Reinhard Rychlik

Cost-effectiveness of psoriasis therapy with etanercept in Germany

Background: We estimated the cost‐effectiveness of intermittent therapy with etanercept in patients with moderate‐to‐severe plaque‐type psoriasis in comparison to non‐systemic therapy in Germany.

New-onset diabetes and antihypertensive treatment.

Introduction Chronic diseases substantially contribute to the continuous increase in health care expenditures, including type-2 diabetes mellitus as one of the most expensive chronic diseases. Arterial hypertension presents a risk factor for the development of type-2 diabetes mellitus. Numerous analyses have demonstrated that antihypertensive therapies promote the development of type-2-diabetes mellitus. Studies indicate, that the application of angiotensin converting enzyme (ACE) inhibitors and angiotensin-receptor-blockers (ARB) lead to less new-onset diabetes compared to beta-blockers, diuretics and placebo. Given that beta-blockers and diuretics impair the glucose metabolism, the metabolic effects of different antihypertensive drugs should be regarded; otherwise not only the disease itself, but also antihypertensive therapies may promote the development of new-onset diabetes. Even though, the cost of ACE inhibitors and ARB are higher, the use in patients with metabolic disorders could be cost-effective in the long-term if new-onset diabetes is avoided. Objectives To evaluate which class of antihypertensive agents promote the development or the manifestation of type-2 diabetes mellitus. How high is the incidence of new-onset diabetes during antihypertensive therapy and how is treatment-induced type-2 diabetes mellitus evaluated clinically? Which agents are therefore cost-effective in the long term? Which ethical, social or legal aspects should be regarded? Methods A systematic literature review was conducted including clinical trials with at least ten participants which reported new-onset diabetes in the course of antihypertensive treatment. The trials had to be published after 1966 (after 2003 for economic publications) in English or German. Results A total of 34 clinical publications meet the inclusion criteria. Of these, eight publications focus on the development of diabetes mellitus under treatment with diuretic and/or beta-blockers, six publications focused on ACE inhibitors alone or in combination with calcium-channel-blockers, ten publications on ARB and/or ACE inhibitors with respect to their effects on new-onset diabetes or their preventive aspects. Furthermore, five publications investigate the role of calcium-channel-antagonists in the development of diabetes, and five publications indicate the development of new-onset diabetes with different antihypertensive agents amongst each other or in comparison to no antihypertensive treatment. The clinical trials show a significant difference in the development of new-onset diabetes. Therapies with diuretics and/or beta-blockers result in a higher incidence of new-onset diabetes. ARB as well as ACE inhibitors have a preventive effect and calcium-channel-blockers show a neutral position regarding the development of new-onset diabetes. Two publications report on economic results. The first one evaluates the cost-effectiveness of ARB alone or in combination with calcium-channel-blockers in comparison to diuretics alone or in combination with beta-blockers. The second publication compares economic outcomes of calcium-channel-blockers and beta-blockers considering the development of new-onset diabetes. Treatment with the ARB candesartan lead to savings in total costs of 549 US-Dollar per patient and in incremental costs of 30,000 US-Dollar per diabetes mellitus avoided. In the second publication, costs to the amount of 18,965 Euro in Great Britain and 13,210 Euro in Sweden are quoted for an avoided event. The treatment with calcium-channel-blockers compared to beta-blockers is proven to be more cost-effective. No publications were identified regarding ethical, social and legal aspects. Discussion The available meta-analyses allow for a high clinical evidence level. A few studies vary in terms of diabetes definition and study duration. In most of the trials, the incidence of new-onset diabetes is not an endpoint. The evaluation of treatment-induced diabetes mellitus cannot be conducted, due to the lack of sufficient results in the identified literature. The two economic studies do not address all the objectives sufficiently. Ethical, social and legal aspects are discussed but not analysed systematically. Conclusion Based on these studies, sufficient evidence to confirm the presumption that diuretics and/or beta-blockers promote the development of new-onset diabetes compared to other antihypertensive agents, especially in patients who are predisposed, is presented with this report. Trials reflecting the clinical relevance of treatment-induced diabetes mellitus compared to existing diabetes mellitus regarding cardiovascular outcomes are required. Also health economic evaluations considering the development of new-onset diabetes should be conducted for the different classes of antihypertensive agents.

Telemedizin in der Tertiärprävention: Wirtschaftlichkeitsanalyse des Telemedizin-Projektes Zertiva® bei Herzinsuffizienz-Patienten der Techniker Krankenkasse

Ziel: Es wurde die Wirtschaftlichkeit einer telemedizinischen Betreuung bei Patienten mit Herzinsuffizienz untersucht.

Long-term efficacy and safety of incobotulinumtoxinA and conventional treatment of poststroke arm spasticity: a prospective, non-interventional, open-label, parallel-group study

Objective To compare the efficacy and safety of incobotulinumtoxinA with conventional antispastic therapy for poststroke arm spasticity in routine clinical practice over a 1-year period. Design Prospective, non-interventional, open-label, parallel-group study. Setting 47 centres in Germany. Participants Patients with poststroke arm spasticity; 108 receiving incobotulinumtoxinA, 110 conventional therapy. Intervention Conventional antispastic treatment including oral antispastic medications, physiotherapy and occupational therapy or 3-monthly incobotulinumtoxinA injections plus conventional therapy if required. Main outcome measures The main outcome measure was changes in muscle tone (Ashworth Scale) over the 1-year treatment period. Changes in functional disability (Disability Assessment Scale) and quality of life (Short-Form-12 Health Survey) were additionally assessed. Ratings for therapy outcome (Goal Attainment Scale), and efficacy and tolerability of treatment (Global Clinical Impression Scale) were also obtained. Results Muscle tone improved for all spasticity patterns with the Ashworth Scale responder rates between 63% and 86% (incobotulinumtoxinA) and 16–27% (conventional therapy). Median improvement in functional disability was –1.0 (incobotulinumtoxinA) and 0.0 (conventional measures) for all domains. Treatment goals were attained by 93% of incobotulinumtoxinA patients and 30% of patients under conventional therapy. Most physicians (93%) and patients (90%) rated efficacy as good or very good under incobotulinumtoxinA; the proportions were much lower under conventional therapy (36% and 37%). Tolerability under incobotulinumtoxinA was considered good or very good by 99% of physicians and patients (76% and 66%, respectively, under conventional therapy). Quality of life under incobotulinumtoxinA improved by 8.0 (physical score) and 10.8 (mental score) and by 0.8 and 5.7, respectively, under conventional therapy. Conclusions IncobotulinumtoxinA combined with rehabilitation and oral medication produces a much more robust improvement in all aspects of arm spasticity than conventional antispastic treatment. Effects are stable over a period of 1 year, whereas adverse effects are negligible. IncobotulinumtoxinA should be considered the treatment of choice for poststroke arm spasticity.

Stand der hausärztlichen Palliativversorgung in Deutschland

To investigate the role of general practitioners among the increasing specialization in outpatient palliative care, meaningful research topics, developments of new collaborations and structures in the outpatient sector of palliative care, 52 articles were reviewed. Results have shown that general practitioners are still involved in outpatient palliative care research and show a distinct participation in quality development. Typical research topics in outpatient palliative care research are quality of care and structures. However, cooperative structures between general practitioners and palliative specialists are rare in the field of outpatient palliative care research.

Krankheitskosten bei Alzheimer-Demenz

ZusammenfassungZiel:Ziel der Analyse war die Generierung von Kostendaten für ärztliche Leistungen, Arzneimitteltherapie, Klinikaufenthalte, Pflegeleistungen, Heilund Hilfsmittelverordnungen für Patienten mit Morbus Alzheimer sowie eine Betrachtung der Verteilung und Entwicklung der Pflegestufen.Material und Methodik:Die Analyse basiert auf den anonymisierten Abrechnungsdaten aller Patienten mit Alzheimer-Demenz der Barmer Krankenkasse (BARMER) aus dem Jahr 2005 (n = 48 322). Diese Patientenpopulation wurde für die Auswertung in drei Behandlungsgruppen eingeteilt: Patienten, die mindestens eine Memantin-Verordnung und keine Verordnungen anderer Antidementiva, Psychopharmaka oder Hypnotika/Sedativa erhielten (Memantin-Gruppe), Patienten, die weder Memantin noch ein anderes Antidementivum, aber Psychopharmaka bzw. Hypnotika/Sedativa erhielten (PHS), und Patienten, die keine antidementive oder symptomatische Therapie erhielten („keine demenzspezifischen AM“). Die Kosten wurden für jede Behandlungsgruppe und nach Pflegestufen berechnet.Ergebnisse:Der Anteil pflegebedürftiger Patienten war in der Memantin- Gruppe niedriger als in den anderen beiden Gruppen. Die durchschnittlichen Gesamtkosten betrugen in der Memantin-Gruppe 7 028 Euro pro Patient, in der PHS-Gruppe 13 549 Euro und in der Gruppe ohne Arzneimitteltherapie 8 817 Euro. Der wesentlich größere Anteil Pflegebedürftiger in der PHS-Gruppe und in der Gruppe ohne demenzspezifische Arzneimitteltherapie war mit höheren durchschnittlichen Gesamtkosten assoziiert, da die Pflegekosten den jeweils größten Anteil an den Gesamtkosten hatten. Geringere Arzneimittelkosten konnten die Mehraufwendungen für Pflegeleistungen nicht kompensieren. Die Patienten der PHS-Gruppe wiesen in allen Kostenarten mit Ausnahme der spezifischen Arzneimittelkosten die höchsten Durchschnittskosten auf.Schlussfolgerung:Die Ergebnisse zeigen, dass eine nichtantidementive Arzneimitteltherapie der Alzheimer-Demenz besonders in der Pflege mit höheren Kosten assoziiert ist. Die niedrigsten Kosten wurden trotz der höchsten Arzneimittelkosten in der Memantin-Gruppe ermittelt.AbstractPurpose:The aim of this analysis was to generate cost data of provider services, drug acquisition, hospitalization, nursing care services, and adjuvants for patients with Alzheimer’s disease, as well as to describe the distribution and development of care levels.Material and Methods:The analysis is based on anonymized data of patients with Alzheimer’s disease who were insured by a large German statutory health insurance (Barmer Krankenkasse [BARMER]) in 2005 (n = 48,322). The study population was classified into three treatment groups: patients, who received memantine and no other antidementives, psychotropic drugs or hypnotics/sedatives (memantine group); patients who neither received memantine nor other antidementives, but psychotropic drugs and hypnotics/ sedatives (PHS group); and patients who received no antidementives or symptomatic therapy at all (“no dementia-specific AM”). Costs were fully assessed for patients in each treatment group and correlated with the care level.Results:In the memantine group, fewer patients needed care than in the other two groups. Total costs per patient averaged 7,028 Euros in the memantine group, 13,549 Euros in the PHS group, and 8,817 Euros in the group with no specific medication. Higher costs in the PHS group and in the group without drug treatment were mainly caused by a considerably higher rate of patients in need of care, of which nursing care made up the highest proportion. Fewer costs for medical treatment could not compensate the additional expenditures for nursing care. Patients in the PHS group had the highest average costs in all cost categories except for specific drug cost.Conclusion:The results demonstrate that non-antidementive therapy for Alzheimer’s disease causes higher costs especially in nursing care. The memantine group proved superior even though it had the highest costs in the specific drug category.

Target patient population: how does the regulatory and reimbursement view differ? Insights from the German IQWiG

AimThis systematic review compares European HTA-agencies (Health Technology Assessment-agencies) for the evaluation of submitted reimbursement dossiers and the acceptance of the by regulatory authorities proven indications (slicing procedure).Subjects and methodsA Europe-wide literature search and Internet survey from 2000 to 2012 was applied. For 10 market leaders and 4 drugs which were approved in 2009 or 2010, the approved indications were compared to the indications which were eligible for reimbursement in Germany, the United Kingdom (UK) and France.ResultsA slicing procedure could be found for 5 applications (drugs) in UK and France and for 6 applications (out of 14) in Germany. Three drugs out of 16 were referred to a fixed price group. The position of the regulatory authorities remained unchanged for eight compounds. As a final result, it is obvious that indications will be cut off (slicing), market authorizations modified and comparators changed. Scientific reasons are not published.ConclusionSlicing (cutting off indications and populations) is well known in European HTA bodies but is applied only in a minority of submissions, which has resulted in a decrease of the population and reimbursement rate. A harmonization process between HTA agencies and regulatory authorities should be initiated.

Elevating the use of sugar-free chewing gum in Germany: cost saving and caries prevention

Abstract Objective: To analyse the lifetime monetary and health related effects of the consumption of sugar-free chewing gum. Material and methods: Using a Markov model we assumed that the German consumption of sugar-free chewing gum (111 gums/year) could be elevated to the level of Finland (202 gums/year). The calculation was based on a model patient representing the development of oral health from the age of 12 to 74 years and clinical data on the effectiveness of chewing sugar-free gum. Lifetime and yearly costs for the ‘Finland-scenario’ were determined and compared with the actual German expenses of the statutory health insurance companies for dental health. Results: The actual total lifetime expenditures of the statutory health insurance companies are 17,199.96€ per capita and would be 12,188.94€ in the scenario with elevated consumption of sugar-free chewing gum in Germany. Thus, 5011.02€ per capita could be saved in a lifetime and 80.82€ per year. Conclusions: On a national scale, the elevation of the consumption of sugar-free chewing gum in Germany to the level of Finland would lead to a considerable benefit for cost saving and oral health for the statutory health insurance companies.

Quality of Life in Chronic Low Back Pain Patients Treated With Opioids

ABSTRACT A noninterventional study under real-life conditions comparing patients receiving prolonged-release oral oxycodone/naloxone with those receiving other World Health Organization (WHO) Step III opioids found patients in the oxycodone/naloxone group had greater quality of life and less low back pain after 12 months. Oxycodone/naloxone was also found to be more cost-effective in the study.

Krankheitskosten bei Alzheimer-Demenz@@@Cost of Illness in Alzheimer’s Disease

ZusammenfassungZiel:Ziel der Analyse war die Generierung von Kostendaten für ärztliche Leistungen, Arzneimitteltherapie, Klinikaufenthalte, Pflegeleistungen, Heilund Hilfsmittelverordnungen für Patienten mit Morbus Alzheimer sowie eine Betrachtung der Verteilung und Entwicklung der Pflegestufen.Material und Methodik:Die Analyse basiert auf den anonymisierten Abrechnungsdaten aller Patienten mit Alzheimer-Demenz der Barmer Krankenkasse (BARMER) aus dem Jahr 2005 (n = 48 322). Diese Patientenpopulation wurde für die Auswertung in drei Behandlungsgruppen eingeteilt: Patienten, die mindestens eine Memantin-Verordnung und keine Verordnungen anderer Antidementiva, Psychopharmaka oder Hypnotika/Sedativa erhielten (Memantin-Gruppe), Patienten, die weder Memantin noch ein anderes Antidementivum, aber Psychopharmaka bzw. Hypnotika/Sedativa erhielten (PHS), und Patienten, die keine antidementive oder symptomatische Therapie erhielten („keine demenzspezifischen AM“). Die Kosten wurden für jede Behandlungsgruppe und nach Pflegestufen berechnet.Ergebnisse:Der Anteil pflegebedürftiger Patienten war in der Memantin- Gruppe niedriger als in den anderen beiden Gruppen. Die durchschnittlichen Gesamtkosten betrugen in der Memantin-Gruppe 7 028 Euro pro Patient, in der PHS-Gruppe 13 549 Euro und in der Gruppe ohne Arzneimitteltherapie 8 817 Euro. Der wesentlich größere Anteil Pflegebedürftiger in der PHS-Gruppe und in der Gruppe ohne demenzspezifische Arzneimitteltherapie war mit höheren durchschnittlichen Gesamtkosten assoziiert, da die Pflegekosten den jeweils größten Anteil an den Gesamtkosten hatten. Geringere Arzneimittelkosten konnten die Mehraufwendungen für Pflegeleistungen nicht kompensieren. Die Patienten der PHS-Gruppe wiesen in allen Kostenarten mit Ausnahme der spezifischen Arzneimittelkosten die höchsten Durchschnittskosten auf.Schlussfolgerung:Die Ergebnisse zeigen, dass eine nichtantidementive Arzneimitteltherapie der Alzheimer-Demenz besonders in der Pflege mit höheren Kosten assoziiert ist. Die niedrigsten Kosten wurden trotz der höchsten Arzneimittelkosten in der Memantin-Gruppe ermittelt.AbstractPurpose:The aim of this analysis was to generate cost data of provider services, drug acquisition, hospitalization, nursing care services, and adjuvants for patients with Alzheimer’s disease, as well as to describe the distribution and development of care levels.Material and Methods:The analysis is based on anonymized data of patients with Alzheimer’s disease who were insured by a large German statutory health insurance (Barmer Krankenkasse [BARMER]) in 2005 (n = 48,322). The study population was classified into three treatment groups: patients, who received memantine and no other antidementives, psychotropic drugs or hypnotics/sedatives (memantine group); patients who neither received memantine nor other antidementives, but psychotropic drugs and hypnotics/ sedatives (PHS group); and patients who received no antidementives or symptomatic therapy at all (“no dementia-specific AM”). Costs were fully assessed for patients in each treatment group and correlated with the care level.Results:In the memantine group, fewer patients needed care than in the other two groups. Total costs per patient averaged 7,028 Euros in the memantine group, 13,549 Euros in the PHS group, and 8,817 Euros in the group with no specific medication. Higher costs in the PHS group and in the group without drug treatment were mainly caused by a considerably higher rate of patients in need of care, of which nursing care made up the highest proportion. Fewer costs for medical treatment could not compensate the additional expenditures for nursing care. Patients in the PHS group had the highest average costs in all cost categories except for specific drug cost.Conclusion:The results demonstrate that non-antidementive therapy for Alzheimer’s disease causes higher costs especially in nursing care. The memantine group proved superior even though it had the highest costs in the specific drug category.