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2008.Stargardt Jourment The Journal of Mental Health Policy and Economics J Ment Health Policy Econ 11, 89-97 (2008) Effectiveness and Cost of Atypical versus Typical Antipsychotic Treatment for Schizophrenia in Routine Care Tom Stargardt,1* Susanne Weinbrenner,2 Reinhard Busse,3 Georg Juckel,4 Christian A. Gericke5 1Dipl.-Vw., Research Fellow, Department of Health Care Management, University of Technology, Berlin, Germany 2MD MPH, Senior Research fellow, Department of Evidence-based Medicine, The German Agency for Quality in Medicine, Berlin, Germany 3MD MPH FFPH, Professor of Health Care Management, Department of Health Care Management, University of Technology, Berlin, Germany 4MD, Professor of Psychiatry, Department of Psychiatry, Ruhr University School of Medicine, Bochum, Germany 5MD MPH MSc FAFPHM, Professor of Public Health Policy, Discipline of Public Health, The University of Adelaide, Adelaide, Australia Abstract reducing various rehospitalisation outcomes. Patients treated with atypical antipsychotics received significantly less prescriptions for anticholinergics or tiaprid (relative risk 0.26, 95% confidence Background: In two recent randomised clinical trials, a meta- interval 0.18 to 0.38). analysis and in an effectiveness study analysing routine data from Discussion: The effectiveness of atypical antipsychotics for the U.S. Veterans Administration the superiority of the newer schizophrenia on rehospitalisation measures appeared similar to that atypical drugs over typical antipsychotic drugs, concerning both of typical antipsychotics. With the exception of severe cases, the their efficacy and their side-effect profile, has been questioned. higher costs for atypical antipsychotics were not offset by savings Aims of the Study: To analyse the effectiveness and cost of atypical from reduced inpatient care. Major limitations include the lack of versus typical antipsychotic treatment for schizophrenia in routine statistical power for subgroup analyses, the lack of clinical severity care. scale data and of life-course medical history data which both Methods: Cohort study using routine care data from a statutory increase the risk of residual confounding by disease severity. sickness fund with 5.4 million insured in Germany. To be included, Conclusions: This study provides evidence that the effectiveness of patients had to be discharged with a diagnosis of schizophrenia in atypical and typical antipsychotics measured in terms of hospital 2003 and fulfil membership criteria. Main outcome measures were readmissions appears to be similar in routine care. rehospitalisation rates, mean hospital bed days, mean length of stay, Implications for Health Care Provision and Use: From a clinical cost of inpatient and pharmaceutical care to the sickness fund during perspective, this study provides evidence that the effectiveness of follow-up and medication used to treat side-effects. atypical and typical antipsychotics measured in terms of hospital Results: 3121 patients were included into the study. There were no readmissions appears to be similar in routine care. statistically significant differences in the effectiveness of atypical Implications for Health Policies: Routine data studies can yield and typical antipsychotics on rehospitalisation during follow-up valuable information for policy decision-makers on the costs and (rehospitalisation rate ratio 1.07, 95% confidence interval 0.86 to the effectiveness of pharmaceuticals in routine care, complementing 1.33). However, there were consistent observations of atypical efficacy data from randomised clinical trials currently used for antipsychotics being more effective for severe cases of licensing and reimbursement decisions. schizophrenia (14.6% of study population; >61 prior bed days per Implications for Further Research: The non-significant year in 2000-2002) in the follow-up period, whereas for the other differences in the effectiveness of atypical compared to typical severity strata typical antipsychotics seemed more effective in antipsychotics according to severity of disease should be investigated in a prospective observational study or in a randomised clinical trial. * Correspondence to*: Tom Stargardt, Berlin University of Technology, Received 9 October 2007; accepted 29 February 2008 Department of Health Care Management, Strasse des 17. Juni 135 EB2, 10623 Berlin, Germany. Tel.: +49-30-3142 8422 Fax: +49-30-3142 8433 Introduction E-mail: [email protected] Source of Funding: This study was supported by an investigator-initiated Schizophrenia is a chronic disease with superimposed research grant from Janssen Cilag, Neuss, Germany, a manufacturer of atypical and typical antipsychotics to the Berlin University of Technology exacerbations of psychotic symptoms and a life time and the Charite Medical School, Berlin. The sponsor had no role in the study prevalence of approximately 0.7%, and an annual incidence design, collection and analysis of data, the writing of the report or the of 20-22 cases per 100,000 inhabitants.1 It affects a broad submission of the paper for publication. GJ has received research support range of mental and neuropsychological functions including and speakers’ honoraria from Janssen Cilag, Eli Lilly, Pfizer, Lundbeck, BMS and Astra Zeneca, manufacturers of atypical antipsychotics. RB has thinking, perception of reality, ideation, concentration and received research support from Novartis and was a member of the Novartis- motivation, in addition to hallucinations and delusional funded Institut des Sciences de la Sante´. beliefs. A third symptom complex is formed by social 89 Copyright g 2008 ICMPE Figure 1. Setting and Data Collection. isolation, loss of sense of pleasure, an inability to make rehospitalisation – is thought to worsen long-term prognosis. decisions, and poor self-care.2 Improved compliance because of more acceptable The early age of onset of the disease – usually in the medication may thus improve long-term outcomes.15 twenties often preceded by a long prodromal period – Consequently mean hospital bed days and rehospitalisation connected with a chronic course, frequent and long hospital rates during follow-up were chosen as the main outcome stays and temporary or permanent inability to work makes parameters for this study. In previous effectiveness studies, the disease very costly.1,3 In the Global Burden of Disease readmission to hospital or days in hospital have been used in Study, schizophrenia ranks at the fifth place accounting for asimilarway.16-19 Cost of inpatient care, cost of 1.15% of the total burden of disease measured in disability- antipsychotic treatment and cost for other pharmaceuticals adjusted life years (DALYs) in western Europe.4 At least one were assessed from a public payer perspective. third of patients with schizophrenia develop a chronic course To compare the effectiveness of atypical and typical of illness. Because every episode of schizophrenia worsens antipsychotics, routine data including prescriptions and the lifetime prognosis, prevention of relapse is one of the major number of days in hospital with a diagnosis of schizophrenia therapeutic goals.5 (ICD-10, F20.0 to F20.9) were collected from the Techniker Since the first market launch of atypical antipsychotics in Krankenkasse (TK), a German sickness fund (public health the 1970s, the superiority of the newer atypical drugs over insurer) with more than 5.4 million insured (i.e. 8% of typical antipsychotic drugs, concerning both their efficacy German residents with public health insurance) which and their side-effect profile, has been repeatedly operates nationwide and competes with other sickness funds demonstrated.6,7 However, these claims have been for customers. Members of the TK from all German federal questioned in recent randomised clinical trials (RCT),8-10 a states with a hospitalisation due to a diagnosis of meta-analysis,11 and in an effectiveness study analysing schizophrenia were followed up for 12 months after their routine data from the U.S. Veterans Administration.12 Akey first discharge from hospital in 2003. To control for possible concern in the debate about the differential efficacy and bias or confounding by severity of disease, data on prior effectiveness of atypical compared to typical antipsychotics hospitalisations with a diagnosis of schizophrenia was has been the substantially higher cost of atypical drugs. collected for 2000, 2001 and 2002 (see Figure 1). Data on Based on limited data from one RCT13 it has been claimed psychopathological scales are not recorded in German that these could be offset by the higher efficacy of the newer sickness fund databases. drugs to reduce rehospitalisation, leading to cost savings for inpatient care.14 We therefore compared the effectiveness Cohort and cost of atypical versus typical antipsychotics in a real- world setting using routine data from the Techniker In 2003, 3397 TK insured were hospitalised at least once Krankenkasse, a German sickness fund with more than 5.4 with schizophrenia. A total of 5604 hospital episodes were million insured. The study therefore also demonstrates how reported. 164 patients were excluded because membership in administrative data can be used to compare the effectiveness the sickness fund ended during follow-up. Another 112 of drugs under real world conditions. insured were excluded, because membership in the sickness fund during the period used to construct the severity index was less than 365 days. The final study population Methods comprised 3121 patients with a mean
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