Barriers to Accessing HCV Therapies in the US

Posted on May 28, 2015

Recent study indicates that newly available, interferon-free HCV therapies will significantly increase access to care for HCV infected individuals in the US, as unlike standard interferon-based therapies, interferon-free therapies are associated with minimal contraindications. However, a large proportion of US individuals with chronic hepatitis C infection are uninsured or under-insured, and this lack of adequate insurance coverage remains a major therapeutic access barrier.

While chronic hepatitis C infection is associated with tremendous economic burden, a study by Maria Stepanova and colleagues, published in the journal Hepatology in 2011, revealed that access to care for approximately 64% of HCV-infected patients in the US was hindered by low insurance rates and a significant number of contraindications to interferon and ribavirin (Stepanova M, et al. Hepatology. 2011;53:737–745). Contraindications for the use of interferon included the presence of severe depression, history of cardiopulmonary diseases, malignancy, or kidney failure.

Novel interferon-free, ribavirin-free anti-HCV regimens are now available in the US. Given that these highly effective and well tolerated regimens appear to have very few contraindications, Maria Stepanova and Zobair Younossi assessed how these novel HCV regimens may change the candidacy and insurance coverage of US patients chronically infected with HCV. Cross-sectional study results were recently published in the journal Digestive Diseases and Sciences (Stepanova M, Younossi ZM. Dig Dis Sci. 2015 May 19. [Epub ahead of print]).

Population data from National Health and Nutrition Examination Survey (NHANES) cycles 2005–2008 and 2009–2012 were analyzed. Health insurance coverage was self-reported by NHANES participants and included private insurance, Medicare, Medi-Gap, Medicaid, military or other state- or government-sponsored health plans.

  • Of 10,799 unique adult NHANES participants surveyed between 2005 and 2008, 1.19% showed detectable HCV viremia (HCV+). This HCV+ cohort included 133 (94.5 %) who had completed insurance and medical history questionnaires.
  • Of 11,840 unique adult NHANES participants surveyed between 2009 and 2012, 0.94% were HCV+. This HCV+ cohort included 130 (100 %) who had completed insurance and medical history questionnaires.
  • Significantly more HCV+ patients aged 65 years or older were in the 2009-2012 cohort: the proportion increased from 1.7% (2005-2008 cohort) to 6.8% (2009-2012 cohort, P = 01)
  • Comorbidities determine the likelihood of treatment candidacy. However, only the rate of type 2 diabetes increased significantly between the two cohorts: the proportion increased from 9.4% (2005-2008 cohort) to 22.8% (2009-2012 cohort, P = 0.0084)
  • The rate of eligibility for interferon-based treatment based on medical contraindications remained stable: 66.6 % (2005–2008), 74.1 % (2009–2012, P = 31)
  • The rate of insurance coverage for HCV+ patients insignificantly increased from 60.2 (2005–2008) to 67.4% (2009–2011), predominantly due to the change in Medicare/Medicaid coverage driven by the aging of the HCV-infected population
  • HCV+ individuals surveyed between 2005 and 2008, and between 2009 and 2011, had significantly lower rates of insurance coverage than HCV-negative individuals (P <0.05)

The authors calculated that if interferon-based regimens remained the standard regimens for treating HCV-infected patients, access to care would change from 35.1 to 48.5 % (P = 0.15). However, if treatment of HCV-infected patients is changed from interferon-based regimens to interferon-free regimens, the access to care changes from 35.1 to 66.6 % (P = 0.0003). This access change is primarily driven by reducing one of the barriers to care, ie, contraindications to treatment.

The authors concluded the following: “Given a significantly better side effect profile of the newly developed interferon- and ribavirin free regimens for HCV with minimal contraindications, an important barrier to HCV treatment has been addressed. Nevertheless, a large proportion of HCV patients remain uninsured, under-insured, or insured through publicly funded health insurance. As the Affordable Care Act and healthcare reform laws are being implemented, providing adequate coverage for HCV patients remains critical.”

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