Burden of hepatitis C in Europe the case of France and Romania

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1 Burden of hepatitis C in Europe the case of France and Romania Presented to: European Liver Patients Association Version: Final version 2.3 Date:

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3 Table of contents 1. Executive summary Introduction Background Epidemiology Natural history A rapidly changing landscape of therapy options Opportunities and challenges in the management of hepatitis C Strategies that provide good value for money Objectives Report outline Disclaimer on data What is hepatitis C How are they infected? Consequences for the individual Epidemiology of HCV (EU-level) What is known about the societal impact (EU-level) Management of hepatitis C History and future of hepatitis C treatments Overview of treatment pathways Screening for hepatitis C Pre-therapeutic assessments Treatment recommendations Treatment monitoring Current treatment access and known challenges The case of France and Romania France Romania Estimating the burden of hepatitis C and consequences of increased treatment uptake Published studies on burden of hepatitis C in France and Romania The logic of a health economic model Fundamental principles of model of the burden of hepatitis C Burden of hepatitis C in Europe the case of France and Romania 1

4 6.4 Analytical approach Questions/Objective The current standard of care in France and Romania The current treatment gap in hepatitis C care Types of output produced by the model Quality of life Included cost elements The estimated current burden of hepatitis C in France and Romania France Romania Current economic burden of hepatitis C in France and Romania Similarities and differences between France and Romania The estimated future burden of hepatitis C under current treatment levels France Romania Similarities and differences between France and Romania Future burden of hepatitis C due to increased treatment France Romania Similarities and differences between France and Romania Discussion References Appendix A. About ELPA Appendix B Model inputs Model specifics Model assumptions Data collection Prevalence Incidence Disease progression Demographics Utility Treatment Distribution of genotypes Burden of hepatitis C in Europe the case of France and Romania

5 Mortality Economic data Appendix C Model outputs France Romania Burden of hepatitis C in Europe the case of France and Romania 3

6 List of abbreviations Abbreviation ELPA European Liver Patients Association DAA Direct-acting antivirals EASL European Association for the study of the Liver EPF European Patients Forum HCC Hepatocellular carcinoma HCV Hepatitis C virus HIV Human immunodeficiency virus PI Protease inhibitors PWID Persons who inject drugs QALY Quality-adjusted life year SVR Sustained virological response WHA World Hepatitis Alliance WHO World Health Organization VHPB Viral Hepatitis Prevention Board 4 Burden of hepatitis C in Europe the case of France and Romania

7 1. Executive summary Hepatitis C is an infectious disease, caused by the hepatitis C virus, which primarily affects the liver. The disease is often asymptomatic and only progresses slowly. An estimated 160 million persons may be infected worldwide and the corresponding estimate for the European Union is 5.5 million. Today s prevalent cases were mainly infected through blood transfusion and unsafe medical procedures before 1989 when the disease was yet to be discovered. Due to the slow progressive nature of the disease, those infected before 1989 now find themselves in more advanced stages of the chronic disease and run a higher risk of developing liver cirrhosis or related complications. The combination of pegylated interferon and ribavirin has been the backbone of hepatitis C treatment. Response to treatment has been poor, however, in particular in individuals with genotype 1. Undergoing treatment was also coupled with a series of adverse effects which made treatment less attractive. The therapeutic landscape is currently rapidly changing. The introduction of protease inhibitors in 2011 increased the response to treatment substantially and further options have since entered the market or are about to enter the market which will improve treatment response further 1. The development of new and better treatment options has, with a few exceptions, unfortunately not been paralleled by an equivalent improvement in the care of hepatitis C across Europe. Still, a large part of the infected population is unaware of their disease status due to a lack of, or underfunding of, screening programs. Moreover, treatment rates are low in many countries, implying that only a small share of those diagnosed with the disease are undergoing treatment. In this sense, France and Romania represent two extremes in the management of hepatitis C. France has implemented three consecutive national plans which called for efforts to prevent transmission, increase detection rates and increase access to treatment. Romania, on the other hand, has no such publicly endorsed plan and both detection and treatment rates are low. This paper analyses the value of increasing treatment rates for a limited time period. The analysis shows that an increase in treatment can have a substantial effect on health outcomes such as mortality and cases of liver cancer. In France, which may have just passed the peak of the burden of hepatitis C, t h e increase of treatment rates has the potential to decrease the burden of hepatitis C from current levels. In Romania, the burden of hepatitis C will increase even when treatment rates are increased. The analysis of Romania reveals that increasing treatment alone is not enough to decrease the disease burden but must be coupled with access to the new more effective treatment options now available. In France, the monetary costs of increasing treatment rates would be completely offset by reduced health care and indirect costs thus making the intervention cost-saving. In the case of Romania, although increased drug costs are not completely offset by reduced health care and indirect costs, the relatively modest net spending should be seen in light of reduced mortality and improvements in other health outcomes among the infected population. 1 Data collection and analytical set-up were performed at a time when boceprevir and telaprevir were the only available direct acting antivirals on the market. Therefore, this report has only taken into account the efficacy and costs of these two drugs in the main analysis. Burden of hepatitis C in Europe the case of France and Romania 5

8 2. Introduction This study on the burden of hepatitis C has been carried out by Quantify Research, a research oriented consultancy specialising in health economics 2. It was prepared for and financed by the European Liver Patients Association (ELPA). More about ELPA s work to support people living with a liver disease can be found in Appendix A. 2.1 Background Epidemiology Worldwide, 160 million persons may be infected with the hepatitis C virus (HCV) [1]. A recent publication funded by the World Health Organization (WHO) estimated the prevalence of hepatitis C in the WHO European Region at 5.5 million people, representing almost 1 in every 50 adults to have chronic HCV [2]. In line with these findings, the overall prevalence of HCV in Europe was found to be between % [3] Natural history The hepatitis infection is caused by the hepatitis C virus and primarily affects the liver. The initial acute phase of the infection is usually clinically silent and although 15-45% of those infected clear the infection spontaneously, the remaining 55-85% develop chronic HCV infection [4, 5]. If left untreated, the infection causes fibrosis, an excessive formation of connective tissue in the liver. The fibrosis progression takes place over several decades and may eventually result in cirrhosis, a condition where liver tissue is replaced by scar tissue causing dysfunction to the liver. Patients with cirrhosis run a higher risk of death due to complications and may also develop hepatocellular carcinoma (HCC) [4] A rapidly changing landscape of therapy options Although it has only been a few decades since the hepatitis C virus was identified, the landscape of treatment for HCV infection has had extraordinary developments. In 2011, telaprevir and boceprevir were introduced as the first wave, first generation direct-acting antivirals (DAAs). These two drugs marked a substantial change in therapeutic options as treatment response was increased significantly [6]. These two drugs were followed in 2014 by the approval of a second-wave of first generation DAAs (sofosbuvir, simeprevir and daclatasvir) and the pace of change is expected to continue to increase Opportunities and challenges in the management of hepatitis C Much remains to be done before reaping the full benefits of these new treatments and improving health care for HCV infected persons in Europe. Already in 2010, the World Health Assembly adopted Resolution WHA which urges member states to strengthen their national health systems in order to address prevention and control viral hepatitis effectively [5]. 2 Contact details: Gustaf Ortsäter +46 (0) Burden of hepatitis C in Europe the case of France and Romania

9 2.1.5 Strategies that provide good value for money The changing treatment landscape and the growing burden of hepatitis C present both opportunities and challenges in the management of hepatitis C. While new efficacious treatment options provide the prospect of reaching and curing a much larger share of the infected population, health care decision makers need to consider allocating resources to HCV treatment and prevention. This is, naturally, done in competition with other high-focus disease areas, such as mental health and oncology. In making the necessary prioritizations and decisions on how to allocate funds, evidence on costs and outcomes of prevention in hepatitis C is required. 2.2 Objectives This study aims to describe the current and future burden of hepatitis C reviewing both epidemiological and economic aspects of the disease. Projections of the future burden of hepatitis C and the consequences of different interventions receive special attention. To estimate the burden of hepatitis C, a health economic model has been developed. Its results may serve as guidance for health care policy makers. The geographical focus of the study is France and Romania. 2.3 Report outline Chapter 3 provides a brief description of hepatitis C, common infection routes, the impact of the disease and the epidemiological situation in Europe. Chapter 4 describes the management of hepatitis C, known challenges and current treatment options. Chapter 5 explores some aspects of management of hepatitis C in France and Romania. The last chapter, chapter 6, presents other burden of hepatitis C studies, the logic of a health economic model and the model estimation of current and future burden of hepatitis C. 2.4 Disclaimer on data To populate the model with inputs, a literature review was conducted. We chose to include data primarily from identified systematic reviews, cost-effectiveness models and clinical trials. In addition, clinical experts were contacted in order to fill data gaps. In order to make the model as robust as possible special emphasis was put on the gathering of local data. Nevertheless, as in all models, there are always uncertainties related to some of the data used in the model. Due to unavailability of recent French epidemiological data at the time of data collection and finalization of this report, this study relied on estimates of prevalence data from Hence, any change in prevalence rates since 2004 was neglected which may cause the model to overestimate the current prevalence of HCV in France. Burden of hepatitis C in Europe the case of France and Romania 7

10 3. What is hepatitis C Hepatitis C virus is an infectious disease which primarily affects the liver. While in some cases the infection resolves spontaneously, i n a majority of cases (55-85%) pa t ie nt s develop chronic infection which is associated with hepatic inflammation and fibrosis progression. This phase is often asymptomatic which makes it difficult to detect. Thus, a large share of infected patients are unaware they are carrying the disease. The progression is generally slow and it may take decades before the disease reaches its later stages. On average, 10 to 20% of hepatitis C patients develop cirrhosis years after infection. Once in the cirrhotic phase, the liver may decompose and cease to function. Hepatitis C is the leading cause of hepatocellular carcinoma in Europe. Approximately 1 to 5% of patients develop this type of liver cancer. Decompensated cirrhosis and hepatocellular carcinoma are associated with an elevated mortality risk [1]. The key messages of this chapter are: A majority of today s prevalent cases acquired HCV through blood transmission and unsafe surgical procedures before the disease was documented in A majority of today s incident cases of HCV are acquired through needle sharing within the PWID community. This group represents more than 75% of the incident cases observed in Europe. Incidence has been reduced by as much as 90% since the disease was discovered. The overall prevalence rate in Europe varies between 0.13 and 3.26%. Generally, prevalence rates are higher in southern and Eastern Europe (more than 1.2%) than in northern Europe (less than 0.1%). The HCV population decreases due to the reduction of incidence rates. On the other hand, an increased severity of prevalent cases implies that European health care systems are facing an increased burden of HCV. 3.1 How are they infected? After the identification of the virus in 1989 by scientific teams led by Daniel W. Bradley and Michael Houghton, the route and rate of transmission of HCV changed dramatically [6]. A significant number of the currently infected population acquired the disease in the 1970s and 1980s through blood transmissions and unsafe surgical procedures. Screening of blood products for HCV has almost completely eradicated transfusion as a source of infection. Likewise, improvements in medical and surgical procedures have reduced this route to become negligible [1]. Today s most common route of transmission is that of needle sharing among the people who inject drugs (PWID) community, representing 76.4% of the reported cases in 2012 (Figure 1) [7]. 8 Burden of hepatitis C in Europe the case of France and Romania

11 Injecting drug use Sexual transmission (Not specified) Blood and blood products Nosocomial (hospitalacquired infection) Heterosexual transmission Men who have sex with men Non-occupational injuries Other Figure 1 Current transmission route of hepatitis C cases in EU/EEA countries, 2012[7] 3.2 Consequences for the individual Albeit that hepatitis C may be asymptomatic in as many as 90% of the cases, and the severity in its early stages is generally low, being diagnosed with hepatitis C has personal consequences for the individual [4, 8]. The stigma associated with hepatitis C partly because the disease is often associated with risky behaviour (see Figure 1) may represent an equal or even heavier burden to the patient than the actual symptoms of the disease. Disease-associated stigma has been documented in other chronic transmissible diseases similar to hepatitis C like tuberculosis, leprosy and human immunodeficiency virus (HIV) [8]. A survey of 175 individuals with chronic hepatitis C in the U.S. found that 66% of participants reported financial insecurity, 63% reported internalised shame, 51% reported social rejection, and 39% reported health impairment [8]. The latter observation pinpoints the fact that hepatitis C may cause additional suffering apart from clinical symptoms. Moreover, a not insignificant proportion of the respondents reported that they had altered their behaviours as a consequence of being diagnosed with hepatitis C (Figure 2) [8]. In a similar study from Germany, 80% of the subjects reported that their hepatitis C infection had a negative impact on their life, work (25%), ability to plan ahead (16%) and family (13%) having been named the three most commonly affected areas [9]. Burden of hepatitis C in Europe the case of France and Romania 9

12 Increase condom use (married) Increase condom use (single) Less likely to have sex Less likely to date Less likely to kiss Less likely to share a drinking glass Less likely to share a towel Less likely to prepare food 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Figure 2 Frequencies of altered behaviours as a consequence of a hepatitis C diagnosis 3.3 Epidemiology of HCV (EU-level) Despite the fact that the hepatitis C accounts for 60% of HCC cases and 30% of liver transplantations in the developed world, reliable data across Europe continues to be the limiting factor for accurately assessing the scale of hepatitis C in Europe [7]. As an example, only 25% of reported cases during 2012 contained information on the route of transmission, and the disease status of these reported cases were unknown in as much as 77.5% [7, 10]. A recent publication funded by the World Health Organization (WHO) estimated the prevalence of hepatitis C in the WHO European Region at 5.5 million people, representing almost 1 in every 50 adults to have chronic HCV [2]. In line with these findings, the overall prevalence of HCV in Europe was found to be between 0.13%-3.26% [3]. As a comparison, 8.45 million are estimated to live with Alzheimer s disease in Europe and 2.2 million with HIV [11, 12]. Since 1989, the incidence of hepatitis C has been reduced significantly due to screening of blood products [1]. The most common source of infection nowadays is needle sharing in relation to drug use [3]. In Europe, the annual average incidence rate is estimated at 6.19 cases per inhabitants [10]. The economic burden to European health care system as a whole is associated with prevalent cases of patients who were infected more than three decades ago and are now reaching the more severe stages most likely will outstrip the potential savings associated with reduced incidence rates unless adequate action is taken. The overall prevalence rate in Europe varies between 0.13% and 3.26% [3]. Generally, prevalence rates are higher in southern and Eastern Europe (more than 1.2%) than in northern Europe (less than 0.1%). Table 1 presents some studies on prevalence rates from a selection of countries. All these studies have been based on samples from the general population. However, prevalence rates may be much higher in certain sub-populations. In Cyprus and France, for example, prevalence rates among intravenous drug users have been estimated at 50% and 59.8%, respectively [3]. 10 Burden of hepatitis C in Europe the case of France and Romania

13 Table 1 Prevalence in general population by country Country Study year Prevalence Source Belgium % Quoilini et al. France % Meffre et al. France % Delarocque-Astagneau et al. Italy % Cozzolongo et al. Italy % Fabris et al. Netherlands % Baaten Romania % Gheorghe et al. 3.4 What is known about the societal impact (EU-level) A couple of recently published studies have assessed the burden of hepatitis C in terms of prevalence, cases of HCC and mortality due to hepatitis C [3, 7, 13-15]. With data from WHO, Blachier et al. compared the number of deaths associated with liver cancer and cirrhosis of the liver together with a number of selected diseases across Europe [3]. Although not all cases of liver cancer and cirrhosis are caused by hepatitis C, the data, presented in Figure 3, reveals that the burden of hepatitis C in terms of mortality is at least comparable to that of other diseases Colon and rectum cancers Breast cancer Chronic obstructive pulmonary disease Nephritis and nephrosis Liver cancer Cirrhosis of the liver Figure 3 Number of deaths associated with selected diseases, WHO 2008 [3] In another review of epidemiological data of hepatitis C, the total number of liver transplantations and the percentage due to hepatitis C were collected from centralised databases in a selection of countries. Within a selection of European countries, hepatitis C accounts for between 18-32% of all liver transplantations conducted in 2011 [13]. Table 2 Number of liver transplantations due to hepatitis C across Europe Liver transplants England France Germany Spain Total liver transplants 572 1,164 1,199 1,137 HCV liver transplants % due to HCV 18% 24% 23% 32% Burden of hepatitis C in Europe the case of France and Romania 11

14 4. Management of hepatitis C The ultimate goal of hepatitis C treatment is the complete eradication of the hepatitis C virus. This is defined as undetectable quantities of the virus 24 weeks after cessation of treatment and is referred to as sustained virological response (SVR). The key messages of this chapter are: Rapid progress has been made during the last few years within the therapeutic field of HCV, which has led to treatment response rates of above 90%. Given the continuously evolving therapeutic landscape, current treatment guidelines may not reflect today s optimal strategy. Despite existing effective treatments, access to these is limited by underfunding of screening and diagnostic activities. A systematic review addressing barriers to treatment found that 57% of patients with a diagnosis were untreated. 4.1 History and future of hepatitis C treatments The backbone of treatment of patients with HCV and the standard of care for the past decade has been a combination of pegylated interferon plus ribavirin. After the identification of the virus in 1989 by scientific teams led by Daniel W. Bradley and Michael Houghton, standard interferon was approved for HCV treatment in 1990 [6]. Although SVR rates were low (about 10% for genotype 1 and 30% for genotype 2 and 3), it marked an important step towards treatment of hepatitis C as it was the first treatment to become available. In 1998, standard interferon was combined with ribavirin which increased treatment response and when interferon was pegylated, it represented a further step as SVR rates increased to around 50% in genotype 1 patients. In patients infected with genotype 2 or 3, between 76% and 82% responded to treatment (SVR) with pegylated interferon plus ribavirin [6]. In 2011, a new drug class, protease inhibitors obtained approval and two types of drugs, boceprevir and telaprevir, were approved for treatment in patients with genotype 1 as a triple therapy in combination with pegylated interferon and ribavirin. This latest development increased SVR rates in patients with genotype 1 to around 80% [6, 16]. The next expected step within hepatitis C treatments has already been taken with the interferon-free second generation of protease inhibitors and polymerase inhibitors. Some of these drugs have already reached market approval while others are expected to reach the market in 2015 [6, 17]. This brings the SVR rate in genotype 1 patients to above 90% [6]. 4.2 Overview of treatment pathways Screening for hepatitis C In order to increase treatment uptake of HCV positive patients, increased screening to identify a larger share of the asymptomatic population may be the most important tool. Based on a systematic review of the literature on screening interventions, the WHO suggests that both practitioner-based approaches and a media-/information-based approaches are effective in increasing both the number of people screened for HCV and the number of people tested positive compared to no intervention [5]. However, due to the heterogeneity of included studies (in terms of study design, population 12 Burden of hepatitis C in Europe the case of France and Romania

15 etc.), the existing evidence is not sufficient to make a recommendation on how to implement any screening activity. Instead screening should be guided by the epidemiology of HCV in the country in question. WHO recommends targeting individuals who are known to be part of a population with high HCV prevalence or have a history of HCV risk exposure/behaviour. Examples of these are listed in Table 3 [5]. Table 3 Populations for targeted screening activity Populations with high HCV prevalence or who have a history of HCV risk exposure/behaviour Persons who have received medical or dental interventions in health-care settings where infection control practices are substandard Persons who have received blood transfusions prior to the time when serological testing of blood donors for HCV was initiated or in countries where serological testing of blood donations for HCV is not routinely performed Persons who inject drugs (PWID) Persons who have had tattoos, body piercing or scarification procedures done where infection control practices are substandard Children born to mothers infected with HCV Persons with HIV infection Persons who have used intranasal drugs Prisoners and previously incarcerated persons Pre-therapeutic assessments Before initiating treatment, the severity of the liver disease, and levels of viral load and the HCV genotype should be assessed as these pieces of information will guide the clinician in therapy decisions and provide predictive information on probable treatment response. It is recommended to assess the severity of the disease as treatment response depends on the stage of the disease progression. The identification of cirrhosis is of particular importance given the risk of developing future complications such as decompensated cirrhosis and HCC [1]. A liver biopsy has been the gold standard in assessing disease severity but other non-invasive options exist, such as liver stiffness measurement and other biomarkers [1]. At baseline, before treatment starts, the viral load levels must be quantified as it serves as a reference in managing treatment duration. It is also recommended to assess the genotype prior to treatment since treatment, dosage and duration depend on the genotype Treatment recommendations The therapeutic landscape of hepatitis C is quickly changing and recently published guidelines may not reflect current optimal strategy or have recently been updated to incorporate the new treatment options that have gained market approval. This study is based on standard of care in each country 3, and although this may not be the optimal treatment strategy for 2014, it should reflect the current clinical practice. In 2011, EASL stated in, The EASL Clinical Practice Guidelines: Management of hepatitis C virus infection that All treatment-naïve and -experienced patients with compensated chronic liver 3 Standard of care in France and Romania are defined in section Burden of hepatitis C in Europe the case of France and Romania 13

16 disease related to HCV, who are willing to be treated and who have no contraindications to treatment, should be considered for therapy. Treatment should be scheduled, rather than deferred, in patients with advanced fibrosis (METAVIR 4 score F3 to F4) For patients with minimal or no fibrosis, the timing of therapy is debatable, and treatment may be deferred pending the development and availability of new therapies. On the particular drug recommendations, EASL writes that The combination of pegylated interferon + ribavirin and TVR or BOC (triple therapy) is the approved standard of care for chronic hepatitis C genotype 1 The combination of pegylated IFN-α and ribavirin (dual therapy) is the approved standard of care for chronic hepatitis C genotype 2, 3, 4, 5, and Treatment monitoring Treatment efficacy is monitored by repeated measurement of HCV RNA levels compared to the level at baseline. A full treatment regime lasts 48 weeks (all genotypes). However, depending on the treatment regime, treatment can be curtailed if viral load levels are undetectable at the early stages of the treatment regime. In triple therapy, telaprevir is used in the first 12 weeks while boceprevir is introduced after 4 weeks of pegylated interferon and ribavirin and administered during 32 weeks pegylated interferon and ribavirin again are administered for the final 12 weeks of the treatment regime. 4.3 Current treatment access and known challenges Despite the high costs of untreated hepatitis C patients, the hepatitis C-related reduction in quality of life, and the existence of highly efficacious therapeutic options, a majority of patients with chronic hepatitis C are currently untreated in many countries. A systematic review addressing barriers to treatment in Europe found that 57% of patients with a diagnosis were untreated [18]. The undertreatment rates in the total infected patient population are of course much higher than the under- treatment among diagnosed cases, as a large proportion of chronic HCV patients remain undiagnosed [18]. Partly, the asymptomatic nature of the disease explains the low treatment levels. However, there are also a series of obstacles along the path from infection to receiving treatment which must be removed if one is to increase the number of patients receiving treatment (Figure 4). Limitations in the availability of diagnostic tests, the process of referral and attending clinic appointments, funding of treatment and reluctance to follow therapy due to adverse events are all obstacles which contribute to the low rates of treatment observed in the HCV population across Europe [18]. Some of these barriers to treatment are currently unavoidable such as characteristics of the patient population (reluctance to adhere to treatment) and inherent limitations of currently available medications (contraindications). However, non-clinical factors such as access to health care, underdiagnosing and underfunding of treatment appear to play an even larger role. The understanding of all these barriers from diagnosis to therapy is critical in increasing the proportion of treated cases and reducing the negative outcomes of hepatitis C [19]. In Table 4, prevalence, number of diagnosed 4 Metavir is a scale to measure the amount and activity of fibrosis, the excessive formation of connective tissue in the liver. 14 Burden of hepatitis C in Europe the case of France and Romania

17 patients and number of patients annually treated across a selection of European countries are presented. Figure 4 Infection to treatment pathway Table 4 Prevalence, diagnosed and treated patients across Europe Prevalence England France Germany Spain Romania* Proportion 0.40% 0.70% 0.50% 1.50% 3.23% Total cases , , , ,000 Diagnosed Total cases 46, , , ,300 60,000 Annual newly diagnosed 5,600 9,000 4,000 15,300 N/a Annual number treated 5,400 10,100 12,700 9,800 6,000 True treatment rate** 2.44% 2.56% 3.10% 1.40% 1.03% Source: Bruggmann et al [13]. *Estimates from discussion with KOLs 5. **Own calculations Reflecting on the series of obstacles that exist to effective treatment, it is important to recall that different countries would take different approaches to most effectively increase the treatment rate modelled in this report. While funding more treatment may be the most straightforward way to increase treatment rates in Romania, the most appropriate solution in France may be to increase screening and thereby, increase treatment rates. This report does not recommend or model any such approach but rather assumes that treatment rates are increased one way or another and aims to assess how this will impact clinical and economic outcomes. 5 Professor Mihai Voiculescu and Associate Professor Liana Gheorghe Burden of hepatitis C in Europe the case of France and Romania 15

18 5. The case of France and Romania France and Romania find themselves at opposite ends regarding the management of hepatitis C within Europe. France has implemented three national action plans targeting improvement in screening, diagnosing and access to treatment. Romania, on the other hand, has no such plan and struggles with a lack of funding in vital areas of combating hepatitis C. The key messages of this chapter are: France has had success in increasing access to treatment but room for improvements exists in areas such as screening or case-finding strategies. Romania can draw several lessons from the action plans implemented in France. Foremost, Romania must improve funding of effective treatment. 5.1 France France has within Europe been described as an A-student in terms of access to treatment and care of hepatitis C with a health care plan against hepatitis B and C implemented more than ten years ago. The latest action plan ( ) called for s c a l i n g - up efforts to prevent transmission, increase detection rates, improve access to treatment and care, provide additional services in the prison milieu, and improve the epidemiological knowledge of the disease(s). The increased efforts have led to a reduction in the prevalence of hepatitis C and fewer deaths attributable to hepatitis C. The greatest accomplishment however, has been the ability to offer treatment where needed. Still, it is acknowledged that if France is to continue to build on the strong success it has had, it must continue its efforts or even increase them in areas such as screening or case-finding strategies [20]. 5.2 Romania Romania struggles with a high prevalence rate of hepatitis C and lack of funding for treatment. With a prevalence rate of 3.23%, Romania has the highest prevalence of hepatitis C in Europe. Furthermore, a large part of today s hepatitis C population was probably infected through blood transmission three or four decades ago and is now facing a more severe disease. Action is urgently required in Romania since the population with a long disease history is at high risk of developing complications such as decompensated cirrhosis and/or HCC. Romania is currently missing a publicly endorsed strategic plan on how to combat hepatitis C. Areas of concern include the lack of screening mechanisms, underfunded screening policies and underfunded therapeutical options. An estimated 600,000 individuals in Romania are infected with hepatitis C, of which only 10% are believed to have received a diagnosis and even fewer to have received treatment [21]. Currently, only 6,000 treatment regimens are funded annually 6. 6 Discussion with KOLs. 16 Burden of hepatitis C in Europe the case of France and Romania

19 6. Estimating the burden of hepatitis C and consequences of increased treatment uptake To estimate the burden of hepatitis C, a health economic model has been developed which provides a structural framework to analyse the current and future burden of hepatitis C in France and Romania. The key messages of this chapter are: The scenarios analysed in this chapter assess the current burden and project the future burden of hepatitis C under three scenarios; 1) current treatment levels are maintained, 2) increased treatment uptake, 3) increased treatment uptake combined with increased efficacy of standards of care. The majority of prevalent cases in both France and Romania are in the chronic stages of hepatitis C. However, total health care costs are largely incurred by those in the latter stages of the disease i.e. decompensated cirrhosis and hepatocellular carcinoma. The number of chronic cases is projected to decrease in France under current treatment levels. However, the average hepatitis C patient will over time be in a more advanced stage of the disease and will require more health care resources. In Romania under current treatment levels, both cirrhotic HCV and end-stage cases will increasingly put a substantial burden on the health care system. Health care costs are expected to double by 2040 compared to today (2014) and annual mortality related to HCV will increase from 1,200 deaths in 2014 to close to 3,500 by Reducing the current treatment gap by 50% with today s standard of care is cost-saving in France. Higher treatment uptake in France has the potential to reduce health care costs. Combining increased treatment uptake with increased efficacy has the potential to reduce health care costs by more than 65% by 2040 compared to today s levels. Increased treatment uptake has limited effect on the increasing burden of HCV in Romania. Combining increased treatment with higher efficacy has the potential to substantially alter the burden of hepatitis C in Romania. Under this scenario, health care costs are expected to be reduced by almost 50% by 2040 compared to current treatment levels. 6.1 Published studies on burden of hepatitis C in France and Romania The societal burden of hepatitis C in France has been studied previously. However, to our knowledge, this study is the first of its kind to also estimate the burden of hepatitis C in monetary terms. As regards Romania, no studies on the societal and/or economic burden of hepatitis C have been published. Previous studies of hepatitis C have focused foremost on health outcomes. A study by Deuffic-Burban et al. from 2008 evaluated the effect of treatment on mortality in France [22]. In addition, two recent publications estimate the burden of hepatitis C in a large variety of countries (among them France) [15, 23]. For instance, Razavi et al. assessed the current and future burden in terms of total number of HCV infections, the disease progression and mortality in 2013 to As regards France, the authors estimate the prevalence to drop by more than 50% [23]. Using the same model as Razavi et al., Burden of hepatitis C in Europe the case of France and Romania 17

20 Wedemeyer et al., found that hepatitis C can be almost completely eradicated by 2025 through increased efficacy of medication and treatment rates [15]. 6.2 The logic of a health economic model A health economic model provides a framework to structurally analyse a complex reality such as disease progression and the resource use associated with it. It synthesises sources of both economic and epidemiological data and produces output which may be expressed both in epidemiological terms (prevalence and incidence of disease, mortality) and in health economic terms (quality-adjusted life years (QALYs), economic burden). Typical epidemiological data include prevalence, incidence and efficacy of intervention while economic data include drug costs, health care costs and potential productivity shortfalls (Figure 5). Figure 5 Health economic model Within health economics, there are several different approaches available to estimate the burden of a disease or the economic cost of an intervention. In many countries, registry data and different databases are available to study the disease prevalence and also the economic burden. A registrybased burden study can give a picture of the historical and current situation with respect to a particular disease. However, it lacks the ability to make predictions on the development of the disease and how novel interventions may affect burden and outcomes. Therefore, a health economic simulation model was developed to estimate the total cost of all prevalent hepatitis C cases, to predict the burden of hepatitis C over the model horizon and to assess the impact of increased treatment on both costs and clinical outcomes such as number of infected individuals and cases of liver cancer. 6.3 Fundamental principles of model of the burden of hepatitis C In health economic models, various health states are chosen to best represent different stages of the disease. Stages are often defined according to a clinical measurement and the underlying idea is that both management costs and utility for patients in one stage are distinctively different to those patients in another stage. Patients are therefore defined according to the health state they belong to. While increasing the number of health states would surely increase the external validity of the model (how 18 Burden of hepatitis C in Europe the case of France and Romania

21 well the model reflects the complex reality), it would also increase the complexity, data requirements as well as reduce the transparency. Health states within hepatitis C are commonly stratified by the degree of fibrosis. As a result of the fibrosis, the patient may develop complications such as decompensated cirrhosis and hepatocellular carcinoma which are represented by individual health states. Each patient incurs costs and attains utility (i.e. quality of life) depending on his/her health states. Heterogeneity may of course exist within one health state. For example, in a mild state, some individuals may suffer from extrahepatic manifestations such as fatigue, joint pain and muscle pain. Others may be completely asymptomatic. However, this between-patient variability is difficult to capture in a modelling framework. The general approach to this is to assume that the cost and quality of life represents that of an average patient in this state of the disease. This is also done in this model. Figure 6 outlines the foundations of the model used in this study. Each box represents a health state. In each year, a patient either remains in his or her current health state or progresses from it to another health state according to the arrows in the figure. Transition between two states is based on the probability of progressing, as found in the literature. When infected with hepatitis C, patients enter the model in its first phase, i.e. mild HCV. Patients in the mild stage may clear the virus spontaneously. In this case, the individual exits the model and returns to the general population. In the mild HCV state, as well as in moderate HCV and cirrhosis, the patient is indicated for treatment and if successful (as measured by SVR), may clear the virus and exit the model without further risk of disease progression other than the general risk of (re-)infection faced by the general population. Patients in mild HCV, moderate HCV, and cirrhotic state are defined as having a METAVIR score between F0-F1, F2-F3, and F4, respectively. If the patient does not respond to treatment or never initiates treatment, he or she will eventually progress into the state of decompensated cirrhosis or hepatocellular carcinoma (HCC). These two states are associated with an elevated mortality risk due to the liver disease. In these states, antiviral treatment is no longer an option. Instead, surgical intervention (e.g. liver transplantation) may be indicated 7. Patients who successfully undergo a liver transplantation will enter the health state p ost transplantation and remain there for the entire time span of the model or die. 7 Due to data restrictions, other HCC interventions such as percutaneous ethanol injection, laser-induced thermotherapy, or multi kinase inhibitors were excluded. Burden of hepatitis C in Europe the case of France and Romania 19

22 Figure 6 Model framework to analyse burden of hepatitis C 6.4 Analytical approach Questions/Objective This study aims to describe the current burden of hepatitis C including both epidemiological and economic aspects of the disease. It will also project the future burden of hepatitis C and the consequences of a higher treatment rate than currently observed. To address this, a model has been developed as outlined in section 0. The model will be used to; i. Estimate the current burden of hepatitis C in France and Romania ii. Estimate the future burden of hepatitis C in France and Romania under current treatment levels iii. Estimate the consequences of an increased treatment uptake on the future burden of hepatitis C iv. Estimate the impact of increased efficacy of the standard of care of hepatitis C on the future burden of hepatitis C To estimate the future burden of hepatitis C in France and Romania under current treatment levels (objective ii), it will be assumed that the same number of infected patients will be treated each year (based on current estimate of annual treatments) up until Furthermore, it will be assumed that today s standard of care (defined in section 6.4.2) and the associated SVR-rates will be the same throughout the entire model horizon (until 2040). To estimate the future burden of hepatitis C in France and Romania under increased treatment rates (objective iii), treatment rates have been increased from current treatment levels up until 2019 when treatment rates again return to 2014 levels until The increase in treatment rates has been set to close the current treatment gap by 50%. The current treatment gap is defined in section In this scenario, patients are assumed to be treated with the standard of care in the respective country throughout the entire model horizon. To estimate the impact of increased efficacy of the standard of care in France and Romania (objective iv), the SVR rates have been increased (see Table 6 for details) throughout the entire model horizon in both countries. Moreover, as in the scenario with increased treatment uptake, treatment is increased from current levels up until 2019 when treatment levels return to current levels until In this scenario, the cost of this future hypothetical treatment basket is set to the same level as the costs of today s standard of care due to lack of information with respect to the costs of future treatment options. 20 Burden of hepatitis C in Europe the case of France and Romania

23 Definitions and logic behind an increased treatment uptake and increased efficacy can be found in section The current standard of care in France and Romania Differences between France and Romania in the care delivery for hepatitis C patients have been described in sections 5.1 and 5.2. In depicting the future burden of hepatitis C, this model will use the current standard of care in each country. In France, treatment has been modelled as a combination of pegylated interferon with ribavirin and either boceprevir or telaprevir in genotype 1. In other genotypes, treatment has been modelled as a combination of pegylated interferon and ribavirin. In Romania, treatment has been modelled as the combination of pegylated interferon and ribavirin in genotype 1, which is the only genotype prevalent in Romania The current treatment gap in hepatitis C care The recently published guidelines from EASL on treatment of hepatitis C state that All treatment-naïve and -experienced patients with compensated chronic liver disease related to HCV, who are willing to be treated and who have no contraindications to treatment, should be considered for therapy Treatment is justified in patients with moderate fibrosis (METAVIR score F2). For patients with minimal or no fibrosis (METAVIR score F0-F1), the timing and nature of therapy is debatable, and treatment may be deferred. 8 A conservative interpretation of these guidelines would result in the exclusive treatment of patients in the cirrhotic stage (column 1 in Table 5). A less conservative interpretation would also recommend patients in the moderate stage (column 2 in Table 5) for treatment. The model adopts the more conservative interpretation when calculating the number of potentially treatable individuals, and further takes into account that around 40% of the infected population is ineligible for treatment with pegylated interferon + ribavirin due to contraindication and reluctance to undergo treatment on the patient s side [15, 24, 25]. Table 5 Current treatment levels and treatment gap No. of cirrhotic patients No. of cirrhotic and moderate patients Potentially treatable* Currently treated Treatment gap Treatment in scenario France 61, ,708 36,828 10,100 26,728 23,464 Romania 46, ,442 27,761 6,000 21,761 16,880 *Conservative assumption As shown in Table 5, France and Romania would have to increase treatment by a factor of 2.6 and 3.6, respectively, in order to meet the recommendations of EASL. An extension of treatment to patients in the moderate stage would increase the treatment gap substantially. A complete closure of the treatment gap in France and Romania would require an increase of current treatment levels by a factor of 14.2 and 44.3, respectively. Given the difficulties in increasing treatment levels, the cautious approach in this analysis will be to make an extra effort to reduce the current treatment gap by 50% from 2014 and up until 2019 when treatment again is assumed to return to today s (i.e. 2014) levels. This means that France would have 8 Metavir is a scale to measure the amount and activity of fibrosis, the excessive formation of connective tissue in the liver. Burden of hepatitis C in Europe the case of France and Romania 21

24 to increase its annual treatment of 10,100 dosages to 23,464 dosages (set to 23,500 in the model) and Romania would have to increase its annual treatment of 6,000 dosages to 16,880 dosages (set to 16,900 in the model). Annual treatment in France in the increased treatment scenario is 23,500 in the years Annual treatment in Romania in the increased treatment scenario is 16,900 in the years Other variables, such as drug costs, efficacy, indirect costs and transition probabilities between stages are assumed to be equal between the two treatment scenarios and over time. In the second analysis, an assumption on increased treatment efficacy will be made. This is done in order to better reflect the therapeutic landscape within hepatitis C as some countries may incorporate recently available DAAs into the clinical practice in the near future. H e n c e, the second analysis will assume that patients are treated according to the new guidelines recently issued by EASL in April 2014 [16]. The sustained virological response (SVR) rates presented in Table 6 are based on the clinical evidence presented in the guideline issued by EASL [16]. Table 6 SVR rates by genotype and disease stage in scenario with increased efficacy of standard of care Mild/Moderate Cirrhosis Genotype 1 92% 80% Genotype 2 or 3 97% 83% Genotype 4, 5, or 6 96% 80% Types of output produced by the model The model estimates the number of patients in each health state and calculates the corresponding cost and loss of quality of life. In this sense, the model employs a bottom-up approach to estimate the total burden, both in terms of monetary costs and quality of life. In addition, the annual number of liver cancer cases, liver transplants and deaths due to hepatitis C will be presented for the entire model horizon which spans from 2014 to In summary, the following outputs will be produced by the model; Prevalent cases by health state Number of liver cancer cases due to hepatitis C Number of deaths due to hepatitis C Health care costs Total cost including health care costs, drug costs and indirect costs Quality of life Quality of life The model estimates the loss of quality of life due to the disease in terms of QALYs. This measure takes into account both increases in the quality (in terms of quality of life) and quantity (number of years of life) of an intervention such as increasing treatment. Estimates on quality of life due to hepatitis C is 22 Burden of hepatitis C in Europe the case of France and Romania

25 assumed to decrease in line with the severity of the disease. The quality of life estimates for the general population is measured with EQ-5D and were only available for France [26]. In the case of Romania, estimates from Hungary have been used. Hungary was chosen due to its geographical proximity to Romania Included cost elements When estimating the monetary costs associated with a disease, a burden study can take a societal perspective including all costs of the disease, regardless of who incurs them. Alternatively, it can take a payer perspective in which normally only costs incurred by the health care system are taken into account. The present study takes a societal perspective and includes all costs associated with hepatitis C independent of who incurs them. These costs include health care costs, drug costs and indirect costs. Health care costs are costs associated with the resource use in the management of the disease. These costs include, but are not limited to, physician visits, diagnosis, acute care, in-patient care, and hospitalisation. Drug costs refer solely to the costs of the drugs given to treat the disease (pegylated interferon, ribavirin or/and protease inhibitors) and hence, are not included in the health care costs. Indirect costs are the costs associated with forgone production due to the disease. Indirect costs are twofold. First, patients infected with hepatitis C may have lower productivity at work and be more likely to miss work due to their sickness and/or be unable to attend work entirely. Secondly, production is also lost when patients in employable age die due to the disease. Both types of production losses are included in this study. This study uses nominal costs and results have not been discounted or inflated. Hence, the costs quoted in this report should be interpreted as the current cost of the disease, notwithstanding when they occur. 6.5 The estimated current burden of hepatitis C in France and Romania The current prevalence in France and Romania is characterised by a large share of patients in the mild and moderate stage of hepatitis C. However, the health care costs are largely driven by those in the cirrhotic and latter stages of the disease. This calls for an immediate action to treat now to prevent those in the mild and moderate stages to progress into the later and more costly stages of hepatitis C France The latest survey on prevalence in France, which has been used in this study, is from 2004 and reported a prevalence of 0.84% [27]. Given the current size of the French population, this would translate into approximately 400,000 infected individuals. Burden of hepatitis C in Europe the case of France and Romania 23

26 Percentage of infected population Prevalnece 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Infected individuals Health care costs Lost QALYs Mild Moderate Cirrhosis Decompensated cirrhosis HCC Figure 7 Distribution of cases and costs by disease stage in France Hepatitis C causes large health care costs for patients in latter stages. Patients in all chronic stages suffer from substantial loss in quality of life. Figure 7 describes the current distribution of the infected French population along with the health care cost and lost QALYs by disease stage. Mild and moderate hepatitis C together represent 80% of the infected population while the cost of these only make up to 15% of the total health care costs associated with the management of hepatitis C patients. The loss in quality of life for patients in mild and moderate stage is substantial. 100% 80% 1,20% 1,00% 60% 40% 20% 0% ,80% 0,60% 0,40% 0,20% 0,00% Mild Moderate Cirrhosis Decompensated cirrhosis HCC Prevalence Figure 8 Distribution and prevalence by age and disease stage in France Figure 8 shows the prevalence by age and disease severity. The prevalence by age group is illustrated by the orange line (right-hand axis). The composition of the disease stages varies by age. As expected, the severity of hepatitis C increases with age. While in the age-group 16-34, close to 60% of the infected individuals find themselves in the mild stage, less than 20% of those 65 years or older remain in the mild stage. In this group, the majority of patients are in a moderate stage and close to 20% are in 24 Burden of hepatitis C in Europe the case of France and Romania

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