for coverage of Sovaldi (sofosbuvir) and Harvoni (ledipasvir+sofosbuvir) for treatment of HCV infection. The DURB guidelines include restrictions that directly contradict treatment recommendations from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, by limiting Medicaid coverage to people with advanced liver disease, and instituting non- evidence- based restrictions on patient drug and alcohol use and criteria related to HIV viral load, and limiting qualified medical providers. As the AASLD/IDSA Treatment Recommendations state: [A]ll patients who receive advice from their doctor to take newest medications should not be denied. The decision across the board should be in the hands of the clinician and the patient to make the decision. Unfortunately payers across America are denying treatment when a doctor has prescribed it for their patient. We adamantly disagree with this decision. 15 The DURB guidelines should be revised to eliminate non- evidence- based barriers to HCV treatment. As with HIV, there are individual and public health benefits to treating HCV, and New York Medicaid should thus cover HCV treatment for as many people as possible. 4. New York State should negotiate discounts with HCV drug manufacturers, and seek to subsequently expand treatment coverage. Although market competition has begun to lower the price of new direct acting antiviral drugs for HCV, pricing remains a significant barrier to insurance coverage and treatment access. New York State should open negotiations with Gilead and AbbVie and other HCV drug manufacturers as new products come to market that are modeled on the successful 2014 negotiations with Gilead for their HIV drugs. The basic premises of this negotiation should be increasing discounts that match volume of treatment coverage, and that the State should not agree to exclusivity deals that limit treatment options for patients. Pharmaceutical 4

5 manufacturers will continue to profit, and their drugs will become available to every New Yorker on Medicaid at a price that does not place Medicaid in jeopardy of exceeding the State s global spending cap. 5. Require the Department of Corrections and Community Supervision and the Department of Health to establish HCV prevention programs in every state prison. (A Gottfried / S Montgomery). At least 7,300 New York State prisoners, or more than 13% of the prison population, are known to be living with HCV. Correctional facilities are a potentially high risk environment for transmission of HCV and other blood- borne diseases, but also afford unique opportunities for prevention, testing, and linkage to care and treatment. The Department of Corrections and Community Supervision should collaborate with the Department of Health to establish programs that include education, counseling, and other prevention efforts, including the distribution of condoms, in every correctional facility to prevent the spread of HCV, HIV, and other blood- borne and sexually transmitted infections. We urge lawmakers to pass legislation to this effect by supporting A4256 (Gottfried) / S1017 (Montgomery). Endorsing Organizations ACRIA ACT UP New York After Hours Project American Run To End AIDS (AREA) BOOM! Health Coalition on Positive Health Empowerment (COPE) End AIDS Now Harlem United Harm Reduction Coalition Health GAP Hepatitis C Mentor and Support Group (HCMSG) Hispanic Federation Housing Works Latino Commission on AIDS Long Island Minority AIDS Coalition (LIMAC) National AIDS Treatment Advocacy Project (NATAP) National Black Leadership Commission on AIDS (NBLCA) New York Harm Reduction Educators (NYHRE) Positive Health Project St. Ann s Corner of Harm Reduction Treatment Action Group VOCAL New York Washington Heights CORNER Project 5

6 References 1 Foster GR. Quality of life considerations for patients with chronic hepatitis C. Viral Hepat Sep;16(9):605-11; Karaivazoglou K Iconomou G, Triantos C, Hyphantis T, Thomopoulos K, Lagadinou M, Gogos C, Labropoulou- Karatza C, Assimakopoulos K.Fatigue and depressive symptoms associated with chronic viral hepatitis patients. health- related quality of life (HRQOL). Ann Hepatol Oct- Dec;9(4): Hart- Malloy R, Carrascal A, DiRienzo AG, Flanigan C, et. al. (August 2013). Estimating HCV Prevalence at the State Level: A Call to Increase and Strengthen Current Surveillance Systems. American Journal of Public Health, Vol. 103, No Pinchoff J, Drobnik A, Bornschlegel K, Braunstein S, Chan C, Varma JK, Fuld J. Deaths Among People With Hepatitis C in New York City, (2014). Clinical Infectious Diseases, Vol. 58, No Pinchoff J, Drobnik A, et. al. Deaths Among People With Hepatitis C in New York City, (2014). Clinical Infectious Diseases, 58(8). 5 Zibbell JE, Hart- Malloy R, Barry J, Fan L, Flanigan C. (2014). Risk Factors for HCV Infection Among Young Adults in Rural New York Who Inject Prescription Opioid Analgesics. American Journal of Public Health, Vol. 104, No Page K, Hahn JA, Evans J, Shiboski S, Lum P, Delwart E, et al. (2009). Acute hepatitis C virus infection in young adult injection drug users: a prospective study of incident infection, resolution, and reinfection. J Infect Dis Vol. 200, No Hahn JA, Page- Shafer K, Lum PJ, Bourgois P, Stein E, Evans JL, et al. (2002). Hepatitis C virus seroconversion among young injection drug users: relationships and risks. J Infect Dis, Vol. 186, No Drobnik A, Pinchoff J, Fuld J, Varma JK, Bornschlegel K, Braunstein SL, et al. (2013). HIV/Hepatitis C (HCV) Co- infection among Men who have Sex with Men (MSM) in New York City (NYC), IDSA, Oct 2-6, 2013 San Francisco, CA. 9 Taylor LE, Swan T, Mayer KH. (2012). HIV Coinfection With Hepatitis C Virus: Evolving Epidemiology and Treatment Paradigms. Clinical Infectious Diseases, Vol. 55 (suppl. 1). 10 Ly KN, Jian X, Klevens RM, Jiles RB, et. al. (2012). The Increasing Burden of Mortality From Viral Hepatitis in the United States Between 1999 and Annals of Internal Medicine, Vol. 156, No NYC Department of Health & Mental Hygiene. (2013). Hepatitis C in New York City: State of the Epidemic and Action Plan. New York, NY. 12 Smith BD, Yartel AK, Brown KA, Krauskopf K, Massoud OI, et. al. Effectiveness of Hepatitis C Virus (HCV) Testing for Persons Born during Summary Results from Three Randomized Controlled Trials. Presentation at the American Association for the Study of Liver Diseases conference, Nov. 11, El Khoury AC, Klimack WK, Wallace C, Razavi H. Economic Burden of Hepatitis C- Associated Diseases in the United States. J Viral Hepat (2012) Mar;19(3): Davis KL, Mitra D, Medjedovic J, Beam C, Rustgi V. Direct Economic Burden of Chronic Hepatitis C Virus in a United States Managed Care Population. J Clin Gastroenterol (2011) Feb;45(2):e17- e AASLD AASLD Position on Treating Patients with Chronic Hepatitis C Virus. Online at: position- treating- patients- chronic- hcv 6