Statutory Health Insurance System Research Articles

The prevalence of cystic fibrosis—a comparison of patient registry data and billing data within the German statutory health insurance system

The prevalence of cystic fibrosis—a comparison of patient registry data and billing data within the German statutory health insurance system

The Incidence of Endometriosis, 2014–2022. An Analysis of Nationwide Claims Data From Physicians in Private Practice.

The epidemiological characterization of endometriosis, particularly with regard to its incidence, has been inadequate to date both in Germany and other countries. The goal of this study was to determine trends in the incidence of diagnosed endometriosis and changes in age structure at the time of first diagnosis over the period 2014-2022. Nationwide claims data from physicians in private practice, obtained according to relevant German law (§ 295 SGB V), were used to identify the population at risk for a first assured diagnosis of endometriosis (ICD-10-GM: N80) during each year of the study period, consisting of women and girls aged 10-52 who were insured by the statutory health insurance system and for whom at least two years of prior observation were possible. Patients were defined as incident if they were documented as having received a first confirmed diagnosis of endometriosis, according to the case definition, during the study year. The case definition comprised multiple options for validating the diagnosis. The incidence of diagnosed endometriosis rose over the period of the study from 2.8 per 1000 persons at risk in 2014 to 4.1 per 1000 in 2022, corresponding to a 44% relative increase. There was also a marked shift in age-specific incidence toward higher values at younger ages: the median age at diagnosis fell from 37 years (2014) to 34 (2022). This is the first study providing nationwide population-based data on the incidence of endometriosis in Germany. The observed rise in newly diagnosed cases is presumably mainly due to an increased awareness of endometriosis and to the growing recognition of the disease.

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

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

Cannabinoid Drugs in the Treatment of Psychiatric Disorders - Data from the German Federal Institute for Drugs and Medical Devices

Since 2017 physicians in Germany can prescribe cannabis based medicines or medical cannabis with subsequent funding by the statutory health insurance system. Physicians prescribing cannabinoid drugs were legally required to take part in a survey conducted by the Federal Institute for Drugs and Medical Devices. This study analyses data from 16.809 case reports that were collected from 30.3.2017 to 31.12.2021. There were 5582 cases documenting the use of cannabinoid drugs in psychiatric disorders. More than half of the prescriptions were Dronabinol. 80% of the treatments concerned somatoform disorders. Most of the treatments for other psychiatric disorders also targeted pain. Doctors reported a positive effect on symptoms in at least 75% of the cases. Most patients with psychiatric disorders received cannabinoid drugs for pain. The evidence from randomized controlled clinical trials for the use of cannabinoid drugs in psychiatric indications is weak.

MRI and 18F-FET PET for Multimodal Treatment Monitoring in Patients with Brain Metastases: A Cost-Effectiveness Analysis.

PET using the radiolabeled amino acid O-(2-[18F]fluoroethyl)-l-tyrosine (18F-FET) has been shown to be of value for treatment monitoring in patients with brain metastases after multimodal therapy, especially in clinical situations with equivocal MRI findings. As medical procedures must be justified socioeconomically, we determined the effectiveness and cost-effectiveness of 18F-FET PET for treatment monitoring of multimodal therapy, including checkpoint inhibitors, targeted therapies, radiotherapy, and combinations thereof in patients with brain metastases secondary to melanoma or non-small cell lung cancer. Methods: We analyzed already-published clinical data and calculated the associated costs from the German statutory health insurance system perspective. Two clinical scenarios were considered: decision tree model 1 determined the effectiveness of 18F-FET PET alone for identifying treatment-related changes, that is, the probability of correctly identifying patients with treatment-related changes confirmed by neuropathology or clinicoradiographically using the Response Assessment in Neuro-Oncology criteria for immunotherapy. The resulting cost-effectiveness ratio showed the cost for each correctly identified patient with treatment-related changes in whom MRI findings remained inconclusive. Decision tree model 2 calculated the effectiveness of both 18F-FET PET and MRI, that is, the probability of correctly identifying nonresponders to treatment. The incremental cost-effectiveness ratio was calculated to determine cost-effectiveness, that is, the cost for each additionally identified nonresponder by 18F-FET PET who would have remained undetected by MRI. One-way deterministic and probabilistic sensitivity analyses tested the robustness of the results. Results: 18F-FET PET identified 94% of patients with treatment-related changes, resulting in €1,664.23 (€1.00 = $1.08 at time of writing) for each correctly identified patient. Nonresponders were correctly identified in 60% by MRI and in 80% by 18F-FET PET, resulting in €3,292.67 and €3,915.83 for each correctly identified nonresponder by MRI and 18F-FET PET, respectively. The cost to correctly identify 1 additional nonresponder by 18F-FET PET, who would have remained unidentified by MRI, was €5,785.30. Conclusion: Given the considerable annual cost of multimodal therapy, the integration of 18F-FET PET can potentially improve patient care while reducing costs.

Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis

The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinical study situation for the preparations was also analyzed. For this purpose, the clinical studies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers’ claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.

Digital Smoking Cessation With a Comprehensive Guideline-Based App-Results of a Nationwide, Multicentric, Parallel, Randomized Controlled Trial in Germany.

Smoking tobacco implies significant health hazards. Digital cessation support can get more smokers in contact with guideline-based cessation. The objective was to test the efficacy of a guideline-based smoking cessation app (NichtraucherHelden®). The hypothesis was a significantly higher cessation rate in the intervention group. The study was a nationwide, multicentric, prospective, parallel, randomized controlled trial in Germany from November 2021 to March 2023. Recruitment took place in medical practices and by telephone via study centers. Eligible participants were adult tobacco-dependent smokers according to ICD-10 (F17.2). Randomization (1:1) was operated by a computer-generated stratified 1:1 block procedure. Intervention (IG; n = 336) and control group (CG; n = 325) were briefly advised with regard to stop smoking, IG was additionally treated with the cessation app. The primary endpoint was the self-reported 7-day-point abstinence after 6 months with an intention to treat analysis. Secondary endpoints comprised prolonged abstinence and biochemically verified abstinence. The study was registered at the German Registry of Clinical Trials (DRKS00025933, UTN U1111-1268-2181) and was approved by the competent ethics committees (leading ethic committee Berlin #Eth-52/20). Three hundred thirty six participants (IG) and 325 (CG) were analyzed. Seven-day point prevalence was significantly higher in the app group (IG) (20% vs. 10%, OR 2.2 (1.4-3.4)). Additionally, the prolonged abstinence and the objective abstinence rates were significantly higher in the app group. The NichtraucherHelden app doubles the abstinence rate. Apps can bridge the gap between the small number of therapeutic offers and the need for modern evidence-based cessation support. The study is the first to provide evidence for the feasibility and efficacy of guideline-based digital smoking cessation provided by a smartphone app for the German statutory health insurance (SHI) system. Smoking cessation support by smartphone apps could be broadly distributed and thus bring more smokers in contact with guideline-based cessation support than to date and increase the number of successful quitters substantially.

Performance-based reimbursement for digital therapeutics in Germany: A misconceptualized opportunity.

Germany has one of the oldest social security systems in the world. Population coverage has subsequently increased, reaching coverage of approximately 90% of the population in the statutory health insurance (SHI) system today. Before this background, Germany has been pioneering the integration of digital therapeutics (DTx) into its SHI system by the introduction of the Digital Healthcare Law (Digitale-Versorgung-Gesetz, DVG) in 2019. Thereby, patients became eligible for digital health applications (Digitale Gesundheitsanwendungen, DiGA), which are available upon prescription by qualified healthcare professionals. As conventional healthcare delivery often lacks direct outcome measures as and is mostly still reimbursed on a fee-for-service basis, DiGA offer the opportunity to continuously provide individual outcome and performance data. They are, therefore, well-suited for a performance-based payment framework. While the DVG introduced the option for performance-based reimbursement components in 2019 already, the ongoing debate about the value of DiGA and to what extent they can contribute to the healthcare system has now been reflected in a 2023 health policy bill by the German Federal Ministry of Health, which aims to introduce a mandatory performance-based reimbursement component for DiGA. In this light, we propose a framework for performance-based reimbursement of DiGA, involving an intervention-specific, performance-linked reimbursement framework with shared accountability between manufacturers and payers. The approach aims to align the often contradicting interests of the involved stakeholders to incentivize the delivery of high-value digital health care. Yet, the proposal also acknowledges the need for further research to establish a robust foundation for implementing such a framework.

Glaucoma care and surgical management in Azerbaijan

Glaucoma accounts for 14.5%–18.7% in the nosological structure of blindness and low vision in Azerbaijan, and for 13.4% in the structure of primary disability. In 2000 the prevalence of glaucoma in Azerbaijan was 0.1 per 10 000 people, in 2005–0.8 per 10 000 people. The overall reported incidence rate of glaucoma in the Republic of Azerbaijan is characterized by an increase of 15.4% for the period from 2001 to 2010 year. In order to organize and provide free comprehensive ophthalmological care in several remote regions of Azerbaijan, in 2015 a National Program “Identification and dispensary registration of glaucoma patients in various regions of the Republic of Azerbaijan” was created. Currently, 23 756 glaucoma patients are included in the official dispensary register.Due to the lack of a unified statutory health insurance system before 2021 year with limited access to comprehensive glaucoma care and irregular follow‐up outside urban areas, as well as insufficient awareness of this disease in the general population, almost one third of all new diagnosed glaucoma patients in different remote regions of Azerbaijan in 2010–2020 years had already an advanced or end stage glaucoma in one or even in both eyes. That increased the percentage (69.8%) of performed traditional penetrating glaucoma surgeries or cyclophotocoagulation procedures, in 30.2% cases non‐penetrating/micro‐invasive glaucoma surgeries, glaucoma drainage device implantation or combined cataract‐glaucoma surgeries were performed.The aim of this study is to evaluate the features of glaucoma surgical management and to present a model of glaucoma care in Azerbaijan. A developed model for comprehensive glaucoma care and glaucoma surgical management with regularly monitoring of IOP and carry on local glaucoma awareness programs in different regions of our country could provide early disease detection, dispensary registration of the patients, optimal treatment strategy with the use of different minimal invasive surgeries and prevent glaucoma related irreversible blindness in Azerbaijan.Keywords: glaucoma awareness; glaucoma surgery; glaucoma drainage devices; trabeculectomy.

Pneumococcal Vaccination Coverage Rates (VCRs) Among Persons with Vaccine-Relevant Underlying Conditions and Persons Aged 60 Years and Older - An Analysis of Secondary Data from the Statutory Health Insurance (SHI) System

In addition to standard vaccination for patients aged 60 and older, the Standing Committee on Vaccination (STIKO) recommends immunization against pneumococci for anyone at increased risk, including patients with chronic vaccine-relevant underlying conditions. In Germany, the Robert Koch Institute (RKI) regularly publishes vaccination coverage rates (VCRs) for these patient groups, without stratifying by other parameters. This study examines VCRs of patients with underlying chronic diseases, stratified by disease groups and entities, the re-vaccination rate, and VCRs in patients aged 60 years and older. This descriptive retrospective cohort study is based on a sample of about 4 million SHI-insured patients aged 16 years and older for the years 2014 to 2019, from the Institute for Applied Health Research (InGef) database. The sample is representative of age and sex distribution in the German population. Extrapolated to the total SHI-population, the overall pneumococcal VCR in patients aged 60 years and older was 45.9 % (of n= InGef standard vaccination cohort: 1 009 763). Among all at-risk patients aged 16 years and older with chronic underlying diseases, only 17.1 % had received an indicated vaccination (InGef indicated vaccination cohort: 1 379 680). Stratified by disease entity, those with underlying pulmonary emphysema had the highest VCR, at 39.0 % (of n= 28 121). Of those who received a vaccination due to an underlying chronic disease, only 23.9 % were re-vaccinated after 6 years (InGef re-vaccination cohort: 12 328). Across all vaccination cohorts, VCRs increased with age. The recommendations made by STIKO for pneumococcal vaccination based on age or an underlying chronic condition are not being implemented adequately in Germany. Although STIKO explicitly recommends vaccination from 60 years of age, the 60 to 64-year-old age group had a strikingly low VCR (13.0 % of n=268 862). Fewer than one in five patients aged 16 years and older with an underlying chronic condition had received the recommended indicated vaccination. To adequately prevent potential disease, higher vaccination rates should be targeted. This could probably be achieved through more stringent vaccination management, appropriate software solutions with vaccination reminders, monetary incentives for achieving higher vaccination rates and documentation of vaccination status in disease management programs.

Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks-evidence from Germany.

Digital health applications that support patients in managing their condition can have a positive impact on patients' health and improve the overall care process. In late 2019, as the first country worldwide, Germany included digital health applications in the benefit basket of the statutory health insurance (SHI) system to enable fast, broad-scale patient access and encourage innovation in the digital health industry. While the policy is widely recognized as a pioneering step toward improving patient care through digital technologies, there are concerns regarding the mechanics of the policy and the resulting financial risks for the SHI system. The primary objective of this article is to provide a comprehensive and balanced overview of the German policy by evaluating its success in achieving its goals and by reviewing challenges that have emerged. The secondary objective is to delineate prospective policy options and areas warranting future research. The article analyzes publicly available data of the Federal Institute for Drugs and Medical Devices collected between February 1st and July 17th, 2023, and complements it with empirical findings published by academic institutions and sickness funds. It discusses policy options and related areas of future research to overcome the identified challenges without jeopardizing the purpose of the legislation to encourage innovation in the digital health industry to improve patient care. In line with the goals of the reimbursement policy, the inclusion of digital health applications in the SHI benefit basked has entailed new digital treatment options for patients across multiple disease areas. However, from a health policy perspective, the policy has several shortcomings, including low prescription rates, the temporary reimbursement of digital health applications that lack proven benefit, and a pricing framework that does not take into account the efficacy and efficiency of a treatment and may lead to a suboptimal allocation of public resources. Rather than the public system covering digital health applications without proven benefit, the authors suggest giving SHI organizations more budget authority to directly incentivize research and development activities and to introduce value-based pricing. More research is needed to determine the details of these mechanisms.

Real-World Cost-Effectiveness of Pulmonary Vein Isolation for Atrial Fibrillation: A Target Trial Approach

ObjectivesRandomized controlled trials of pulmonary vein isolation (PVI) for treating atrial fibrillation (AF) have proven the procedure’s efficacy. Studies assessing its empirical cost-effectiveness outside randomized trial settings are lacking. We aimed to evaluate the effectiveness and cost-effectiveness of PVI versus medical therapy for AF. MethodsWe followed a target trial approach using the Swiss-AF cohort, a prospective observational cohort study that enrolled patients with AF between 2014 and 2017. Resource utilization and cost information were collected through claims data. Quality of life was measured with EQ-5D-3L utilities. We estimated incremental cost-effectiveness ratios (ICERs) from the perspective of the Swiss statutory health insurance system. ResultsPatients undergoing PVI compared with medical therapy had a 5-year overall survival advantage with a hazard ratio of 0.75 (95% CI 0.46-1.21; P = .69) and a 19.8% SD improvement in quality of life (95% CI 15.5-22.9; P < .001), at an incremental cost of 29 604 Swiss francs (CHF) (95% CI 16 354-42 855; P < .001). The estimated ICER was CHF 158 612 per quality-adjusted life-year (QALY) gained within a 5-year time horizon. Assuming similar health effects and costs over 5 additional years changed the ICER to CHF 82 195 per QALY gained. Results were robust to the sensitivity analyses performed. ConclusionsOur results show that PVI might be a cost-effective intervention within the Swiss healthcare context in a 10-year time horizon, but unlikely to be so at 5 years, if a willingness-to-pay threshold of CHF 100 000 per QALY gained is assumed. Given data availability, we find target trial designs are a valuable tool for assessing the cost-effectiveness of healthcare interventions outside of randomized controlled trial settings.

Correction: Analysis of Sickness-Related Days of Absence among Soldiers of the German Armed Forces from 2008 to 2018 Part 1: Retrospective Analysis with Comparison to the Statutory Health Insurance System

Correction to: Analyse der krankheitsbedingten Fehltage von Soldatinnen und Soldaten der Bundeswehr von 2008 bis 2018 Teil 1: Retrospektive Analyse mit Vergleich zur Gesetzlichen KrankenversicherungGesundheitswesen eFirstDOI: 10.1055/a-1987-5847

Herausforderungen in der Prostatabiopsie

Prostate biopsy is acore area of urology and acentral component in the detection of the most common cancer in older men. Increasing demands on hygiene and quality of diagnostics have not been adjusted in the current reimbursement system for outpatient provision in the SHI (statutory health insurance) system. Presentation of the current situation regarding prostate biopsy; discussion about the further feasibility in the outpatient setting. Professional political assessment and creation of alist of demands for economic coverage of the cost associated with prostate biopsies in the SHI system. Discussion of basic work and negotiations with the KBV ("Kassenärztliche Bundesvereinigung") using the current valid S3guideline prostate cancer. Assessment of federal billing modalities of the SHI system. Costs associated with prostate biopsies are not adequately covered under the current outpatient billing options, considering the steadily increasing demands on the quality of diagnostics as specified in the S3guideline for prostate cancer, and the required hygiene levels; thus, atwo-class medical system is encouraged by self-pay services for improved diagnostics. Urology specialists are encouraged to find solutions. Prostate biopsy must be considered as an outpatient operation and financed accordingly.

Mental health of people with limited access to health services: a retrospective study of patients attending a humanitarian clinic network in Germany in 2021

BackgroundGermany has a statutory health insurance system. However, a substantial part of the population still suffers from limited access to regular health services. While humanitarian organizations are partially filling this gap, people with limited access show a high prevalence of mental disorders. This study investigates the prevalence, and social determinants of mental disorders in patients attending the clinics of a humanitarian health network in three major cities in Germany, as well as perceived barriers to healthcare access in this population.MethodsWe performed a descriptive, retrospective study of individuals attending the outpatient clinics of the humanitarian organization Ärzte der Welt, in Berlin, Hamburg and Munich, in 2021. Medico-administrative data was collected using a digital questionnaire at first presentation to the clinics. We report the prevalence of both perceived altered mental health and diagnosed mental disorders, as well as the perceived barriers to healthcare access in this population. We performed a logistic regression analysis to identify the socio-demographic factors associated with mental disorders.ResultsOur study population consisted of 1,071 first presenters to the clinics in 2021. The median age at presentation was 32 years and 57.2% of the population were male. 81.8% experienced a form of homelessness, 40% originated from non-EU countries and only 12.4% had regular statutory health insurance. 101 (9.4%) patients had a diagnosed mental disorder. In addition, 128 (11.9%) patients reported feeling depressed, 99 (9.2%) reported a lack of interest in daily activities, and 134 (12.5%) lacked emotional support in situations of need on most days. The most reported barrier to accessing health services was high health expenses, reported by 61.3% of patients.In the bivariate logistic regression analysis age, insurance status and region of origin were significantly associated with mental disorders. In the multivariable analysis, only age groups 20–39 and 40–59 years remained significant.ConclusionsPeople with limited access to regular health services have a high need for mental health services. As a chronic condition, this is even more difficult to manage outside of regular services, where humanitarian clinics are only filling the gap in serving basic health needs.

Tasks and Expectations of the Medical Officer in the Statutory Health Insurance System

Tasks and Expectations of the Medical Officer in the Statutory Health Insurance System Abstract. The statutory health insurance OKP is based on the principle that all insured persons have equal access to the approved services. If so, why does it actually need the "medical officer"? What role is assigned to this professional title? What requirements must be met for working as a medical officer? What are the special challenges? This article will provide you with answers to these questions.

Analysis of Sickness-Related Days of Absence among Soldiers of the German Armed Forces from 2008 to 2018 Part 1: Retrospective Analysis with Comparison to the Statutory Health Insurance System

Sickness-related absences are of particular importance both in the German armed forces and in the civilian sector. was to analyze the incidence of sick leave among soldiers in comparison to the working population covered by the statutory health insurance (SHI) system. According to the systematics of the SHI, the key figures on incapacity to work in the period 2008-2018 are calculated in an age- and gender-standardized manner. Likewise, a list of the TOP 20 ICD-10 diagnoses in relation to incapacity to work was determined, and their average annual rates of change were calculated for trend analysis. The annual rate of sick leave among soldiers was between 1.5 and 2.3%, which was lower than that of the SHI (3.1 to 5.0%). The duration of illness (sick days per case) among soldiers was between 9.0-15.6 days per year, compared with 10.9-14.4 days in the SHI system. The sickness frequency (cases per 100 persons) was lower among soldiers (48.2-75.0 cases) than in the SHI (96.8-131.0 cases). Most days of absence among soldiers were due to "respiratory infections (J06)" with 13.2%, "stress reactions (F43)" with 8.7%, "other infectious gastroenteritis and colitis (A09)" with 6.5%, "back pain (M54)" with 4.4% and "depressive episode (F32)" with 4.0% of all days of absence and were comparable to the values in SHI. "Depressive episode (F32)", "injuries (T14)", sreactions (F43)", "respiratory infections (J06)" and "pregnancy complaints (O26)" showed the highest rates of increase of+6.1% to+3.6% of days off work. For the first time, it was possible to compare the sickness rate of soldiers with that of the general population in Germany, which may also provide indications for further measures for primary, secondary and tertiary prevention. The lower sickness rate among soldiers compared with the general population is mainly due to a lower incidence of illness, with a similar duration and pattern of illness, but with an overall upward trend. The ICD-10 diagnoses "Depressive episode (F32)," "injuries (T14)," "stress reactions (F43)," "acute upper respiratory tract infections (J06)" and "pregnancy complaints (O26)," which are increasing at an above-average rate in relation to the number of days absent, require further analysis. This approach seems promising, for example, to generate hypotheses and ideas for further improvement of health care.

Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.

Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Wie belastbar sind Studien der aktuell dauerhaft aufgenommenen digitalen Gesundheitsanwendungen (DiGA)? Methodische Qualität der Studien zum Nachweis positiver Versorgungseffekte von DiGA

IntroductionSince September 2020 digital health applications (DiGA) can be prescribed by physicians and psychotherapists and are reimbursed within the German Statutory Health Insurance (SHI) system for the first time worldwide. For full reimbursement, the manufacturers have to provide evidence based on scientific studies that the DiGA can provide ‘positive health care effects’. This study aims to analyze and evaluate the methodological quality of efficacy studies of DiGA in the categories ‘Nervensystem’ and ‘Psyche’ of the DiGA register that are permanently accepted. MethodsThe methodological quality was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The risk of bias was assessed for the primary endpoint of each study according to an intention-to-treat analysis. ResultsSix DiGA were assessed for their methodological quality. Randomized controlled trials were conducted for all 6 DiGA that showed a high risk of bias, which was, in particular, due to a lack of blinding of the studies. In addition, drop-outs were significantly higher in the intervention group than in the control group in most studies. For most of the DiGA no published study protocol was available in advance so an analysis of a potential selective choice of the evaluation methodology was not possible. DiscussionFor reasons of transparency, verifiability, and comprehensibility of the study results, registration in a study registry and, more importantly, the publication of study protocols should be mandatory before the start of the studies. In addition, studies should be blinded by comparing the DiGA with a ‘sham application’ to reduce the high risk of bias. Differences in the drop-out rates of the investigated studies could indicate a lack of efficacy of the treatment in the intervention group, (technical) problems in the application of the DiGA, or a lack of motivation of the participants. ConclusionThe interim results 18 months after the introduction of DiGA in the German SHI system show that the studies on the evidence of the benefits of DiGA have a high potential for bias in certain areas. However, it should be positively emphasized that the manufacturers submitted randomized controlled trials to prove the medical benefit of the DiGAs investigated.

Evidence of positive care effects by digital health apps-methodological challenges and approaches

Since 2020, digital health applications (DiGA) can be prescribed at the expense of the German statutory health insurance (SHI) system after undergoing an approval procedure by the Federal Institute for Drugs and Medical Devices (BfArM). DiGA can be approved provisionally for 1year (with the option of extension) or permanently. The latter is dependent on scientific evidence of apositive effect on care, which can be amedical benefit or apatient-relevant structural and procedural improvement in care. However, it is apparent that the investigation of DiGA in scientific studies is challenging, as they are often complex interventions whose success also includes user and prescriber factors. In addition, health services research data underpinning the benefits of DiGA are lacking to date. In the current article, methodological considerations for DiGA research are presented, and aselection of internal medicine DiGAs is used to critically discuss current research practice.