Abstract
Background:
Treatment uptake amongst patients with chronic Hepatitis C virus (HCV) in Australia is relatively low. New approaches to assessment have the potential to reduce public waiting lists, improve access to treatment, and to reduce healthcare costs.
Aim:
To describe the costs to the public hospital system and waiting time associated with a novel integrated rapid access to assessment and treatment (RAAT) model of care that utilizes Transient Elastography (TE) as a specialist outpatient-based approach for a streamlined assessment of patients with chronic HCV, compared to conventional outpatient management with liver biopsy (LB).
Methods:
Time from first medical review to treatment plan and costs associated with detection of fibrosis were recorded for patients receiving RAAT during a 3-month period, and for a similar historical cohort managed conventionally with LB. Costs related to medical and multidisciplinary team reviews and the TE/LB test itself were included.
Results:
Patients receiving RAAT had lower costs (n = 27, median AU$2716) and shorter time to treatment (median = 194 days) than for conventional management (n = 13, median $5005, 420 days; p < 0.01). Differences related to the lower TE test costs and the lower cost of consults between first medical review and establishment of a treatment plan.
Conclusions:
Based on real world audit data, this evaluation suggests TE, used as part of a new RAAT model of care, is cost saving to the health system in the short-term and reduces waiting times. The analysis reported here was intended to assess the costs related to detection of fibrosis, and is limited by the small sample size and potential selection bias. Future research should undertake a full economic evaluation at a whole of service level, to consider a more comprehensive and longer-term assessment of the costs and benefits associated with HCV management.
Introduction
Hepatitis C virus (HCV) is a major cause of chronic liver disease worldwide, with an estimated 3% of the world population (1.3–2.3% of the Australian population) chronically infectedCitation1–3. Chronic HCV is associated with variable degrees of hepatic inflammation and fibrosis over a period of decades, with 10–40% of patients developing cirrhosisCitation1. HCV is also a leading cause of hepatocellular carcinoma, which develops in 1–5% of those who progress to cirrhosis each yearCitation1. A range of co-factors such as alcohol consumption, diabetes mellitus, acquisition at an older age, and co-infection with Human Immunodeficiency Virus (HIV) accelerate the development of hepatic complicationsCitation1. Thus, surveillance for liver disease in those with chronic HCV is a mainstay of management. Further, anti-viral treatments for HCV are capable of achieving a sustained virological response in ∼40–80% of patients, with response predicted by genetic polymorphisms, HCV genotype, lower BMI, absence of HIV and stage of fibrosisCitation1,Citation4. As a consequence, assessment of liver disease is recommended prior to therapyCitation1. Nevertheless, treatment uptake in Australia remains low as a proportion of the prevalent population who might be expected to benefitCitation2. This is likely to be aggravated by blockages to access assessment, as evidenced by the high proportion of patients (30%) in a sub-cohort of the Australian Chronic Hepatitis C Observational StudyCitation5 who had not completed assessment within 6 months of their first clinic visit.
Liver biopsy (LB) has remained the reference method to assess the grade of inflammation and stage of fibrosis associated with chronic HCV infectionCitation1. However, LB is an invasive and potentially uncomfortable procedureCitation6 and is associated with a small risk of complications (1/1000–10,000) including mortality (1 in 10,000), along with potential sampling errorsCitation1,Citation7. Guidelines now recommend consideration of hepatic ultrasonic transient elastography (TE, also known as Fibroscan®), as an alternative to LB for the assessment of liver disease prior to initiating therapy, providing clinicians consider factors such as obesity, age, and biochemical necroinflammatory activity that may adversely affect its predictive performanceCitation1. TE is a non-invasive method in which a painless low frequency elastic wave is delivered to the skin above the liver, enabling an estimate of liver stiffness (in kilopascals, kPa) and the diagnosis of hepatic fibrosisCitation7. The examination can be performed in the outpatient setting. Importantly, from a health service perspective, newer techniques such as TE offer the opportunity for delivery of new models of care around the screening and triaging of patients with chronic HCV infection, potentially avoiding costs associated with an invasive LB and increasing patient throughput. Potentially, these new approaches have the capacity to reduce public patient waiting lists, which anecdotally can exceed well beyond a year with conventional models employing LB. However, these potential benefits are based largely on anecdote; there is little published evidence to confirm these benefits are realized in practiceCitation8.
In Australia, screening for liver disease in HCV patients is undertaken in the public and private hospital settings. Queensland is the third largest state by population, with approximately four and a half million residents. The state Government health department, Queensland Health, is primarily responsible for funding and providing public hospital and health services, financed through general taxation. Queensland Health introduced a new State-wide Health Technology Assessment (HTA) Program in 2009, which aimed to facilitate a co-ordinated and evidence-based process to inform policy and fund new health technologies in Queensland’s public hospitals. In November 2011, the HTA program funded a feasibility study to use TE to improve access to care. As a consequence the service model for patients with chronic liver disease was re-designed and a new integrated, multi-professional rapid access to assessment and treatment (RAAT) model established. The RAAT model was implemented in a 986-bed publicly funded metropolitan tertiary and teaching hospital, which delivers specialist liver services. A key feature of the RAAT clinic was the concept of a one-stop-shop. As many data as possible were obtained from the referring General Practitioners prior to the appointment for patients potentially requiring anti-viral therapy for chronic hepatitis. At the RAAT consultation, patients received TE followed by an assessment by a hepatologist. Thus, the clinical assessment and decision-making were streamlined and the TE was essentially fully embedded into the routine clinical assessment of the patient.
This health service research study aims to describe the costs and waiting time associated with the detection of liver fibrosis via a new rapid access to treatment and assessment (RAAT) model of care utilizing specialist outpatient clinic based TE for a prospective cohort of patients with a diagnosis of chronic HCV, and compares these to the costs and waiting times for a retrospective cohort receiving conventional management with LB. The overall aim is to assess whether the desired economic and organizational outcomes of the feasibility study, in terms of lower costs to the health service and reduced patient waiting times for a defined treatment plan, were achieved.
Materials and methods
Prospective patient level audit data related to implementation of the RAAT model including the TE technology were collected and evaluated alongside retrospective data on the conventional management and screening of HCV patients with LB in a historical cohort. The analysis is based on ‘real world’ data and is undertaken from the perspective of the provider of public hospital services in Queensland, Australia (Queensland Health). The costs for management and time to a treatment plan with the new RAAT model and for the conventional model are evaluated and compared on a per patient basis.
Patients and procedures
The RAAT model is based upon the concept that as much data as possible are available on the day of the initial appointment and that a TE is performed in the setting of the specialized outpatient clinic, imbedded into the clinical assessment. Resource utilization and wait time data were prospectively recorded for all eligible patients undergoing the RAAT model of care. Eligible patients were defined as adults aged 35–65 years referred to the hospital specialist liver clinic who (i) had a diagnosis of chronic HCV infection (positive serology and viral load); (ii) were treatment naïve; and (iii) were managed using the RAAT model including undergoing a TE procedure in the 3-month implementation period (between July–October 2012).
To provide data on the costs and waiting times associated with conventional management including LB, a retrospective historical cohort was identified using hospital patient records systems. Eligible patients were defined as per the RAAT model eligibility criteria, but were managed using conventional outpatient care and underwent a liver biopsy (LB) procedure during 2008. Although this comparison is likely to be limited by selection bias, these data represent the best comparative data available within the resources available for the study.
Data
Costs were evaluated from the perspective of the provider of public hospital services in Queensland, Australia (Queensland Health). For both the conventional and RAAT cohorts, the use of hospital resources was recorded from the time of first medical review until the time a treatment plan was determined. The resources recorded included medical reviews and multidisciplinary team reviews (including nurse education session, dietician, psychology). Unit costs were assigned to these resources using a standardized costing source (Queensland unit costs from the Activity Based Funding FrameworkCitation9,Citation10). Cost data for the episode of care related to the TE and LB procedures were extracted from the hospital cost reporting system (Transition II), which applies costs to each component of care for every service consumed by the patient during the episode of careCitation11. For the RAAT cohort, the use of LB subsequent to TE to inform a treatment plan was also recorded.
An allowance for the purchase costs of TE equipment was included in the analysis, since this represents an incremental cost that is not accounted for in the Transition II data. An establishment cost for clinic set-up and related training was also allowed for the RAAT cohort. This was estimated to be equivalent to 0.5 of a full time equivalent nurse (level 6). Both equipment and labour costs were annuitized over 1000 patients (the estimated number of episodes of care involving RAAT including TE for any indication once the clinic was established), assuming a 5% interest rate per year for a 5-year lifespan and no residual value. All costs were converted to AU$2012 using a web-based cost conversion tool (AU$1 ≈ US$0.90 ≈ GBP0.6 ≈ Euro0.7 July 2013)Citation12. The resources recorded and unit cost inputs for the evaluation are summarized in .
Table 1. Resources and unit costs included in the analysis.
The waiting time was defined for the purposes of this study as the time between first medical review and the development of a treatment plan post the TE or LB procedure (time to treatment plan). As a secondary outcome, we also examine the waiting time between the first medical review and the screening test (time to screening test). Data analysis was performed with Stata version 12.1 for Windows (Stata, College Station, TX). Characteristics of the cohort were compared using unpaired T-tests and Fisher Exact tests. The distribution for total costs and waiting time were compared using the non-parametric Wilcoxon Rank Sum (two sample) testCitation13.
Results
Thirteen patients received LB in the 1-year period during 2008 (conventional cohort) and 27 patients received RAAT during the 3-month feasibility phase, two of whom subsequently received LB (RAAT cohort). summarizes the patient characteristics for each cohort. The patients in the two cohorts were broadly similar in terms of key socio-demographic and clinical characteristics, with the exception of HCV genotype; the RAAT cohort had a higher proportion of patients diagnosed with genotype 1 (56%), whilst the conventional cohort were more likely to have genotype 3 (62%; although, this difference did not reach statistical significance). Overall, approximately half of the patients with HCV infection in Australia have Genotype 1, although this varies according to characteristics such as age and route of transmissionCitation2,Citation3. Thus, the RAAT cohort was slightly more likely (56%) and the conventional cohort was less likely (38%) to have genotype 1 infection than the average HCV patient in Australia.
Table 2. Characteristics of the conventional with LB and RAAT cohorts.
summarizes the healthcare treatment costs and waiting time for the two cohorts. Patients who received RAAT had significantly lower healthcare costs to the public hospital associated with their hepatology review than did patients receiving conventional management, saving the health system on average $3040 per patient (mean AU$2782, median AU$2716 for RAAT patients compared to mean AU$5822, median AU$5005 for conventional LB patients; Wilcoxon Rank Sum Test for difference in medians, p < 0.001). This difference was explained to a similar extent by both the higher test costs associated with the LB procedure and the higher cost of management between first medical review and establishment of a treatment plan for the conventional cohort. This was consistent with the longer waiting time in the conventional cohort; patients who received conventional management waited 119 days longer for the test and 226 days longer for a treatment plan than those who received the new RAAT model (difference in median wait time, p < 0.01).
Table 3. Mean and median time and cost per patient for the conventional with LB and RAAT cohorts.
Discussion
TE is now a well-accepted methodology for the non-invasive assessment of liver fibrosis. However, very limited data are as yet available to quantify the potential effects on the efficiency of service delivery. The findings of this health service evaluation suggest that—if used within the context of a new model of care implementing TE for screening of fibrosis in chronic HCV infection into the setting of a specialist hepatologist outpatient setting—a rapid access model of care incorporating TE is cost-saving to the health service provider in the short-term. Across the cohort, the total annual cost for the hospital to screen and develop a treatment plan for the 13 patients with a conventional approach including LB is estimated to be AU$75,686 (13 × $5822). The data suggest the hospital can now screen and develop a treatment plan for approximately twice as many chronic HCV patients with the new RAAT model of care (27.2 as compared to 13) for an equivalent cost to the health service. While this gain in productivity can partly be attributed to the use of a new technology, it needs to be emphasized that a re-design of the service delivery with better access to all relevant information to the specialist making the treatment decisions was a substantial driver for the better system performance. As part of this the TE was administered by a consultant or trained nurse in the outpatient clinic on the day of the consultation.
The improved service is reflected by the fact that, in patients with HCV, the time until a definitive treatment plan could be developed was reduced by ∼50% after their first medical review with the new RAAT model. Consequently, the findings indicate that the new RAAT model of care utilizing TE will make a substantial contribution to reducing the existing long waiting lists for liver disease screening associated with chronic HCV infection, resulting in faster access to a treatment plan for patients with HCV. Crucially, this reduced waiting time would also be anticipated to have an impact on patients’ health-related quality-of-life and the psychosocial impact of having an HCV diagnosisCitation14.
These findings are limited by several assumptions that were necessarily made given this evaluation occurred in a real world setting alongside implementation of a technology into the health service, and should, therefore, be interpreted cautiously. Firstly, any comparison of costs and wait time assumes the conventional LB and RAAT cohorts are similar. As this evaluation compares two cohorts with selection based on utilization of a screening test, we cannot be confident this is the case. Despite this potential selection bias, the cohorts were similar in their key characteristics except genotype. Whilst genotype would be expected to affect treatment outcome, it is less clear whether it would affect the costs or waiting times associated with the model of care for screening estimated here. A sub-group analysis excluding patients with HCV genotype 1 found that, although the cost and time to treatment plan decreased for both cohorts, the difference between cohorts remained substantial and significant (not reported here, details available from authors on request). It should also be noted that, whilst body mass index (BMI) was similar for both cohorts (23.8 conventional vs 26.3 RAAT, p = 0.18), it was relatively low compared to the population average. A better approach to undertaking this evaluation would have been to match patients in the two cohorts according to key demographic (e.g., age, gender) and clinical (e.g., BMI, genotype) characteristics. However, this was not feasible given the limited sample size.
Further, the number of patients included in the RAAT cohort was higher than the number in the conventional cohort, suggesting that some chronic HCV patients treated at the hospital in 2008 did not receive LB and, therefore, were not included in the analysis. Management of HCV is a rapidly evolving area. The requirement for a LB as a criterion for access to antiviral treatments was removed in Australia in April 2006Citation5, and many patients with HCV (up to 81% in one 2008/9 Australian studyCitation5) do not have a LB. Only the costs of those HCV patients receiving a LB were included in the analysis, the costs of patients managed by alternative means were not included. It is also likely that the faster turnover of patients seen from the waitlist with the RAAT model increased the number of chronic HCV patients seen during the 3-month period, and a greater proportion of HCV patients may be managed with RAAT including TE than would be managed with a conventional LB model. Therefore, patient selection is a limitation of this study and the true total costs of investigating liver fibrosis in chronic HCV patients may be under-estimated in this analysis, particularly in the conventional cohort. Further research exploring the costs and benefits of new models of care such as the RAAT approach should take a whole of service evaluative approach. Although evaluating the management of all patients managed by a specialist liver clinic is resource-intensive and was not feasible in this study, it would provide a more complete indication of the comparative costs and benefits of different models of care.
The evaluation implicitly assumes the two models of care, encompassing the screening tests and associated clinical judgment, are equally effective at diagnosing fibrosis levels. When TE is used in clinical practice alongside consideration of patient characteristics that might reduce its predictive performance and other clinical indicators of disease, and with appropriate secondary LB testing (which occurred for two patients in this RAAT cohort and was accounted for in the costs), this would seem a reasonable assumption. However, any potential benefits of liver biopsy beyond the detection of liver fibrosis, the disutility associated with the procedure, and the small but relevant risk of potential harm have not been considered in this analysis. Longer term evaluations including a full economic analysis of all costs and meaningful clinical and patient outcomes associated with HCV are needed to support a more conclusive assessment of the costs and benefits of these different approaches. Finally, the generalizability of the results is limited. The study is from a large tertiary hospital and the costs may differ across hospitals in Queensland as well as across other jurisdictions. However, given the bottom-up approach to costing within the hospital, which is based on resource requirements such as staff time, any deviation from the costs used here are likely to have a minimal impact on the total difference in costs between groups. This model is potentially scalable across Queensland Health and has the potential for application in other conditions with possible liver fibrosis requiring efficient triage to the appropriate treatment pathway.
Conclusion
Based on real world audit data from a large tertiary care public hospital in Queensland, this evaluation suggests a new rapid access model of care incorporating TE to assess fibrosis stage in patients with chronic HCV is cost-saving to the health system in the short-term and reduces patient waiting times compared to conventional management with a LB. Expanded implementation of TE screening in RAAT models with appropriate clinical oversight and further scientific evaluation should be considered to manage the increasing demand due to the growing public health burden associated with HCV infectionCitation2,Citation15. This approach has the potential to improve the efficiency with which patients with HCV infection are managed in our public health systems. However, future research should undertake a full economic evaluation at a whole of service level and consider a more comprehensive and longer-term assessment of the costs and benefits associated with HCV management, to confirm whether this potential is likely to be realized in practice.
Transparency
Declaration of funding
Data collection and costs related to the audit were funded by Queensland Health.
Declaration of financial/other interests
Jennifer Whitty is supported by a Research Fellowship from the Queensland Government Department of Employment, Economic Development and Innovation, Queensland Health and Griffith University. Jennifer Whitty, Kim-Huong Nguyen, and Paul A Scuffham are employees of Griffith University, Queensland, Australia. Caroline Tallis, Paul Crosland, Kaye Hewson, Rekha Pai Mangalore, Marianne Black, and Gerald Holtmann are employees of Queensland Health, Queensland, Australia. JME Peer Reviewers on this manuscript have no relevant financial relationships to disclose.
Specific author contributions
CT, PC, KH, GH conceived of the study. CT, RPM, MB, GH acquired and contributed to interpretation of the data. KH, JW, PC, PS analysed and interpreted the data. JW, KH drafted the manuscript. All authors critically revised the draft manuscript and approved the final version including the authorship list.
Acknowledgments
The authors thank the clinical staff and project officers employed by Queensland Health who contributed to the implementation of the RAAT model of care and TE technology and members of the Queensland Policy Advisory Committee on Technologies for their support and guidance for the evaluation.
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