Disparate Access to Treatment Regimens in Chronic Hepatitis C Patients

Data From the TRIO Network

Z. M. Younossi; B. R. Bacon; D. T. Dieterich; S. L. Flamm; K. Kowdley; S. Milligan; N. Tsai; A. Nezam


J Viral Hepat. 2016;23(6):447-454. 

In This Article

Abstract and Introduction


Despite the clinical success in the real-world of all oral hepatitis C virus (HCV) therapy with response rates approaching that seen in the clinical trials, access has been limited by many payers with discussion of prioritization of treatment based upon AASLD guidelines. We evaluated patients in the TRIO network who were prescribed sofosbuvir (SOF)-based regimens to determine reasons for not starting treatment. Trio Health is a disease management company that works in partnership with academic medical centres, community physicians and specialty pharmacies in the United States to optimize care for HCV. Data for 3841 patients prescribed a sofosbuvir-containing regimen between December 2013 and September 2014 were obtained through this programme. Of the entire group, 315 (8%) patients did not start the prescribed sofosbuvir-containing therapy. A total of 141 (45%) of the nonstart patients had a commercial plan as their primary insurance, 137 (44%) were primarily covered by Medicaid, 17 (5%) were primarily covered by Medicare, and 20 (6%) were either without coverage or coverage was not specified. Reasons for nonstarts were varied and overlapping. Only 15 patients (5% of nonstarts) did not start because they were unreachable or failed to complete required testing. Another 39 patients who did not start (12%) were following their physicians' direction to either wait for new treatment options or to hold treatment for an unspecified reason. Insurance-related processes and financial reasons accounted for 254 (81%) of the 315 nonstarts. The remaining 7 (2%) patients did not have a specified reason for not starting treatment. Nonstart rates were highest in the Medicaid-covered population at 35%. Medicare and Commercial nonstart rates were 2% and 6%, respectively. In a matched comparison, patients with commercial coverage were 6.5 times as likely to start SOF-based therapy compared to patients with Medicaid. Despite high SVR rates of SOF-based regimens in clinical practice, there are still barriers to access to care. In fact, almost half of the nonstart patients had advanced fibrosis scores (F3 or F4) and should have been prioritized to start treatment. As better treatment for HCV with high efficacy and low side effect rates become available, the disparity in access to treatment, as evidenced by the high nonstart rate in the Medicaid-covered group, must be resolved.


Advances starting with the approval of sofosbuvir have provided patients with chronic hepatitis C a chance to experience high cure rates with a shorter and simpler treatment regimen without the tremendous burden of side effects.[1,2] Although the cost per pill is higher, the cost per cure associated with sofosbuvir-based regimens is lower than previous regimens.[3] Furthermore, there is strong evidence that interferon-free regimens improve patient-reported outcomes[4] and lead to significant saving by improving work productivity.[5] Even with these gains and several economic analyses providing evidence that these treatments are cost effective, the cost of medication is controversial.[6] Payers are focused on the budget impact of treatment cost in the short run while cost–utility analyses assess the long-term gains for the society.[7] To manage the budget impact, many State Medicaid and some commercial payers have limited access to these therapies by implementing prioritization of care guidance as eligibility criteria. These criteria may grant care access to patients with advanced fibrosis and/or those who abstain alcohol or IV drug use for varying periods of time.[8] Subsequent pricing deals by competing drug manufacturers have led to some payers becoming more liberal with their treatment coverage while others remain restrictive.[9]

Despite the debate on the high costs of hepatitis C virus (HCV) medications, physicians have been prescribing sofosbuvir-containing regimens since their approval in late 2013.[10] One of the most important issues in gauging the impact of a new treatment regimen is to assess access in the real-world setting. The purpose of this study was to explore the population who has been prescribed sofosbuvir-containing regimens in a real-world setting but did not start the intended therapy.