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Since fall of 2020, the first Digital Health Applications (DiGA) have been available as a service of the statutory health insurance. The National Association of Statutory Health Insurance Funds considers digital applications to have the potential to improve health care, e.g., for people with chronic diseases, and to consolidate the interconnectedness of the provided offers. DiGA can empower the insured persons to help shape their health care actively and to self-contribute to a successful treatment. At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements for the authorization of DiGA for reimbursement by insurance and the conceptional design of the fast-track process from the Federal Institute for Drugs and Medical Devices (BfArM).This article examines the DiGA, which have been listed in the BfArM directory up to this point, and takes stock after six months of the fast-track process being in place. According to this, the requirements and legal specifications for directory listings and reimbursement via the fast-track process are insufficient from the point of view of the statutory health insurance regarding proven medical effectiveness and economically efficient health care. At present, most of the authorized DiGA, which so far could not provide sufficient evidence about positive healthcare effects, are subsequently only listed provisionally. At the same time, the requirements for proof of medical benefit do not ensure the generation of valid results in studies or clinical trials with regards to routine everyday care. So far, there has been only a moderate qualitative reliability of results. Furthermore, in the context of free pricing by manufacturers, significant price increases can be observed in some cases compared to prices before the BfArM listing.This paper gives recommendations towards further development of the legal basis for the fast-track process, particularly in the subject areas of benefit and patient safety as well as cost effectiveness., (© 2021. Springer-Verlag GmbH Deutschland, ein Teil von Springer Nature.)

Objectives: Enrolment into the SAMMPRIS trial published in September 2011 had to be stopped due to a 2.5 higher 30-day stroke and death rate in patients with percutaneous transluminal angioplasty and stenting (PTAS) compared with the control group with only medical therapy. After these results were published, one would have expected a change toward a clearer definition of indications for intracranial stent implantation in patients with intracranial artery stenosis, using this treatment only in patients suffering from recurrent strokes despite aggressive medical management., Methods: The frequency of intracranial stenting and indication parameters in patients with intracranial artery stenosis were assessed from 2010 to 2013 using claims data for all inpatient episodes from Germany's largest provider of statutory health insurance., Results: The number of intracranial stenting procedures decreased slowly from 580 in 2010 to 375 in 2013. With a rate of 29 percent there was no change between 2010 and 2013 of patients who were admitted to hospital for stent implantation, without documentation of an acute stroke or transient ischemic attack (TIA). Before PTAS, one-third of patients were admitted twice because of a stroke or TIA over a period of 5 years, 17 percent of patients had been prescribed platelet aggregation inhibitors and at least two admissions to hospital were for an ischemic cerebrovascular event before PTAS., Conclusions: Our analysis of German claims data provides little evidence of changed indications for stenting in cases of intracranial atherosclerotic disease which one might expect to be caused by the emergence of high-level evidence.

In 2004, the Federal Joint Committee (G-BA) published a new directive for examination and treatment methods with respect to sleep-related breathing disorders for SHI-accredited physicians. The examination procedure is classified in four steps: anamnesis, clinical assessment, cardiorespiratory polygraphy (PG) and cardiorespiratory polysomnography (PSG). Starting with the date of the first PSG we analysed 1. whether this examination was preceded by a polygraphy, 2. whether there was a gain of diagnostic information through PSG, and 3. whether a PSG was used for the first adjustment examinations and controls after prescription of a positive airway pressure device. The analysis is based on claims data from the Techniker Krankenkasse (2009-2012). Diagnostic services were identified by fee schedule codes (EBM) for outpatient services and by procedure codes (OPS) for inpatient services. Sleep disorders were operationalised by ICD-10 codes and information was completed by prescriptions of a CPAP equipment.The study is based on data from 6.6 million persons who were permanently insured from 01.01.2009 to 30.06.2012 by TK. A preceding PG 90 (180) days before PSG was found for less than 56% (73%) of the analysed insured persons. By the latter procedure, only about 60% of the cases with no clear diagnostic information (G47.39) in the preceding quarter could be specified. Prescription of a positive airway pressure device within 90 days after PSG was found for about 45% of the insured. Concerning the stepwise diagnostic procedure for sleep disorders for SHI-accredited physicians, the directive was followed only partly. Against the background of an evidence-based, effective, and efficient diagnostic approach, the results show a clear need for action., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Compared to conventional human basal insulin (neutral protamine Hagedorn; NPH) the long-acting analogue insulin glargine (GLA) is associated with a number of advantages regarding metabolic control, hypoglycaemic events and convenience. However, the unit costs of GLA exceed those of NPH. This study aims to systematically review the economic evidence comparing GLA with NPH in basal-bolus treatment (intensified conventional therapy; ICT) of type 1 diabetes in order to facilitate informed decision making in clinical practice and health policy., Methods: A systematic literature search was performed for the period of January 1st 2000 to December 1st 2009 via Embase, Medline, the Cochrane Library, the databases GMS (German Medical Science) and DAHTA (Deutsche Agentur für Health Technology Assessment), and the abstract books of relevant international scientific congresses. Retrieved studies were reviewed based on predefined inclusion criteria, methodological and quality aspects. In order to allow comparison between studies, currencies were converted using purchasing power parities (PPP)., Results: A total of 7 health economic evaluations from 4 different countries fulfilled the predefined criteria: 6 modelling studies, all of them cost-utility analyses, and one claims data analysis with a cost-minimisation design. One cost-utility analysis showed dominance of GLA over NPH. The other 5 cost-utility analyses resulted in additional costs per quality adjusted life year (QALY) gained for GLA, ranging from € 3,859 to € 57,002 (incremental cost effectiveness ratio; ICER). The cost-minimisation analysis revealed lower annual diabetes-specific costs in favour of NPH from the perspective of the German Statutory Health Insurance (SHI)., Conclusions: The incremental cost-utility-ratios (ICER) show favourable values for GLA with considerable variation. If a willingness-to-pay threshold of £ 30,000 (National Institute of Clinical Excellence, UK) is adopted, GLA is cost-effective in 4 of 6 cost utility analyses (CUA) included. Thus insulin glargine (GLA) seems to offer good value for money. Comparability between studies is limited because of methodological and country specific aspects. The results of this review underline that evaluation of insulin therapy should use evidence on efficacy of therapy from information synthesis. The concept of relating utility decrements to fear of hypoglycaemia is a plausible approach but needs further investigation. Also future evaluations of basal-bolus insulin therapy should include costs of consumables such as needles for insulin injection as well as test strips and lancets for blood glucose self monitoring.

Background: Body weight management is a key factor in diabetes mellitus. However, both behavioral and pharmacological innovations to manage obesity may imply additional costs. In order to provide further insights into the role of obesity in diabetes-associated resource consumption, this study aims to estimate incremental costs of concomitant obesity in German adult patients (≥ 18 years) with different types of diabetes., Methods: Adopting a third-party payer perspective, claims data from a German statutory sickness fund (N=1,094,496) were analyzed for costs of annual drug prescriptions and out- and inpatient care in adult beneficiaries with diabetes in 2004. Using diagnostic information, 37,570 beneficiaries with diabetes were identified. Concomitant obesity was assessed by ICD-10-codes (E66) in the claims data. Adjusting for sex, age, and micro- and macro-vascular complications, one generalized gamma regression model with the log link was performed for type 2 diabetes patients (N=24,562), type 1 diabetes patients (N=5,663), and an unclassified group (N=7,345), respectively., Results: Overall, 33% of the patients with diabetes were identified as obese (type 2 diabetes: 34%, type 1 diabetes: 20%, unclassified: 38%). Affirming descriptive analyses, the generalized gamma regression models revealed that obesity is associated with significant increments in health care costs regardless of type of diabetes (type 2 diabetes: € 454, type 1 diabetes: € 812, unclassified: € 532). The interaction of obesity and macro-vascular complications was numerically stronger in type 1 than in type 2 diabetes but reached statistical significance only in type 2 diabetes (and the unclassified group). Moreover, concurrent macro- and micro-vascular complications were associated with higher incremental costs in all groups., Conclusions: Concomitant obesity is independently associated with incremental health care costs in adult patients with type 2 diabetes and, even more so, type 1 diabetes. Results are discussed with respect to the fact that in this sample, concurrent micro- and macro-vascular complications were more frequent in type 1 diabetes. At any rate, in light of these health care costs, obesity seems relevant in both types of diabetes. Due to claims data limitations, it was not possible to distinguish obesity classes based on body height and weight information. Further research should identify adiposity thresholds for increased resource consumption using both primary and secondary data., (© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York.)

Background and Objectives: The purpose of this study was to review studies reporting on quality of life and treatment satisfaction of patients with diabetes mellitus being treated with long-acting insulin analogues., Material and Methods: A systematic literature search was made of trials published between January 1, 2000 and June 28, 2007. Retrieved studies were analysed, using predefined inclusion criteria as well as methodological and quality aspects., Results: Twelve studies were included, all of them dealing with insulin glargine as the trial drug or for comparison. With regard to treatment satisfaction, insulin glargine was superior in one head-to-head comparison with NPH (neutral protamine Hagedorn) and one head-to-head comparison with NPH as an add-on to oral glimepiride. There was no difference in comparisons with continuous subcutaneous insulin infusion (CSII), insulin aspart or exenatide. Regarding health related quality of life (HRQoL), insulin glargine was shown to be superior to rosiglitazone as an add-on to metformin and sulfonylurea. Again, there were no differences in comparisons with NPH, CSII or exenatide., Conclusion: There are only a limited number of high quality studies showing that insulin glargine is superior regarding treatment satisfaction and HRQoL of patients with diabetes mellitus. There are fewer publications with good evidence of patient-reported outcomes than those reporting well-established outcomes using HbA1c levels or the incidence of hypoglycaemia.

Background: Our goal was to quantify outcomes, resource use, and treatment costs for the first 2 years after renal transplantation in a "real-life" European setting and to assess the impact of preoperative risk factors and postoperative complications on treatment costs., Methods: Inpatient and outpatient records of all patients who received a renal transplant at Medizinische Hochschule Hannover, Germany, between January 1998 and July 2000, were evaluated. Key clinical events were recorded. Direct costs were calculated for primary hospitalization, the remainder of year 1, and year 2 after transplantation. Cost of organ procurement, pretransplant care, and transplant surgery were excluded. Cost consequences for key clinical events were determined., Results: Of 204 patients undergoing transplantation, 195 and 149 completed 1 year and 2 years of follow-up, respectively. The outcomes of years 1 and 2, respectively, were as follows: graft failure, 5.4%, 0.7%; acute rejection, 35.9%, 5.4%; cytomegalovirus (CMV) infection, 29.2%, 2.0%; and delayed graft function, 30.9%. Costs for primary hospitalization, the remainder of year 1, and year 2 averaged Euro 15,380, Euro 18,636, and Euro 14,484, respectively. Cost-driving events included graft failure Euro 36,228), acute rejection (Euro 9,638), delayed graft function (Euro7,359), and CMV infection (Euro 4,149). Graft failure and acute rejection for year 1 also added significantly to the costs for year 2., Conclusions: These results show that posttransplant clinical outcomes result in a significant increase in treatment costs. Because the economic impact of primary causes of chronic rejection (acute rejection and CMV) and delayed graft function is substantial, careful selection of the most appropriate immunosuppressive regimen is essential.