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INTRODUCTION: Despite antifungal advancements, candidaemia still has a high mortality rate of up to 40%. The ECMM Candida III study in Europe investigated the changing epidemiology and outcomes of candidaemia for better understanding and management of these infections. METHODS: In this observational cohort study, participating hospitals enrolled the first ten consecutive adults with blood culture-proven candidemia. Collected data included patient demographics, risk factors, hospital stay duration (follow-up of 90 days), diagnostic procedures, causative Candida spp., management details, and outcome. Controls were included in a 1:1 fashion from the same hospitals. The matching process ensured similarity in age (10-year range), primary underlying disease, hospitalization in intensive care versus non-ICU ward, and major surgery within 2 weeks before candidemia between cases and controls. Overall and attributable mortality were described, and a survival probability for cases and controls was performed. RESULTS: One hundred seventy-one pairs consisting of patients with candidemia and matched controls from 28 institutions were included. In those with candidemia, overall mortality was 40.4%. Attributable mortality was 18.1% overall but differed between causative Candida species (7.7% for Candida albicans, 23.7% for Candida glabrata/Nakaseomyces glabratus, 7.7% for Candida parapsilosis and 63.6% for Candida tropicalis). Regarding risk factors, the presence of a central venous catheter, total parenteral nutrition and acute or chronic renal disease were significantly more common in cases versus controls. Duration of hospitalization, and especially that of ICU stay, was significantly longer in candidemia cases (20 (IQR 10-33) vs 15 days (IQR 7-28); p = 0.004). CONCLUSIONS: Although overall and attributable mortality in this subgroup analysis of matched case/control pairs remains high, the attributable mortality appears to have decreased in comparison to historical cohorts. This decrease may be driven by improved prognosis of Candida albicans and Candida parapsilosis candidemia; whereas candidemia due to other Candida spp. exhibits a much higher attributable mortality.
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Candida , Candidemia , Humanos , Candidemia/mortalidad , Candidemia/microbiología , Masculino , Femenino , Persona de Mediana Edad , Europa (Continente)/epidemiología , Anciano , Factores de Riesgo , Estudios de Cohortes , Candida/aislamiento & purificación , Candida/clasificación , Adulto , Anciano de 80 o más Años , Antifúngicos/uso terapéutico , Estudios de Casos y ControlesRESUMEN
OBJECTIVES: Novel interventions (axicabtagene ciloleucel [axi-cel], lisocabtagene maraleucel [liso-cel], tafasitamab-lenalidomide [Tafa-L], polatuzumab-rituximab-bendamustine [pola-BR]) improve clinical outcomes in second-line (2 L) treatment of transplant-ineligible patients with early relapse or refractory (R/R) diffuse large B cell lymphoma (DLBCL). The costs vary depending on the respective treatment regimen and the treatment duration, difficult comparability in reimbursement decisions. The objective was to analyze the health economic impacts of novel 2 L interventions and conventional immunochemotherapies (bendamustine-rituximab [BR], rituximab-gemcitabine-oxaliplatin [R-GemOx]) from a German healthcare payer's perspective as a function of treatment duration. METHODS: An economic model was developed to compare treatment costs of 2 L interventions depending on the treatment duration. Treatment duration was measured by progression-free survival (PFS), identified based on a systematic review. Total and average costs were calculated over 5 years to evaluate incremental costs at median PFS for each intervention. RESULTS: Average costs per month at median PFS ranged from 2846 (95% CI: 5067-1641) to 40 535 (95% CI: 91180-N/A) for BR and liso-cel, respectively. Incremental costs at the lowest median PFS (R-GemOx: 5.3 months) revealed -664, 5560, 11 817, 53 145, and 67 745 for BR, Tafa-L, pola-BR, axi-cel, and liso-cel as compared to R-GemOx, respectively. CONCLUSIONS: Analyses uncovered a variation of incremental costs of 2 L transplant-ineligible DLBCL interventions as a function of time leading to amortization of high-priced interventions.
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Protocolos de Quimioterapia Combinada Antineoplásica , Análisis Costo-Beneficio , Linfoma de Células B Grandes Difuso , Humanos , Linfoma de Células B Grandes Difuso/economía , Linfoma de Células B Grandes Difuso/terapia , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/mortalidad , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Modelos Económicos , Costos de la Atención en Salud , Resistencia a Antineoplásicos , Recurrencia , Resultado del TratamientoRESUMEN
BACKGROUND: Clostridioides difficile is the most common cause of healthcare-associated diarrhea. Research suggests that treating C. difficile infections (CDI) with fidaxomicin (FDX) is more effective than vancomycin (VAN), with potential cost savings. The objective was to calculate the budget impact of FDX treatment compared to VAN from a German payer perspective. RESEARCH DESIGN AND METHODS: The analysis used real-world data of patients discharged from University Hospital Cologne between Jan-01-2018 and Dec-31-2019. We identified recurrent and non-recurrent CDI cases and calculated direct treatment costs based on G-DRG flat rates. To calculate average costs per treatment and the budget impact, recurrence probabilities for VAN and FDX were taken from published evidence (28-day and 90-day scenarios). RESULTS: Totally, 475 cases were analyzed, thereof 421 non-recurrent, causing mean costs of 32,901 per case (95% CI: 27.752-38.050). Thirty-two patients experienced a recurrence within 28 days, yielding mean costs of 10,952 (95% CI: 5.627-16.277) for their additional hospital stay. The resulting budget impact was 1,303 (95% CI: 670 - 1.937) in favor of FDX, ranging from 148.34 to 2,190.30 in scenario analyses. CONCLUSION: The analysis indicates FDX treatment can lead to cost savings compared to VAN. Future research should focus on specific patient groups, such as refractory CDI patients.
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BACKGROUND: Triple-negative breast cancer (TNBC) is responsible for 10-20% cases of breast cancer and is resulting in rising healthcare costs. Thus, health-economic evaluations are needed to relate clinical outcomes and costs of treatment options and to provide recommendations of action from a health-economic perspective. METHODS: We investigated the cost-benefit-ratio of approved treatment options in metastatic TNBC in Germany by applying the efficiency frontier approach. These included sacituzumab-govitecan (SG), eribulin, vinorelbine, and capecitabine. Clinical benefit was measured as (i) median overall survival (mOS) and (ii) health-related quality of life (HRQoL) in terms of time to symptom worsening (TSW). To assess medical benefits, literature was systematically reviewed in PubMed for (i) and (ii), respectively. Treatment costs were calculated considering annual direct outpatient treatment costs from a statutory healthcare payer perspective. It was intended that both, (i) and (ii), yield an efficiency frontier. RESULTS: Annual direct outpatient treatment costs amounted to EUR 176,415.21 (SG), EUR 47,414.14 (eribulin), EUR 13,711.35 (vinorelbine), and EUR 3,718.84 (capecitabine). Systematic literature review of (i) and statistical analysis resulted in OS values of 14.3, 9.56, 9.44, and 7.46 months, respectively. Capecitabine, vinorelbine, and SG are part of the efficiency frontier including OS. The highest additional benefit per additional cost was determined for vinorelbine, followed by SG. Systematic review of (ii) revealed that no TSW data of TNBC patients receiving vinorelbine were available, preventing the presentation of an efficiency frontier including HRQoL. CONCLUSIONS: Vinorelbine is most cost-effective, followed by SG. Health-economic evaluations support decision-makers to assess treatment options within one indication area. In Germany, the efficiency frontier can provide decision support for the pricing of innovative interventions. Results of our analysis may thus guide reimbursement determination.
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OBJECTIVE: This study aimed to assess the budget impact of vacuum-induced hemorrhage control (VHC) devices for treating postpartum hemorrhage (PPH) from the perspective of the German statutory health insurance (SHI). STUDY DESIGN: Evidence shows that treating PPH with VHC instead of uterine balloon tamponade (UBT) can reduce resource consumption (e.g., reduced number of blood transfusions and length of stay). A budget impact model combining aggregated German real-world reimbursement data of PPH cases with the assumption of resource reduction due to VHC usage was developed. Diagnosis-related groups (DRG) of PPH cases and their frequencies were collected using a publicly available database. A "downgrading mechanism" was performed, leading to a less resource-intensive DRG, i.e., resulting in a lower flat fee to be paid by SHI. Four subgroups were differentiated based on coded diagnoses and procedures: 1) PPH (O72.-) as main diagnosis, 2) PPH as secondary diagnosis, 3) UBT procedure coded, and 4) UBT or standard tamponade coded. Weighted averages of cost savings per case were calculated. RESULTS: Data from 7,129 (subgroup 1), 49,523 (subgroup 2), 1,668 (subgroup 3), and 3,406 (subgroup 4) cases were retrieved. After applying the downgrading mechanism, cost savings (weighted average) resulted in 184.09 , 210.50 , 921.33 , and 633.74 for subgroups 1-4, respectively, CONCLUSION: This is the first German budget impact analysis of VHC for the treatment of PPH. Results showed the highest cost-saving potential for cases currently treated with UBT. Demonstrating not only clinical but also financial consequences of innovative treatments is crucial for the adoption into clinical practice.
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Obstetricia , Hemorragia Posparto , Taponamiento Uterino con Balón , Embarazo , Femenino , Humanos , Hemorragia Posparto/terapia , Vacio , Taponamiento Uterino con Balón/métodos , Transfusión SanguíneaRESUMEN
OBJECTIVES: The treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) changed remarkably since the European Medicines Agency-approved chimeric antigen receptor T-cell (CAR-T) therapies (axicabtagene ciloleucel [axi-cel], lisocabtagene maraleucel [liso-cel], tisagenlecleucel [tisa-cel]) for the third-line onwards (3+L), and targeted therapies (polatuzumab vedotin-bendamustine-rituximab [pola-BR], tafasitamab-lenalidomide [Tafa-L]) for the second-line (2L) onwards. As associated rising treatment costs represent an economic burden, the cost-effectiveness of transplant-ineligible R/R DLBCL interventions was assessed from a German healthcare payer's perspective, using the efficiency frontier (EF) approach. METHODS: A systematic literature review was performed to determine the clinical benefit concerning median overall survival (OS) of bendamustine-rituximab (BR), rituximab-gemcitabine-oxaliplatin (R-GemOx), axi-cel, liso-cel, tisa-cel, pola-BR, and Tafa-L. First-year treatment costs (drug and medical services costs) were calculated. Results were merged on two-dimensional graphs illustrating 2L and 3+L EFs. RESULTS: Second-line EF is formed by BR (median OS 11.49 months, 23 958) and Tafa-L (45.7, 104 541), 3+L EF is formed by R-GemOx (12.0, 29 080), Tafa-L (15.5, 104 541), and axi-cel (18.69, 308 516). These interventions build the respective cost-effectiveness thresholds for novel interventions. CONCLUSIONS: Using the EF approach, the currently most cost-effective interventions (based on cost-effectiveness ratios) in the indication of R/R DLBCL were identified to guide international reimbursement decisions.
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Linfoma de Células B Grandes Difuso , Linfoma no Hodgkin , Humanos , Análisis de Costo-Efectividad , Clorhidrato de Bendamustina , Rituximab , Linfoma de Células B Grandes Difuso/diagnóstico , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Inmunoterapia Adoptiva , Antígenos CD19RESUMEN
INTRODUCTION: Pathogen inactivation (PI) utilizing amotosalen and UVA light (INTERCEPT® Blood System) is a well-established method for the production of safer platelet concentrates (PCs). While many studies describe clinical and logistical benefits of PI, the implications and potential challenges from a hospital management perspective have not yet been analyzed - health economic analyses considering reimbursement of PI are lacking. The objective of this analysis was to examine the real-life inpatient treatment costs from a hospital perspective and to assess the economic impact of PI-PC versus conventional PC (CONV-PC) administration in Germany. METHODS: Real-life cost data for inpatient cancer cases from 2020 of the University Hospital Cologne were identified by operating and procedure codes. The German diagnosis-related groups, extra fees, case mix index (CMI), length of stay (LOS), and average resource consumption of PC were evaluated from a micro-management perspective. The potential economic impact of implementing PI-treated PCs was modeled retrospectively. RESULTS: In total, 951 inpatient cases were analyzed (CMI [median 4.7-9.9], LOS [median 26 days], number of cases in intensive care units [38%]). The median DRG fee was between EUR 13,800 and EUR 26,400. According to our model, the use of PI-PC compared to CONV-PC would result in savings between EUR 184 and EUR 306 per case. CONCLUSION: From a hospital management perspective, oncological cases requiring PC transfusion are associated with a high CMI (reimbursement per DRG flat fee) and moderate costs with sufficient add-on payment for PI on a case level. Investment and process costs for PI implementation can be analyzed for site-specific scenarios.
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Grupos Diagnósticos Relacionados , Neoplasias , Humanos , Estudios Retrospectivos , Hospitalización , Unidades de Cuidados Intensivos , Hospitales UniversitariosRESUMEN
Background: The presence of pleural effusions and ascites in patients is often considered a marker of illness severity and a poor prognostic indicator. This study aims to compare inpatient and outpatient costs of alternative invasive treatments for ascites and pleural effusions. Methods: The retrospective single-institution study included inpatient cases treated for pleural effusion (J90 and J91) or ascites (R18) at the University Hospital Cologne (UHC) in Germany between January 01, 2020, and December 31, 2021. Costs for punctures and indwelling catheter systems (ICSs) as well as pleurodesis were analyzed in different comparator treatment pathways. Real-world data from the UHC tertiary care center were based on diagnosis-related group fees from 2020 to 2021. A simulation of outpatient expenses was carried out to compare inpatient and outpatient costs for each pathway from a payer perspective. Results: A total of 4323 cases (3396 pleural effusions and 1302 ascites) were analyzed. For ascites, inpatient implantation with home care drainage was found to be the most expensive option, with total costs of 1,918.58 per procedure, whereas outpatient puncture was the least expensive option at 60.02. For pleural effusions, the most expensive treatment pathway was pleurodesis at 8,867.84 compared with the least costly option of outpatient puncture resulting in total costs per procedure of 70.03. A break-even analysis showed that outpatient puncture remains the most inexpensive treatment option, and the ICS comprises a cost-saving potential. Longevity of several months with the use of ICSs results in both enhanced quality of life for patients and increased cost savings.
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Derrame Pleural Maligno , Derrame Pleural , Humanos , Catéteres de Permanencia , Derrame Pleural Maligno/terapia , Estudios Retrospectivos , Ascitis/terapia , Calidad de Vida , Ahorro de Costo , Derrame Pleural/terapia , Pleurodesia/métodos , DrenajeRESUMEN
Objective: Candida species are responsible for fungal diseases and the development of nosocomial bloodstream infections. Treatment is resource-intensive and economically challenging for healthcare systems. Cost analyses of drugs against candidiasis, such as rezafungin, are thus of great interest to healthcare payers. Methods: We conducted a cost-of-illness study of patients with Candida infections based on real-word data of the Department I of Internal Medicine, University Hospital Cologne (Germany) between 2016 and 2021. Health-economic parameters were analysed to describe the economic impact of Candida infections. Potential cost savings due to the administration of rezafungin were modelled for patients with invasive candidiasis or candidaemia based on a 5â day reduction of ICU length of stay (LOS) shown by the STRIVE study. Results: We found 724 cases (652 patients) with Candida infections, of which 61% received ICU treatment (nâ=â442) and 29% were mechanically ventilated (nâ=â207). Twenty-six percent died during hospitalization (nâ=â185). Median LOS was 25 and 15â days, on normal wards and ICU, respectively. Median total treatment costs per case accounted for 22â820. Based on the ICU LOS reduction, the retrospective model showed a median cost-saving potential of 7175 per hospital case with invasive candidiasis or candidaemia. Accumulated cost savings for 37 patients of 283â335 were found. Conclusions: Treatment of candidiasis is cost intensive due to increased hospital LOS. The ICU LOS reduction rezafungin showed in STRIVE would lead to sustainable cost savings.
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BACKGROUND: The treatment of acute bacterial skin and skin structure infections (ABSSSI) usually involves intravenous (i.v.) antibiotics requiring hospitalisation and increasing hospital costs. Since 2014, dalbavancin is approved for ABSSSIs treatment. However, evidence of its health economic impact on the German healthcare system is still limited. METHODS: Diagnosis-related groups (DRG) based cost analysis was used to evaluate real-world data (RWD) from a German tertiary care center. All patients treated with i.v. antibiotics in the Department of Dermatology and Venereology at the University Hospital of Cologne were included to detect potential cost savings from a payer perspective. Thus, for the inpatient care German diagnosis-related groups (G-DRG) tariffs, length of stay (LOS), main- and secondary DRG-diagnoses and for the outpatient setting 'Einheitlicher Bewertungsmaßstab' (EBM) codes were evaluated. RESULTS: This retrospective study identified 480 inpatient cases treated for ABSSSI between January 2016 until December 2020. Complete cost data were available for 433 cases and the detection of long-hospital-stay patients based on surcharges for exceeding the upper limit LOS led to 125 cases (29%) including 67 females (54%) and 58 males (46%) with an overall mean age of 63.6 years; all treated for International Classification of Diseases (ICD -10th revision) code A46 'erysipelas'. A sub-analysis focussed on DRG J64B with a total of 92 cases exceeding the upper limit LOS by a median of 3 days resulted in a median surcharge of 636 (mean value 749; SD 589; IQR 459-785) per case. In comparison, we calculated outpatient treatment costs of approximately 55 per case. Thus, further treatment of these patients in an outpatient setting before exceeding the upper limit LOS might result in a cost-saving potential of approximately 581 per case. CONCLUSION: Dalbavancin appears a cost-efficient option to reduce inpatient treatment costs by transitioning to an outpatient setting of patients with ABSSSI potentially exceeding the upper limit LOS.
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Pacientes Internos , Enfermedades Cutáneas Bacterianas , Masculino , Femenino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Ahorro de Costo , Enfermedades Cutáneas Bacterianas/tratamiento farmacológico , Antibacterianos , Atención AmbulatoriaRESUMEN
BACKGROUND: Invasive fungal diseases (IFD) are life-threatening and demand timely and appropriate treatment. Research showed that isavuconazole treatment positively affects clinical outcome and length of hospital stay (LOS). OBJECTIVES: The aim of this study was to assess the hospital costs of patients diagnosed with IFD and treated with isavuconazole using real-world data from a German cancer centre. PATIENTS/METHODS: Data and LOS collected from Jan-2016 to Jun-2021 at Department I of Internal Medicine, University Hospital Cologne were retrieved. Case-related resources consumed during the hospital stay across isavuconazole routes of administration (oral, parenteral, and mixed administration) were identified, quantified, valued and compared via a cost analysis that adopted the healthcare payer perspective. RESULTS: In total, 101 cases with isavuconazole treatment were identified (oral: n = 22, 21.8%; parenteral: n = 59, 58.4%; mixed: n = 20, 19.8%). Median total LOS was greater in the mixed group (46.5 days; p = .009). Median ICU LOS and ventilation duration were both longest in the parenteral-only group (16 days, p = .008; 224 h, p = .003). Invasive aspergillosis was the most frequent isavuconazole indication (n = 86, 85.2%). Average hospital costs were highest in the mixed group ( 101,226). The median overall costs of cases treated with isavuconazole was 52,050. CONCLUSIONS: Treating IFD is resource intensive, often requires intensive care and implies high rates of in-hospital mortality. Our study emphasises the high hospital treatment costs and thus the need for reimbursement systems to enable live-saving costly treatments.
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Aspergilosis , Infecciones Fúngicas Invasoras , Neoplasias , Humanos , Antifúngicos/uso terapéutico , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Triazoles/uso terapéutico , Nitrilos/uso terapéutico , Infecciones Fúngicas Invasoras/tratamiento farmacológico , Infecciones Fúngicas Invasoras/microbiologíaRESUMEN
BACKGROUND: In the past decades, highly innovative treatments in the field of diffuse large B-cell lymphoma (DLBCL) became available in clinical practice. The aim of this study was to assess the cost-benefit relation of third-line interventions in DLBCL from a German payer perspective. METHODS: Clinical benefit of allogeneic stem cell transplantation (alloSCT), chimeric antigen receptor T cells therapy (CAR T) [tisagenlecleucel (tisa-cel) and axicabtagene ciloleucel (axi-cel)] and best supportive care (BSC) was assessed in terms of median overall survival (median OS) derived from a systematic literature review in PubMed. Real-world treatment costs were retrieved from the university hospitals Cologne and Hamburg-Eppendorf. The cost-benefit relation was analysed using the efficiency frontier concept. RESULTS: Median OS varied from 6.3 months in BSC to 23.5 months in CAR T (axi-cel), while median real-world treatment costs ranged likewise widely from 26,918 in BSC to 340,458 in CAR T (axi-cel). Shown by the efficiency frontier, alloSCT and axi-cel were found as most efficient interventions. CONCLUSION: The efficiency frontier supports the pricing of innovative therapies, such as third-line interventions in DLBCL, in relation to appropriate comparators. Yet, studies with longer follow-up periods are needed to include studies with unreached median OS and to reflect experiences gained with CAR T in clinical practice.
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Multidrug-resistant Gram-negative bacteria (MDR-GNB) cause serious infections and aggravate disease progression. Last resort antibiotics are effective against MDR-GNB and are reimbursed by flat rates based on German diagnosis-related groups (G-DRG). From a hospital management perspective, this analysis compared hospital reimbursement for last resort antibiotics with their acquisition costs to outline potential funding gaps. Retrospective analyses based on medical charts and real-life reimbursement data included patients with pneumonia due to MDR-GNB treated in intensive care units (ICU) of a German tertiary care hospital (University Hospital Cologne) between January 2017 and December 2020. Drug-associated hospital reimbursement of G-DRG was compared with drug acquisition costs based on preliminarily approved last resort antibiotics (cefiderocol, ceftazidime-avibactam, ceftolozane-tazobactam, and imipenem-cilastatin-relebactam) according to label. Funding gaps were determined for the treatment of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii, and mixed infections, respectively. Most of the 31 patients were infected with Enterobacterales (n = 15; 48.4%) and P. aeruginosa (n = 13; 41.9%). Drug-associated G-DRG reimbursement varied from 44.50 EUR (mixed infection of P. aeruginosa and Enterobacterales) to 2265.27 EUR (P. aeruginosa; mixed infection of P. aeruginosa and Enterobacterales). Drug acquisition costs ranged from 3284.40 EUR in ceftazidime-avibactam (minimum duration) to 15,827.01 EUR for imipenem-cilastatin-relebactam (maximum duration). Underfunding was found for all MDR-GNB, reaching from 1019.13 EUR (P. aeruginosa; mixed infection of P. aeruginosa and Enterobacterales) to 14,591.24 EUR (Enterobacterales). This analysis revealed the underfunding of last resort antibiotics in German hospital treatment. Insufficient reimbursement implies less research in this field, leading to a more frequent use of inappropriate antibiotics. The cycle closes as this contributes to the development of multi-drug resistant bacteria.
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OBJECTIVES: Internationally, healthcare systems are confronted by an ever-increasing scarcity of medical resources due to the ongoing novel coronavirus disease 2019 (COVID-19) pandemic. The aim of this study was to investigate the impact of remdesivir on the demand of hospital bed capacities for hospitalized COVID-19 patients and to evaluate the potentially created capacities for treating additional COVID-19 patients or elective treatments at the hospital. METHODS: An epidemiological model was developed that utilized the population of Cologne (Germany) during the first COVID-19 wave (first hospitalized patient-30 September 2020) to compare two scenarios: no administration of remdesivir (A) and the administration of remdesivir according to the EMA label (B). The results of the Adaptive COVID-19 Treatment Trial were used to evaluate the potential impact of remdesivir on hospital capacity. RESULTS: With the first recorded patient on 2 March 2020, a total of 576 COVID-19 hospitalized patients were detected during the first wave in Cologne. Comparing both scenarios (A versus B) of the model, the administration of remdesivir increased the number of discharges from 259 to 293 (+5.8%) and fewer patients needed ICU admission [214 versus 178 (-6.3%)]. In addition, the model estimated 20 fewer deaths (scenario B). Based on a reduced length of stay, 31.4 hospital beds (57.0 versus 25.6) could have been freed by administering remdesivir to eligible patients. This would have allowed either the treatment of an additional 730 COVID-19 patients or 660 elective treatments. CONCLUSIONS: In our model, remdesivir administration profoundly contributed to free hospital capacities in the metropolitan city Cologne in Germany.
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Tratamiento Farmacológico de COVID-19 , Adenosina Monofosfato/análogos & derivados , Alanina/análogos & derivados , Capacidad de Camas en Hospitales , Humanos , Estudios Retrospectivos , SARS-CoV-2RESUMEN
PURPOSE: First detected in China in 2019, the novel coronavirus disease (COVID-19) has rapidly spread globally. Since then, healthcare systems are exposed to major challenges due to scarce personnel and financial resources. Therefore, this analysis intended to examine treatment costs of COVID-19 inpatients in a German single centre during the first pandemic wave in 2020 from a healthcare payer perspective. Potential cost savings were assessed considering the administration of remdesivir according to the European Medicines Agency label. METHODS: A retrospective medical-chart review was conducted on COVID-19 patients treated at University Hospital Cologne, Germany. Patients were clustered according to an eight-category ordinal scale reflecting different levels of supplemental oxygen. Potential cost savings due to the administration of remdesivir were retrospectively modelled based on a reduced length of stay, as shown in the Adaptive COVID-19 Treatment Trial. RESULTS: 105 COVID-19 patients were identified. There was wide variability in the service data with median treatment costs from EUR 900 to EUR 53,000 per patient, depending on major diagnosis categories and clinical severity. No supplemental oxygen was needed in 40 patients (38.1%). Forty-three (41.0%) patients were treated in intensive-care units, and 30 (69.8%) received invasive ventilation. In our model, in-label administration of remdesivir would have resulted in costs savings of EUR 2100 per COVID-19 inpatient (excluding acquisition costs). CONCLUSION: We found that COVID-19 inpatients suffer from heterogeneous disease patterns with a variety of incurred G-DRG tariffs and treatment costs. Theoretically shown in the model, financial resources can be saved by the administration of remdesivir in eligible inpatients.
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Tratamiento Farmacológico de COVID-19 , Adenosina Monofosfato/análogos & derivados , Alanina/análogos & derivados , Ahorro de Costo , Costo de Enfermedad , Humanos , Pandemias , Estudios Retrospectivos , SARS-CoV-2 , Centros de Atención TerciariaRESUMEN
BACKGROUND: Clostridioides difficile infection (CDI) is one of the leading nosocomial infections, resulting in increased hospital length of stay and additional treatment costs. Bezlotoxumab, the first monoclonal antibody against CDI, has an 1 A guideline recommendation for prevention of CDI, after randomized clinical trials demonstrated its superior efficacy vs. placebo. METHODS: The budget impact analysis at hand is focused on patients at high risk of CDI recurrence. Treatment with standard of care (SoC) + bezlotoxumab was compared with current SoC alone in the 10 most associated Diagnosis Related Groups to identify, analyze, and evaluate potential cost savings per case from the German hospital management perspective. Based on variation in days to rehospitalization, three different case consolidation scenarios were assessed: no case consolidation, case consolidation for the SoC + bezlotoxumab treatment arm only, and case consolidation for both treatment arms. RESULTS: On average, the budget impact amounted to 508.56 [range: 424.85 - 642.19] for no case consolidation, 470.50 [range: 378.75 - 601.77] for case consolidation in the SoC + bezlotoxumab treatment arm, and 618.00 [range: 557.40 - 758.41] for case consolidation in both treatment arms. CONCLUSIONS: The study demonstrated administration of SoC + bezlotoxumab in patients at high risk of CDI recurrence is cost-saving from a hospital management perspective. Reduced length of stay in bezlotoxumab treated patients creates free spatial and personnel capacities for the treating hospital. Yet, a requirement for hospitals to administer bezlotoxumab is the previously made request for additional fees and a successful price negotiation.
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Antibacterianos , Clostridioides difficile , Antibacterianos/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Neutralizantes , Anticuerpos ampliamente neutralizantes , Alemania/epidemiología , Hospitales , Humanos , Recurrencia , Nivel de AtenciónRESUMEN
BACKGROUND: Kron et al (Mycoses, 64, 2021, 86) found cost savings for the use of the innovative pharmaceutical isavuconazole in the inpatient setting in Germany (Bismarck-based healthcare system). Little is known about the reimbursement of innovative pharmaceuticals in the inpatient setting of Beveridge-based healthcare systems. OBJECTIVES: The aim of this study was to evaluate the market access process and reimbursement of isavuconazole, exemplary for innovative pharmaceuticals, in England and Spain. PATIENTS/METHODS: Market access processes of both countries were described. Focussing on typical patient clusters for isavuconazole treatment, reimbursement data regarding inpatients with (i) allogeneic haematopoietic stem cell transplantation or (ii) acute myeloid leukaemia was considered. Data were publicly available and of high topicality (England 2020/2021, Spain 2018). Discounting and a currency conversion to Euro were applied. RESULTS: This study showed that market access processes of both countries are broadly similar. Further, full reimbursement of isavuconazole as an innovative pharmaceutical may lead to reduction in resource utilisation. Without medication costs, isavuconazole can thus result in cost savings for both patient clusters due to a reduction in length of stay. CONCLUSIONS: Expenses for innovative pharmaceuticals may be balanced or even lead to cost savings due to a reduction in length of stay. The latter contributes to a greater patient benefit. For both healthcare system, the analyses highlighted drugs' cost-effectiveness and assessing its added value into reimbursement decisions is highly relevant.
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Antifúngicos , Reembolso de Seguro de Salud , Nitrilos , Piridinas , Triazoles , Antifúngicos/economía , Antifúngicos/uso terapéutico , Inglaterra , Costos de la Atención en Salud , Hospitales , Humanos , Pacientes Internos , Nitrilos/economía , Nitrilos/uso terapéutico , Piridinas/economía , Piridinas/uso terapéutico , España , Triazoles/economía , Triazoles/uso terapéuticoRESUMEN
INTRODUCTION: Robust data on the outcome of MET-aberrant NSCLC with nontargeted therapies are limited, especially in consideration of the heterogeneity of MET-amplified tumors (METamp). METHODS: A total of 337 tumor specimens of patients with MET-altered Union for International Cancer Control stage IIIB/IV NSCLC were analyzed using next-generation sequencing, fluorescence in situ hybridization, and immunohistochemistry. The evaluation focused on the type of MET aberration, co-occurring mutations, programmed death-ligand 1 expression, and overall survival (OS). RESULTS: METamp tumors (n = 278) had a high frequency of co-occurring mutations (>80% for all amplification levels), whereas 57.6% of the 59 patients with MET gene and exon 14 (METex14) tumors had no additional mutations. In the METamp tumors, with increasing gene copy number (GCN), the frequency of inactivating TP53 mutations increased (GCN < 4: 58.2%; GCN ≥ 10: 76.5%), whereas the frequency of KRAS mutations decreased (GCN < 4: 43.2%; GCN ≥ 10: 11.8%). A total of 10.1% of all the METamp tumors with a GCN ≥ 10 had a significant worse OS (4.0 mo; 95% CI: 1.9-6.0) compared with the tumors with GCN < 10 (12.0 mo; 95% confidence interval [CI]: 9.4-14.6). In the METamp NSCLC, OS with immune checkpoint inhibitor (ICI) therapy was significantly better compared with chemotherapy with 19.0 months (95% CI: 15.8-22.2) versus 8.0 months (95% CI: 5.8-10.2, p < 0.0001). No significant difference in median OS was found between ICI therapy and chemotherapy in the patients with METex14 (p = 0.147). CONCLUSIONS: METex14, METamp GCN ≥ 10, and METamp GCN < 10 represent the subgroups of MET-dysregulated NSCLC with distinct molecular and clinical features. The patients with METex14 do not seem to benefit from immunotherapy in contrast to the patients with METamp, which is of particular relevance for the prognostically poor METamp GCN ≥ 10 subgroup.
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Neoplasias Pulmonares , Heterogeneidad Genética , Humanos , Inmunoterapia , Hibridación Fluorescente in Situ , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/genética , Mutación , Proteínas Proto-Oncogénicas c-met/genéticaRESUMEN
BACKGROUND: Isavuconazole (ISA) is a frequently used antifungal agent for the treatment of invasive fungal diseases (IFDs). However, hospital reimbursement data for ISA is limited. OBJECTIVES: The primary objective of this study was to analyse the different perspectives of relevant stakeholders and the (dis)incentives for the administration of ISA in Germany. To that aim, the health economic effects of using ISA from a hospital management perspective were analysed. PATIENTS/METHODS: Based on principal-agent theory (PAT), the perspectives of (a) the patient (principal) as well as (b) physicians, (c) pharmacists and iv. hospital managers (all agents) were analysed. For the evaluation of the cost-containment and reimbursement strategies of ISA, the German diagnosis-related group (G-DRG) system was used. RESULTS: Hospitals individually negotiating additional payments for innovative treatment procedures (zusatzentgelte [ZE]) within the G-DRG system is a key element of hospital management for the reduction of total healthcare expenditure. Our analysis demonstrated the beneficial role of ISA in healthcare resource utilisation, primarily due to a shortened overall length of hospital stay. Depending on underlying disease, coded G-DRG and ISA formulation, large differences in total reimbursement and the amount of ZE was shown. The PAT demonstrated disincentives for hospital managers to use innovative drugs. CONCLUSIONS: Based on the PAT, beneficial, detrimental and indifferent perspectives of different stakeholders regarding the usage of ISA were shown. A reduction of bureaucratic hurdles is needed in Germany for the extension of effective and innovative antifungal treatment strategies with ISA.
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Costos y Análisis de Costo , Hospitales , Nitrilos/uso terapéutico , Piridinas/uso terapéutico , Triazoles/uso terapéutico , Análisis Costo-Beneficio , Grupos Diagnósticos Relacionados/economía , Economía Hospitalaria , Alemania , Humanos , Tiempo de Internación/economía , Nitrilos/administración & dosificación , Nitrilos/economía , Piridinas/administración & dosificación , Piridinas/economía , Triazoles/administración & dosificación , Triazoles/economíaRESUMEN
AIM: The introduction of new and innovative treatment options for cancer patients is accompanied by a tremendous increase in healthcare costs. Consequently, new financing approaches are strongly needed to reduce the burden on the healthcare system. The introduction of biosimilars - biological drugs containing the active substance of an already approved reference biological drug - can potentially relieve the burden on healthcare systems. Calculating the costs for three frequently used biosimilars, we simulated the health-economic impact of biosimilars in the real world for the German healthcare system. METHODS: Based on available health-economic analyses, the actual prescription and cost containment potential of biosimilars compared to the originator were calculated exemplarily for the cost-intensive therapies trastuzumab in breast cancer, rituximab in follicular lymphoma and G-CSF in supportive care. Incidence calculations were based e.g. on data from the Robert-Koch-Institution, Munich Cancer Registry, and quality indicators of certified centres. Cost calculation was based on Lauer-Taxe® (official reference for pharmaceutical price information). RESULTS: The application of biosimilars would generate potential annual savings for the chosen examples of up to 4.9 Mio EUR for rituximab in follicular lymphoma, 40.5 Mio EUR for filgrastim, 56.4 Mio EUR for pegfilgrastim, and between 95.9 and 120.5 Mio EUR for trastuzumab. CONCLUSIONS: The consequent use of biosimilars allows a considerable reduction of overall treatment costs, especially for cost-intensive long-term maintenance treatments and therapies with high incidences. If the option of biosimilar usage is fully exploited, enormous resources could be released within the healthcare system in order to offset financing new innovative therapies.