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Asthma causes various clinical symptoms, including unpredictable severe exacerbations, and even though most patients can achieve a reasonable disease control due to adequate treatment, some patients do not. This study seeks to describe healthcare resource utilization (HCRU) and treatment of asthma and severe asthma patients in Germany.A retrospective claims data analysis has been conducted on adult asthma patients and a subset of patients with severe asthma, identified during July 2017 - June 2018. A proxy was used to identify severe asthma patients based on therapy options recommended within the German treatment guideline for treating these patients. These include (i) biologics, (ii) medium/high-dose inhaled corticosteroids (ICS) in conjunction with LABA/montelukast and antibiotics/oral corticosteroids (OCS), and (iii) long-term OCS therapy. HCRU and treatment of patients were observed during a 1-year follow-up period (July 2018 - June 2019).The study included 388 932 adult asthma patients (prevalence: 7.90%), with 2.51%-12.88% affected by severe asthma (depending on the definition). 22.60% of all asthma patients experienced hospitalizations (severe asthma: 36.11%). Furthermore, 13.59% received OCS (severe asthma: 39.91%), but only 0.18% (severe asthma: 1.25%) received biologics. Only 23.95% (severe asthma: 41.17%) visited a pulmonologist.A considerable proportion of severe asthma patients receive long-term OCS therapy. However, less than 50% have seen a pulmonologist who would typically seek a change in treatment to avoid the long-term consequences of OCS. To optimize the treatment of severe asthma in Germany, better referral of these patients to specialists is needed and considering potential treatment alternatives.

There are different levels of severity among patients who suffer from chronic rhinosinusitis with nasal polyps (CRSwNP). In this study, the epidemiology of CRSwNP and severe CRswNP was estimated.A retrospective claim data analysis was conducted on adult CRSwNP patients (ICD-10: J33), and those classified as severe CRSwNP patients with inadequate disease control (based upon combinations of previous and current treatments) between 2015 and 2019. Prevalence and incidence figures were calculated and extrapolated to the German population. In addition, baseline characteristics and treatment outcomes were analysed.Overall, the 5-year prevalence of adult CRSwNP cases from 2015 to 2019 in Germany was 374,115 cases (about 5500 per million), with 12,989 (about 200 per million) patients being classified as severe CRSwNP with inadequate disease control, whereas 267,880 (about 3900 per million) patients were identified as having an incident CRSwNP diagnosis between 2016 and 2019. From the incident CRSwNP cohort, 80.55% had received at least one intranasal corticosteroid (INCS), 24.27% received at least 1 systemic corticosteroid (SCS), and 17.33% received at least one functional endoscopic sinus surgery (FESS) within 12 months after their incident diagnosis.Severe CRSwNP with inadequate disease control affects about 200 per million people in Germany. INCS is the first-choice treatment for most CRSwNP patients; however, for patients with severe CRSwNP, SCS are prescribed more frequently and long-term effects of these should be further investigated, especially if despite treatment, adequate disease control cannot be achieved.

Purpose The aim of this study was to investigate the burden of disease among a real-world cohort of patients with prevalent Crohn’s disease (CD) in Germany. Methods We conducted a retrospective cohort analysis using administrative claims data from the German AOK PLUS health insurance fund. Continuously insured patients with a CD diagnosis between 01 October 2014 and 31 December 2018 were selected and followed for at least 12 months or longer until death or end of data availability on 31 December 2019. Medication use (biologics, immunosuppressants (IMS), steroids, 5-aminosalicylic acid) was assessed sequentially in the follow-up period. Among patients with no IMS or biologics (advanced therapy), we investigated indicators of active disease and corticosteroid use. Results Overall, 9284 prevalent CD patients were identified. Within the study period, 14.7% of CD patients were treated with biologics and 11.6% received IMS. Approximately 47% of all prevalent CD patients had mild disease, defined as no advanced therapy and signs of disease activity. Of 6836 (73.6%) patients who did not receive advanced therapy in the follow-up period, 36.3% showed signs of active disease; 40.1% used corticosteroids (including oral budesonide), with 9.9% exhibiting steroid dependency (≥ 1 prescription every 3 months for at least 12 months) in the available follow-up. Conclusions This study suggests that there remains a large burden of disease among patients who do not receive IMS or biologics in the real world in Germany. A revision of treatment algorithms of patients in this setting according to the latest guidelines may improve patient outcomes.

Aim: This study assessed whether a single pill combination (SPC) is associated with lower direct healthcare costs. Materials & methods: Anonymized claims data of patients ≥18 years treated with drugs for cardiovascular (CV)-related diseases either as a single pill combination or multi-pill combination (follow-up to 1 year) were evaluated. After propensity score matching, 59,336 out of 1,369,840 patients were analyzed. Results: In all cohorts, patients receiving a single pill combination had a lower frequency of general practitioner and specialist visits. The patients also had a significantly lower ratio of all-cause hospitalization days and number of CV-related prescriptions as well as all-cause prescriptions (with one exception) compared with those receiving a multi-pill combination. Conclusion: Direct CV-related costs were significantly lower in four out of seven comparisons, with a trend toward lower costs in the other three comparisons.

Zusammenfassung Hintergrund Vergleichende Krankenkassendatenstudien können wichtige Evidenz zur Bewertung der Wirksamkeit und Sicherheit von Therapien in der Versorgungspraxis generieren. Ihre Interpretation ist jedoch angesichts methodischer Unsicherheiten herausfordernd. Ziel der Arbeit Ziel dieses Beitrags ist es, auf Basis einer erarbeiteten Systematik für die Methodik von vergleichenden Krankenkassendatenstudien (separater Teil 1) den Einfluss spezifischer methodischer Annahmen und Entscheidungen exemplarisch an einem Beispiel zu erläutern. Material und Methoden Verschiedene methodische Optionen wurden für Patienten mit prävalenter Colitis ulcerosa (CU), die eine Therapie mit Vedolizumab vs. Adalimumab starteten, analysiert. Verwendet wurden Daten der AOK PLUS. Verglichen wurde ein „composite endpoint“ (CEP), bestehend aus CU-bezogenen Hospitalisierungen und Operationen, Kortikosteroidverschreibungen, Therapiebeendigung sowie -switch. Ergebnisse In der Analyse wurde deutlich, dass spezifische Annahmen in den dargestellten 7 methodischen Dimensionen einen erheblichen Einfluss auf die Ergebnisse einer Studie sowie deren interne und externe Validität haben. Im Beispiel zeigte sich, dass bei Analyse des CEP Vedolizumab eine höhere Wirksamkeit als Adalimumab aufwies. Schlussfolgerungen Publikationen zu vergleichenden Krankenkassendatenstudien sollten transparent die getroffenen Annahmen in den 7 genannten Dimensionen darstellen und begründen, warum entsprechende Annahmen getroffen wurden.

Objectives: This study aimed to investigate the prevalence, incidence, and real-world diagnostic and treatment patterns, healthcare resource utilization (HCRU), and associated costs of narcolepsy in Germany. Methods: This study was based on German claims data (2013–2018). Any patient with at least two outpatient specialist diagnoses and/or one inpatient diagnosis of narcolepsy was eligible for inclusion. Three cohorts were specified: 1) narcolepsy-prevalent patients alive on July 1, 2017; 2) narcolepsy-incident patients; and 3) newly treated patients. Descriptive analyses of the outcome measures were conducted. Results: We identified 133 prevalent narcolepsy patients (mean age: 46.2 years, 36.3% female), 71 incident patients, and 41 treatment starters. The prevalence of narcolepsy was 3.1–9.1 per 100,000 persons within the German population; the cumulative incidence between July 1, 2017, and June 30, 2018, was 0.83/100,000 persons. Among the incident patients, 62.0% underwent at least one predefined diagnostic procedure. Modafinil was the most prescribed medication for the treatment starters (46.3%) and prevalent patients (24.1%), but 59.4% of the prevalent patients did not receive any narcolepsy-specific pharmacological treatment. Prevalent patients with narcolepsy consulted physicians significantly more often than a healthy matched control group and experienced more all-cause hospitalizations. The mean total direct healthcare costs were higher for narcolepsy patients by €2,429 per patient-year. Conclusions: Not all narcolepsy patients undergo appropriate diagnostic procedures or narcolepsy-specific medications, as indicated by the treatment guidelines. More emphasis on the optimization of the management of this disease is needed, given its high prevalence and associated economic burden.

Roland Buhl,1 Thomas Wilke,2 Nils Picker,3 Olaf Schmidt,4 Marlene Hechtner,5 Anke Kondla,5 Ulf Maywald,6 Claus F Vogelmeier7 1Pulmonary Department, Mainz University Hospital, Mainz, Germany; 2IPAM e.V, Wismar, Germany; 3Cytel Inc - Ingress-Health HWM GmbH, Wismar, Germany; 4Pulmonary Group Practice, Koblenz, Germany; 5Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 6AOK PLUS, Dresden, Germany; 7Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: Roland Buhl, Medizinische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Langenbeckstraße 1, Mainz, 55131, Germany, Tel +49 6131 17 7271, Email roland.buhl@unimedizin-mainz.dePurpose: This study aimed to describe the real-world treatment of German incident COPD patients, compare that treatment with clinical guidelines, and provide insight into disease development after incident diagnosis. In addition, the economic burden of the disease by assessing COPD-related healthcare costs was described.Patients and Methods: Based on a German claims dataset, continuously insured individuals (04/2014-03/2019) aged 40 years or older with at least two incident pulmonologist’s diagnoses or one inpatient diagnosis of COPD (ICD-10-GM code J44.-; no respective diagnosis in a 12-month baseline period) were selected. Treatment patterns after incident diagnosis considering inhaled maintenance therapies identified by ATC codes (outpatient prescriptions) were analyzed. Prescription patterns were compared with recommendations of German COPD treatment guidelines. Severe exacerbations were assessed as hospitalizations with main diagnosis ICD-10-GM code J44.1. COPD-associated costs from the perspective of the health insurance fund AOK PLUS were calculated per patient-year (PY).Results: The sample comprised 17,464 incident COPD patients with a mean age of 71.5 years. 58.9% were male and the mean Charlson-Comorbidity-Index was 5.3. During follow-up (median: 2.0 years), 57.1% of the patients received at least one prescription of an inhaled maintenance therapy, whereas 42.9% did not. Among treated patients, 35.2% started their treatment with LABA/LAMA, 25.3% with LAMA monotherapy, 16.2% with LABA/ICS, and 7.8% with LABA/LAMA/ICS therapy. Within four weeks after initial diagnosis, ICS-containing therapies were prescribed in 14.1% of patients. Of all patients with a prescribed triple therapy, 68.9% had no corresponding exacerbation history documented. On average, 0.16 severe exacerbations and 0.19 COPD-related hospitalizations were observed per PY during available follow-up. Direct COPD-related costs were 3,693 €/PY, with COPD-related hospitalizations being responsible for about 79.2% of these costs.Conclusion: Long-acting bronchodilators are the mainstay of pharmacological treatment of incident COPD patients in Germany, in line with guideline recommendations. Yet, a considerable proportion of incident COPD patients did not receive any inhaled maintenance therapy.Keywords: COPD, real-world treatment, exacerbation frequency, healthcare costs

People with multiple sclerosis (pwMS) have a higher risk of serious infection (i.e., infection-related hospitalizations) than people without MS. Few studies have explored the risk of serious infections by MS phenotype in a real-world setting. This retrospective study compared the incidence of serious infections among people with relapse remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).Adult pwMS were selected from a German claims database, based on one inpatient or two outpatient diagnoses of MS (ICD-10 G35) by a neurologist from 01/01/2016 to 12/31/2018. Three cohorts (RRMS, PPMS, SPMS) were identified based on codes for MS subtypes included in the German Modification of the ICD-10 system. A fourth cohort of unspecified MS patients combined those with conflicting MS subtype diagnoses and multiple unspecified codes for MS. Serious infections were defined as hospitalizations for which infections were selected as the primary inpatient diagnosis. Infections were identified from a basket of ICD-10 codes distributed across 11 main categories, according to possible pathogen (e.g., other bacterial diseases [A30-A49]) or anatomical location (e.g., urinary tract infection [N39.0]). Multiple infections were counted if an interval of at least 60 days was recorded between episodes. Serious infections were counted from index (i.e., first recorded MS code) until the end of the study period or death. Incidence rates (IRs) were reported per 100 patient years (PY).A total of 4,250 pwMS (RRMS: 2,307, PPMS: 282, SPMS: 558, unspecified MS: 1,135) were included; 32 patients progressed from RRMS to SPMS during the follow-up period. Mean (SD) age at baseline was 46.6 (13.6), 61.9 (12.4), and 62.5 (11.8) years in patients with RRMS, PPMS, and SPMS, respectively. Most pwMS were female (RRMS 74.8%, PPMS 62.1%, SPMS 67.4%). Progressive pwMS were more likely to have at least 1 comorbidity (PPMS 87.2%, SPMS 87.5%) compared to those with relapsing MS (61.9%). Most RRMS patients received disease-modifying therapy during follow-up (82.1%), while less than half of progressive MS patients did (PPMS 23.8%, SPMS 31.4%). Over a mean (SD) follow-up period of 3.5 (0.8) years, the IR of serious infections per 100 PY was higher in progressive MS cohorts (PPMS 13.5 [11.3-16.1], SPMS 13.6 [12.0-15.3]) than in the RRMS group (3.4 [3.0-3.7]). Yearly IRs remained stable over time in each cohort. Where anatomical location was specified, respiratory (2.0 per 100 PY) and genitourinary (1.9 per 100 PY) infections were most common. Across all subtypes, higher rates of serious infections were observed in men and older patients.Progressive MS, older age and male sex are associated with an increased risk of serious infections. Overall, respiratory and genitourinary infections were the most commonly reported serious infections.

Background: This study aimed to evaluate differences in healthcare resource utilization and cost among patients with controlled and uncontrolled asthma. Methods: Claims data from a German sickness fund was linked to patient survey data. Outpatient physicians enrolled patients and assessed asthma control using the ACTTM questionnaire. All-cause and asthma-specific healthcare resource use (HCRU)/costs were compared descriptively and based on multivariable models using a continuous ACTTM score. Results: Overall, 492 asthma patients were included (mean age: 53.8, 73.8% female). The mean/median ACTTM score was 19.9/20.7, with 183 patients (37.2%) classified as having uncontrolled asthma (mean ACTTM score Conclusion: Considering continuous patient care, improving asthma control is not only desirable from a clinical perspective, but could also be an effective approach to reduce asthma-related HCRU and cost burden.

The objective of this study was to assess non-adherence (NA) and non-persistence (NP) to long-acting asthma medications in Germany by differentiating between measurement of NA in periods of therapy continuation and measurement of NP in therapy-naïve patients.We analyzed treatment adherence to long-acting asthma medication using German claims data for periods of treatment continuation based on the medication possession ratio (MPR) and the proportion of days covered. Persistence was assessed in treatment-naïve patients. Outcomes were observed from the date of the first to the last prescription within a 12-month period. Both NA and NP analyses considered prescription supply, using either defined daily dosages, or prescribed daily dosages derived from a medical chart review.We identified 52,508 asthma patients (mean age: 40.1, 58.4% female) who received at least two long-acting asthma prescriptions within 12 months; 50,660 treatment-naïve patients were included in the NP analysis (mean age: 39.7, 58.8% female). The mean 12-month MPR was 38.5% (89.4% NA according to MPR ≤ 80%) and the average proportion of days covered was 40.4% (85.9% NA). Agent-specific MPR and NA rates varied between 31.8% (91.8% NA) and 56.2% (71.6% NA). The average weighted-MPR increased to 53.1% when using the prescribed daily dosage. Based onHigh levels of treatment NA and NP indicate a substantial need to improve adherence and persistence to long-acting asthma medication in Germany.

Background This study analyzes the impact of skeletal-related events (SRE) on healthcare resource utilization (HCRU) and costs incurred by patients with bone metastases (BM) from solid tumors (ST), who are therapy-naïve to bone targeting agents (BTAs). Methods German claims data from 01/01/2010 to 30/06/2018 were used to conduct a retrospective comparative cohort analysis of BTA-naive patients with a BM diagnosis and preceding ST diagnosis. HCRU and treatment-related costs were compared in two matched cohorts of patients with and without a history of SREs, defined as pathological fracture, spinal cord compression, surgery to bone and radiation to bone. The first SRE was defined as the patient-individual index date. Conversely, for the non-SRE patients, index dates were assigned randomly. Results In total, 45.20% of 9,832 patients reported experiencing at least one SRE (n = 4444) while 54.80% experienced none (n = 5388); 2,434 pairs of SRE and non-SRE patients were finally matched (mean age: 70.87/71.07 years; females: 39.07%/38.58%). Between SRE and non-SRE cohorts, significant differences in the average number of hospitalization days per patient-year (35.80/30.80) and associated inpatient-care costs (14,199.27€/10,787.31€) were observed. The total cost ratio was 1.16 (p Conclusion The underutilization of BTAs within a clinical setting poses an ongoing challenge in the real-world treatment of BM patients throughout Germany. Ultimately, the economic burden of treating SREs in patients with BM from ST was found to be considerable, resulting in higher direct healthcare costs and increased utilization of inpatient care facilities.

Fraence Hardtstock,1 Julia Krieger,1 Thomas Wilke,1 Marco Lukas,2 Bernhard Ultsch,2 Robert Welte,2 Renate Quinzler,3 Ulf Maywald,4 Hartmut Timmermann5 1IPAM e.V, Wismar, Germany; 2GlaxoSmithKline GmbH & Co. KG, München, Germany; 3AOK Baden-Württemberg, Stuttgart, Germany; 4AOK PLUS, Dresden, Germany; 5Schwerpunktpraxis Colonnaden, Hamburg, GermanyCorrespondence: Fraence Hardtstock, Email Fraence.hardtstock@ipam-wismar.deBackground: Asthma is one of the most common chronic diseases in Germany. While many patients achieve asthma control under standard therapies, some patients still experience exacerbations and persistent airway obstructions. Thus, further pharmacological treatment is needed, and biologics could fill this gap, as they have shown clinical benefit in patients with severe asthma. Therefore, this real-world study aimed to compare healthcare resource utilization (HCRU) and associated costs before and after biologic therapy initiation.Methods: A retrospective claims data analysis has been conducted on adult asthma patients who initiated a long-term biologic therapy between January 2015 and June 2018. Patients were therapy-naïve to biologics for at least 12 months. HCRU and cost incurred by patients during 12 months before and after therapy initiation were compared.Results: Overall, 571 asthma patients initiated a biologic therapy during the observational period (316 omalizumab, 232 mepolizumab, 16 benralizumab, and 7 reslizumab). Patients had a mean age of 54.86 (62.70% female), and the majority (93.70%) received at least one follow-up prescription of their index-biologic agent within one year. During baseline, patients received on average 2.75 OCS prescriptions compared to 2.17 during follow-up. Most patients received less or the same amount of OCS after therapy initiation. Moreover, hospitalizations and asthma-related sick leave days decreased significantly. The average total costs per patient were € 6618.90 during baseline and € 22,832.33 during follow-up. Biologics mainly drove the increase; however, hospitalization costs were reduced significantly (€ 2443.37 vs € 1941.93; p< 0.001).Conclusion: Our study demonstrates an improved asthma control due to the initiation of a biologic therapy in terms of decreased hospitalization frequency, OCS consumption, and sick leave days. However, biologics are associated with high costs for healthcare providers during the first year after initiation. Therefore, short- and long-term clinical benefits and financial burden must be considered in the overall context of healthcare.Keywords: biologics, treatment pattern, claims data, real-world evidence, Germany

Aims: Using German claims, the authors replicated the CHAARTED trial in metastatic hormone-sensitive prostate cancer. Methods: The authors identified metastatic hormone-sensitive prostate cancer patients replicating the inclusion/exclusion criteria of CHAARTED. Patients treated with docetaxel in combination with androgen deprivation therapy (ADT) at first line (docetaxel group) were compared with patients treated with ADT monotherapy (ADT mono group). After propensity score matching, overall survival was compared between the matched cohorts. Results: The authors included 441 patients. After propensity score matching, two equally sized matched cohorts of 74 patients each were compared in terms of overall survival. The hazard ratio (HR) was 0.71 (95% CI: 0.42–1.19), comparable to the HR in CHAARTED (HR: 0.72; 95% CI: 0.59–0.89). Conclusions: Using early comparative evidence from real-world data for regulatory and health technology assessment decisions is useful.

Purpose Endometrial cancer (EC) is the sixth most common malignancy among females worldwide. Due to limited therapeutic options, treatment of advanced or recurrent disease is associated with poor outcomes. The aim of this study was to describe the real-world treatment of patients with advanced or recurrent EC who received a systemic treatment following platinum-based chemotherapy. Methods This retrospective cohort study was based on anonymized German claims data covering the period between January 1, 2010, and June 30, 2020. Patients with EC who started an anticancer treatment following platinum-based chemotherapy were observed for a minimum follow-up of 12 months. Available claims data were used to describe patient characteristics, subsequent treatment lines, healthcare resource utilization, and overall survival (OS) of patients. Results Out of 713 patients with advanced or recurrent EC and who had received a platinum-based treatment, 201 (mean age: 68.9 years) with a post-platinum-based treatment were identified and observed. The median OS in this population was 335.0 days. Of the 201 patients, 79 patients (39.3%) received a second line of treatment (LOT), and 21 patients (10.4%) had 3 or more treatment lines. In the LOTs following platinum-based chemotherapy, more than 70 different treatment regimens were observed. The hospitalization rate was generally high, with 5.2 hospitalizations per patient-year in the follow-up period. Conclusion The wide variety of therapeutic regimens applied in patients in Germany who progressed after platinum-based therapy confirms the lack of therapeutic strategy for these patients, and the poor prognosis highlights the urgent need for new treatment strategies.

Thomas Wilke,1 Burkhard Weisser,2 Hans-Georg Predel,3 Roland Schmieder,4 Sven Wassmann,5 Anton Gillessen,6 Jörg Blettenberg,7 Ulf Maywald,8 Olaf Randerath,9 Sabrina Mueller,10 Michael Böhm11 1Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM)/Institute for Pharmacoeconomics and Pharmaceutical Logistics, Wismar, Germany; 2Institute of Sports Science, Christian-Albrechts-University of Kiel, Kiel, Germany; 3Institute of Cardiology and Sports Medicine, German Sport University, Cologne, Germany; 4Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University Erlangen Nürnberg, Erlangen, Germany; 5Faculty of Medicine, Cardiology Pasing, Munich and University of the Saarland, Homburg/Saar, Germany; 6Department of Internal Medicine, Herz-Jesu-Hospital, Münster, Germany; 7Practice Dr. J. Blettenberg, Lindlar, Germany; 8AOK PLUS – The Health Insurance for Sachsen und Thüringen; GB Medicines/Remedies, Dresden, Germany; 9Medical Department, APONTIS PHARMA GmbH & Co.KG, Monheim, Germany; 10Ingress-Health HWM GmbH, Wismar, Germany; 11Clinic for Internal Medicine III, University Clinic of Saarland, Saarland University, Homburg/Saar, GermanyCorrespondence: Thomas Wilke, Institute of Pharmacoeconomics and Medication Logistics, University of Wismar, Alter Holzhafen 19, Wismar, 23966, Germany, Tel +4938417581014, Fax +4938417581011, Email Thomas.wilke@ipam-wismar.deAim: Current guidelines for the treatment of arterial hypertension (AH) or cardiovascular (CV) prevention recommend combination drug treatments with single pill combinations (SPC) to improve adherence to treatment. We aimed to assess whether the SPC concept is clinically superior to multi pill combination (MPC) with identical drugs.Methods and Results: In an explorative study, we analyzed anonymized claims data sets of patients treated with CV drugs for hypertension and/or CV disorders who were insured by the German AOK PLUS statutory health fund covering 01/07/2012-30/06/2018. Patients at age ≥ 18 years who received either a SPC or MPC with identical drugs were followed for up to one year. A one to one propensity score matching (PSM) was applied within patient groups who started identical drug combinations, and results were reported as incidence rate ratios (IRRs) as well as hazard ratios (HRs). After PSM, data from 59,336 patients were analyzed. In 30 out of 56 IRR analyses, superiority of SPC over MPC was shown. In 5 out of 7 comparisons, the HR for the composite outcome of all-cause death and all-cause hospitalizations was in favor of the SPC regimen (SPC versus MPC): valsartan/amlodipine: HR=0.87 (95% CI: 0.84– 0.91, p ≤ 0.001); candesartan/amlodipine: 0.77 (95% CI: 0.65– 0.90, p = 0.001); valsartan/amlodipine/hydrochlorothiazide: HR=0.68 (95% CI: 0.61– 0.74, p ≤ 0.001); ramipril/amlodipine: HR=0.80 (95% CI: 0.77– 0.83, p ≤ 0.001); acetylsalicylic acid (ASA)/atorvastatin/ramipril: HR=0.64 (95% CI: 0.47– 0.88, p = 0.005).Conclusion: SPC regimens are associated with a lower incidence of CV events and lower all-cause mortality in clinical practice. SPC regimens should generally be preferred to improve patient’s prognosis.Keywords: single pill, adherence, cardiovascular outcomes, mortality, prognosis, clinical practice

464 Background: This study assessed real-world treatment (tx) and outcomes in patients with metastatic urothelial carcinoma (mUC) in Germany. Methods: Using 2 statutory health insurance (SHI) claims databases (SHI 1 and SHI 2; 2013-2020, ≈8 million insured), adults with an incident mUC diagnosis from 2015-2019 were identified. Those with other malignant tumors were excluded. Patients were observed for ≥12 mo after incident mUC diagnosis (index) or until death. Treated patients were delineated into 3 groups based on first-line (1L) tx received: platinum-based chemotherapy (PB CT), non–PB CT, and immunotherapy (IO). Patient characteristics were analyzed descriptively. Multivariable logistic regression was used to identify factors associated with receiving tx. Overall survival (OS) was calculated from 1L tx initiation by Kaplan-Meier estimation. Analyses were done separately for each database. Results: The study included 3,226 patients with mUC (male, 70.8%), with a mean (SD) follow-up of 13.8 mo (16.1). The mean (range) age was 73.8 y (23-99), and the mean (SD) Elixhauser Comorbidity score was 17.6 (11.4). Overall, 1,286 patients (39.9%) received tx in the first 12 mo post index; PB CT was the most common 1L tx (n=825, 64.2%), followed by non–PB CT (n=322, 25.0%) and IO (n=139, 10.8%). Over time, the number of patients receiving 1L tx increased (2015, 35.8%; 2019, 45.7%). Multiple factors were associated with a higher likelihood of receiving 1L tx: younger age (OR, 0.93), male sex (OR, 0.83), lower comorbidity score (OR, 0.97), previous UC-related interventions (OR, 1.65), and a more recent mUC diagnosis (OR, 1.11). In treated patients, the unadjusted median OS (interquartile range [IQR]) from index diagnosis was 13.7 mo (7-33) for SHI 1 and 13.8 mo (7-42) for SHI 2. In untreated patients, the median OS (IQR) from index diagnosis was 3.0 mo (1-11) for SHI 1 and 3.6 mo (1-18) for SHI 2. The median OS (IQR) after 1L tx initiation in PB CT–treated patients was 12.9 mo (6-33) for SHI 1 and 13.8 mo (7-49) for SHI 2; in non–PB CT–treated patients was 11.2 mo (4-36) for SHI 1 and 6.5 mo (3-15) for SHI 2; and in IO-treated patients was 4.11 mo (2-14) for SHI 1 and 8.19 mo (3 to not reached) for SHI 2. Conclusions: Our study describes real-world tx patterns/rates and clinical outcomes in patients with mUC in Germany, and highlights that the majority received no systemic tx within the first 12 mo, despite a positive trend in 1L tx rates over time. Treated patients were more likely to be younger, male, and have fewer comorbidities vs untreated patients. Systemic tx was associated with longer OS. Among treated patients, OS was longer in those receiving 1L PB CT vs other 1L tx. Future research should explore the unmet need in untreated patients to confirm alignment with updated tx guidelines and newer standards of care.

Real-world evidence in multiple sclerosis (MS) is limited by the availability of data elements in individual real-world datasets. We introduce a novel, growing database which links administrative claims and medical records from an MS patient management system, allowing for the complete capture of patient profiles. Using the AOK PLUS sickness fund and the Multiple Sclerosis Documentation System MSDS3D from the Center of Clinical Neuroscience (ZKN) in Germany, a linked MS-specific database was developed (MSDS-AOK PLUS). Patients treated at ZKN and insured by AOK PLUS were recruited and asked for informed consent. For linkage, insurance IDs were mapped to registry IDs. After the deletion of insurance IDs, an anonymized dataset was provided to a university-affiliate, IPAM e.V., for further research applications. The dataset combines a complete record of patient diagnoses, treatment, healthcare resource use, and costs (AOK PLUS), with detailed clinical parameters including functional performance and patient-reported outcomes (MSDS3D). The dataset currently captures 500 patients; however, is actively expanding. To demonstrate its potential, we present a use case describing characteristics, treatment, resource use, and costs of a patient subsample. By linking administrative claims to clinical information in medical charts, the novel MSDS-AOK PLUS database can increase the quality and scope of real-world studies in MS.

Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune disease of the central nervous system which causes recurrent relapses, resulting in blindness, paralysis, and spinal cord damage. This study sought to explore the real-world burden, treatment, and cost of NMOSD in Germany using claims data.Our study consisted of a retrospective analysis of two anonymized health insurance datasets covering around 9 million patients in Germany from 01/01/2013 to 31/12/2019. NMOSD patients were identified using inpatient and outpatient International Classification of Diseases, Tenth Revision (ICD-10) diagnoses of neuromyelitis optica (NMO; G36.0) and relevant symptom codes. Active periods of disease were identified based on relapse events (including hospitalizations and acute treatment); healthcare resource utilization (HCRU) and direct costs were allocated to active and inactive periods based on treatment dates. Propensity score matching was used to compare HCRU and cost outcomes among patients with and without NMOSD.Overall, 130 patients were identified as having NMOSD (mean age: 46.84 years; 58% female). NMOSD patients recorded 16.52 active and 348.48 inactive days per patient year (PPY). HCRU and associated costs were approximately tenfold higher during active periods than during inactive periods, with the largest share of the cost difference driven by hospitalizations (€6424.09/€259.10 per active/inactive month) and outpatient drug prescriptions (€412.83/€271.58). Direct healthcare costs incurred by patients with NMOSD (€12,913.28 PPY) were approximately threefold higher than those incurred by patients without NMOSD (€4667.66 PPY). Costs of hospitalization (€6448.32/€1937.64 PPY) and outpatient prescriptions (€3335.67/€1037.64 PPY) contributed most strongly to the difference.Patients with NMOSD consume substantial healthcare resources and incur heavy costs during active disease phases. This study captured direct measurable healthcare costs and likely underestimates the real societal/emotional burden on patients and their families. Nevertheless, prevention of acute relapses represents one compelling strategy to minimize the economic burden of NMOSD in Germany.

Background Idiopathic pulmonary fibrosis (IPF) is a progressive form of fibrosing interstitial pneumonia with poor survival. This study provides insight into the epidemiology, cost, and disease course of IPF in Germany. Methods A cohort of incident patients with IPF (n = 1737) was identified from German claims data (2014–2019). Incidence and prevalence rates were calculated and adjusted for age differences compared with the overall German population. All-cause and IPF-related healthcare resource utilization as well as associated costs were evaluated per observed person-year (PY) following the initial IPF diagnosis. Finally, Kaplan–Meier analyses were performed to assess time from initial diagnosis to disease deterioration (using three proxy measures: non-elective hospitalization, IPF-related hospitalization, long-term oxygen therapy [LTOT]); antifibrotic therapy initiation; and all-cause death. Results The cumulative incidence of IPF was estimated at 10.7 per 100,000 individuals in 2016, 10.9 in 2017, 10.5 in 2018, and 9.6 in 2019. The point prevalence rates per 100,000 individuals for the respective years were 21.7, 23.5, 24.1, and 24.1. On average, ≥ 14 physician visits and nearly two hospitalizations per PY were observed after the initial IPF diagnosis. Of total all-cause direct costs (€15,721/PY), 55.7% (€8754/PY) were due to hospitalizations and 29.1% (€4572/PY) were due to medication. Medication accounted for 49.4% (€1470/PY) and hospitalizations for 34.8% (€1034/PY) of total IPF-related direct costs (€2973/PY). Within 2 years of the initial IPF diagnosis (23.6 months), 25% of patients died. Within 5 years of diagnosis, 53.1% of patients had initiated LTOT; only 11.6% were treated with antifibrotic agents. The median time from the initial diagnosis to the first non-elective hospitalization was 5.5 months. Conclusion The incidence and prevalence of IPF in Germany are at the higher end of the range reported in the literature. The main driver for all-cause cost was hospitalization. IPF-related costs were mainly driven by medication, with antifibrotic agents accounting for around one-third of the total medication costs even if not frequently prescribed. Most patients with IPF do not receive pharmacological treatment, highlighting the existing unmet medical need for effective and well-tolerated therapies.

Background There exists a range of treatments in the management of asthma. Non-adherence to these medications has been identified as a factor negatively impacting the effects of treatment. Objective The objective of this study was to identify the potential barriers to medication adherence among adult patients with asthma in Germany. Patients and Methods A multi-center observational study was conducted addressing adult patients with asthma who were prescribed regular maintenance medication between 2014 and 2016. Data were derived from physicians’ documentation as well as claims data, which were linked to the above primary observational data, and patient survey data. Adherence barriers were assessed by the validated Adherence Barriers Questionnaire, both descriptively and in a logistic regression framework. Cluster analysis identified distinct patient groups with respect to the relevance of specific adherence barriers. Results We included 524 patients with asthma (mean age 53.1 years, 74.6% female, 43.1% allergic asthma, 37.6% nonallergic, 19.3% mixed). Most of the participants reported to face at least three barriers (61.1%). Frequently reported barriers were the perception that medications are all harmful (53.6% of the participants), the burden of medication co-payment (44.1%), positive perception about current health status (39.9%), feeling of depression (30.9%), and the fear of side effects (27.5%). Four distinct patient clusters could be identified: cluster 1 with a low number of barriers (28.6% of participants), cluster 2 (11.6%) with a comparably high number of existing barriers, cluster 3 with high importance of depression as a barrier (27.3% of participants), and cluster 4 that was dominated by the perception that medications are all harmful (32.5% of participants). Conclusions Results of this study provide important insights for further development of adherence programs, which should focus on distinct patients’ clusters that differ substantially in the relevance of specific adherence barriers.

Objectives Previous studies have shown that weekend hospitalizations are associated with poorer health outcomes and higher mortality (“weekend effect”). However, few of these studies have adjusted for disease severity and little is known about the effect on costs. This work investigates the weekend effect and its costs for patients with cerebral infarction in Germany, adjusting for patient characteristics and proxies of stroke severity. Methods Adult patients with a cerebral infarction hospitalization 10th revision of the International statistical classification of diseases and related health problems (ICD-10: I63) between 01 January 2014 and 30 June 2017 were included from German health claims (AOK PLUS dataset). Propensity score matching was used to match patients hospitalized on weekends or on public holidays (weekend group) with patients hospitalized during the working week (workday group), based on baseline characteristics and proxies for disease severity such as concomitant diagnoses of aphasia, ataxia, and coma, or peg tube at index hospitalization. Matched cohorts were compared in terms of in-hospital, 7-day, and 30-day mortality, as well as risk and costs of stroke and rehabilitation stays in the year after first stroke. Results Of 32,311 patients hospitalized with cerebral infarction between 01 January 2014 and 30 June 2017, 8409 were in the weekend group and 23,902 in the workday group. After propensity score matching, 16,730 patients were included in our study (8365 per group). Matched cohorts did not differ in baseline characteristics or stroke severity. In the weekend group, the risk of in-hospital death (11.2%) and the seven-day mortality rate (6.8%) were 13.1% and 17.2% higher than in the workday group, respectively (both p Conclusions A significant weekend effect emerged after controlling for observable patient characteristics and proxies of stroke severity. This effect also resulted in higher costs for patients admitted on weekends.

BackgroundMigraine is still an area of significant unmet therapeutic needs with a high degree of underdiagnosis and undertreatment of patients. This retrospective claims data analysis aimed to describe the acute and prophylactic treatment patterns of German migraine/headache patients as well as associated healthcare resource use (HCRU) and costs. MethodsThis retrospective, cohort analysis of German claims data from 2013-2017 included over three million publicly insured patients. Continuously insured adult patients were included if they received at least one inpatient or two confirmed outpatient claims for headache or migraine from 2013-2016. Patients were separated into four main cohorts based on their prophylactic/acute prescription (Rx) medication history in 2017. These four groups included patients receiving: neither acute nor prophylactic Rx (cohort N), only acute Rx (cohort A), only prophylactic Rx (cohort P), and both acute and prophylactic Rx (cohort AP). Baseline characteristics were observed from 2013-2016, while treatment and HCRU/costs were assessed in 2017. ResultsIn total, 199,283 patients were included in this analysis (mean age, 49.49 years; 73.04%, female), among which 9,005 prophylactic therapy starters could be identified during 2014-2015. Overall, 43.47% of the patients included in the study did not receive acute or prophylactic medication in 2017. Approximately 33.81% received only acute treatment, while 9.45% received only prophylactic medication; 13.28% received both. Only 28.90% of patients starting a therapy with prophylactic Rx continued this therapy for at least two years. Generally, HCRU and costs were high in the entire study population, with direct costs ranging from 2,288-7,246€ per year, and indirect costs due to sick-leave ranging from 868-1,859€. ConclusionsDespite experiencing migraine-related hospitalizations and sick-leave, a sizable proportion of patients included in this study only received substantial amounts of acute Rx treatment or no prescribed treatment for migraine whatsoever. Patients who began receiving prophylactic therapy were found to frequently discontinue their therapy early. Thus, there is a high unmet need for the safe, timely, and efficacious use of prophylactic therapies among migraine patients.

Sabrina Mueller,1 Antje Groth,1 Stefan G Spitzer,2,3 Anja Schramm,4 Andreas Pfaff,5 Ulf Maywald6 1Institute for Pharmacoeconomics and Medication Logistics, University of Wismar, Wismar, Germany; 2Praxisklinik Herz und Gefäße Dresden, Academic Educational Practice Clinic, TU Dresden, Dresden, Germany; 3Institute of Medical Technology, Brandenburg University of Technology Cottbus–Senftenberg, Senftenberg, Germany; 4AOK Bayern, Regensburg, Germany; 5AOK Baden-Württemberg, Stuttgart, Germany; 6AOK PLUS, Dresden, Germany Objective: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment. Methods: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included. Outcomes and measures: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs). Results: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA2DS2VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA2DS2VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17–1.28/1.22; 1.17–1.28), IS (1.90; 1.69–2.15/1.92; 1.69–2.19), non-specified strokes (2.04; 1.16–3.70/1.93; 1.13–3.32), TIAs (1.52; 1.29–1.79/1.44; 1.21–1.70), MIs (1.26; 1.10–1.15/1.31; 1.13–1.52), AE (1.75; 1.32–2.32/1.81; 1.36–2.34) and severe bleeding (1.92; 1.71–2.15/1.95; 1.74–2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616). Conclusion and relevance: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients. Keywords: atrial fibrillation, AF, anticoagulation, NOAC, VKA, cohort study

Sabrina Müller,1 Thomas Wilke,1 Andreas Fuchs,2 Ulf Maywald,2 Jan-Paul Flacke,3 Harald Heinisch,4 Klaus Krüger5 1Institute for Pharmacoeconomics and Medication Logistics, University of Wismar, Wismar, 2AOK PLUS, Dresden, 3Roche Pharma AG, Grenzach-Wyhlen, 4Chugai Pharma Europe Ltd, Frankfurt/M, 5Praxiszentrum St Bonifatius, Munich, Germany Objective: This study aimed to assess the level of nonpersistence (NP) and nonadherence (NA) to methotrexate (MTX) therapy in German patients with rheumatoid arthritis (RA). Materials and methods: Based on German claims data, RA patients who received a MTX therapy (subgroup: treatment-naive patients) were analyzed. NP was defined as treatment gap >12weeks. Regarding NA, it is the overall medication possession ratio (MPR) during an observational period of 12 or 24months after therapy, and the MPR is calculated only for the periods of therapy continuation; NA was defined as MPR