Abstracts by key term: Diabetes mellitus
When discussing surrogates and endpoints, one quickly comes to the question of which treatment results and characteristics are actually relevant for the patient. The appropriate expression “patient-relevant endpoint” is anchored in the legal basis for early benefit assessment according to Section 35a SGB V.1 While in other places there is explicit talk of a “therapy-relevant higher benefit” or “therapy-relevant side effects” (cf. e.g. § 35 Para. 1b SGB V), is clearly aimed at the patient. In the associated dossier specifications for Section 35a SGB V, module 3.3.6 mentions patient preferences as a data source to be taken into account.2 Thus, the importance of patient-relevant endpoints and patient preferences has increased with the AMNOG (Law on the Reorganization of the Medicines Market), but what role they play in concrete terms plays is still to be clarified. Nevertheless, the IQWiG (Institute for Quality and Efficiency) commissioned pre-AMNOG for two pilot studies on preference measurement (Conjoint Analysis, Analytical Hierarchy Process), one of which has already been published. IQWiG also focuses on patient preferences in its current method paper (see IQWIG (2013); IQWIG (2010b); IQWIG (2011)).
24.01.2013
With around six million diagnosed patients, diabetes mellitus is one of the most common chronic diseases in Germany. In addition, the number of diabetics is increasing - regardless of population aging (RKI 2011). In addition, diabetes is one of the most costly diseases. In statutory health insurance (GKV), a diabetic incurs about twice as high direct treatment costs as a non-diabetic insured person (Köster et al. 2006). Almost 30 percent of all diabetics are treated with insulin (Hauner 2007); These include all type 1 diabetics and those type 2 diabetics for whom the body's own insulin production is no longer sufficient despite lifestyle changes and treatment with oral antidiabetics. When it comes to insulin, a distinction can be made between mixed insulins, short-acting, so-called bolus insulins, and long-acting, so-called basal insulins. The latter include NPH insulin (Neutral Protamine Hagedorn), insulin glargine and insulin detemir. Basal insulin accounts for around 30 percent of the total daily insulin doses prescribed on an outpatient basis and 34 percent of statutory health insurance expenditure on insulin (Mengel 2010; INSIGHT Health 2011). The aim of the study presented here is to compare the costs of three treatment strategies that differ in terms of the basal insulin used. Only diabetics who received at least two prescriptions of either insulin glargine or insulin detemir or NPH insulin at the expense of the statutory health insurance in 2010 are included. The outpatient diabetes-related prescriptions for bolus insulins, antidiabetics, blood sugar test strips, needles and lancets billed via pharmacy computing centers are also taken into account. The prescriptions are valued at pharmacy sales prices (Lauer tax) less the statutory manufacturer discounts in accordance with Section 130a Paragraphs 1, 1a, 3b SGB V.
02.10.2012
The Defined Daily Dose (DDD) is a theoretical quantity that was developed as an international standard comparison quantity for drug consumption research. It indicates the assumed mean maintenance dose per day in adults for an active ingredient in its main indication. In Germany, the official German version of the ATC classification (Anatomical-Therapeutic-Chemical Classification) including the DDD information is published by the DIMDI (German Institute for Medical Documentation and Information) (DIMDI 2010). This is based on the version of the WHO, which is responsible for creating the internationally standardized ATC/DDD system (Fricke et al. 2011). Both the WHO and the AOK Scientific Institute (WIdO), which in turn publishes the methodology of the ATC classification and DDD determination for Germany, point out that the DDD is a calculated quantity that is not related to the therapeutic or prescribed dose may be confused. For longitudinal drug consumption research, the DDDs must be kept stable and are therefore unsuitable as a basis for decision-making for questions regarding drug reimbursement, pricing and therapy (Fricke et al. 2011).
02.10.2012
According to the latest figures from the International Diabetes Federation (IDF), Germany is the country with the highest diabetes prevalence in Europe. 12% 20 to 79 year olds are affected, a total of around 7.5 million people. In Germany, around 90% are type 2 diabetics, while around 5-10% are type 1 diabetics. Patients are cared for by 50,000 to 60,000 general practitioners nationwide (approx. one doctor per 1,500 inhabitants), around 1,100 specialist practices with diabetologists and around 350 special clinics. The aim of treating patients with diabetes is to prevent complications such as macroangiopathy (coronary heart disease, stroke, arterial occlusive disease), microangiopathy (eye and kidney damage), neuropathy or diabetic foot syndrome and to maintain the quality of life of those affected. In addition to lifestyle adjustments or medication measures, structured patient training is essential for successful diabetes treatment. Although there are still serious deficits in patient training despite disease management programs (DMP), patient training in Germany can be of a high standard compared to other countries.
23.09.2012
The aim of the present analysis is to compare treatment costs between insulin-glargine and NPH-insulin-based therapies in patients with diabetes mellitus. Using a representative sample of health insurance data, simultaneous co-medication in the indication groups bolus insulin, oral antidiabetics, test strips and lancets/needles over three calendar years was determined for a total of six payers. During the analysis period (2006 - 2008), the aggregated absolute annual treatment costs per diabetes patient for insulin glargine-based therapies tended to be slightly below the costs of the respective NPH comparison groups. The analysis of the individual costs shows that the higher procurement costs for insulin glargine are overcompensated by savings in bolus insulin and test strip consumption. The present database analysis confirms the results of previously published health care research studies, according to which, from the perspective of statutory health insurance (GKV), there is a cost-neutrality between insulin glargine and NPH insulin-based treatment regimens under real care conditions.
01.12.2009
Diabetes mellitus has become a widespread disease in Germany. There are at least 7 million people with diagnosed diabetes mellitus in Germany and, taking into account the undiagnosed cases and the increasing prevalence of the disease worldwide, especially among younger people, the German health system will face major challenges, including economic ones. Under certain conditions, self-monitoring of blood sugar can be a very useful and cost-effective therapeutic element in the treatment of the disease. Although this benefit in insulin-dependent diabetics is largely undisputed, there is still no consensus in Germany about the benefit in non-insulin-dependent type 2 diabetics. However, what is often overlooked in the benefit assessment is that self-measurement of blood glucose is a diagnostic procedure which – unlike medicines – cannot have an intrinsic effect. Applying drug evaluation methods to a diagnostic procedure can subsequently lead to misleading results. If blood glucose measurement is used correctly by patients and appropriate assessment methods are used, self-assessment of blood glucose in type 2 patients even proves to be cost-saving for health insurance companies.