Is there a place for sigmoidoscopy in colorectal cancer screening? A systematic review and critical appraisal of cost-effectiveness models.

INTRODUCTION: Screening for colorectal cancer (CRC) is effective in reducing both incidence and mortality. Colonoscopy and stool tests are most frequently used for this purpose. Sigmoidoscopy is an alternative screening measure with a strong evidence base. Due to its distinct characteristics, it might be preferred by subgroups. The aim of this systematic review is to analyze the cost-effectiveness of sigmoidoscopy for CRC screening compared to other screening methods and to identify influencing parameters. METHODS: A systematic literature search for the time frame 01/2010-01/2023 was conducted using the databases MEDLINE, Embase, EconLit, Web of Science, NHS EED, as well as the Cost-Effectiveness Registry. Full economic analyses examining sigmoidoscopy as a screening measure for the general population at average risk for CRC were included. Incremental cost-effectiveness ratios were calculated. All included studies were critically assessed based on a questionnaire for modelling studies. RESULTS: Twenty-five studies are included in the review. Compared to no screening, sigmoidoscopy is a cost-effective screening strategy for CRC. When modelled as a single measure strategy, sigmoidoscopy is mostly dominated by colonoscopy or modern stool tests. When combined with annual stool testing, sigmoidoscopy in 5-year intervals is more effective and less costly than the respective strategies alone. The results of the studies are influenced by varying assumptions on adherence, costs, and test characteristics. CONCLUSION: The combination of sigmoidoscopy and stool testing represents a cost-effective screening strategy that has not received much attention in current guidelines. Further research is needed that goes beyond a narrow focus on screening technology and models different, preference-based participation behavior in subgroups.

Lifestyle interventions for patients with non-alcoholic steato-hepatitis-Design, rationale and protocol of the study "target group-specific optimisation of lifestyle interventions for behavior change in non-alcoholic steato-hepatitis (OPTI-NASH)".

BACKGROUND: Non-alcoholic steato-hepatitis (NASH) is the inflammatory, progressive form of non-alcoholic fatty liver disease (NAFLD). A delayed diagnose interval is typical for the majority of the patients because of the asymptomatic natural course. However, serious sequelae may develop such as cirrhosis or hepatocellular carcinoma. NASH is also associated with an increased risk of metabolic diseases. Obesity developed due to a lack of exercise or a disadvantageous diet often leads to NAFLD or NASH, thereby interventions including enhanced physical activity and calorie reduction form the actual gold standard of treatment. To date, patients rarely use these. The project aims to model lifestyle interventions based on the preferences of the NASH patients. METHODS: Based on a systematic review and focus group discussions, two discrete choice experiments (DCE) will be designed, one on aspects influencing successful uptake of lifestyle interventions and one to analyses parameters contributing to long-term participation. An online survey will be used to elicit patient's preferences on program design and on motivational aspects in a cross-sectional design. The recruitment will take place in nine certified specialist practices and hospital outpatient clinics aiming to reach a sample size of n = 500 which is also required for the DCE design. DISCUSSION: The results will provide an overview of the NASH patient's preferences regarding the successful uptake and long-term implementation of lifestyle interventions. Recommendations for optimized lifestyle change programs will be derived and an intervention manual will be developed to facilitate target group-specific inclusion in programs in practice.

[Prevalence of metabolic syndrome : Analysis based on routine statutory health insurance data]. / Prävalenz des metabolischen Syndroms : Eine Analyse auf Basis von Routinedaten einer gesetzlichen Krankenversicherung.

BACKGROUND: The metabolic syndrome is a decisive risk factor for the manifestation of cardiovascular and metabolic diseases. Metabolic syndrome is the term used to describe the joint presence of specific diseases (obesity, hypertension, type 2 diabetes mellitus, disorders of fat metabolism). A classification is made more difficult by inconsistent definition criteria and a missing International Statistical Classification of Diseases and Related Health Problems (ICD) code. There are no known prevalence studies for Germany based on routine data of the statutory health insurance (GKV). OBJECTIVE: The main aim of the present study was to classify the metabolic syndrome based on routine data of the GKV and to estimate the frequency of diagnosis. In addition, the influence of social factors (school and educational qualifications) was examined for the subgroup of employees with social insurance. MATERIAL AND METHODS: A retrospective routine data analysis was carried out based on routine administrative data from the AOK Lower Saxony (AOKN). In contrast to the established definitions, which use medical parameters, the risk factors are taken into account via four coded diagnoses according to the ICD-10 classification: 1) obesity (E66.0, E66.8, E66.9), 2) type 2 diabetes mellitus (E11), 3) hypertension (I10) and 4) metabolic disorders (E78). A metabolic syndrome is present if at least two of the four diagnoses are present. RESULTS: The prevalence of metabolic syndrome in the population of the AOKN in 2019 was 25.7%. The standardized comparison according to the census population of 2011 showed an increase in the frequency of diagnosis (2009: 21.5% and 2019: 24%). The frequency of diagnosis differed according to school and educational qualifications. CONCLUSION: A classification and analysis of the frequency of the metabolic syndrome based on routine data of the GKV is possible. Between 2009 and 2019 there was a clear increase in the frequency of diagnoses.

[Intersectoral management of patients with abnormal liver enzymes and non-alcoholic fatty liver disease (NAFLD)]. / Intersektorales Management von Patienten mit unklarer Leberwerterhöhung und nichtalkoholischer Fettlebererkrankung (NAFLD).

The prevalence of fatty liver disease has increased significantly in Germany in recent years. With an estimated 18 million German citizens being affected, it is now among the most prevalent diseases. Furthermore, it is also considered a relevant and independent risk factor for other common cardiovascular diseases such as heart attack or stroke. Finally, diabetes mellitus promotes the development of and an unfavorable course of fatty liver disease. Given the high prevalence and complications, the German healthcare system is reaching its limits.Therefore, close coordination of all healthcare providers and specialists involved in the treatment of these patients is essential. In an expert consensus involving private practice and hospital doctors from the fields of gastroenterology, endocrinology, cardiology, general practitioners and laboratory physicians, as well as in close coordination with patient representatives, we have designed a concept for the care of these patients in the German healthcare system. Necessary developments are also addressed. In addition to being useful as a practical guideline, this should also support health policy work, especially in the development of practical care solutions at the medical level.

Real-world experience for the outcomes and costs of treating hepatitis C patients: Results from the German Hepatitis C-Registry (DHC-R).

BACKGROUND & AIMS: With long-term consequences like the development of liver cirrhosis and hepatocellular carcinoma, chronic hepatitis C virus (HCV) infection is associated with a significant health burden. Information on HCV treatment outcomes and costs in routine care is still rare, especially for subgroups. The aim of this study was to analyse the treatment outcomes and costs of subgroups in routine care and to compare them over time with previous analyses. METHODS: Data were derived from a noninterventional study including a subset of 10298 patients receiving DAAs with genotypes 1 and 3. Sociodemographic, clinical parameters and costs were collected using a web-based data recording system. The total sample was subdivided according to treatment regimen, cirrhosis status as well as present HIV infection and opioid substitution treatment (OST). RESULTS: 95% of all patients achieved SVR. Currently used DAA showed higher SVR-rates and less adverse events (AE) compared to former treatments. Concerning subgroups, cirrhotic patients, HIV-coinfected patients and OST patients showed lower but still high SVR-rates. In comparison, cirrhotic had considerably longer treatment duration and more frequent (serious) AE. Overall, average treatment costs were €48470 and costs per SVR were €51129; for currently used DAAs costs amounted to €30330 and costs per SVR to €31692. After the end of treatment, physical health is similar to the general population in all patients except cirrhotic. Mental health remains far behind in all subgroups, even for currently used DAA. CONCLUSIONS: Over time, some relevant factors developed positively (SVR-rates, costs, treatment duration, adverse events, health-related quality of life (HRQoL)). Further research on HRQoL, especially on mental health, is necessary to evaluate the differences between subgroups and HRQoL over time and to identify influencing factors.

[Frequency of diagnosed non-alcololic fatty liver disease (NAFLD) in the German population - An analysis based on health insurance data]. / Die Häufigkeit von diagnostizierten Fettlebererkrankungen (NAFLD) in der deutschen Bevölkerung ­ Eine Analyse auf der Basis von GKV-Routinedaten.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in Germany. In the long term, there is an increased risk of developing liver cirrhosis and subsequent diseases. Epidemiologic studies on NAFLD prevalence in Germany are scarce. The aim of the study was to assess administrative incidence and prevalence or, more specifically, the number of patients diagnosed with NAFLD in the period from 2008 to 2018. METHODS: Analyses are based on administrative data of a large statutory health insurance fund. All individuals who were insured in the year of analysis and in the three-year pre-observation period were included (between 1.7-2 million insured per analysis year). NAFLD-patients were identified using relevant ICD-10 codes (K76.0 und K75.8). RESULTS: In 2018, 4.66 % of insured persons had a NAFLD diagnosis, 0.87 % were diagnosed first-time. Diagnoses of nonalcoholic steatohepatitis (NASH) were comparatively rare (0.09 %). Data show an uptake of NAFLD diagnoses over time. The number of incident cases per year has hardly changed. Patients with diseases of the metabolic syndrome had an increased chance of being diagnosed with NAFLD. CONCLUSION: It becomes evident that NAFLD is frequently diagnosed in everyday medical practice, although data from population-based studies suggest an even higher prevalence.

Non-Invasive Reliable Methods to Objectify the Positive Influence of Hepatitis C Virus Treatment on Liver Stiffness.

BACKGROUND: Chronic active hepatitis C virus (HCV) infection is a major public health problem and causes liver fibrosis (LF) up to liver cirrhosis (LC). LF can be estimated by non-invasive, easy handling methods. With implementation of new HCV therapies, elimination rates of HCV are near 100%, resulting in less clinical complications and costs. The aim of our study was to evaluate the positive influence of HCV treatment on liver stiffness by non-invasive assessments of LF. METHODS: Sixty-two patients with HCV were treated with antiviral drug regimes. Serological fibrosis scores and ultrasound elastography (acoustic radiation force impulse and shear wave elasticity imaging (ARFI-SWEI)) were used for LF assessment on day 0 and 6 months after therapy. RESULTS: Antiviral treatment was successful in all cases. ARFI-SWEI measurements showed an improvement of all LF stages. Results of serological markers and scores were heterogeneous. Significant positive effects of treatment were seen for aspartate aminotransferase-to-platelet ratio index (APRI) and fibrosis-4 (FIB-4) scores, only. Further Pearson's coefficient showed moderate till very high correlations for ARFI-SWEI and FIB-4/APRI scores. CONCLUSION: Today HCV therapy is able to cure HCV. Positive influences are improvement of LF stages. ARFI-SWEI, APRI and FIB-4 score are useful, easy handling tools to verify positive influence of HCV treatment on LF alone or in combination.

[Acute exacerbation of reactivated chronic hepatitis-b after stopping antiviral medication followed by loss of HBsAg]. / Akute Exazerbation einer reaktivierten chronischen Hepatitis B nach Absetzen der antiviralen Therapie mit nachfolgendem Verlust des HBsAg.

HISTORY AND CLINICAL FINDINGS: A 66-year-old women with chronic hepatitis-b and antiviral therapy was presented with icterus and sickness 2 weeks after cold symptoms. The treatment was stopped by patient 6 month before. The liver was enlarged, the abdomen and further body status unsuspicious. FINDINGS AND DIAGNOSIS: The chemical results showed elevated liver enzymes and bilirubin values. The hepatitis-b status revealed signs of chronical course (HBsAg positive), the virus amount was > 21 Mio IU/ml. The sonographic abdominal status was normal. THERAPY AND COURSE: The antiviral therapy was re-established and liver enzymes improved. The virus amount was falling and after 22 weeks antiviral therapy seroconversion (HBsAg negative) and healing up of hepatitis-b was objectified. CONCLUSION: Acute exacerbation of chronic hepatitis-b followed stopping antiviral treatment can lead to healing by loss of HBsAg.

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies.

BACKGROUND: Chronic hepatitis C is a major public health burden. With new interferon-free direct-acting agents (showing sustained viral response rates of more than 98%), elimination of HCV seems feasible for the first time. However, as HCV infection often remains undiagnosed, screening is crucial for improving health outcomes of HCV-patients. Our aim was to assess the long-term cost-effectiveness of a nationwide screening strategy in Germany. METHODS: We used a Markov cohort model to simulate disease progression and examine long-term population outcomes, HCV associated costs and cost-effectiveness of HCV screening. The model divides the total population into three subpopulations: general population (GEP), people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM), with total infection numbers being highest in GEP, but new infections occurring only in PWIDs and MSM. The model compares four alternative screening strategies (no/basic/advanced/total screening) differing in participation and treatment rates. RESULTS: Total number of HCV-infected patients declined from 275,000 in 2015 to between 125,000 (no screening) and 14,000 (total screening) in 2040. Similarly, lost quality adjusted life years (QALYs) were 320,000 QALYs lower, while costs were 2.4 billion EUR higher in total screening compared to no screening. While incremental cost-effectiveness ratio (ICER) increased sharply in GEP and MSM with more comprehensive strategies (30,000 EUR per QALY for total vs. advanced screening), ICER decreased in PWIDs (30 EUR per QALY for total vs. advanced screening). CONCLUSIONS: Screening is key to have an efficient decline of the HCV-infected population in Germany. Recommendation for an overall population screening is to screen the total PWID subpopulation, and to apply less comprehensive advanced screening for MSM and GEP.

Outcomes and costs of treating hepatitis C patients with second-generation direct-acting antivirals: results from the German Hepatitis C-Registry.

OBJECTIVE: Chronic hepatitis C virus infection is associated with a significant health burden. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The introduction of direct-acting antivirals (DAA) has led to an increase in sustained virologic response rates (SVR), but is accompanied by higher treatment costs. The aim of this study was to assess the outcomes and costs of treating hepatitis C virus infected patients with DAAs in clinical practice in Germany. PATIENTS AND METHODS: Data were derived from a noninterventional study including a pharmacoeconomic subset of 2673 patients with genotypes 1 and 3 who initiated and completed treatment between February 2014 and February 2017. Sociodemographic and clinical parameters as well as resource utilization were collected using a web-based data recording system. Costs were calculated using official remuneration schemes. RESULTS: The mean age of the patients was 54.6 years; 48% were men. 93.5% of all patients achieved an SVR. The average total treatment costs were &OV0556;67 979 (&OV0556;67 131 medication costs, &OV0556;824 ambulatory care, &OV0556;24 hospital costs). The average costs per SVR of &OV0556;72 705 were calculated. Differences in SVR and costs according to genotype, treatment regimen, treatment experience, and cirrhosis were observed. Quality-of-life data showed no or a minimal decrease during treatment. CONCLUSION: This analysis confirms high SVR rates for newly introduced DAAs in a real-world setting. Costs per SVR estimated are comparable to first-generation DAA. Given the fact that the costs for the currently used treatment regimens have declined, it can be assumed that the costs per SVR have also decreased. Our insight into real-world outcomes and costs can serve as a basis for a comparison with the mentioned newly introduced treatment regimens.

Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany.

BACKGROUND: Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany. MATERIAL AND METHODS: We used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness. RESULTS: Base-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses. CONCLUSIONS: Our analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds.

Ultrasound Elastography Used for Preventive Non-Invasive Screening in Early Detection of Liver Fibrosis.

BACKGROUND: Early discovery of liver fibrosis is becoming more popular because of enhanced incidence of hepatocellular carcinoma. Ultrasound-based liver elastography is a method used to approve suspected liver fibrosis or cirrhosis. We assessed the clinical usefulness of acoustic radiation force impulse shear wave elasticity imaging (ARFI-SWEI) as a preventive screening method to uncover fibrosis. METHODS: We screened 382 patients by native routine sonography for abnormal liver results and divided them into six groups: group 1: normal liver, groups 2-4: fatty liver grade I-III, group 5: liver cirrhosis, and group 6: inhomogenic liver tissue. Then ARFI-SWEI was performed and the results were compared with published shear wave velocity cut-off values that were predictive of each fibrosis stage (F0-4). A control group consisted of 20 healthy volunteers. RESULTS: The part of liver fibrosis ≥ F2 was in groups 1-4: 20-32%, group 5: 100%, and group 6: 91%. Main causes for fibrosis stage ≥ F2 were (non)-alcoholic steatohepatitis, chronic viral or autoimmune hepatitis and chronic heart failure. CONCLUSIONS: Screening of the liver tissue in b-mode ultrasound can underestimate possible liver fibrosis; by using ARFI-SWEI, liver fibrosis can be uncovered early. It is a suitable preventive method comparable to colonoscopy for colon cancer.

Outcomes and Costs of Treating Hepatitis C Patients in the Era of First Generation Protease Inhibitors - Results from the PAN Study.

1 OBJECTIVE: Chronic hepatitis C virus infections (HCV) cause a significant public health burden. Introduction of telaprevir (TVR) and boceprevir (BOC) has increased sustained virologic response rates (SVR) in genotype 1 patients but were accompanied by higher treatment costs and more side effects. Aim of the study was to assess outcomes and costs of treating HCV with TVR or BOC in routine care. 2 MATERIAL AND METHODS: Data was obtained from a non-interventional study. This analysis relates on a subset of 1,786 patients for whom resource utilisation was documented. Sociodemografic and clinical parameters as well as resource utilisation were collected using a web-based data recording system. Costs were calculated using official remuneration schemes. 3 RESULTS: Mean age of patients was 49.2 years, 58.6% were male. In treatment-naive patients SVR-rates of 62.2% and 55.7% for TVR and BOC were observed (prior relapser: 68.5% for TVR and 63.5% for BOC; prior non-responder: 45.6% for TVR and 39.1% for BOC). Treatment costs are dominated by costs for pharmaceuticals and range between €39,081 and €53,491. We calculated average costs per SVR of €81,347 (TVR) and €70,163 (BOC) in treatment-naive patients (prior relapser: 78,089 €/SVR for TVR and 82,077 €/SVR for BOC; prior non-responder: 116,509 €/SVR for TVR and 110,156 €/SVR for BOC). Quality of life data showed a considerable decrease during treatment. 4 CONCLUSION: Our study is one of few investigating both, outcomes and costs, of treating HCV in a real-life setting. Data can serve as a reference in the discussion of increasing costs in recently introduced agents.

High prevalence of chronic hepatitis B and C virus infection in a population of a German metropolitan area: a prospective survey including 10 215 patients of an interdisciplinary emergency unit.

PURPOSE: The prevalence of chronic hepatitis B virus- and hepatitis C virus-infections in the general German population has been estimated to be 0.6-0.7 and 0.3-0.4%, respectively. The population of Frankfurt/Main is multicultural and marked by different risks of chronic viral hepatitis. The aim of this prospective study was to define epidemiologic data for hepatitis B and C from consecutive patients of an interdisciplinary emergency unit in Frankfurt. PATIENTS AND METHODS: Over a period of 12 months, 10 215 patients of an interdisciplinary emergency unit in Frankfurt/Main were screened for hepatitis B surface-antigen (HBsAg) and hepatitis C virus-antibodies (HCV-Ab). In case of positive HBsAg or HCV-Ab, a quantitative PCR analysis of virus was carried out. RESULTS: The prevalence of HBsAg and HCV-Ab in the study population was 1.32% (n=135; group 1) and 2.70% (n=276; group 2), respectively, with a sex ratio close to 1. Quantitative PCR tests of virus load were performed in 72.59% (group 1) and in 82.61% (group 2), with confirmed viremia in 54.08% (group 1) and 41.67% (group 2), and correlated to elevated liver enzymes in 49.05% (group 1) and in 75.78% (group 2) of the cases. The ethnic distribution was 87.09% White (n=8897; group A) versus 12.90% other ethnic groups (n=1318; group B), with a prevalence of HBsAg-positive and HCV-Ab-positive cases of 1.08 and 2.76% (group A) and 2.96 and 2.28% (group B). CONCLUSION: The results show that in multicultural areas, the prevalence of chronic viral hepatitis is increased. Because of the potential of progressive liver damage in viral hepatitis, field screening in specific populations at high risk for hepatitis should be performed.

Outcomes, costs and cost-effectiveness of treating hepatitis C with direct acting antivirals.

Hepatitis C is a global public health burden. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Introduction of different direct acting antivirals targeting the hepatitis C proteins has considerably increased rates of sustained viral response. First active substances introduced in 2011 were NS3/4A protease inhibitors telaprevir and boceprevir. In 2013/2014 the second generation of direct acting antivirals sofosbuvir, simeprevir, daclatasvir, ledipasvir and 3D therapy containing ombitasvir/paritaprevir/ritonavir and dasabuvir followed. This review focuses on treatment outcomes and costs of introduced direct acting antivirals. We provide an overview on SVR-rates in clinical trials and clinical practice, treatment costs in different countries as well as results of cost-effectiveness analyses for different treatment strategies.

[Rare cause of recurrent subileus]. / Seltene Genese eines rezidivierenden Subileus.

HISTORY AND CLINICAL FINDINGS: An 85-years-old woman with percutaneous endoscopic gastrostomy (PEG) presented at our emergency unit with repeating abdominal pain and changes in the consistency of the stool. The PEG was placed during a treatment of an oropharynxcarcinoma in the past, was replaced repeatedly and is still in use. INVESTIGATIONS: The initial clinical results were unobtrusive; the ultrasound of the abdomen showed mild distended loops of the small intestine, the x-ray of the abdomen was unsuspicious with diagnosis of subileus by constipation. The esophagogastroduodenoscopy was also without pathological findings and showed correct position of the PEG and normal aspect of the gastric tissue. An additional computerized tomography (ct-scan) of the abdomen demonstrated a foreign body nearly 2.5 cm in diameter in the distal part of the small intestine, the terminal ileum, differentiated as PEG retaining plate, also seen retrospectively in the initial x-ray. TREATMENT AND COURSE: Because the endoscopic salvage failed, the foreign body had to be removed surgically. The retaining plate was the cause for subtotal occlusion and also for the perforation of the small intestine. It was found nearly 15 cm before ileo-terminal valve. After operation the patient recovered soon. CONCLUSION: The history gave no hints of accidentally broken PEG-tube; presumably the retaining plate was cut off while the PEG was changed and let go on natural way. The aim of gastroenterologists should be removing PEG under endoscopic control.

Cost of treating hepatitis C in Germany: a retrospective multicenter analysis.

BACKGROUND: Viral hepatitis is major a public health problem affecting millions of people worldwide. Estimates assume 400 000-500 000 people chronically infected with hepatitis C virus (HCV) in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess the costs for treating patients with chronic HCV in Germany. METHODS: We conducted a retrospective multicenter observational study. The design was approved by an ethics committee, and patients were asked for their informed consent. Patients were grouped in four different health states. Healthcare utilization data were extracted from doctor files of six medical centers in Germany. RESULTS: Data of 315 patients with chronic HCV were analyzed. The mean age was 49.4 years, 57.5% were male and 67.9% had a genotype 1 infection. The most common routes of transmission were injection drug use (39.0%) and infection through blood products (15.9%). The average total cost was €19 147 including ambulatory care and diagnostics (€1686), pharmaceuticals (€14 875), inpatient care (€1293), and sick leave (€1293). For patients in stable health states (mild and moderate HCV, compensated cirrhosis), costs did not differ significantly and were mainly influenced by antiviral treatment. For patients with decompensated cirrhosis, inpatient care accounted for the largest part of the costs. CONCLUSION: Treatment of HCV patients involves high costs, mainly associated with the length of antiviral therapy. Viral eradication can prevent severe disease stages, which are associated with high costs. It is necessary to follow current guidelines and monitor patients closely to avoid unnecessary costs.

Cost-effectiveness of Triple Therapy with Telaprevir for Chronic Hepatitis C Virus Patients in Germany.

Background: About 400,000-500,000 people are infected with hepatitis C in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The introduction of first generation protease inhibitors has significantly improved the treatment of hepatitis C genotype 1 patients. The aim of the study was to assess the cost-effectiveness of triple therapy with telaprevir in Germany. Methods: We used a Markov model on disease progression and natural history to assess the cost-effectiveness of triple therapy with telaprevir compared to standard treatment with pegylated interferon and ribavirin. Model structure and inputs were discussed with clinical experts. Deterministic and probabilistic sensitivity analyses were performed to verify the robustness of results. Results: The base-case analyses shows that triple therapy results in higher costs (untreated patients: €48,446 vs. €30,691; previously treated patients: €63,228 vs. €48,603) and better outcomes (untreated patients: 16.85 qualily of life years [QALYs] vs. 15.97 QALYs; previously treated patients: 14.16 QALYs vs. 12.89 QALYs). The incremental cost-effectiveness ratio (ICER) was €20,131 per QALY and €30,567 per life year gained (LYG) for previously untreated patients. ICER in treatment experienced patients was €7,664 per QALY for relapse patients, €12,506 per QALY for partial responders and €28,429 per QALY for null responders. Results were robust in sensitivity analyses. Conclusion: Although triple therapy with telaprevir leads to additional costs, there is a high probability of being cost-effective for different thresholds. This health economic analysis makes an important contribution to current debates on cost savings and efficient resource allocation in the German healthcare sector.

Clinical effectiveness and cost effectiveness of tailoring chronic hepatitis C treatment with peginterferon alpha-2b plus ribavirin to HCV genotype and early viral response: a decision analysis based on German guidelines.

BACKGROUND: Recently developed German guidelines for antiviral treatment in patients with chronic hepatitis C recommend basing drug dosage, intended treatment duration and early stopping rules on the genotype of the hepatitis C virus and early viral responses to treatment. OBJECTIVES: To evaluate effectiveness and cost effectiveness of different antiviral treatment strategies including the German guidelines, for chronic hepatitis C. METHODS: A validated lifetime Markov model was used to project life expectancy, QALYs and lifetime costs for the following strategies: (i) no antiviral therapy (NoAVT); (ii) interferon-alpha-2b plus ribavirin for 48 weeks (IFN + R); (iii) peginterferon-alpha-2b plus weight-based ribavirin for 48 weeks (PEG + R); (iv) peginterferon-alpha-2b plus ribavirin according to German guidelines with genotype-dependent treatment duration, dosage and 12-week viral response evaluation (GUIDE). Clinical and resource utilization data were derived from a clinical trial, the published literature and a survey of German hepatologists. Incremental cost-effectiveness ratios (ICERs) were calculated adopting the German societal perspective. Costs (in euro, year 2005 values) and health outcomes were discounted at 3% annually. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. RESULTS: Compared with NoAVT, PEG + R increased undiscounted life expectancy by 5.0 life-years (5.2 QALYs) and GUIDE increased undiscounted life expectancy by 4.9 years (5.1 QALYs). Compared with PEG + R, GUIDE saved 13% of hepatitis C virus-related lifetime costs per patient. GUIDE dominated IFN + R. Compared with NoAVT, discounted ICERs were euro1500 per QALY for GUIDE and euro3200 per QALY for PEG + R. CONCLUSION: Administering GUIDE should allow tailoring treatment efficiently to genotype, bodyweight and early viral response in patients with chronic hepatitis C, and appears cost effective compared with other well accepted medical interventions.