Friday, February 1, 2019

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas

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DOI: 10.1200/JOP.18.00525
Journal of Oncology Practice
Published online before print January 22, 2019
PMID: 30668219

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas 
Laura Tenner, MD, MPH12; Trisha V. Melhado, MPH2; Raudel Bobadilla2; Barbara J. Turner, MD, MSED2; and Robert Morgan, PhD3

Source - Journal of Oncology Practice 

Mortality rates for hepatocellular carcinoma (HCC) are increasing faster than those of any other cancer, nearly doubling since the 1980s.1 Only one in five individuals diagnosed with HCC will survive 5 years after diagnosis despite the improvements in treatment.1 One of the top three contributing factors to HCC deaths is the high prevalence of hepatitis C virus (HCV) infection.1,2 The number of US residents currently infected with HCV is estimated at approximately 3.5 million.3 Baby boomers account for 81% of all new HCV diagnoses, and this cohort has the highest rates of HCV-related liver transplantation secondary to the development of HCC.4 Connecting patients infected with HCV to care has been problematic because approximately half of individuals with HCV are asymptomatic and are not seeking treatment.5,6

The need for HCV screening has increased significantly as a result of the development of highly effective direct-acting antiviral (DAA) treatments, which can cure more than 90% of patients.7 Curing HCV offers long-lasting, substantial health benefits including reduction in the incidence of liver cancer.7 A consensus committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) has proposed a strategy to decrease the prevalence of HCV by 2030.5 Their models predict that, if 260,000 patients can be treated annually, the incidence of HCV would be reduced by 90% relative to 2015 levels. This model presumes that all patients with chronic HCV infection would be treated, regardless of their level of fibrosis. In an effort to increase capacity to meet these treatment goals, the NASEM committee recommended using primary care as a result of the limited number of specialists to meet the high demand for HCV treatment.5 Moreno et al8 reported that expanding coverage to patients regardless of their fibrosis level was highly cost effective and saved a net social benefit of $500 billion at a $150,000 per quality-adjusted life-year valuation. The study found that the benefits of treatment extended beyond immediate improved patient health by decreasing the pool of individuals who can transmit the infection and by decreasing future health care expenditures related to end-stage liver disease.8

However, treating this population has significant challenges. For example, Texas has one of the highest liver cancer death rates in the nation.1 South Texas, specifically Region 11, encompasses a 19-county area in the Rio Grande Valley and has the highest prevalence of liver cancer in the state.9 Over the course of implementing screening and treatment guidelines, significant challenges to addressing the HCC epidemic have been identified in this region. Up to a third of individuals live in poverty, well above the state average of 17.5%, and up to a third of individuals are without health insurance (state average of 24.8%).10 This population tends to be less educated with less health care literacy.11 Furthermore, this region is more than 50,000 square miles, and access to health services is limited by lack of transportation and poor proximity to care.10 These factors all present major challenges to screening and treatment of HCV. There is a significant need for health policy to increase funding or reimbursement for social services in this region and regions like these around the United States.

Yet even privately insured individuals can experience significant cost barriers to care if they are found to be chronically infected with HCV. Because screening is a US Preventative Services Task Force recommendation,12 HCV tests and supporting laboratories are covered by insurance, but treatment can be difficult to afford. It is not unusual for HCV antiviral therapies that have previously ranged from $60,000 to $80,000 for a 12-week course of treatment to require a 20% to 30% cost-sharing responsibility by the patient.13 AbbVie recently released glecaprevir/pibrentasvir (Mavyret; AbbVie, North Chicago, IL), which has a significantly lower cost than other DAAs on the market at a cost of $13,200 per month or $39,600 for the 12-week treatment.13 This may help decrease the out-of-pocket cost, although the expense of treatment is still sizeable, especially in a region where a significant number of individuals live in poverty. A study of patients seeking treatment for HCV showed significant disparities in accessing these drugs.14 Many insurance companies as well as government-sponsored insurance are striving to decrease spending by limiting access to these medications. Up to 46% of Medicaid, 10% of private insurance, and 5% of Medicare beneficiaries have been denied treatment of HCV.14 This high cost sharing can cause significant financial toxicity to privately insured individuals, and many are faced with the decision to pursue treatment with a significant financial risk or refrain from treatment until they have irreparable damage to their liver. Sadly, it is easier for uninsured individuals to obtain DAAs due to medication assistance programs that provide the drugs for free.15 Health policy change is needed to decrease the out-of-pocket expenditures for insured patients for DAAs.

Texas Health and Human Services reports that more than 4 million individuals in the state rely on Texas Medicaid for their health insurance.16,17 There are particular concerns, however, that Texas Medicaid poses significant challenges for access to HCV care. The National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation of Harvard Law School developed the “Hepatitis C: The State of Medicaid Access” report card for each state.17 Texas was rated poorly, receiving a D+.17 The report identified severely restricted access to HCV medications as a cost-containment measure, citing requirements such as severe liver damage, a prescription written by or in consultation with a specialist, and 90 days of sobriety as the main barriers to medication access. Overall, the report cites restrictions that limit treatment to persons with severe fibrosis as one of the primary barriers to receipt of HCV medication, not just in Texas but across all state Medicaid programs.17

To the first restriction, as emphasized by the NASEM, the benefit of prevention of end-stage disease is greatly diminished or lost with restricting treatment to individuals who already have severe fibrosis. Although immediately cost effective for the organization, the pool of individuals who can transmit the infection will be not substantively decreased, so this measure does not create long-term cost savings. Legislation across all state Medicaid programs is needed to open treatment to all infected individuals.

To the second restriction, Texas Medicaid requires that a board-certified specialist must prescribe the DAA.18 Patients often face transportation challenges for specialist care as a result of the limited number of specialists in rural areas of Texas. Although telehealth programs such as Project ECHO (Extension for Community Healthcare Outcomes),19 which helps to connect primary care providers with specialists using telecommunication, are in existence in South Texas, most clinics serving vulnerable populations lack access to this consultation. More funding is needed for telehealth programs because remote specialist to primary care consultation could play a larger role for Texas Medicaid HCV treatment in South Texas.

Finally, there are restrictive requirements by Texas Medicaid concerning drug and alcohol addiction for treatment of HCV.16 If a patient has a history of illicit drug use, the patient must have initiated a substance use disorder program for 6 months before becoming eligible for treatment.16 In addition, the patient can be denied treatment if he or she consumes alcohol.16 Access to substance use disorder programs in South Texas is a significant barrier for HCV treatment because of the limited availability of treatment programs and transportation concerns.20 Data show no difference between the high rates of sustained viral response for individuals consuming alcohol while on DAAs and those who are abstinent.21 Physicians should lobby Texas Medicaid to remove this restriction. In addition, further funding to support substance abuse treatment is needed across the state.

Medical oncologists have an ethical obligation to advocate for health interventions that aid in the prevention of cancer, especially in settings where there are limited effective cancer treatment options. Although cancer death rates are decreasing in almost every other cancer, they continue to increase in liver cancer. Treating HCV infection could slow the rate of increase of HCC, yet the high price tag on curative treatments for HCV creates significant barriers to patient access, especially in areas with low socioeconomic status. Payers trying to control spending by only treating the sickest patients may undermine the benefit that might be achieved in HCV control and liver cancer prevention. Until these challenges are addressed through effective health policy reform in a collaborative effort between specialists and primary care physicians, not only on a local but also a national level, the serious impact of HCV and HCC on morbidity and mortality will not be mitigated.

Copyright © 2019 by American Society of Clinical Oncology

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