Background New hepatitis C virus (HCV) treatments deliver higher cure rates with fewer contraindications, increasing demand for treatment and healthcare costs. The cost-effectiveness of new treatments is unknown. Methods We conducted a microsimulation of guideline testing followed by alternative treatment regimens for HCV among the US population aged 20 and older to estimate cases identified, treated, sustained viral response, deaths, medical costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) of different treatment options expressed as discounted lifetime costs and benefits from the healthcare perspective. Results Compared to treatment with pegylated interferon and ribavirin (PR), and a protease inhibitor for HCV genotype (G) 1 and PR alone for G2/3, treatment with PR and Sofosbuvir (PRS) for G1/4 and treatment with Sofosbuvir and ribavirin (SR) for G2/3 increased QALYs by 555 226, reduced deaths by 80 682, and increased costs by $26.2 billion at an ICER of $47 304 per QALY gained. As compared to PRS/SR, treating with an all oral regimen of Sofosbuvir and Simeprevir (SS) for G1/4 and SR for G2/3, increased QALYs by 1 110 451 and reduced deaths by an additional 164 540 at an incremental cost of $80.1 billion and an ICER of $72 169. In sensitivity analysis, where treatment with SS effectiveness was set to the list price of Viekira Pak and then Harvoni, treatment cost $24 921 and $25 405 per QALY gained as compared to PRS/SR. Conclusions New treatments are cost-effectiveness per person treated, but pent-up demand for treatment may create challenges for financing.

Background From December 2012-March 2014, three randomized trials, each implementing a unique intervention in primary care settings (mail recruitment [repeated-mailing], an electronic health record best practice alert [BPA], and patient-solicitation [patient-solicitation]), evaluated HCV antibody testing, diagnosis, and costs for each of the interventions compared to standard-of-care testing. Multilevel multivariable models were used to estimate the adjusted risk ratio (aRR) for receiving an HCV antibody test, and costs were estimated using activity-based costing. Rationale To estimate the effects of interventions conducted as part of the Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C study on hepatitis C virus (HCV) testing and costs among persons of the 1945–1965 birth-cohort (BC). Main Results Intervention resulted in substantially higher HCV testing rates compared to standard-of-care (26.9% vs. 1.4% for repeated-mailing, 30.9% vs. 3.6% for BPA, and 63.5% vs. 2.0% for patient-solicitation), and significantly higher aRR for testing after controlling for sex, birth year, race, insurance type, and median household income (19.2 [95% Confidence Interval (CI) 9.7–38.2] for repeated-mailing, 13.2 [95% CI 3.6–48.6] for BPA, and 32.9 [95% CI 19.3–56.1] for patient-solicitation). The BPA intervention had the lowest incremental cost per completed test ($24 with fixed startup costs, $3 without) and also the lowest incremental cost per new case identified after omitting fixed startup costs ($1,691). Conclusion HCV testing interventions resulted in an increase in BC testing compared to standard-of-care but also increased costs. The effect size and incremental costs of BPA intervention (excluding startup costs) support more widespread adoption compared to the other interventions.

The aim of this work was to estimate and describe the Medicare beneficiaries diagnosed with hepatitis C virus (HCV) in 2009, incremental annual costs by disease stage, incremental total Medicare HCV payments in 2009 using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data covering the years 2002 to 2009. We weighted the 2009 SEER-Medicare data to create estimates of the number of patients with an HCV diagnosis, used an inverse probability-weighted two-part, probit, and generalized linear model to estimate incremental per patient per month costs, and used simulation to estimate annual 2009 Medicare burden, presented in 2014 dollars. We summarized patient characteristics, diagnoses, and costs from SEER-Medicare files into a person-year panel data set. We estimated there were 407,786 patients with diagnosed HCV in 2009, of whom 61.4% had one or more comorbidities defined by the study. In 2009, 68% of patients were diagnosed with chronic HCV only, 9% with cirrhosis, 12% with decompensated cirrhosis (DCC), 2% with liver cancer, 2% with a history of transplant, and 8% who died. Annual costs for patients with chronic infection only and DCC were higher than the values used in many previous cost-effectiveness studies, and treatment of DCC accounted for 63.9% of total Medicare's HCV expenditures. Medicare paid $2.7 billion (credible interval: $0.7-$4.6 billion) in incremental costs for HCV in 2009. Conclusions: The costs of HCV to Medicare in 2009 were substantial and expected to increase over the next decade. Annual costs for patients with chronic infection only and DCC were higher than values used in many cost-effectiveness analyses. (HEPATOLOGY 2016;63:1135-1144 H epatitis C virus (HCV) is the most common blood-borne infection in the United States, with at least 2.7 million chronically infected Americans.(1) Current patients with HCV were primarily infected by behavioral and medical exposures between the 1960s and the early 1990s, and as a result, an estimated 70.1% of those HCV antibody positive were born during the years of 1945-1965. (2,3) In 2010, the first members of the 1945-1965 birth cohort became eligible for the U.S. Medicare program through the aged (age 65) eligibility pathway, and many more are likely to enter the program over the coming decades.To date, no paper has attempted to estimate either the per person costs or the aggregate health impact of HCV on the Medicare system, and the number of HCV patients seeking care in Medicare is unknown. This is an important knowledge gap because at least 1 million new chronically infected persons are likely to age into Medicare over the next 10-20 years. (3) Costs for HCV patients in Medicare may be different than in private insurance owing to their age, the high prevalence of other comorbidities, and differences in Medicare reimbursements compared to other payers. Finally, the need to offer treatment to patients before Medicare entry is in dispute. (4)

No abstract