Large German Statutory Health Insurance Research Articles

Exceeding the guideline-recommended maximum daily dose of opioids for long-term treatment of non-cancer pain in Germany – a large retrospective observational study

BackgroundHigh-dose long-term opioid therapy (LTOT) has been associated with increased mortality and hospitalizations. Therefore, the evidence-based German guideline on LTOT for chronic non-cancer pain (CNCP) recommends to only exceed the maximum daily dose (MDD) of opioids in exceptional cases. This study aimed to determine the portion of LTOT patients who exceeded the guideline-recommended MDD and identify predictors of exceeding in administrative claims data.MethodsThe retrospective observational analysis of opioid prescriptions in patients receiving LTOT for CNCP was based on administrative claims by a large German statutory health insurance company. Patients with at least two quarters of opioid prescriptions between January 2018 and June 2019 were included and followed up for two years. Predictors were identified by logistic regression. In addition, the number of patients still in opioid therapy and the extent of exceeded MDDs were analyzed over time.ResultsThe sample consisted of 113,475 patients. Overall, 10.5% of the patients exceeded the guideline-recommended MDD averaged over the observation period. Strong predictors for exceeding the MDD were receiving opioid prescriptions from > 7 physicians (OR = 7.66, p < .001), receiving predominantly strong opioids (OR = 6.79, p < .001) and receiving opioids for at least one year prior to inclusion (OR = 5.35, p < .001). Within the non-exceeding group, 28.1% discontinued opioid therapy. In contrast, 9.9% of patients in the exceeding group discontinued opioid therapy, whereas the vast majority remained on treatment until the end of the observation period. Furthermore, a slight increase in prescribed doses was observed over time.ConclusionsThe results indicate that a moderate proportion of patients exceeded the guideline-recommended MDD. However, certain patient groups were more likely to receive high doses. This applied in particular to those who were already on treatment at the time of inclusion and continued to receive opioids until the end of the observation period. Further research should examine whether the continuous opioid therapy among the patients with exceeding the guideline-recommended MDD might be related to specific indications, a lack of therapeutic options or avoidance of withdrawal.Trial registrationGerman Clinical Trials Register (drks.de/search/en). Identifier: DRKS00024854. Registered 28 April 2021.

Association of hydrochlorothiazide treatment compared to alternative diuretics with overall and skin cancer risk: a propensity-matched cohort study

Abstract Introduction Hydrochlorothiazide (HCT) has been suggested to induce photosensitivity, thereby increasing the incidence of skin cancers. After a pharmacovigilance alert, HCT was frequently withdrawn or substituted by other diuretics. The aim of this study was to compare the association of exposure to HCT with cancer risk versus alternative diuretics. Methods A retrospective cohort study was conducted based on data from the AOK PLUS, a large German statutory health insurance fund. Patients with HCT treatment were propensity score matched (PSM) to patients using non-HCT diuretics. Incidence of cancer of any kind and, specifically, skin cancer was assessed in both groups. Time to incident cancer diagnosis was evaluated and compared between the groups. Results A total of 199,708 patients were included in the final analysis (n=76,855 in the HCT-group; n=122,853 in the non-HCT-diuretics group). After PSM, 122,554 patients remained in the sample (n=61,277 for both groups, of which &amp;gt;96% had hypertension, mean age 73 years, 61% female). HCT treatment was associated with a lower incidence of cancer of any kind, compared with non-HCT diuretics (Incidence rate ratio (IRR) per 100 patient years 0.84 95% Confidence interval (CI): 0.82-0.87). HCT treatment was associated with a small albeit significantly higher IRR of skin cancer (1.14 95% CI: 1.06-1.24) with significant variances over time. Although numerically higher, the difference accounts to only 0.05 more skin cancer diagnoses in 100 patient years. Conclusions HCT treatment compared to alternative diuretics was associated with a lower all-cancer risk and was not associated with a meaningful increase in skin cancer risk in a large German population. Nevertheless, advice for skin protection is warranted in all patients taking thiazide or thiazide-like diuretics.HR of overall and skin cancerTime to cancer diagnosis - time to event

Association of hydrochlorothiazide treatment compared with alternative diuretics with overall and skin cancer risk: a propensity-matched cohort study.

Hydrochlorothiazide (HCT) has been suggested to induce photosensitivity, thereby increasing the incidence of skin cancers. After a pharmacovigilance alert, HCT was frequently withdrawn or substituted by other diuretics. The aim of this study was to compare the association of exposure to HCT with cancer risk versus alternative diuretics. A retrospective cohort study was conducted based on data from the AOK PLUS, a large German statutory health insurance fund. Patients with HCT treatment were propensity score matching to patients using non-HCT diuretics. Incidence of cancer of any kind and, specifically, skin cancer was assessed in both groups. Time-to-incident cancer diagnosis was evaluated and compared between the groups. A total of 199 708 patients were included in the final analysis ( n = 76 855 in the HCT group; n = 122 853 in the non-HCT-diuretics group). After propensity score matching, 122 554 patients remained in the sample ( n = 61 277 for both groups, of which >96% had hypertension, mean age 73 years, 61% female). HCT treatment was associated with a lower incidence of cancer of any kind compared with non-HCT diuretics (incidence rate ratio per 100 patient years 0.84 95% confidence interval: 0.82-0.87). HCT treatment was associated with a small albeit significantly higher incidence rate ratio of skin cancer (1.15 95% confidence interval: 1.06-1.24) with significant variances over time. Although numerically higher, the difference accounts to only 0.05 more skin cancer diagnoses in 100 patient-years. HCT treatment compared with alternative diuretics was associated with a lower all-cancer risk and a numerically small increased skin cancer risk in a large German population. Risk-benefit evaluation should be executed in patients with increased skin cancer risk and treatment with HCT. Furthermore, advice for skin protection is warranted in all patients taking thiazide or thiazide-like diuretics.

Management of Children and Adolescents with Chest Trauma in Pediatric and Non-Pediatric Departments-A Claims Data Analysis.

To investigate the management of children and adolescents with isolated and combined chest trauma in pediatric (PD) and non-pediatric departments (non-PD). Anonymized claims data were provided by two large German statutory health insurance funds, covering 6.3 million clients over a 10-year period (2010-2019). Data were extracted for patients who had an inpatient ICD diagnosis of section S20-S29 (injuries to the thorax) and were ≤18 years of age. Demographic and clinical data were analyzed. A total of 4064 children and adolescents with chest trauma were included (mean age 12.0 ± 5.0 years; 55% male). In 1928 cases (47.4%), treatment was provided at PD. Patients admitted to PD underwent CT imaging less frequently (8.1%; non-PD: 23.1%; p < 0.0001). Children with a chest drain treated at university/maximum care hospitals (UM) showed more injuries involving multiple body regions compared with non-UM (25.8% vs. 4.5%; p = 0.0061) without a difference in the length of hospital stay. Children and adolescents with chest trauma are treated almost equally often in pediatric and adult departments. CT is significantly less frequently used in pediatric departments. Patients with a chest drain treated at a UM showed more concomitant injuries without a longer hospital stay. However, the clinical validity of this finding is questionable.

Appendiceal Carcinoids in Children-Prevalence, Treatment and Outcome in a Large Nationwide Pediatric Cohort.

Background and Objectives: Appendiceal carcinoids are rare neuroendocrine tumors and mainly found incidentally during histopathological examination following appendectomy. This observational cohort study was performed to determine the prevalence, treatment modalities and outcomes in children diagnosed with an appendiceal carcinoid tumor. Materials and Methods: Data from the largest German statutory health insurance "Techniker Krankenkasse" were analyzed within an 8-year period: January 2010 to December 2012 and January 2016 to December 2020. Patient characteristics, surgical technique, type of surgical department, diagnostic management, and postoperative morbidity were analyzed. Results: Out of 40.499 patients following appendectomy, appendiceal carcinoids were found in 44 children, resulting in a prevalence of 0.11%. Mean age at appendectomy was 14.7 (±2.6) years. Laparoscopic approach was performed in 40 (91%) cases. Right-sided hemicolectomy was performed in 8 (18%) patients. Additional diagnostic work-up (CT and MRI) was recorded in 5 (11%) children. Conclusions: This large nationwide pediatric study shows that 1 in 1000 patients was found to have a neuroendocrine tumor of the appendix (prevalence 0.11%), emphasizing its low prevalence in the pediatric age group. The majority of patients were treated with appendectomy only. However, treatment modalities are still variable. Longer follow-up analyses are needed to evaluate published guidelines and recommendations to aim for a limited surgical approach.

Identification of rheumatoid arthritis in German claims data using different algorithms: Validation by cross-sectional patient-reported survey data.

To evaluate different algorithms for the identification of rheumatoid arthritis (RA) in claims data using patient-reported diagnosis as reference. Within longitudinal data from a large German statutory health insurance, we selected a random sample of persons with ICD-10 code for RA (M05/M06) in ≥2 quarters in 2013. The sample was stratified for age, sex, and M05/M06. Persons were asked to confirm RA diagnosis (gold standard), which was linked to claims data given consent. Analyses were weighted to represent the total RA population of the database. Positive predictive values (PPVs) and discriminative properties were calculated for different algorithms: ICD-10 code only, additional examination of inflammatory markers, prescription of specific medication, rheumatologist appointment, or combination of these. Of 6193 persons with a claims diagnosis of RA, 3184 responded (51%). Overall, PPV for the ICD-10 code was 81% (95% confidence interval 79%-83%) with 94% (92%-95%) for M05 and 76% (73%-79%) for M06. PPVs increased (with loss of case numbers) if inflammatory markers (82% [80%-84%]), rheumatology visits (85% [82%-87%]) or specific medication (89% [87%-91%]) had been used in addition. Specific medication had the best discriminative properties (diagnostic odds ratio of 3.0) among persons with RA diagnosis. The ICD-10 codes M05 and (less optimal) M06 have high PPVs and are valuable to identify RA in German claims data. Depending on the respective research question, researchers should use different criteria for identification of RA.

Epidemiology of cardiac amyloidosis and burden on health care system in Germany: a retrospective analysis from 2009 to 2018

Abstract Aims Improved imaging modalities contributed to increasing disease awareness of cardiac amyloidosis. Contemporary data on frequency trends and impact on health system are lacking. Methods and results In a retrospective study using health claims data of the largest German statutory health insurance patients with a diagnostic code of amyloidosis and concomitant heart failure or cardiomyopathy between 2009 and 2018 were identified. Temporal trends in frequency, patient characteristics, all-cause mortality and measures of health care burden were examined. 8,279 patients were identified of whom 5,618 were incident without diagnosis of amyloidosis within the previous year. Prevalence increased from 15.5 to 47.6 per 100,000 person-years, and incidence increased from 4.8 to 11.6 per 100,000 person-years, with a continuous steepening in the slope of incidence trend. Age and male gender significantly increased whereas prevalence of myeloma and nephrotic syndrome significantly decreased over time. Median (IQR) survival time after first diagnosis was 2.5 years (0.5 to 6 years), with a 9% (95% CI 2–15%, p=0.008) reduced risk of death in the second compared to the first five years of observation. In the first year after diagnosis mean total health care costs were 21,955 € (median 9,873 €, IQR 3,922 to 24,714 €) per person. Conclusion The rise in patients with cardiac amyloidosis has continuously accelerated in the last decade which, based on patient characteristics, is mainly driven by underlying wildtype transthyretin amyloidosis. Considering the adverse outcome and high health care burden further effort should be put on early detection of the disease to implement treatment. Funding Acknowledgement Type of funding sources: None.

One-year follow-up healthcare costs of patients diagnosed with skin cancer in Germany: a claims data analysis

BackgroundRoutine skin cancer screening (SCS) is covered by the German statutory health insurance (SHI) since 2008. The objective of this study was to compare direct healthcare costs between patients in whom skin cancer was detected by routine SCS and patients in whom skin cancer was not detected by routine SCS.MethodsA retrospective observational study of administrative claims data from a large German SHI was performed. Patients with a diagnosis of malignant melanoma (MM) or non-melanoma skin cancer (NMSC) diagnosed in 2014 or 2015 were included. Costs were obtained for one year before and one year after diagnosis and analyzed in a difference-in-differences approach using regression models. Frequency matching was applied and risk adjustment was performed. Additional analyses were conducted, separately for specific age groups, excluding persons who died during the observation period and without taking costs for screening into consideration.ResultsA total of 131,801 patients were included, of whom 13,633 (10.3%) had a diagnosis of MM and 118,168 (89.7%) had a diagnosis of NMSC. The description of total costs (without risk adjustment) shows lower mean total costs among patients whose skin cancer was detected via routine SCS compared to patients in whom skin cancer was not detected by routine SCS (MM: €5,326 (95% confidence interval (CI) €5,073; €5,579) vs. €9,038 (95% CI €8,629; €9,448); NMSC: €4,660 (95% CI €4,573; €4,745) vs. €5,890 (95% CI €5,813; €5,967)). Results of the regression analysis show cost savings of 18.8% (95% CI -23.1; -8.4) through routine SCS for patients with a diagnosis of MM. These cost savings in MM patients were more pronounced in patients younger than 65 years of age. For patients with a diagnosis of NMSC, the analysis yields a non-substantial increase in costs (2.5% (95% CI -0.1; 5.2)).ConclusionCost savings were detected for persons with an MM diagnosed by routine SCS. However, the study could not detect lower costs due to routine SCS in the large fraction of persons with a diagnosis of NMSC. These results offer important insights into the cost structure of the routine SCS and provide opportunities for refinements.

Effects of Influenza Vaccination in Patients with Interstitial Lung Diseases: An Epidemiological Claims Data Analysis

RationaleVaccination is the most effective protection against influenza. Patients with interstitial lung diseases (ILDs) represent a high-risk group for influenza complications. Thus, yearly influenza vaccination is recommended, but evidence on its effects is sparse.ObjectivesThis study aimed to compare all-cause mortality and all-cause and respiratory-related hospitalization between vaccinated and unvaccinated patients with ILD.MethodsUsing data from the largest German statutory health insurance fund (about 27 million insurees in 2020), we analyzed four influenza seasons from 2014–2015 to 2017–2018 and compared vaccinated with unvaccinated patients with ILD. Starting from September 1 of each year, we matched vaccinated and unvaccinated patients in a 1:1 ratio using a rolling cohort design. Mortality and hospitalization were compared with Kaplan-Meier plots, and effects were calculated during the influenza season (in season) with risk ratios.ResultsBoth the vaccinated and the unvaccinated cohorts included 7,503 patients in 2014–2015, 10,318 in 2015–2016, 12,723 in 2016–2017, and 13,927 in 2017–2018. Vaccination rates were low at 43.2% in season 2014–2015 and decreased over time to 39.9% in season 2017–2018. The risk ratios for all-cause mortality were 0.79 (95% confidence interval [CI], 0.65–0.97; P = 0.02) in season 2014–2015, 0.66 (95% CI, 0.54–0.80; P < 0.001) in 2015–2016, 0.89 (95% CI, 0.76–1.04; P = 0.15) in 2016–2017, and 0.95 (95% CI, 0.81–1.12; P = 0.57) in 2017–2018. The effects on all-cause hospitalization and respiratory-related hospitalization were similar in all seasons.ConclusionsAlthough an unequivocally beneficial impact of influenza vaccination in patients with ILD could not be demonstrated, we observed promising results regarding avoidance of all-cause mortality in half of the seasons observed. Given the low vaccination rates, further efforts are necessary to improve vaccination rates in patients with ILD.

Metastatic Breast Cancer Recurrence after Bone Fractures.

Simple SummaryBone fractures bear potential risk to promote metastatic relapse in breast cancer. We conducted a population-based cohort study of 84,300 breast cancer patients diagnosed between January 2015 and November 2019. Bone fracture after breast cancer diagnosis was associated with an increased metastasis risk. Fractures may pose an increased risk to developing metastasis. Potential clinical implications for cancer patients are in support of fall prevention programs.Experimental studies suggest that bone fractures result in the release of cytokines and cells that might promote metastasis. Obtaining observational data on bone fractures after breast cancer diagnoses related to distant breast cancer recurrence could help to provide first epidemiological evidence for a metastasis-promoting effect of bone fractures. We used data from the largest German statutory health insurance fund (Techniker Krankenkasse, Hamburg, Germany) in a population-based cohort study of breast cancer patients with ICD-10 C50 codes documented between January 2015 and November 2019. The risk of metastasis overall, regional, distant non-bone or bone metastasis related to a fracture was modeled by an adjusted discrete time-to-event analysis with time-dependent exposure. Of 154,000 breast cancer patients, 84,300 fulfilled the inclusion criteria and had a follow-up time of more than half a year. During follow-up, fractures were diagnosed in 13,579 (16.1%) patients. Metastases occurred in 7047 (8.4%) patients; thereof 1544 had affected regional lymph nodes only and 5503 distant metastases. Fractures demonstrated a statistically significant association with subsequent metastasis overall (adjusted HR 1.12, 95% CI 1.04, 1.20). The highest risk for metastasis was observed in patients with subsequent bone metastasis (adjusted HR 1.18, 95% CI 1.05, 1.34), followed by distant non-bone metastasis (adjusted HR 1.16, 95% CI 1.07, 1.26) and lymph node metastasis (adjusted HR 1.08, 95% CI 0.97, 1.21).

The youngest are hit hardest: The influence of the COVID-19 pandemic on the hospitalization rate for children, adolescents, and young adults with anorexia nervosa in a large German representative sample.

The COVID-19 pandemic has severely impacted the mental health of children and adolescents. Young people at risk for anorexia nervosa (AN) have been especially shown to be affected. There are no studies that have investigated the respective proportions of hospitalized children, adolescents, and young adults separately as well as of both sexes during the COVID-19 crisis. This study is based on the administrative data of the largest German statutory health insurance. All children (0-14 years) and adolescents (15-19 years) with a discharge diagnosis of typical and atypical AN according to the International Classification of Diseases (ICD)-10 were included. Admission rates per 10,000 person-years were calculated separately by sex and age group, based on admission numbers from the 9-month interval from January to September of 2019, 2020, and 2021 and the number of insured persons per sex and age group of each year. The entire sample comprised approximately 4.7 million children and adolescents. There was a highly significant increase of 40% (relative risk (RR): 1.4; [1.27, 1.55]; p < 0.0001) in admission rates in the female children's and the adolescents' group (RR:1.32; [1.24, 1.41]; p< 0.0001) between the pre-COVID-19 and peri-COVID-19 periods in 2019 and 2021, respectively. Among males, hospitalization rates significantly increased in the children (RR: 1.69; [1.09, 2.62]; p < 0.02). Young people appear to be especially prone to develop AN during a crisis, such as with social isolation and school closures. Home-based or mobile pediatric services should be established to prevent this often chronic and disabling disorder in young patients.

Vascular Diagnostic and Surgical Treatments Before Lower Limb Amputations in Patients with Arterial Vascular Diseases: A Population Based Study from 2013 to 2015 in Germany

Patients with peripheral artery disease (PAD) have an increased risk of lower limb amputation. Given the international wide variance in major amputations, the high mortality rates and follow up costs as well as the significantly reduced quality of life of patients with amputations, vascular diagnostics and vascular surgery treatments are of great importance for lower limb preservation in patients with PAD. This study examines these guideline based procedures in patients before a first lower limb amputation and PAD. This was a retrospective longitudinal study. Data from a large German statutory health insurance scheme were examined on patients with first amputation of lower extremities and PAD between 2013 and 2015 (incidence). Pre-defined vascular diagnostic and vascular surgical procedures were considered, as specified by guidelines within inpatient and outpatient care in a defined time before lower limb amputation. The overall estimated incidence of lower extremity amputations in the total population was 0.12% from 2013 to 2015. Of these, 51.7% had PAD; 81.8% of patients received at least one vascular diagnostic measure and 61.0% a vascular surgery procedure before the lower extremity amputation. There were only minor variations in the use of diagnostic or surgical treatments between patients with major and minor amputation. In total, 63.9% of patients had vascular surgery before the incident major amputation compared with 60.0% of patients with a minor amputation. Noticeable regional differences were found ranging from 91% (Berlin) to 67% (Bremen) regarding diagnostic procedures provided before amputation, and from 83% (Hamburg) to 55% (Saxony-Anhalt) regarding vascular surgery before amputations. Of patients with PAD, 18.2% did not receive a vascular diagnostic examination before amputation as specified in the guidelines, which reflects an underuse of health services. In one third of patients who did not receive vascular surgery, major amputation probably could have been avoided.

N-Nitrosodimethylamine-Contaminated Valsartan and the Risk of Cancer—A Longitudinal Cohort Study Based on German Health Insurance Data.

N-Nitrosodimethylamine (NDMA), classified as a probable human carcinogen, has been found as a contaminant in the antihypertensive drug valsartan. Potentially carcinogenic effects associated with the consumption of NDMAcontaminated valsartan have not yet been analyzed in large-scale cohort studies. We therefore carried out the study reported here to explore the association between NDMA-contaminated valsartan and the risk of cancer. This cohort study was based on longitudinal routine data obtained from a large German statutory health insurance provider serving approximately 25 million insurees. The cohort comprised patients who had filled a prescription for valsartan in the period 2012-2017. The endpoint was an incident diagnosis of cancer. Hazard ratios (HR) for cancer in general and for certain specific types of cancer were calculated by means of Cox regression models with time-dependent variables and adjustment for potential confounders. A total of 780 871 persons who had filled a prescription for valsartan between 2012 and 2017 were included in the study. There was no association between exposure to NDMA-contaminated valsartan and the overall risk of cancer. A statistically significant association was found, however, between exposure to NDMA-contaminated valsartan and hepatic cancer (adjusted HR 1.16; 95% confidence interval [1.03; 1.31]). These findings suggest that the consumption of NDMA-contaminated valsartan is associated with a slightly increased risk of hepatic cancer; no association was found with the risk of cancer overall. Close observation of the potential long-term effects of NDMA-contaminated valsartan seems advisable.

Epidemiology of Vitiligo - A Dual Population-Based Approach.

BackgroundMost epidemiological data on vitiligo refer to selected environments or focus on the prevalence of comorbidity unrelated to the population.ObjectiveAim of the study was to gain robust representative prevalence data on vitiligo and on associated dermatologic comorbidity in the German adult population.MethodsA dual population-based approach was applied with 1) primary data obtained between 2004 and 2014 from dermatological exams in the general working population; 2) claims data from a large German statutory health insurance, reference year 2010.ResultsIn the working cohort (N = 121,783; 57% male; mean age 43 years), the prevalence of vitiligo was 0.77% (0.84% in men; 0.67% in women). In the claims data (N = 1,619,678; 38% male; mean age 46 years), prevalence was 0.17% (0.14% in men; 0.18% in women). In the working cohort, vitiligo was significantly more common in people with fair skin type, ephelides and port-wine stains and less common in people with acne and solar lentigines. In the claims data, vitiligo was associated with a variety of skin conditions, eg, atopic dermatitis, psoriasis and alopecia areata.ConclusionThe resulting discrepancy of claims vs primary data between 0.17% and 0.77% indicates the most probable spectrum of vitiligo prevalence in Germany. It is more frequently observed in clinical exams than recorded in claims data, indicating a marked proportion of people seeking no medical help. Such nonattendance may result from the fact that many treatment options do not provide satisfying benefits to the patients.

Early integration of palliative care for outpatients with advanced cancer in general practice: how is the situation?-a cohort study.

Compared with standard care alone, early integration of specialist palliative care in the treatment of patients with advanced cancer offers significant benefit with respect of symptom control, healthrelated quality of life and survival. The early integration of specialist palliative care means that patients receive palliative care concurrent with, or shortly after, the diagnosis of advanced cancer. Using data from 2015 compiled from a large German statutory health insurance company (AOK Baden-Wuerttemberg) which insures 3.87 million people, we evaluated how many patients were identified with advanced metastatic cancer and at what point in time, if ever, general practitioners referred them to a specialist palliative home care team. The data were collected exclusively from general practices in the BadenWürttemberg province of Germany. Patients with advanced cancer where identified using all ICD-10 codes for cancer and the ICD-10 codes for metastases. Patients receiving care from a palliative care team were identified using the codes 01425 or 01426 of the German medical fee schedule. We identified 3,535 patients diagnosed with advanced cancer as having palliative care needs. 669 (18.9%) of these were referred to a specialist home care team. Of these, 302 (45.1%) where referred to a palliative care team on the day they were diagnosed but 367 (54.9%) were referred only at a later point in time. Two hundred and six (30.8%) patients had a delayed referral after 8 weeks or more and 153 (22.9%) after more than 12 weeks. Over half of the cancer patients in general practice who are referred for specialist palliative care are done so very late. General practitioners appear to need encouragement for the early integration of palliative care for patients with advanced cancer and to initiate early referrals to palliative care teams.

Cardiovascular disease prevalence in type 2 diabetes \u2013 an analysis of a large German statutory health insurance database

BackgroundThe aim of this study was to determine the prevalence of cardiovascular disease in persons with type 2 diabetes mellitus (T2D) in Germany.MethodsA claims database with an age- and sex-stratified sample of nearly 4 million individuals insured within the German statutory health system was used. All patients aged ≥18 years with T2D documented between 1 January 2015 and 31 December 2015 and complete retrospective documentation of ≥5 years (continuous enrollment in the German statutory health system) before 2015 were selected based on a validated algorithm. Cardiovascular disease (CVD) events were identified based on ICD-10 and OPS codes according to a previous clinical study (EMPA-REG OUTCOME trial).ResultsThe prevalence of T2D in Germany in 2015 was 9.9% (n = 324,708). Using a narrow definition of CVD, the 6-year observation period prevalence of CVD was estimated as 46.7% [95% CI: 46.52%;46.86%]. Applying a wider CVD definition, the proportion of T2D patients who showed a history of CVD was 57.1% [95% CI: 56.9%;57.24%]. The prevalence of CVD in patients with T2D ranged from 36.3 to 57.1%, depending on the observation period and definition of CVD.ConclusionsThe results underline the need for a population-based registration of cardiovascular complications in T2D.

Social inequalities in mild and severe myocardial infarction: how large is the gap in health expectancies?

BackgroundAcute myocardial infarction (MI) remains a frequent health event and a major contributor to long-term impairments globally. So far, research on social inequalities in MI incidence and mortality with respect to MI severity is limited. Furthermore, evidence is lacking on disparities in the length of life affected by MI. This study investigates social inequalities in MI incidence and mortality as well as in life years free of MI and affected by the consequences of mild or severe MI.MethodsThe study is based on data of a large German statutory health insurance provider covering the years 2008 to 2017 (N = 1,253,083). Income inequalities in MI incidence and mortality risks and in life years with mild or severe MI and without MI were analysed using multistate analyses. The assessment of MI severity is based on diagnosed heart failure causing physical limitations.ResultsDuring the study period a total of 39,832 mild MI, 22,844 severe MI, 276,582 deaths without MI, 15,120 deaths after mild MI and 16,495 deaths after severe MI occurred. Clear inequalities were found in MI incidence and mortality, which were strongest among men and in severe MI incidence. Moreover, substantial inequalities were found in life years free of MI in both genders to the disadvantage of those with low incomes and increased life years after mild MI in men with higher incomes. Life years after severe MI were similar across income groups.ConclusionsSocial inequalities in MI incidence and mortality risks led to clear disparities in the length of life free of MI with men with low incomes being most disadvantaged. Our findings stress the importance of primary and secondary prevention focusing especially on socially disadvantaged groups.

Compression, expansion, or maybe both? Growing inequalities in lung cancer in Germany.

BackgroundLung Cancer (LC) is one of the most common malign diseases worldwide. So far, it is unclear if the development of LC incidence and mortality leads to morbidity compression or expansion and whether these developments differ by socioeconomic characteristics. This study analyses time trends in social and gender inequalities in life years with and without LC in Germany.MethodsThe study is based on data of a large German statutory health insurance provider (N = 2,511,790). Incidence and mortality risks were estimated from multistate survival models. Trends in life years with and without LC were analysed using multistate life table analyses. All analyses were performed separately for gender, time period (2006–2009 and 2014–2017), and income group (<60% and ≥60% of the German average income).ResultsAmong men, declining LC incidence rates resulted in gains of life years free of LC and declining LC- affected life years and led to a relative compression, which was strongest in men with higher incomes. Among women, a clear increase in life years with LC led to an expansion of the lifespan affected by LC. This expansion was mainly driven by increasing incidence rates in women with low incomes. Overall, income inequalities in LC increased in both genders.ConclusionsOur analyses reveal that developments in the length of life affected by LC differed substantially by gender and income and led to widening health inequalities over time. Public health efforts should mainly focus on vulnerable groups to reduce the persisting social inequalities in LC.

Anticoagulation treatment of cancer patients with deep or superficial leg vein thrombosis - a retrospective observational study of German statutory health insurance claims data (the CERTIFICAT initiative).

Background: Thrombosis is a common complication of cancer with a negative impact on quality of life and overall prognosis. Guidelines recommend low-molecular-weight heparin (LMWH) as initial and prolonged anticoagulation treatment. Little is known about current treatment patterns of these patients in ambulatory care. Patients and methods: The current retrospective observational study interrogates a large German statutory health insurance claims database in order to understand which kind of data can be extracted and analysed. An age- and sex-adjusted sample of about 4.1million insured people from 2011 to 2016 could be used. Cancer patients with incident deep and superficial leg vein thrombosis were identified. Patients with preexisting cancer were allocated to a normal risk group; those who suffered from simultaneously diagnosed cancer and thrombosis were classified as high-risk group. Results: We identified 322,600patients with inpatient or outpatient documented cancer diagnosis in at least two different quarters within one year. 87,755patients were identified with an incident deep or superficial vein thrombosis. 8,201patients suffered from both cancer and incident thrombosis. 56.9% of the patients received an anticoagulation regimen with predominant LMWH prescription, 24.2% vitaminK antagonists, 17.2% direct oral anticoagulants; in 1.7% of patients, no predominant anticoagulant drug/regime could be identified. On average, patients were prescribed anticoagulants for 4.5months. An estimate of clinically relevant gastrointestinal bleeding could be derived (1.8% of patients). Conclusions: The dataset allows assigning detailed information of anticoagulant prescriptions in ambulatory care to well-defined groups of cancer patients. A first analysis suggests that in Germany current medical care of patients with cancer-related deep or superficial vein thrombosis does not entirely comply with guideline recommendations regarding type and duration of anticoagulation.

Treatment-Related Healthcare Costs of Metastatic Castration-Resistant Prostate Cancer in Germany: A Claims Data Study.

PurposeTreatments for patients with metastatic castration-resistant prostate cancer (mCRPC) have expanded rapidly. They include the chemotherapies docetaxel and cabazitaxel, hormonal drugs abiraterone and enzalutamide, and best supportive care (BSC). Cabazitaxel has proven to be the last life-prolonging option, associated with a significant risk of serious adverse events. Given the lack of real-world evidence, we aimed to compare healthcare resource utilization (HRU) and costs in patients with mCRPC treated with cabazitaxel, docetaxel, abiraterone, enzalutamide, and BSC.MethodsWe used 2014–2017 claims data from a large German statutory health insurance fund, the Techniker Krankenkasse, to identify patients with mCRPC. Patient allocation to individual therapy regimens was based on clinical knowledge and included therapy cycles, duration of therapy, and continuous treatment. The study period lasted from the first claim until death, the end of data availability, a drug switch, or discontinuation of therapy, whichever came first. Multivariate regression models were used to compare monthly all-cause and mCRPC-related HRU and costs across cohorts by adjusting for baseline covariates (including age and comorbidities).ResultsThe 3944 identified patients with mCRPC initiated treatment with cabazitaxel (n = 240), docetaxel (n = 539), abiraterone (n = 486), enzalutamide (n = 351), or BSC (n = 2328). In most domains, HRU was highest in the cabazitaxel cohort and lowest in the BSC group. Accordingly, the highest all-cause and mCRPC-related costs per month, respectively, were observed in patients receiving cabazitaxel (€7631/€6343), followed by abiraterone (€5226/€4579), enzalutamide (€5079/€4416), docetaxel (€2392/€1580), and BSC (€959/€438). Cost variations were mostly attributable to drugs, inpatient treatment, and sick leave payments.ConclusionmCRPC treatment imposes a high economic burden on statutory health insurance. Cabazitaxel is associated with substantially higher expenses, resulting from higher drug costs and a greater need for inpatient treatment. As mCRPC continues to be incurable, decision makers and clinician leaders should carefully evaluate public access to innovative agents and optimal treatment strategies.Electronic supplementary materialThe online version of this article (10.1007/s41669-020-00219-6) contains supplementary material, which is available to authorized users.