Statutory Health Insurance Perspective Research Articles

Cost-Effectiveness and Budget Impact Analyses of Selective Internal Radiation Therapy versus Atezolizumab Plus Bevacizumab from a German Statutory Health Insurance Perspective.

To compare personalized dosimetry with yttrium-90 (90Y)-loaded glass microspheres (SIRT) vs atezolizumab and bevacizumab (A+B) in hepatocellular carcinoma (HCC) treatment in terms of cost-effectiveness and budget impact from a German statutory health insurance (SHI) perspective. Cost-effectiveness analysis (CEA) and budget impact analysis (BIA) models were developed in MS Excel. The available key studies (IMbrave150 and DOSISPHERE-01) suggest that both strategies are comparable in terms of progression-free survival and overall survival in HCC, but a difference in severe adverse events (SAE) in favor of SIRT was observed. Accordingly, the CEA model investigates the endpoints "cost per SAE avoided" and "cost per quality-adjusted life year (QALY) gained", whereas the BIA simulates the impact of a stepwise re-allocation of current market share to the option which emerges as more cost-effective from the CEA. The model suite estimated a mean annual total per-patient costs of € 29,984 for SIRT, compared to € 75,725 for A+B. SIRT was associated with a lower number of SAE and a higher number of QALYs compared to A+B. Switching additionally 25% of the eligible patients (≈500) from systemic therapy to SIRT could generate annual savings of approximately € 22.6 million Euros to the SHI. SIRT was identified as dominant treatment strategy. SIRT use not only saves SHI expenditure compared to systemic immunotherapy but also yields extra QALYs. This positions SIRT as the dominant and more cost-effective treatment strategy for patients with HCC. The savings to the SHI system, derived from the BIA conducted, become increasingly significant with rising adoption rates of SIRT.

Patients on vitamin K treatment: is switching to direct-acting oral anticoagulation cost-effective? A target trial on a prospective cohort

AimsDirect-acting oral anticoagulants (DOACs) have, to a substantial degree, replaced vitamin K antagonists (VKA) as treatments for stroke prevention in atrial fibrillation (AF) patients. However, evidence on the real-world causal...

Protocol for an economic evaluation of a tele-neurologic intervention alongside a stepped wedge randomised controlled trial (NeTKoH)

BackgroundA significant and growing portion of the global burden of diseases is caused by neurological disorders. Tele-neurology has the potential to improve access to health care services and the quality of care, particularly in rural and underserved areas. The economic evaluation of the stepped wedge randomised controlled trial NeTKoH aims to ascertain the cost-effectiveness and cost-utility regarding the effects of a tele-neurologic intervention in primary care in a rural area in Germany.MethodsThis protocol outlines the methods used when conducting the trial-based economic evaluation of NeTKoH. The outcomes used in our economic analysis are all prespecified endpoints of the NeTKoH trial. Outcomes considered for the cost-utility and cost-effectiveness analyses will be quality-adjusted life years (QALYs) derived from the EQ-5D-5L, proportion of neurologic problems being solved at the GP’s office (primary outcome), hospital length-of-stay and number of hospital stays. Costs will be prospectively collected during the trial by the participating statutory health insurances, and will be analysed from a statutory health insurance perspective within the German health care system. This economic evaluation will be reported complying with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.DiscussionThis within-trial economic evaluation relaying the costs and outcomes of an interdisciplinary tele-consulting intervention will provide high-quality evidence for cost-effectiveness and policy implications of a tele-neurological programme, including the potential for application in other rural areas in Germany or other jurisdictions with a comparable health system.Trial registrationGerman Clinical Trials Register (DRKS00024492), date registered: September 28, 2021.

Cost Effectiveness and Budget Impact of Nivolumab Plus Ipilimumab Versus Platinum Plus Pemetrexed (with and Without Bevacizumab) in Patients with Unresectable Malignant Pleural Mesothelioma in Switzerland.

Malignant pleural mesotheliomas (MPMs) are aggressive and often unresectable. In the past, chemotherapy was the standard for palliative treatment. However, immunotherapy with nivolumab+ipilimumab has recently received marketing approval. This study evaluated the cost effectiveness of nivolumab+ipilimumab versus pemetrexed+platinum (with/without bevacizumab) for Swiss patients with unresectable MPM, overall and by histological subtype. We developed a three-state Markov cohort model with a cycle length of 1month, a 30-year time horizon, and a discount rate of 3% per year for costs and benefits. The model included the updated survival and treatment-dependent utility results from the Checkmate-743 and MAPS registration trials. A Swiss statutory health insurance perspective was considered with unit costs for 2022 from publicly available and real-world sources. We assumed a willingness-to-pay (WTP) threshold of CHF100,000/QALY. Model robustness was explored in sensitivity and scenario analyses. Compared with chemotherapy, nivolumab+ipilimumab incurred additional costs of CHF109,115 and 0.57 additional quality-adjusted life-years (QALYs), yielding an incremental cost-effectiveness ratio (ICER) of CHF192,585/QALY (i.e. USD201,829/QALY) gained. Relative to their 2022 list price, nivolumab+ipilimumab may be cost effective if priced at 48% across all histologies. Assuming cisplatin-based instead of carboplatin-based chemotherapy reduced the ICER to CHF158,911/QALY (i.e. USD166,539/QALY). For the non-epithelioid subtype, nivolumab+ipilimumab was cost effective compared with chemotherapy (ICER of CHF97,894/QALY, i.e. USD102,593/QALY). Chemotherapy+bevacizumab was often a dominated strategy or would require a bevacizumab cost reduction to 28%. Our model projected nivolumab+ipilimumab to be cost effective for the non-epithelioid subtype but not for all histologies. Substantial discounts for nivolumab+ipilimumab would be necessary to achieve cost effectiveness for all histologies.

Vaccinating the German Population Aged 60 Years and Over with a Quadrivalent High-Dose Inactivated Influenza Vaccine Compared to Standard-Dose Vaccines: A Transmission and Budget Impact Model.

In Germany, influenza vaccination is mainly advised for persons aged 60 years and over and individuals with health risks. Since 2021, an inactivated, quadrivalent high-dose influenza vaccine (IIV4-HD) has been recommended for persons aged 60 years and over. The aim of this study was to calculate the impact of vaccinating the German population aged 60 years and over with IIV4-HD compared to standard-dose influenza vaccines (IIV4-SD) with regard to health outcomes and costs. An age-stratified deterministic compartment model was built to simulate the course of influenza infection for the German population in the season 2019/20. Probabilities for health outcomes and cost data were searched from the literature and were used to compare the influenza-related health and economic effects for different scenarios. Perspectives were those of the statutory health insurance and the society. Deterministic sensitivity analyses were conducted. From the statutory health insurance perspective, vaccinating the German population aged 60 years and over with IIV4-HD would have prevented 277,026 infections (-1.1%) with an increase of overall direct costs of €224 million (+40.1%) compared with IIV4-SD. A separate analysis showed that increased vaccination of 75% (World Health Organization recommendation for older age groups) in persons aged 60 years and over using IIV4-SD only would prevent 1,289,648 infections (-5.1%) and would save costs from a statutory health insurance perspective of €103 million (-13.2%) compared with IIV4-HD at actual vaccination rates. The modeling approach offers important insights into the epidemiological and budgetary impact of different vaccination scenarios. Achieving a higher vaccination coverage with IIV4-SD in persons aged 60 years and over would result in lower costs and fewer influenza infections compared with the scenario with IIV4-HD and actual vaccination rates.

Real-world treatment patterns and healthcare resource utilization among migraine patients: a German claims database analysis

AimsDespite migraine being one of the most common neurological diseases, affected patients are often not effectively treated. This analysis describes the burden of migraine in Germany and assesses real-world treatment patterns and healthcare resource utilization (HCRU) of preventive-treated migraine patients from the perspective of Statutory Health Insurance.MethodsA retrospective analysis was conducted using InGef Research Database claims data from 2018–2019. Migraine patients were stratified into cohorts by acute and preventive treatment status. Patients on preventive treatment were further stratified according to the type of prophylaxis received. Disease burden in preventively treated migraine patients was reported via treatment patterns, pathways, and comorbidities. HCRU was assessed through outpatient provider visits, hospitalizations, and sick leave.Results160,164 adult migraine patients were identified, of which 55,378 (34.6%) were prescribed preventive treatment with conventional (n = 25,984, 46.9%), calcitonin gene-related peptide monoclonal antibody (CGRP mAb) (n = 613, 1.1%), or off-label therapies (n = 28,781, 52.0%). 936 (1.7%) patients received Botulinum Neurotoxin Type A (BoNTA). CGRP mAb-treated patients had a high rate of triptan prescriptions (2018: 95.5%; 2019: 88.9%), migraine-related hospitalizations (2018: 33.0%; 2019: 21.0%), and sick leave (2018: 26.8%; 2019: 22.5%). A high proportion of CGRP mAb- and BoNTA-treated patients was diagnosed with abdominal and pelvic pain (34.3% and 36.2%) and low back pain (34.1% and 35.3%). These patients also showed a high prevalence of depressive episodes (49.1% and 50.1%) and chronic pain disorders (37.5% and 32.9%).LimitationsThis study focused on descriptive analyses which do not allow for assessment of causality when comparing treatment groups.ConclusionsDisease burden was high in patients receiving CGRP mAbs suggesting that patients treated preventively with CGRP mAbs shortly after product launch in Germany were severely affected, chronic migraine patients. The same may be true for patients receiving BoNTA who also showed an increased disease burden.

Cost-Effectiveness of SAPIEN3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk.

In the randomized PARTNER3 trial, transcatheter aortic valve implantation (TAVI) with the SAPIEN3 device significantly reduced a composite of all-cause death, stroke, and rehospitalization, compared with surgical aortic valve replacement (SAVR), in patients with severe symptomatic aortic stenosis and low risk of surgical mortality. Furthermore, TAVI has been shown to be cost-effective in low-risk patients, compared with SAVR, in a number of countries. This study aimed to determine the cost-effectiveness of TAVI with SAPIEN3 versus SAVR in Germany. A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER3 trial was adapted for the German context using the German Statutory Health Insurance perspective. The model had a lifetime horizon. The cost-utility analysis estimated changes in direct healthcare costs as well as survival and health-related quality of life using TAVI with SAPIEN3 compared with SAVR. TAVI with SAPIEN3 increased quality-adjusted life years (QALYs) by + 0.72 at an increased cost of €8664 per patient. The incremental cost-effectiveness/QALY ratio was €12,037, which fell below that of other cardiovascular interventions in use in Germany. The cost-effectiveness of TAVI over SAVR remained robust across multiple challenging scenarios and was driven by lower longer-term management costs compared with SAVR. TAVI with SAPIEN3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and low risk for surgical mortality in Germany. www. gov identifier: NCT02675114.

Hyaluronic acid treatment versus standard of care in chronic wounds in a German setting: Cost-effectiveness analysis.

Chronic wounds are a major burden for worldwide health care systems. In the management of chronic wounds several strategies with innovative and active agents emerged in the past few years, such as hyaluronic acid containing wound dressings. Evidence comparing the cost-effectiveness of hyaluronan and standard of care dressings (hydrofiber with silver) is still missing. The aim of the study is thus, to assess the cost-effectiveness of hyaluronan versus standard of care dressings (hydrofiber with silver) in chronic wounds from a German statutory health insurance perspective. A decision tree was modeled to quantify the cost and healing rate at 12 weeks for the hyaluronan and silver dressings strategies. Input parameters were collected literature-based, accounting for healing rates, dressing prices and prices for dressing changes and associated home care. Parameter uncertainty was accounted for by one-way and probabilistic sensitivity analysis. Hyaluronic acid showed a better healing rate (60.68%) and noticeable lower cost (749.80 Euro) compared to standard of care (silver containing) dressings (59.62%; 883.05 Euro), resulting in an Incremental Cost Effectiveness Ratio of -12,570.57. The hyaluronan approach is hence a dominant strategy in chronic wound management. Sensitivity analysis confirmed these results, giving a range of 60%- 70% of cost-effective scenarios. Hyaluronic acid dressings showed to be a clinical more effective strategy at significantly lower cost in chronic wounds compared to standard of care (hydrofiber with silver).

EE566 Cost-Effectiveness and Budget Impact Analysis of Selective Internal Radiation Therapy Versus Atezolizumab Plus Bevacizumab From a German Statutory Health Insurance Perspective

Non-metastasized, non-resectable hepatocellular carcinoma (HCC) in patients with Barcelona clinic liver cancer (BCLC) stages B and, in part, C (≈25%) can be treated by systemic immunotherapy or selective internal radiation therapy (SIRT). Therapies vary in terms of required infrastructure, medical specialization(s), facilities, preparation, conduct, and cost. Our objective was to undertake a cost-effectiveness analysis (CEA) and budget impact analysis (BIA) of SIRT – here: with 90Y-labelled glass microspheres (TheraSphere®) compared to immunotherapy with atezolizumab plus bevacizumab (A+B) – from the perspective of the German statutory health insurance (SHI).

Health economic evaluation of the ‘Flying Intervention Team’ as a novel stroke care concept for rural areas: study protocol of the TEMPiS-GÖA study

IntroductionProviding comprehensive stroke care poses major organisational and financial challenges to the German healthcare system. The quasi-randomised TEMPiS–Flying Intervention Team (TEMPiS-FIT) study aims to close the gap in the treatment...

Cost-effectiveness of the MitraClip device in German heart failure patients with secondary mitral regurgitation

AimTo evaluate the cost-effectiveness of the MitraClip device (MitraClip) in addition to optimal medical therapy (OMT) in patients with heart failure and secondary mitral regurgitation in Germany.Methods and resultsA model-based economic evaluation was performed to estimate the incremental cost per quality-adjusted life-years (QALYs) for patients with a moderate-to-severe or severe secondary mitral regurgitation receiving MitraClip plus OMT compared with OMT alone from the statutory health insurance (SHI) perspective. Transition probabilities, data on survival rates, and hospitalization rates were obtained from the COAPT trial, a randomized-controlled multicenter trial. Data on health utility and costs were taken from published evidence. To assess parameter uncertainty, several deterministic and probabilistic sensitivity analyses were performed. The incremental costs per QALY gained were € 59,728 (costs/incremental life years gained: € 42,360). The results were most sensitive to the transition probabilities and the hospitalization rates. The probabilistic sensitivity analysis showed that the MitraClip strategy was cost-effective with a probability of 80% at a willingness-to-pay threshold of € 67,000/QALY.ConclusionsDepending on the willingness-to-pay threshold, for patients with heart failure and a moderate-to-severe or severe secondary mitral regurgitation the MitraClip can be cost-effective from the perspective of the German SHI.Graphical abstract

Cost-effectiveness analysis of superabsorbent wound dressings in patients with moderate-to-highly exuding leg ulcers in Germany.

The study aims to estimate the cost‐effectiveness of superabsorbent wound dressings compared to the standard‐of‐care (SoC) dressings mix for treatment of patients with moderate‐to‐highly exuding leg ulcers in the German healthcare settings. A model‐based cost‐effectiveness analysis was conducted from the German statutory health insurance perspective, following German specific and international recommendations of good research practice. An individual‐level (microsimulation) state‐transition model has been used with a cycle length of 1 week and time horizon of 6 months. Several comprehensive systematic reviews were conducted to inform all model inputs, including clinical parameters, efficacy, quality of life, resources utilisation, and cost inputs. In addition, primary data from two clinical trials were used. Based on this cost‐effectiveness analysis, using superabsorbent wound dressings instead of the SoC dressings of patients with moderate‐to‐highly exuding leg ulcers in Germany can lead to an improved healing rate of 2.57% (benefit ratio 1.08), improved health‐related quality of life of 0.152 quality‐adjusted life weeks, and total direct cost savings of €771 per patient in 6 months. Robustness of results was confirmed in sensitivity and scenario analyses.

Health care utilization and excess costs after pelvic fractures among older people in Germany

SummaryOur study demonstrates a strong increase in utilization of inpatient health care and clear excess costs in older people in the first year after pelvic fracture, the latter even after adjustment for several confounders. Excess costs were particularly high in the first few months and mainly attributable to inpatient treatment.IntroductionWe aimed to estimate health care utilization and excess costs in patients aged minimum 60 years up to 1 year after pelvic fracture compared to a population without pelvic fracture.MethodsIn this retrospective population-based observational study, we used routine data from a large statutory health insurance (SHI) in Germany. Patients with a first pelvic fracture between 2008 and 2010 (n=5685, 82% female, mean age 80±9 years) were frequency matched with controls (n=193,159) by sex, age at index date, and index month. We estimated health care utilization and mean total direct costs (SHI perspective) with 95% confidence intervals (CIs) using BCA bootstrap procedures for 52 weeks before and after the index date. We calculated cost ratios (CRs) in 4-week intervals after the index date by fitting mixed two-part models including adjustment for possible confounders and repeated measurement. All analyses were further stratified for men/women, in-/outpatient-treated, and major/minor pelvic fractures.ResultsHealth care utilization and mean costs in the year after the index date were higher for cases than for controls, with inpatient treatment being particularly pronounced. CRs (95% CIs) decreased from 10.7 (10.2–11.1) within the first 4 weeks to 1.3 (1.2–1.4) within week 49–52. Excess costs were higher for inpatient than for outpatient-treated persons (CRs of 13.4 (12.9–13.9) and 2.3 (2.0–2.6) in week 1–4). In the first few months, high excess costs were detected for both persons with major and minor pelvic fracture.ConclusionPelvic fractures come along with high excess costs and should be considered when planning and allocating health care resources.

PCN126 A Cost IMPACT Analysis of Clonoseq® As a Valid and CE-Certified Minimal Residual Disease (MRD) Diagnostic in Multiple Myeloma in Germany

The measurement of minimal residual disease (MRD) with clonoSEQ®-Assay is being used in the assessment of residual lymphoid B-cell tumor burden throughout treatment with increased accuracy, higher sensitivity and objective assessment compared to traditional cytomorphological approaches. With more targeted therapies and immunotherapies in lymphoid cancers, standardized MRD assessment methods with higher sensitivity and specificity are becoming increasingly important. The primary aim of this analysis is to estimate the cost-effectiveness of MRD testing with clonoSEQ® compared to no MRD testing for patients with multiple myeloma (MM) on maintenance drug therapy in Germany. The cost impact of clonoSEQ® was analyzed from the German statutory health insurance perspective. Clinical data were derived from literature and expert opinions. Cost input was utilized based on publicly available data and literature. Patients in the MRD arm were assumed to be tested every 6 months. The deterministic Markov model consists of six health states and every patient begins at the start of their drug maintenance therapy. Included therapies are RVD (lenalidomide, bortezomib, dexamethasone), bone marrow transplantation / stem cell transfusion, lenalidomide and for the relapsed health state carfilzomib, lenalidomide and dexamethasone. For a time horizon of ten years, the cost impact analysis shows total cost of € 336’056 for patients with MRD testing using the clonoSEQ® in comparison to € 364’576 for simulated patients without an MRD test. The cost savings per patients are calculated to be € 28’520 per patient in Germany. Cost savings after 3 years are 25’224 € per patient. The main drivers for the cost differences are the saved cost of unnecessary drug therapies. Based on the underlying health economic model, the clonoSEQ® MRD test can support health insurance funds in Germany to more efficiently use high cost drugs in the treatment of multiple myeloma.

Cost of Human Immunodeficiency Virus (HIV) and Determinants of Healthcare Costs in HIV-Infected Treatment-Naive Patients Initiated on Antiretroviral Therapy in Germany: Experiences of the PROPHET Study

The purpose of the prospective clinical and pharmacoeconomic outcomes study of different first-line antiretroviral treatment strategies (PROPHET) was to examine the healthcare costs of human immunodeficiency virus (HIV)-infected persons in Germany treated with different antiretroviral therapy (ART) strategies and to identify variables associated with high costs. The setting was a 24-month prospective multicenter observational cohort study in a German HIV-specialized care setting from 2014 to 2017. A microcosting approach was used for the estimation of healthcare costs. Data were obtained via electronic case report forms. The costs were calculated from both the societal and the statutory health insurance perspective. Regression models were performed that took into consideration the impact of several independent variables. Four hundred thirty-four patients from 24 centers throughout Germany were included. Average annual healthcare costs were €20 118 (standard deviation [SD] €6451) per patient from the societal perspective (n= 336) and €17 306 (SD €4106) from the statutory health insurance perspective (n= 292). Expenditures for the ART medication had the highest impact. Total costs declined in the second year of therapy. There was a significant association between the amount of total cost and clinical or therapeutic variables from both perspectives; a diagnosis of acquired immune deficiency syndrome (AIDS) led to higher costs as well as the chosen ART strategy. Age also increased cost from the statutory health insurance perspective. The main cost driver of the healthcare costs for HIV-positive patients was antiretroviral drug expenses. Further variables that influenced the costs were identified. The results provide a detailed overview of the resource use of patients in the PROPHET cohort.

Lifetime cost of unilateral cochlear implants in adults: a Monte Carlo simulation.

Due to increasing prevalence of hearing loss and relaxation of candidacy criteria of cochlear implant (CI) supply, the number of implantations is likely to further increase. Statutory health insurances are facing ever more urgent financing challenges since CI treatment causes high life-long costs. Additionally, increasing life expectancy and earlier implantation may extend therapy time and cost. With every case being individual, this study aims to calculate the possible lifetime cost of unilateral CI treatment in adults including stochastic uncertainties. Taking a statutory health insurance perspective, relevant cost components of CI therapy and their values were identified. The Monte Carlo method was used to simulate lifetime cost considering age at first implantation and distributions of costrelevant variables. A sensitivity analysis was conducted to determine the most crucial variables impacting on lifetime cost. Lifetime cost of CI treatment varies according to age at first implantation, respectively remaining lifetime; the earlier the implantation, the higher the overall cost. According to our simulation, the average lifetime cost for an adult patient first implanted between the age of 20-80 is at 53,030 € (present value). Cost of implantation and periodic speech processor exchanges show the highest impact on the total cost. Health care systems could face rising expenses for CI supply by technical development. Innovative life-long CIs could achieve significant savings per case that could finance additional implant cost. Until then, further targeted research will be required. CI-related cost for statutory health insurance crucially depends on the patient-side demand for cochlear implants. Therefore, cost forecasts must also consider the development of demand.

Comparative cost-effectiveness of cabozantinib as second-line therapy for patients with advanced hepatocellular carcinoma in Germany and the United States

BackgroundCabozantinib was approved by the European Medicines Agency and the Federal Drug Administration as an option for sorafenib-resistant advanced hepatocellular carcinoma, increasing overall survival and progression-free survival compared with placebo. We evaluated the cost-effectiveness of cabozantinib in the second-line setting for patients with an advanced hepatocellular carcinoma from the German statutory health insurance perspective compared with an US scenario using US prices.MethodsA Markov model was developed to compare the costs and effectiveness of cabozantinib with best supportive care in the second-line treatment of advanced hepatocellular carcinoma over a lifetime horizon. Health outcomes were measured in discounted life years and discounted quality-adjusted life years. Survival probabilities were estimated using parametric survival distributions based on CELESTIAL trial data. Utilities were derived from the literature. Costs contained drugs, monitoring and adverse events measured in US Dollars. Model robustness was addressed in univariable, scenario and probabilistic sensitivity analyses.ResultsCabozantinib generated a gain of 0.18 life years (0.15 quality-adjusted life years) compared with best supportive care. The total mean cost per patient was $56,621 for cabozantinib and $2064 for best supportive care in the German model resulting in incremental cost-effectiveness ratios for cabozantinib of $306,778/life year and $375,470/quality-adjusted life year. Using US prices generated costs of $177,496 for cabozantinib and $4630 for best supportive care and incremental cost-effectiveness ratios of $972,049/life year and $1,189,706/quality-adjusted life year.ConclusionsOur analysis established that assuming a willingness-to-pay threshold of $163,371/life year (quality-adjusted life year) for the German model and $188,559/life year (quality-adjusted life year) for the US model, cabozantinib is not cost-effective compared with best supportive care. Sensitivity analyses showed that cabozantinib was not cost-effective in almost all our scenarios.

PND48 BURDEN OF MULTIPLE SCLEROSIS IN GERMANY — A MATCHED COHORT STUDY USING A LARGE CLAIMS DATABASE

Multiple sclerosis (MS) is the most common neurological disorder of young adults in Germany. It is associated with significant medical, social and economic consequences. Aim of this study was to assess the epidemiology of MS and to describe the healthcare resource utilization and costs for MS compared to patients without MS from a statutory health insurance (SHI) perspective. This was a retrospective cohort study utilizing claims data of a large German health insurance. Prevalent MS patients in 2013 were identified using ICD-10-GM codes as well as ATC codes and matched to a control group of patients without MS. Matching parameters included age, gender, state of insurance, Elixhauser Comorbidity Index, federal state and residence in urban/rural areas. Demographic characteristics, healthcare resource consumption and healthcare costs were determined for 2013. Statistical differences between the groups were assessed using paired tests. In 2013, 24,150 prevalent MS patients were identified. The age- and gender-adjusted prevalence rate was 416.6 per 100,000. Extrapolated to the German population, 335,440 patients suffered from MS. After the matching process 22,492 MS patients remained, of which 80.3% were female and the mean age was 52.7 years. Differences in healthcare consumption between the groups were most notable in the inpatient, aids, devices, and care-giving sector. The total costs from the SHI perspective were €14,240 per MS patient and €4,214 per control group patient (p<0.001). The difference was mainly due to medication costs (€7,336 vs. €1,075, p<0.001) and care-giving expenses (€2,143 vs. €241, p<0.001). The age- and gender-adjusted prevalence in this study was considerably higher than described in literature. Resource consumption of MS patients was significantly increased compared to the control group, especially concerning the inpatient, care-giving and pharmaceutical sectors. This was also reflected in the substantially higher costs per patient.

PBI5 EVALUATION OF THE COST SAVING POTENTIAL OF INTRODUCING AN ADALIMUMAB BIOSIMILAR FOR THE TREATMENT OF ALL LICENSED ADULT ADALIMUMAB INDICATIONS IN GERMANY

To assess the budget impact of introducing an adalimumab biosimilar in Germany for all licensed adult adalimumab indications from a Statutory Health Insurance perspective. A cost-minimisation model was used to estimate the cost-saving potential of introducing adalimumab biosimilars across Germany over a one-year time horizon to identify the full year effect. Current adalimumab treated populations have been estimated through INSIGHTHealth sales data (retail segment data only) and the population was assumed to remain constant during the time period. Prices of adalimumab products were obtained from published sources. For the purposes of this model, calculations assumed that no further discounting would be offered. A full year effect cost saving potential was determined as well as savings opportunities at varying market share of the biosimilars of 30%, 40%, 50%, 60% and 70% within the time period. The full year effect of introducing adalimumab biosimilars into the German market was estimated to be approximately €373m assuming the market reverted to biosimilar pricing. The estimated cost saving potential with previously identified varying market share of biosimilars compared with the reference biologic was determined to be approximately €112m, €149m, €186m, €224m and €261m respectively. The introduction of biosimilars represents an opportunity for price competition, substantial budget saving potential within the therapeutic group and the potential for better access to biological therapy within Germany. This supports the AkdA recommendation of a more economical biosimilar prescription alternative in each case, initial prescribing of biosimilars and a physician-driven switch for continuation therapy. The cost minimisation scenario did not include any further discounting which may lead to a potential underestimation of the cost savings.

An early analysis of cost-utility of baroreflex activation therapy in advanced chronic heart failure in Germany

BackgroundThis study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neo™ device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon.MethodsA decision analytic model was developed using the combination of a decision tree and the Markov process. The model included transitions between New York Heart Association (NYHA) health states, each of which is associated with a risk of mortality, hospitalization, cost, and quality of life. The effectiveness of BAT was projected through relative risks for mortality (obtained by application of patient-level data to the Meta-analysis Global Group in Chronic Heart Failure risk prediction model) and hospitalization owing to worsening of heart failure (obtained from BAT Randomized Clinical Trial). All patients were in NYHA class III at baseline.ResultsBAT led to an incremental cost of €33,185 (95% credible interval [CI] €24,561–38,637) and incremental benefits of 1.78 [95% CI 0.45–2.71] life-years and 1.19 [95% CI 0.30–1.81] quality-adjusted life-years (QALYs). This resulted in an incremental cost-effectiveness ratio of €27,951/QALY (95% CI €21,357–82,970). BAT had a 59% probability of being cost-effective at a willingness-to-pay threshold of €35,000/QALY (but 84% at a threshold of €52,000/QALY).ConclusionsBAT can be cost-effective in European settings in those not eligible for cardiac resynchronization therapy among patients with advanced heart failure.