[Health economic evaluation based on administrative data from German health insurance]. / Gesundheitsökonomische Evaluation auf Grundlage von GKV-Routinedaten.

Although the quality of administrative data of German health insurance is relatively good, administrative data are rarely used for the purpose of health economic evaluations in Germany. Health economic evaluations in Germany have so far mainly been performed based on primary data while in other countries the use of secondary data is quite common. The objective of the article is to give an introduction into the possibilities of performing health economic evaluations based on administrative data. First, we show that German health insurance have data sets that allow the follow-up of patients across all sectors of health care. Subsequently, characteristics of primary data and administrative data of health insurance for the purpose of health economic evaluations are compared. Finally we present an overview of recently performed health economic evaluations based on administrative data in Germany and conclude with lessons from other countries on the use of administrative data and implications for Germany.

[Authorization and reimbursement of orphan drugs in an international comparison]. / Zulassung und Erstattung von Orphan Drugs im internationalen Vergleich.

BACKGROUND: This paper analyses schemes to promote the authorisation of and reimbursement for orphan drugs. METHODS: 8 countries - Australia, Canada, Germany, Great Britain, France, Netherlands, Switzerland, USA - were studied to compare specific regulations for orphan drugs regarding drug admission, health technology assessment (HTA), decision-making for reimbursement, and off-label and compassionate use. Information was obtained by reviewing published and grey literature. Expert interviews were also conducted. RESULTS: The comparison of orphan drug legislation reveals that the EU and the USA offer the greatest incentives for the development of orphan drugs, whereas there is a tendency for Australia and Switzerland to profit from incentives in other countries. Although not explicitly stated, economic evaluation of orphan drugs takes the special circumstances for orphan drugs into account. In addition to common reimbursement practices, special schemes or programmes for the reimbursement of high-priced orphan drugs exist in all countries that were analysed. Therefore access to orphan drugs seems to be warranted. However, due to co-payments of 5%, the USA may form an exception. CONCLUSION: On the one hand, the use of special criteria for drug admission, HTA, and reimbursement promotes R&D for orphan drugs. On the other hand, high opportunity costs arise, because huge efforts are made for a minority of patients. A solution for this moral dilemma may be the application of "rule of rescue" or of "no cure, no pay" programmes.

Patient-reported outcomes in a survey of patients treated with oral antihyperglycaemic medications: associations with hypoglycaemia and weight gain.

AIM: To examine the association between medication side-effects (SEs) and patient-reported outcomes (PROs) among patients with type 2 diabetes treated with oral antihyperglycaemic agents (OAHAs). METHODS: A total of 1984 participants responded to an internet-based survey in the United States. Data were collected on hypoglycaemia 6 months and weight gain 12 months prior to the survey. Health-related quality of life (HRQoL) was measured using the EuroQol-5D (EQ-5D). Also administered were the Treatment Satisfaction Questionnaire for Medication v.1.4 (TSQM) and the Hypoglycaemia Fear Survey II (HFS). RESULTS: Symptoms of hypoglycaemia were reported by 62.9% of participants, and 36.9% reported weight gain. For those reporting hypoglycaemia, mean scores were lower for TSQM and EQ-5D and higher for HFS when compared with those with no symptoms (TSQM: 69.7 vs. 75.1; EQ-5D: 0.78 vs. 0.86; HFS: 17.5 vs. 6.2; all p < 0.0001). The same remained true when accounting for symptom severity, where severity was monotonically related with PRO scores (all p < 0.0001). Similarly, reported weight gain was associated with lower treatment satisfaction (69.0 vs. 73.3) and HRQoL (0.77 vs. 0.83), and increased fear of hypoglycaemia (15.7 vs. 11.8) (all p < 0.0001). In mixed linear regression analysis, the associations between medication SEs and PROs remained significant after adjusting for patient and disease characteristics. CONCLUSIONS: Among patients with type 2 diabetes treated with OAHAs, self-reported hypoglycaemia and weight gain were associated with decreased treatment satisfaction and HRQoL. In addition, the presence of these SEs was associated with increased fear of hypoglycaemia.

Drug prescription patterns in schizophrenia outpatients: analysis of data from a German health insurance fund.

INTRODUCTION: The aim of this study was to investigate routine administrative data from a major German health insurance fund, Techniker Krankenkasse, which covers 5.4 million insured individuals. Using a retrospective cohort design, this study analysed data collected from patients with a hospital diagnosis of schizophrenia in 2003 (index hospitalisation) in order to evaluate prescription patterns of antipsychotic drugs. METHODS: Patients with an ICD-10 diagnosis of schizophrenia, at least one year prior membership with the insurance fund and a follow-up period of one year were identified. Results were standardised by age and stratified by the severity of their illness, defined by the number of hospital bed days during the three years preceding the index hospitalisation. RESULTS: A total of 3,121 patients with schizophrenia (male 56.4%, female 43.6%) received 56 692 single prescriptions of antipsychotics. Of these, 35.4% of the prescriptions were for typical and 64.6% for atypical antipsychotics; 55% were for high-potency, 45% for low-potency typical antipsychotics. The most frequently prescribed drugs were olanzapine (26.6%), clozapine (21.3%) and risperidone (19%). There were no relevant gender differences concerning prescription patterns. During a 12-month follow-up period after the first hospitalisation, 1 372 patients (43.9%) were treated exclusively with an atypical antipsychotic, another 499 patients (16%) had a combination of an atypical plus a low-potency typical antipsychotic. Thus, basal therapy with an atypical was observed in 59.9% of our study population. Only 327 patients (10.5%) were treated exclusively with a typical antipsychotic. A total of 645 patients (20.7%) were treated with a combination of atypical plus typical antipsychotic. Changes of medication within one substance group occurred more often with typical antipsychotics (50%) as compared to atypical antipsychotics (25%). DISCUSSION: At 60%, the proportion of patients in this study treated with atypical antipsychotics was surprisingly high. Of significant interest is the frequent prescription of clozapine (14%). The results are discussed in comparison to comparable studies from other countries.

Treatment choice and effectiveness of adding sulphonylurea or glitazones to metformin for the treatment of type 2 diabetes mellitus.

AIM: This study investigates the treatment choice between, and the effectiveness of, adding sulphonylurea or glitazone to ongoing metformin therapy for patients with type 2 diabetes mellitus in the clinical practice setting. METHODS: A multicentre observational study using data from clinical records was conducted in Finland, France, Germany, Norway, Poland, Spain and the UK. Data were collected for patients who added sulphonylurea or glitazone to metformin. Effectiveness was defined as a change in haemoglobin A1c (HbA(1c)) from baseline to approximately 1 year after the initiation of additional therapy. To allow for comparisons between the two medication regimens, propensity score matching was employed. Treatment choice was analysed using a probit regression model. We hypothesized that treatment choice was associated with factors reflecting patient's characteristics, patient's experience with diabetes, patient's health or to physician's characteristics at baseline. RESULTS: Compared with baseline, adding sulphonylurea to metformin reduced HbA(1c) by 0.8% (p < 0.0001), while adding glitazone to metformin reduced HbA(1c) by 0.9% (p < 0.0001). Percentage at HbA(1c) goal (6.5%) increased from 6.9 to 23.8% for the sulphonylurea group and 8.3 to 33.3% for the glitazone group. Both groups had similar changes in high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglycerides. In the probit regression model, age, HbA(1c), weight, treatment for weight reduction, history of macrovascular complications and type of physician were significant factors associated with treatment choice. CONCLUSIONS: This study is consistent with the results of long-term randomized clinical trials in a clinical practice setting. Both regimens were able to reduce HbA(1c) by about 1%.

Defining the "Health Benefit Basket" in nine European countries. Evidence from the European Union Health BASKET Project.

This article identifies and analyses a framework for "health baskets," the taxonomy of benefit catalogues for curative services, and the criteria for the in- or exclusion of benefits in nine EU member states (Denmark, England, France, Germany, Hungary, Italy, The Netherlands, Poland and Spain). Focusing on services of curative care, it is found that the explicitness of benefit catalogues varies largely between the countries. In the absence of explicitly defined benefit catalogues, in- and outpatient remuneration schemes have the character of benefit catalogues. The criteria for the in- or exclusion into benefit catalogues are often not transparent and (cost-)effectiveness is applied only for certain sectors. An EU-wide harmonization of benefit baskets does not seem realistic in the short or medium term as the variation in criteria and the taxonomies of benefit catalogues are large but not insurmountable. There may be scope for a European core basket.

[Pharmaceutical reference pricing in Germany: definition of therapeutic groups, price setting through regression procedure and effects]. / Arzneimittelfestbeträge: Gruppenbildung, Preisberechnung mittels Regressionsverfahren und Wirkungen.

The German reference pricing system defines a reimbursement threshold for groups of pharmaceuticals. Pharmaceuticals are grouped according to certain criteria by the Federal Joint Committee. To make different active ingredients comparable, so called reference values are defined. Subsequently, the federal association of sickness funds sets reference prices using a regression procedure. However, the impact of the reference price system is limited. On the one hand there is a strong incentive for pharmaceutical companies to decrease prices to the reference price. On the other hand there is no incentive for further price reductions. Additionally, only one part of the pharmaceutical market is affected by reference pricing. Therefore the instrument has only managed to lower pharmaceutical expenditure in the short run. For sustainable long-term cost containment the use of other regulatory instruments is necessary. Nevertheless, compared to other instruments of price-regulation, reference pricing seems to be a good alternative to control pharmaceutical prices, since rationing is kept as little as possible.