Search

Kai-Michael Beeh,1 Kieran J Rothnie,2 Jing Claussen,3 Fränce Hardtstock,4 Rachel K Knapp,4 Thomas Wilke,5 Alexandrosz Czira,2 Chris Compton,6 Afisi S Ismaila7,8 1Insaf Respiratory Research Institute, Wiesbaden, Germany; 2Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, UK; 3Global Medical Affairs, GSK, Munich, Germany; 4Real World & Advanced Analytics (RWAA), Cytel, Berlin, Germany; 5IPAM e.V., Institute affiliated with University of Wismar, Wismar, Germany; 6Global Medical, GSK, London, UK; 7Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, USA; 8Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GSK, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: To assess patient characteristics of users and new initiators of triple therapy for chronic obstructive pulmonary disease (COPD) in Germany.Patients and Methods: Retrospective cohort study of patients with COPD and ≥ 1 prescription for single-inhaler triple therapy (SITT; fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI] or beclomethasone dipropionate/glycopyrronium bromide/formoterol [BDP/GLY/FOR]) or multiple-inhaler triple therapy (MITT), using data from the AOK PLUS German sickness fund (1 January 2015– 31 December 2019). The index date was the first date of prescription for FF/UMEC/VI or BDP/GLY/FOR (SITT users), or the first date of overlap of inhaled corticosteroid, long-acting β2-agonist, and long-acting muscarinic antagonist (MITT users). Two cohorts were defined: the prevalent cohort included all identified triple therapy users; the incident cohort included patients newly initiating triple therapy for the first time (no prior use of MITT or SITT in the last 2 years). Patient characteristics and treatment patterns were assessed on the index date and during the 24-month pre-index period.Results: In total, 18,630 patients were identified as prevalent triple therapy users (MITT: 17,945; FF/UMEC/VI: 700; BDP/GLY/FOR: 908; non-mutually exclusive) and 2932 patients were identified as incident triple therapy initiators (MITT: 2246; FF/UMEC/VI: 311; BDP/GLY/FOR: 395; non-mutually exclusive). For both the prevalent and incident cohorts, more than two-thirds of patients experienced ≥ 1 moderate/severe exacerbation in the preceding 24 months; in both cohorts more BDP/GLY/FOR users experienced ≥ 1 moderate/severe exacerbation, compared with FF/UMEC/VI and MITT users. Overall, 97.9% of prevalent triple therapy users and 86.4% of incident triple therapy initiators received maintenance treatment in the 24-month pre-index period.Conclusion: In a real-world setting in Germany, triple therapy was most frequently used after maintenance therapy in patients with recent exacerbations, in line with current treatment recommendations.Plain Language Summary: Triple therapy (a combination of three different respiratory inhaled medications) is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience repeated short-term symptom flare-ups when taking dual therapy (a combination of two different respiratory medications). Previously, patients had to take triple therapy using two or three separate inhalers. More recently, single-inhaler triple therapies have been developed, meaning patients can take all three different medications at the same time via one single inhaler. This study assessed the characteristics of patients who were already receiving triple therapy, or who started triple therapy (either via multiple inhalers or a single inhaler), in Germany between January 2015 and December 2019.In total, 18,630 patients who were already receiving triple therapy during the study period, and 2932 patients who newly started using triple therapy were included. The study reported that more than two-thirds of included patients had experienced at least one flare-up of COPD symptoms in the 2 years before starting triple therapy. Most patients had also received another therapy for COPD before starting triple therapy. A small proportion of patients started taking triple therapy after receiving no other therapy for COPD in the previous 2 years.The results of the study suggest that triple therapy for COPD in Germany is most often used in accordance with recommendations (patients already receiving therapy and experiencing repeated symptom flare-ups).Keywords: COPD, Germany, MITT, patient characteristics, real-world treatment, SITT

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

Thomas Wilke,1 Nils Picker,2 Sabrina Müller,2 Anna Stürmlinger,3 Barthold Deiters,4 Axel Dittmar,1 Jens Aberle,5 Maximilian Gabler3 1IPAM e.V., Wismar, Germany; 2Ingress-Health HWM GmbH, Wismar, Germany; 3Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim, Germany; 4GWQ ServicePlus AG, Düsseldorf, Germany; 5Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg, GermanyCorrespondence: Nils Picker, Ingress-Health HWM GmbH, Alter Holzhafen 19, Wismar, 23966, Germany, Tel +49 3841 758 1013, Fax +49 3841 758 1011, Email nils.picker@ingress-health.comPurpose: Achieving good glycemic control in type 2 diabetes (T2DM) may require individualized pharmacological approaches. We aimed to compare direct healthcare costs in patients treated with empagliflozin (EMPA) compared to dipeptidyl peptidase-4 inhibitors (DPP-4i) or glucagon-like peptide-1 receptor agonists (GLP-1-RA).Patients and Methods: This German claims data study included continuously insured persons with at least two outpatient diagnoses and/or one inpatient diagnosis of T2DM if they started EMPA, DPP-4i, or GLP-1-RA in 2015– 2018. Healthcare costs were assessed from therapy initiation until the end of data availability, death, or therapy discontinuation and compared among propensity score-matched cohorts.Results: Of 24,465 patients included, 3285 received EMPA, 19,443 DPP-4i, and 1747 GLP-1-RA. Matched cohorts were balanced on baseline characteristics (EMPA versus DPP-4i: n1/n2 = 3100/3100 and EMPA versus GLP-1-RA: n3/n4 = 1346/1346). Mean total costs after start of DPP-4i were € 7009 (95%-CI: 6573– 7444) versus € 4274 (3982– 4566) for EMPA. Costs associated with GLP-1-RA treatment were also significantly higher compared with EMPA (€ 6851 [6183– 7518] versus € 4895 [4345– 5445]).Conclusion: Although the individual clinical patient profile and physician assessment are paramount in treatment decisions, substantial differences in the economic impact of different antidiabetic therapies should be considered.Keywords: type 2 diabetes mellitus, sodium-glucose cotransporter-2 inhibitor, DPP-4 inhibitors, GLP-1 receptor agonists, healthcare costs

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

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