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In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)

Published:November 24, 2018DOI:https://doi.org/10.1016/j.amjmed.2018.10.031
      Recent advances in hepatitis C virus (HCV) treatment could be described as revolutionary: for uncomplicated patients, treatment is nearly 100% effective, oral only, has a low pill burden, minimal side effects, and results in a cure.
      • Asselah T
      • Marcellin P
      • Schinazi RF
      Treatment of hepatitis C virus infection with direct‐acting antiviral agents: 100% cure?.
      Comparisons we have heard from clinicians are that HCV is now easier to treat than either diabetes or hypertension. Unfortunately for many patients, their state of residence is the decisive factor for whether they will receive lifesaving treatment. As part of a tribal telehealth network for HCV, we support several rural clinics successfully treating HCV and see this dilemma all too frequently.
      Consider a patient with chronic HCV infection who presents with a recent history of marijuana use and has been late picking up hypertension medication. The patient has cirrhosis and is at high risk of HCV-related mortality. He is enrolled in state Medicaid and highly motivated for treatment. What is the treatment plan? It depends on the state. A resident of New Mexico can start treatment without delay. If instead the patient lives in Montana, a state that determines treatment eligibility based on advanced liver fibrosis, documented sobriety, and compliance with existing medications, the consultation is effectively moot; treatment will be denied. Montana is far from alone in its HCV treatment restrictions. Patients in South Dakota, Nebraska, and several other states we serve face similar hurdles (see Figure).

      Mountain-Pacific Quality Health. Montana Medicaid prior authorization request for hepatitis C treatment. Available at: https://medicaidprovider.mt.gov/Portals/68/docs/forms/HepatitisCTxPAFormRevised10172016.pdf. Accessed November 27, 2018.

      New Mexico Human Services Department. Uniform New Mexico HCV checklist for centennial care. Available at: http://www.hsd.state.nm.us/providers/uniform-new-mexico-hcv-checklist-for-centennial-care-revision-date-12-15-2017.pdf. Accessed November 17, 2018.

      Hepatitis C State of Medicaid Access. Home page. Available at: http://www.stateofhepc.org. Accessed June 6, 2018.

      Figure
      FigureHepatitis C virus treatment eligibility requirements, Montana and New Mexico Medicaid programs.
      Sources:
      *Montana Medicaid: https://medicaidprovider.mt.gov/Portals/68/docs/forms/HepatitisCTxPAFormRevised10172016.pdf.

      Mountain-Pacific Quality Health. Montana Medicaid prior authorization request for hepatitis C treatment. Available at: https://medicaidprovider.mt.gov/Portals/68/docs/forms/HepatitisCTxPAFormRevised10172016.pdf. Accessed November 27, 2018.

      ***Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable. Hepatitis C: the State of Medicaid Access, http://www.stateofhepc.org, accessed June 6, 2018.

      Hepatitis C State of Medicaid Access. Home page. Available at: http://www.stateofhepc.org. Accessed June 6, 2018.

      These delays matter because prompt treatment saves lives. The number of deaths from HCV outnumber those caused by human immunodeficiency virus, tuberculosis, and pneumococcal disease combined.
      • Ly KN
      • Hughes EM
      • Jiles RB
      • Holmberg SD
      Rising mortality associated with hepatitis C virus in the United States, 2003-2013.
      Successful treatment of HCV has been documented to reduce liver failure by 90%, liver cancer by 70%, and all-cause mortality by 50%.
      • van der Meer AJ
      • Veldt BJ
      • Feld JJ
      • et al.
      Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis.
      • Lok AS
      • Gardiner DF
      • Lawitz E
      • et al.
      Preliminary study of two antiviral agents for hepatitis C genotype 1.
      • Ghany MG
      • Strader DB
      • Thomas DL
      • Seeff LB
      Diagnosis, management, and treatment of hepatitis C: an update.
      Patients with HCV-related cirrhosis who are cured can have a full life expectancy.
      • Bruno S
      • Di Marco V
      • Iavarone M
      • et al.
      Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population.
      In spite of the clinical importance of treatment, a recent study inclusive of 45 states found that about one-third of persons with HCV were denied treatment by public or private insurance.
      • Gowda C
      • Lott S
      • Grigorian M
      • et al.
      Absolute insurer denial of direct-acting antiviral therapy for hepatitis C: a national specialty pharmacy cohort study.
      Patients with private insurers fared even worse than Medicaid; in the same study, over 50% were denied treatment. The paradox for patients residing in states with restrictive treatment criteria is that the intended safety net of public insurance leads instead to long delays that end in denials, and the surest route to treatment is to have no insurance and be ineligible for Medicaid, a profile that qualifies for drug assistance from manufacturers.
      The requirement of advanced liver fibrosis is in direct opposition to best practice and against clinical evidence. Treatment of patients in early stages of disease has demonstrated a reduction of all-cause mortality.
      • Backus LI
      • Belperio PS
      • Shahoumian TA
      • Mole LA
      Direct‐acting antiviral sustained virologic response: impact on mortality in patients without advanced liver disease [e-pub ahead of print].
      Nor is documented sobriety as a precondition to treatment supported by evidence-based medicine.

      American Association for the Study of Liver Diseases, Infectious Society of America. Recommendations for testing, managing, and treating hepatitis C. When and in whom to initiate HCV therapy. Available at: https://www.hcvguidelines.org/evaluate/when-whom. Accessed July 6, 2018.

      Regardless, the sobriety requirement, ranging from 1 to 12 months, is the norm in many states. While the impact of these restrictive policies is hard to quantify, clinicians using our HCV telehealth services have reported multiple instances of motivated patients who were lost to follow-up after the frustration of having Medicaid deny treatment.
      That said, adherence concerns that underpin sobriety requirements are not completely without merit. Assessing patient sobriety is highly important. A patient should be encouraged and supported to seek reduction, cessation, or otherwise less harmful intake of alcohol, tobacco, and controlled substances. Not all patients with HCV will be ready to initiate treatment. However, the decision on if and how to proceed with treatment should be made in accordance with medical guidelines, by the patient and provider, and at the point of care.
      Similarly, treating a person with HCV who is actively injecting drugs can be successful and a key part of a treatment as prevention. As with human immunodeficiency virus and tuberculosis, treating a patient with HCV has the added benefit of stopping ongoing disease transmission. In a recent multicenter trial, 97 of 103 (94%) participants who had recently injected drugs achieved sustained virologic response (cure).
      • Grebely J
      • Dalgard O
      • Conway B
      • et al.
      Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.
      Reinfection risk is not grounds to systematically deny treatment, and recent data suggest it is a rare occurence.
      • Weir A
      • Mcleod A
      • Innes H
      Hepatitis C reinfection following treatment induced viral clearance among people who have injected drugs.
      The reasons that insurers deny treatment for HCV are unclear. Prices for HCV treatment have dropped considerably in recent years. Treatment is cost effective in the long run and benefits every patient who is cured.
      • Rein DB
      • Wittenborn JS
      • Smith BD
      • et al.
      The cost-effectiveness, health benefits, and financial costs of new antiviral treatments for hepatitis C virus.
      • Najafzadeh M
      • Andersson K
      • Shrank WH
      • et al.
      Cost-effectiveness of novel regimens for the treatment of hepatitis C virus.
      No other infectious disease has treatment categorically withheld because of adherence or reinfection concerns. In fact, it is standard public health practice to develop and implement measures to support adherence in patients who seek treatment for other diseases.
      • Chaulk CP
      • Moore-Rice K
      • Rizzo R
      • Chaisson RE
      Eleven years of community-based directly observed therapy for tuberculosis.
      • Higa DH
      • Crepaz N
      • Mullins MM.
      Identifying best practices for increasing linkage to, retention, and re-engagement in HIV medical care: findings from a systematic review, 1996–2014.
      As this nation grapples with record levels of opioid addiction, coupled with a shortage of support services for patients who want to quit using drugs, a blanket denial of HCV treatment degrades the clinician's role, is paternalistic, harmful to the patient, and counterproductive to public health goals. Treatment restrictions will propagate disparities in liver disease mortality seen at the state level.
      • Desai AP
      • Mohan P
      • Rouubal AM
      • Bettencourt R
      • Loomba R
      Geographic variability in liver disease related mortality rates in the United States.
      Public and private insurers need to align policies on access to treatment with clinical recommendations. Clinicians must work with HCV patients to ensure adherence to these costly medications.
      Some states, such as Washington and New York, have adopted a comprehensive response to the HCV epidemic, largely aligned with the goals of the World Health Organization, National Academies of Medicine, and the Health and Human Services National Viral Hepatitis Plan that include not only treatment, but also the systemic elimination of HCV.
      World Health Organization
      Combating hepatitis B and C to reach elimination by 2030, advocacy brief.
      The National Academies
      A national strategy for the elimination of hepatitis B and C: phase two report.
      Department of Health and Human Services
      National viral hepatitis action plan 2017-2020.
      This is the path that every State, Tribe, and the Nation should follow.

      Acknowledgments

      The opinions expressed are those of the authors and do not necessarily reflect the official position of Cherokee Nation Health Services or Northwest Portland Area Indian Health Board.

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