Can Routine Data be used to Determine the Target Population of Patients with Type 2 Diabetes in Early Benefit Assessments in Germany?

OBJECTIVES: Since 2011, early benefit assessment of all new drugs launched in Germany is mandatory. The exact determination of the appropriate target population (i. e. patients eligible for a drug) plays an important role for subsequent price negotiations. In type 2 diabetes, the size of the target population varies considerably between company dossiers submitted for assessment. Our aim was to explore whether routine data from all persons insured in German statutory health insurance (SHI) funds can be used to derive information on the size of the target population with type 2 diabetes. METHODS: We explored how the data available at the German Institute of Medical Documentation and Information (DIMDI) can be used to obtain the information required. A data-based concept was chosen and the selection criteria were developed in a multidisciplinary project group. Before finalizing the database query, the criteria were evaluated in a test database and the database query was then repeatedly modified. RESULTS: At the time of the design of our analysis in 2017, the most recent data available at DIMDI were for 2013. The algorithm we developed for identifying patients with type 2 diabetes and classifying them according to their medication, based primarily on the combination of ICD and ATC codes, enabled us to determine the size of target populations for different indications in diabetes mellitus type 2. CONCLUSION: Our methodological approach seems to be suitable to determine target populations in type 2 diabetes.

Decision making in Germany: is health economic evaluation as a supporting tool a sleeping beauty?

For many years, the legal situation within the statutory health insurance (SHI) system in Germany has allowed for health economic evaluations. There are various reasons why health economic evaluations have played virtually no role in decision making until now: to begin with, a method for the evaluation of the relation between benefits and costs which needed to be in accordance with the legal requirements had to be developed, the outcome of which was the efficiency frontier approach. Subsequent health care reforms have led to changing objectives and strategies. Currently, price negotiations of newly launched drugs are based on an early benefit assessment of dossiers submitted by pharmaceutical manufacturers. Other reasons might be the presently very comfortable financial situation of the statutory health insurance system as well as a historically grown societal fear and discomfort towards what is perceived to be a rationing of medicinal products. For the time being, it remains open how long the German health care system can afford to continue neglecting the benefits of health economic evaluations for drug and non-drug interventions, and when it will be time to wake this sleeping beauty.

Cost-effectiveness analysis of coronary artery disease screening in HIV-infected men.

BACKGROUND: HIV-infected patients are at increased risk of coronary artery disease (CAD). We evaluated the cost-effectiveness of cardiac screening for HIV-positive men at intermediate or greater CAD risk. DESIGN: We developed a lifetime microsimulation model of CAD incidence and progression in HIV-infected men. METHODS: Input parameters were derived from two HIV cohort studies and the literature. We compared no CAD screening with stress testing and coronary computed tomography angiography (CCTA)-based strategies. Patients with test results indicating 3-vessel/left main CAD underwent invasive coronary angiography (ICA) and received coronary artery bypass graft surgery. In the stress testing + medication and CCTA + medication strategies, patients with 1-2-vessel CAD results received lifetime medical treatment without further diagnostics whereas in the stress testing + intervention and CCTA + intervention strategies, patients with these results underwent ICA and received percutaneous coronary intervention. RESULTS: Compared to no screening, the stress testing + medication, stress testing + intervention, CCTA + medication, and CCTA + intervention strategies resulted in 14, 11, 19, and 14 quality-adjusted life days per patient and incremental cost-effectiveness ratios of 49,261, 57,817, 34,887 and 56,518 Euros per quality-adjusted life year (QALY), respectively. Screening only at higher CAD risk thresholds was more cost-effective. Repeated screening was clinically beneficial compared to one-time screening, but only stress testing + medication every 5 years remained cost-effective. At a willingness-to-pay threshold of 83,000 €/QALY (∼ 100,000 US$/QALY), implementing any CAD screening was cost-effective with a probability of 75-95%. CONCLUSIONS: Screening HIV-positive men for CAD would be clinically beneficial and comes at a cost-effectiveness ratio comparable to other accepted interventions in HIV care.

Are HIV patients undertreated? Cardiovascular risk factors in HIV: results of the HIV-HEART study.

BACKGROUND: Antiretroviral therapy improved the survival of patients with human immunodeficiency virus (HIV) infection. With increased life expectancy, HIV-infected patients increasingly are experiencing comorbidities, most notably cardiovascular risk factors (CRFs) and coronary heart disease (CHD). DESIGN: This study utilized a prospective, cross-sectional multicentre long-term design. METHODS: In 803 patients (82% male; mean age 44.2 ± 10.3 years) we evaluated the prevalence of CRFs and 10-year risk of CHD using the Framingham risk model. The presence of a risk factor was determined based on the guidelines of the National Cholesterol Education Program (NCEP ATP III), the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7), and the German Society of Cardiology. RESULTS: The most common CRFs were smoking (51.2%), high triglycerides (39.0%), low high-density lipoprotein cholesterol (27.5 %) and high blood pressure (21.4%). In total, 60.3%, 21.6%, and 18.1% of patients were categorized as being at low (<10%), moderate (10-20%), and high (>20%) 10-year risk for CHD, respectively. In patients with hypertension, at least one antihypertensive drug was given in 91/163 (55.8%) patients. The percentage of patients on treatment with diabetes mellitus was 23/41 (56.1%). Anti-platelet therapy was prescribed to 42/102 (41.2%) patients with known CHD or CHD equivalent. In patients of moderate or high CHD risk there were more than 50% and 30% for LDL cholesterol and more than 60% and 40% for total cholesterol untreated. CONCLUSIONS: The prevalence of CRFs remains high in an HIV-infected population. CRF management of HIV-infected patients deserves further improvement.