Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data.

OBJECTIVE: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. METHODS: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. RESULTS: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. CONCLUSIONS: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

The efficiency of several one-step testing strategies for the diagnosis of hepatitis C.

BACKGROUND: implementing one-step strategies for hepatitis C diagnosis would help shorten the time to treatment access. Thus avoiding disease progression and complications, while facilitating hepatitis C virus (HCV) elimination. OBJECTIVE: to assess the validity and certainty of potential one-step strategies for the diagnosis of HCV infection and their associated cost and efficiency. METHODS: the study design is an economic appraisal of efficiency (cost/efficacy) using decision trees and deterministic sensitivity analysis. The analysis was performed from the payer perspective (Spanish National Health System), which exclusively considers the direct costs. Only the differential costs (diagnostic testing costs) were taken into account and the study was set in Spain. The efficacy of a diagnostic strategy was defined as the percentage of patients with an active HCV infection who received a positive diagnosis and the efficiency was defined as the cost per patient with a correctly diagnosed and active infection. RESULTS: the one-step strategies evaluated for the diagnosis of HCV had an acceptable validity and certainty due to the high sensitivity and specificity of the considered tests. The Ab-Ag strategy was the most efficient, followed by Ab-Ag-VL and Ab-VL. Ab-Ag was the most efficient due to the lower cost per patient tested, although the efficacy was lower than the Ab-VL efficacy. CONCLUSION: the study findings may help to establish more appropriate one-step diagnostic approaches whilst considering the efficacy and efficiency.

Uptake of and Expenditure on Direct-Acting Antiviral Agents for Hepatitis C Treatment in Australia.

BACKGROUND: Direct-acting antiviral agents (DAAs) have revolutionised treatment for the hepatitis C virus (HCV). Currently, treatment costs between 20,000 and 80,000 Australian dollars ($A) per patient. The Australian Federal Government provided $A1 billion over 5 years to subsidise these drugs. OBJECTIVE: The aim of this paper was to evaluate the uptake and financial impact of DAA prescribing in Australia. METHODS: We undertook a retrospective analysis of Medicare prescription and expenditure data for March 2016 to August 2017. Prescription numbers and expenditure data were extracted from the Medicare Statistical Reports website. Numbers of prescriptions were converted to per capita rates. HCV prevalence measures were used to provide context to prescription rates. All costs were reported in $A, year 2017 values. RESULTS: Nationally, 211,184 DAA prescriptions were reimbursed. Whilst $A3.6 billion was expended through the Pharmaceutical Benefits Scheme, confidential pricing agreements precluded calculation of the precise cost. In 18 months, estimated expenditure greatly exceeded the $A1 billion in funding for 5 years. Nationally, the rate of prescriptions was 872/100,000 individuals. Prescription rates were highest in the Australian Capital Territory (1087/100,000) and lowest in Western Australia (625/100,000) despite HCV prevalence being comparable to the national rate in both regions. CONCLUSIONS: Uptake of DAAs has been enthusiastic in the first 18 months of this funding agreement. However, the lack of transparency due to the confidential special pricing agreements means actual government expenditure is unknown. Post-marketing review by the Pharmaceutical Benefits Advisory Committee may enable renegotiation of DAA prices with the sponsors.

The impact of lifetime alcohol use on hepatitis C treatment outcomes in privately insured members of an integrated health care plan.

UNLABELLED: Treatment of chronic hepatitis C infection (HCV(+) ) has historically been shown to be less effective in patients with a heavy drinking history. The effect of moderate and heavy alcohol use on treatment with pegylated interferon-alpha and ribavirin (P/R) in an insured household population has not been previously reported. We investigated the effect of alcohol on treatment outcome in a cohort of 421 treatment-naïve HCV(+) patients, members of an integrated health care plan treated with P/R between January 2002 and June 2008. A detailed drinking history was obtained for 259 (61.5%) eligible patients. Regular drinking was reported by 93.1% of patients before HCV diagnosis, by 30.9% between HCV diagnosis and treatment, by 1.9% during treatment, and 11.6% after the end of treatment. Heavy drinking patterns were reported by 67.9%, 63.5% of patients drank more than 100 kg of ethanol before initiating HCV treatment, and 29.3% reported abstaining less than the required 6 months before treatment. Despite these reports of heavy drinking, sustained virological responses (SVRs) were obtained in 80.2% of patients with HCV genotypes 2 or 3 and 45.1% of patients with genotypes 1, 4, or 6. Pretreatment drinking patterns and total alcohol intake were both unrelated to SVR rates. Abstaining less than 6 months before treatment was related to lower SVR rates in moderate, but not heavy, drinkers. HCV treatment relapse was unrelated to drinking after treatment ended. CONCLUSION: The amount of alcohol consumed before HCV treatment did not have a negative effect on treatment outcomes in our population. A history of heavy drinking should not be considered a deterrent to HCV treatment in members of an integrated health care plan who are closely monitored.

Hepatitis C: What lies ahead and can we afford it?

Hepatitis C is a chronic disease with a slow and variable progression over 20-50 years and it is an important public health problem for the 21st century. This paper describes the information required to estimate what lies ahead in terms of morbidity, mortality and the implications for the health service in Scotland and summarises work undertaken in other countries. There will be an increasing number of people with severe liver disease in the next 10-20 years and we need to invest now in primary prevention and effective treatment strategies to reduce the burden of disease in the future.

Shed mediastinal blood transfusion after cardiac operations: a cost-effectiveness analysis.

BACKGROUND: Cardiac surgical patients consume a significant fraction of the annual volume of allogeneic blood transfused. Scavenged autologous blood may serve as a cost-effective means of conserving donated blood and avoiding transfusion-related complications. METHODS: This study examines 834 patients after cardiac operations at the University of Alabama Hospital. Data were collected on patients receiving unwashed, filtered, autologous transfusions from shed mediastinal drainage and those receiving allogeneic transfusions. The data were incorporated into clinical decision models; confidence intervals for parameters were estimated by bootstrapping sample statistics. Costs were estimated for transfusing both allogeneic and autologous blood. RESULTS: The study found a 54% reduction in transfusion risk or a mean reduction of 1.41 allogeneic units per case (95% confidence interval, 1.04 to 1.79 units). The process saved between $49 and $62 per case. CONCLUSIONS: The use of autologous blood has the potential to significantly reduce the costs and risks associated with transfusing allogeneic blood after cardiac operations.

Cost effectiveness of blood substitution in elective orthopedic operations.

Cost effectiveness was compared between substitution with autologous blood, implying no risk of transmission of diseases, and homologous blood, with a definite risk of transmission. Primary and revision hip arthroplasties were included in this study, as well as scoliosis operations. The risk of contracting chronic non-A, non-B hepatitis (NANBH) was included in the calculations of the long-term economic consequences of a transmittable disease. Our study showed that predonated blood alone, with a donation of up to four units, was the most suitable and cost-effective method for substitution of blood losses up to about 2.5-3 liters A combination of predonated blood and intraoperative autotransfusion was more suitable and less expensive for substituting blood losses of 2.5 liters or more. Homologous blood was the least cost-effective alternative considering the influence of non-A, non-B hepatitis.