AOK PLUS Research Articles

Real life pharmaceutical treatment patterns for adult patients with focal epilepsy in Germany: a longitudinal and cross-sectional analysis of recently approved anti-epileptic drugs.

Objectives: The aim of this study was to investigate the antiepileptic drug (AED) treatment of adults suffering from focal epilepsies (FE) in Germany. Of special interest was the number and percentage of the patients 16 years and older receiving no treatment with an AED, treatment with one AED (monotherapy), treatment with more than one AED, and treatment with a novel AED. The definition for “novel” was newly approved at the time of market entry since 2006 (last 10 years): eslicarbazepine (ESL), lacosamide (LCM), perampanel (PER), and retigabine (RTG). Methods: The analysis was based on a claims data set covering the years 2007 to 2014, provided by AOK PLUS, a German statutory health insurance. Two patient samples were defined: (1) prevalent patients suffering from FE (at least one in- or outpatient diagnosis of FE and at least one prescription of an AED), and (2) incident FE patients (first in- or outpatient diagnosis of FE without any previous diagnoses/AED prescriptions in the preceding 6 months). Patient observation started at date of first observed inpatient or outpatient focal epilepsy diagnosis within the analyzed period.Each patient was classified as a “no AED therapy”, “AED monotherapy” or “more than one AED therapy”. Patients were analyzed by number and type of concomitantly prescribed AEDs in yearly tranches (no, one, two, three, four, more than four AEDs; novel versus non-novel AEDs). Results: A total of 34,422 patients diagnosed with FE aged 16 year or older (mean age 59.6 years, 48.7% female) were identified. The mean follow-up period was 1,891 days (5.2 years) since first confirmed diagnosis. The percentage of prevalent patients diagnosed with FE who received one AED (monotherapy) was stable overall and ranged between a minimum of 66.2% (2007) and a maximum of 68.9% (2010). The percentage of patients who received two AEDs ranged from 23.6% (2012) to 25.8% (2007). The remaining patients received therapies with three (6.0% in 2010 to 6.7% in 2007), four (1.0% in 2010 to 1.2% in 2009) or more than four AEDs (0.1% in 2014 to 0.3% in 2013). Between 8.1%–16.6% (2007; 2014) of the patients received no AED therapy in the observed period.In the first year after the diagnosis of FE (incident patients), 9.7% of patients didn’t receive any AED therapy. Of those treated with at least one AED, 80.0% received one AED (monotherapy) only, 17.0% received therapy with two AEDs, 2.6% with three AEDs, 0.3% with four AEDs, and 0.1% with >4 AEDs during the respective observation time window and remained stable throughout the four-year follow-up period.Of prevalent patients with a diagnosis of FE, 1,889 (5.5%) received at least one prescription of a novel AED during the observation period; 98.6% of these patients received the novel AED in combination with at least one other AED. Of those patients, 269 (14.2%) received >1 novel AED. The analysis of the patients receiving novel AEDs by the time from the first confirmed diagnosis of FE until the prescription of a novel AED resulted in a mean duration of 4.0 years (SD 2.0) for ESL, 3.6 years (SD 2.2) for LCM, 5.7 years (SD 1.2) for PER, and 4.6 years (SD 0.8 years) for RTG. The mean number of AEDs prescribed before the novel AEDs were 3.2 for ESL, 2.4 for LCM, 5.0 for PER and 5.2 for RTG. Conclusions: Most patients aged 16 years or older, suffering from focal seizures, received AED monotherapy. Novel AEDs were prescribed in a small proportion of patients (<6%) and relatively late in the treatment course. These results are consistent with the recommendations of the German Society for Epileptology (Deutsche Gesellschaft für Epileptologie, DGfE) which suggests a number of monotherapy options – these options do not include the novel AEDs described in this study.

Association of Atopic Dermatitis with Cardiovascular Risk Factors and Diseases

Epidemiological studies suggested an association between atopic dermatitis (AD) and cardiovascular disease. Therefore, we investigate associations and potential underlying pathways of AD and cardiovascular disease in large cohort studies: the AOK PLUS cohort (n= 1.2 Mio), the GINIplus/LISAplus birth cohorts (n= 2,286), and the Cooperative Health Research in the Region of Augsburg (KORA) F4 cohort (n= 2,990). In addition, metabolomics in KORA F4 and established cardiovascular risk loci in genome-wide data on 10,788 AD cases and 30,047 controls were analyzed. Longitudinal analysis of patients with AD in AOK PLUS showed slightly increased risk for incident angina pectoris (adjusted risk ratio 1.17 [95% confidence interval 1.12-1.23]), hypertension (1.04 [1.02-1.06]), and peripheral arterial disease (1.15 [1.11-1.19]) but not for myocardial infarction (1.05 [0.99-1.12]) and stroke (1.02 [0.98-1.07]). In KORA F4 and GINIplus/LISAplus, AD was not associated with cardiovascular risk factors and no differences in metabolite levels were detected. There was no robust evidence for shared genetic risk variants of AD and cardiovascular disease. This study indicates only a marginally increased risk for angina pectoris, hypertension, and peripheral arterial disease and no increased risk for myocardial infarction or strokein patients with AD. Relevant associations of AD with cardiovascular risk factors reported in US populations could not be confirmed. Likewise, patients with AD did not have increased genetic risk factors for cardiovascular disease.

Burden of soft-tissue and bone sarcoma in routine care: Estimation of incidence, prevalence and survival for health services research

BackgroundSarcomas constitute a rare group of malignant tumors which can originate from any organ, tissue, bone or cartilage. Due to their heterogeneity, estimates of sarcoma incidence, prevalence and survival are rare. We estimated the burden of sarcoma in Germany from a large unselected cohort of patients from routine healthcare. MethodsWe utilized the AOK PLUS health services research database covering complete medical information on 2,615,865 individuals from the German federal state of Saxony from 2005 to 2012. Persons were defined as sarcoma cases if they had ≥4 medical accounts with respective ICD-10 code C49 (soft-tissue sarcoma) or C40/C41 (bone sarcoma). We assessed sarcoma burden by calculating five-year prevalences, cumulative incidences, and one- and five-year relative survival rates. ResultsOverall 1,468 persons with soft-tissue sarcoma and 671 persons with bone sarcoma were identified. Age-standardized cumulative incidence was 4.5/100,000 persons for soft-tissue and 2.1/100,000 persons for bone sarcoma (European Standard). One- and five-year relative survival was 87.8% and 66.4% for soft-tissue and 91.8% and 52.9% for bone sarcoma, respectively. ConclusionThis is the first estimation of the burden of sarcoma based on an unselected sample of routine care data and the first estimation of the burden of sarcoma in Germany. We believe that the proposed methods offer a valuable approach for further outcomes research on cancer.

Recommendation of rotavirus vaccination and herd effect: a budget impact analysis based on German health insurance data.

The objective of this study was to assess the budget impact and health effects of introducing rotavirus (RV) vaccination in Saxony, Germany, from a health insurance perspective. Special emphasis is given to the herd effect. We analyzed direct medical and non-medical costs of RV infection for Social Health Insurance between 2007 and 2010 based on 360,000 routine data observations from the AOK PLUS for children below 5 years of age. We compared the actual annual number of RV cases (vaccination scenario) with the number derived from 2005 (no vaccination, base case scenario). The vaccination coverage rate has increased from 5 % to 61 % between 2007 and 2010. The number of RV cases decreased by 21 % from 32,274 in 2007 to 25,614 in 2010. Based on vaccination coverage, the total cost savings per 1,000 children due to RV vaccination was estimated to be 39,686 Euros. The overall share of outpatient costs was 60 %. Mean gross cost savings were expected to be 304 Euros per avoided case. The net cost savings were expected to be 19 Euros per avoided case. About 59 % of total savings was due to herd protection resulting from increasing vaccine rates. The herd effect per avoided case increased with increasing vaccine coverage. Incidence of RV cases, vaccination costs and days absent from work were sensitive parameters. This retrospective analysis showed that the increase in RV vaccination coverage in Saxony has been budget neutral if not cost saving for sick funds.

Analyse der ambulanten Kodierqualität in Sachsen und Thüringen anhand von Leistungsdaten der AOK PLUS – die Verwendung des Zusatzkennzeichens „Z“ in der Diagnosedokumentation

As a part of the health care reform 2007 the German risk structure compensation scheme was extended so as to connect the financial cash flow towards the payers to morbidity information from ambulatory care. Within this context, morbidity information consists of prescriptions as well as coded ambulatory diagnoses. Accordingly, a high quality of coding is essential for a morbidity compatible allocation of funds. The aim of this study was to evaluate coding quality via qualifying characters as well as to identify future challenges. It focuses on diagnoses which are qualified as "assured" or "post-treatment" from about 350 million diagnoses of about 11 k practitioners' treatment of 2.7 million AOK PLUS insurants in Saxony and Thuringia during the years 2007-2010. The practitioners' documented diagnoses were aggregated within several groups according to the code of specialisation which is attached to the practitioner's 9-digit lifelong identification number (LANR). As a result, the number of "assured" diagnoses generally rose from year to year. Furthermore, diagnoses marked as "assumption" or "exclusion" remain constant over time. We identified a lack of diagnosis coding precision regarding the condition after certain medical events. In particular, general practitioners tend to use diagnosis codes qualified as "post-treatment" instead of using correct "assured" diagnoses qualified for conditions after certain events. Consequently, we expect adverse effects evaluating the cost of diseases as only "assured" diagnoses are considered within the risk transfer compensation scheme.

Evaluation of a program of integrated care to reduce recurrent osteoporotic fractures

To evaluate the outcomes of patients participating in a program of integrated care for osteoporosis in terms of medication supply, fracture incidence and expenses. Outcomes were assessed from secondary data provided by the AOK PLUS health insurance for 2455 participants of the program and the same number of matched controls who were also diagnosed with osteoporosis but did not participate in the program. Supply with Calcium and Vitamin D, antiresorptive agents and analgesics was assessed by defined daily doses. Osteoporotic fractures were identified by hospitalization data. Costs for fracture treatment, medication supply and additional expenses of the program were also included in the dataset. Patients enrolled in the program of integrated care received significantly more medication to treat osteoporosis than controls. There was no significant reduction in fracture incidence among participants of integrated care, but a reduced need of analgesics was noted. Additional costs for patients enrolled in the program were caused by a higher number of drug prescriptions, higher costs for stationary treatment and additional expenses for program related care and diagnostics. The program of integrated care was not found to be effective in reducing recurrent fractures. Cost effectiveness defined as a reduced rate of fractures in integrated care patients could not be shown by the assessed outcome measures. This missing reduction in fracture incidence may be explained by a non-sufficient improvement - compared to a placebo-controlled clinical trial - in medication supply and non-comparability of our real-world patient population with highly controlled clinical trial participants.

Ausgaben einer Krankenkasse für Kinder in den ersten fünf Lebensjahren – eine kohortenbasierte Analyse

The development of paediatrics is characterised by several changes in the past few years, concerning, in particular holistic treatments or preventive check-ups, but also the transfer of treatment from the inpatient to the outpatient sector. There are no reference values for assessing emerging health insurance expenses. The aim of this study was to obtain a frame of reference for the costs of the treatment for neonates, infants, and young children using the example of the expenditures of one health insurance fund. The individual health insurance expenditures were analysed for the first five years of life of children insured with the AOK PLUS in Saxony, Germany, in 2005. Costs of hospital treatment, ambulatory care, remedies, tools, medicines and care were included. The costs per insured child and year amounted to approximately 1,277 Euro (N = 11,147), with the highest costs arising in the first two years. 858 Euro were spent annually for an "average" child; 5,691 Euro per year incurred for a child with special medical needs. The present cost analysis describes both the height and structure of a health insurance's spendings on children within the first five years of their life in consideration of regional medical care offers. The question of whether this analysis provides valid reference values for other health insurances or other service areas will have to be answered by other analyses.

PHS15 Recommendation for Rotavirus Vaccination and Herd Effect: Analyzing Cost Data from a German Statutory Health Insurance

To quantify the financial effects of the introduction of a recommendation for rotavirus vaccination in Saxony, Germany, in 2008 using a retrospective data analysis. Special emphasis is given to the herd effect. We analyzed the costs of rotavirus infection between 2007 and 2010 based on 360.000 observations from the AOK Plus of children under 5 years for Saxony. To investigate the cost impact of the regional recommendation, we compared the associated costs of the expected annual RVGE cases derived from 2005 when rotavirus vaccination was not yet available, with the actual annual number of RVGE cases, vaccinations and associated costs per age cohort. A decrease in RVGE cases in not vaccinated cohorts was attributed to herd effect. We make distinction between in- and outpatient cases, societal and SHI perspective as well as different age groups. Given that the vaccination rate has increased from 5% to 61% in the observed period, we obtained following estimates: the mean total cost reduction per year attributable to introducing a recommendation for rotavirus vaccination is 4.5 million € (2.4 million €) from the societal (SHI) perspective. The mean cost savings of vaccination per avoided case rise from 572 € (291 €) in 2007 to 718 € (375 €) in 2010. The overall share of outpatient costs is about 72% (60%). About 45% of the total savings is attributable to herd effect. The herd effect per avoided case decreases over time while immunity increases. A recommendation for rotavirus vaccination in Saxony turns out to be cost saving from the SHI as well as the societal perspective. This is mainly attributed to the herd effect being present when having high vaccination rates.

Effectiveness of skin cancer screening for individuals age 14 to 34 years

Approximately 15 % of all cases of melanoma are diagnosed before age 35 years. In Germany, individuals ≥ 35 years are eligible for the national skin cancer screening program. The effectiveness of a population-based skin cancer screening in general and in particular for young adults is unclear. Assessment of the effectiveness of a skin cancer screening program and of risk factors for detection of a melanoma/atypical nevus in the setting of a screening for the age group 14 to 34 years. A total of 12,187 individuals age 14 to 34 years were screened in Saxony for skin cancer by a dermatologist in the program "Haut-Check 14-34 Jahre" of the AOK PLUS, a large German health insurance, between January and July 2009. Demographic, clinical and histopathological data and UV-exposure data were collected from each participant. Multivariate logistic regression models were used to assess risk factors for the detection of a (histopathologically confirmed) melanoma or atypical nevus. 2.8 % of the eligible individuals participated in the skin cancer screening program with women being more likely to do so. In 1 072 individuals (8.8 %) screening included at least one excision of a skin lesion leading to the diagnosis of melanoma in two participants, melanoma in situ in four persons, and atypical nevus in 641 persons. Use of tanning beds, higher age, number of nevi, and previous cutaneous excision were independent risk factors for the detection of a melanoma or atypical nevus. In 5.5 % of all cases skin cancer screening resulted in the excision of a malignant or atypical melanocytic lesion. It remains unclear what proportion of these cases would have been detected in routine care. The rate of excisions per newly diagnosed melanoma was 179 : 1. Further investigations are necessary to explore the reasons for this low diagnostic specificity. This study highlights the possibilities and limitations of routine data to evaluate screening programs and indicates the need to collect additional information on healthcare utilization behaviour.

10th Annual Congress of the German Association of Clinical Pharmacology

10th Annual Congress of the German Association of Clinical Pharmacology

Integrierte Versorgung – Aspekte der Qualität und Wirtschaftlichkeit

Integrated health care still remains an important future issue for AOK PLUS. Nevertheless, it is necessary to critically analyze the projects in terms of quality and cost-effectiveness. Only health care that can offer medical treatment at a high level to the patient and, at the same time, is cost-effective and relevant for the market will strengthen the health insurance fund within the competitive process.

CARDIO – „Ein Herz für Sachsen“

Mit CARDIO-Integral nutzte die AOK PLUS die Chance, im Rahmen der Integrierten Versorgung eine kardiologische Behandlungskette zu definieren und zu etablieren. Steigende Teilnehmerzahlen und stetige Weiterentwicklungen sprechen fur die hohe Akzeptanz und den Erfolg des Vertrages. Hohe Qualitat, Patientenorientierung und eine enge Zusammenarbeit der Leistungserbringer pragen CARDIO-Integral.