CLINICAL OUTCOMES STUDIES

PCOS1: COMMUNITY-BASED OUTCOMES RESEARCH INITIATIVE FOR CHRONIC RENAL DISEASES

Sasahara E1, Iida E1, Tajima Y1, Terajima T1, Ogawa M2, Yoshida H3, Irie Y3, Yamagata S1, Satoh N1, Ueda S1, 1Chiba University Graduate School of Pharmaceutical Sciences, Chiba-shi, Chiba, Japan; 2Chiba University Graduate School of Medicine, Chiba-shi, Chiba, Japan; 3Sanai Memorial Hospital, Chiba-shi, Chiba, Japan

OBJECTIVES: Despite enormous efforts to improve chronic renal diseases management, the lack of evidenced resources focusing on Japanese patients persists. In order to implement pharmacoeconomics and outcomes research contributing to daily healthcare, it is essential to review and quantify the series of consecutive cases at clinical levels. In collaboration with community hospitals in the Chiba area, we are currently developing a database to assess clinical outcomes, resource utilization and effectiveness in the fields of renal diseases. This presentation illustrates the framework and results of our pilot study. METHODS: At the first stage, our fieldwork team collected baseline data on medical records of 205 outpatients with chronic renal diseases at 5 hospitals. The data included patient profiles, drug history and clinical test history from September 1988 to April 2002. At the second stage, using the data and other resources, our pharmaceutical research team conducted retrospective approaches to assess the renal protective effects of angiotensin-converting-enzyme inhibitors (ACEIs). Those approaches included Meta-analysis, Survival-analysis and Regression-analysis. At the third stage, in collaboration with clinic physicians, our economic/managerial research team is reviewing the assessment to develop cost-effectiveness simulation scenarios for improvement in medical management. RESULTS: By using the slope of the regression line for the reciprocal serum creatinine, the median of a reprieve from chronic renal failure by ACEIs was estimated as 2.50 years regarding 7 cases. For example, in case of a 40-year-old man with the estimated reprieve of 2.19 years, the patient gained 2.37 years of really extended period. And follow-up interviews with the clinic physicians indicated that those reprieve estimates will contribute to their decisions in drug prescription and the medical management. CONCLUSIONS: The pilot study is not evidence-based and contains uncertainty regarding future decision-making in individual cases. However, to let Japanese people understand effectiveness of pharmacoeconomics and outcomes research, project initiative should be community-centric and get involved with multidisciplinary team from the beginning.





PCOS2: DO CONTROLLED TRIALS OF ADHERENCE TO ANTIHYPERTENSIVE DRUGS GENERATE HIGHER RATES? EVIDENCE FROM THE LITERATURE

Iskedjian M1, Piwko C1, Walker J2, Vicente C1, Einarson T3, 1PharmIdeas Research and Consulting Inc, Oakville, ON, Canada; 2Brock University, St. Catharines, ON, Canada; 3University of Toronto, Toronto, ON, Canada

Controlled trials (CTs) of cardiovascular (CVS) therapies often report relatively high adherence rates, in the neighborhood of 80 - 95%. However, the compliance literature refers to lower rates. We suspect that the CT environment may provide conditions that result in artificially increased adherence rates. OBJECTIVE: The purpose of this study was to review the adherence literature both qualitatively and quantitatively to determine whether rates from noncomparative studies were lower than those from CTs.
METHODS: We accepted all noncomparative studies that reported adherence rates to CVS drugs, including clinical trials, database studies, chart reviews, or observational cohort studies. There must have been a minimum of 25 patients under study, suffering from hypertension. Articles that reported interventions, to enhance compliance, and long-term persistence were excluded. Articles were identified and data were extracted by a single reviewer and verified independently by a second person. Data were combined using weighted-means for a series of mean adherence rates. Results were compared with those of CTs of the same types of patients, as reported in previous research. RESULTS: Of the 25 studies identified, we were able to use data from 16, which studied 57,406 patients. The overall weighted-mean adherence rate (range) was 74% (46 - 87%), which was 20% lower than the previously reported rate of 94% in 9436 patients in 6 RCTs. CONCLUSIONS: The rate of adherence reported in noncomparative studies was found to be 20% lower than that reported in CTs in the same types of patients.



PCOS3: PATIENT SURVIVIAL AMONG PERITONEAL DIALYSIS PATIENTS IN THE UNITED STATES: A CLOSE LOOK AT THE 1999, 2000 AND 2001 INCIDENT COHORTS

Guo A, Salim M, Baxter Healthcare Corporation, Deerfield, IL, USA

Innovation and advances in peritoneal dialysis (PD) over time have resulted in significantly improved outcomes in end-stage renal disease (ESRD) patients. OBJECTIVES: To evaluate the current PD patient survival in the US and identify opportunities for improving PD patient care using recent available data. METHODS: Data was obtained from On-call Comparative Data Resource (Baxter Healthcare Corp., internal data), a program aimed at providing a comparative analysis of the reasons why patients enter or leave home dialysis. Over 30,000 incident patients who started peritoneal dialysis in 1999, 2000, and 2001 were included. Kaplan-Meier (KM) estimation was used to calculate the unadjusted actuarial patient survival. Adjusting for patients’ age, diabetic status, gender, center-size, and year of dialysis initiation, patient survival was also determined by Cox proportional hazard model. Censoring events in the analysis included switching to hemodialysis (HD), transplantation, death, and loss to follow-up, recovery of native renal function. RESULTS: One-year patient survival was 82%, 84%, and 86% respectively for 1999, 2000, and 2001 cohort, showing improvement over time. Two-year patient survival was also improved over time (69% in 1999, 72% in 2000, and 79% in 2001). The relative risk ratios of age, diabetes, and initial modality choice of CAPD (continuous ambulatory PD) vs. APD (automated PD) on patient survival were 1.038, 1.467 and 1.379 respectively. Dialysis center with less than 20 PD patients was not a significant risk factor for patient survival. The risk ratio of PD initiation year was 0.757, showing an improvement in patient survival over time. CONCLUSIONS: We found secular trend of improved outcomes as measured by patient survival of PD patients in the United States. The temporal profile of modality transfer from PD to HD could be used as a guide to practice optimization for PD patient care.




PCOS4: HOW TO COMPARE THE SAFETY AND EFFICACY OF ANTIPYSCHOTIC THERAPIES, WITH A LACK OF HEAD TO HEAD TRIAL EVIDENCE; THE EXAMPLE OF OLANZAPINE VERSUS QUETIAPINE

Montgomery W1, Mullen K1, Croker V1, Davey P2, 1Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 2M-TAG, Sydney, Australia


OBJECTIVES: This meta-analysis compares effects directly of olanzapine and haloperidol and indirectly olanzapine and quetiapine via haloperidol in the treatment of schizophrenia. The indirect comparison provides a method to compare safety and efficacy of different medications in the absence of head to head studies. As many of the trials had fixed dosing regimes this analysis examines effect of varying the dose of all three antipsychotics on the results. METHODS: Trials of olanzapine or quetiapine versus haloperidol were identified. Each was compared using all doses of olanzapine, quetiapine and haloperidol. A second comparison analysed clinically relevant doses of these antipsychotics based upon their approved Product Information. RESULTS: The analyses with all doses of haloperidol and olanzapine and the clinically relevant dose analysis showed that for the efficacy and tolerability outcomes, olanzapine was statistically superior to haloperidol. When comparing olanzapine and quetiapine via haloperidol, the all dose analysis highlighting superior efficacy and safety of olanzapine include more dropouts due to lack of efficacy for quetiapine, greater change in PANSS total for olanzapine and better CGI severity score. The superior efficacy and safety of olanzapine when analysing trials using clinically relevant doses of olanzapine (10-15mg), quetiapine (300-450mg) and haloperidol (5-15mg), is shown by statistically more dropouts for any reason and lack of efficacy for quetiapine and a higher likelihood of response and a better improvement in PANSS total score for olanzapine. CONCLUSION: The analysis of clinically relevant doses is considered to be most informative as it looks at efficacy and safety in patients taking doses of drugs most likely to be used in clinical practice. In fixed dose trials sub or supra-therapeutic levels of the study drug can be used which could affect side effects and efficacy of therapy.



PCOS5: EVIDENCE ON THE RELATIVE EFFECTIVENESS OF OLANZAPINE AND RISPERIDONE OVER TIME

Davey P, FitzGerald P, Birinyi-Strachan L, M-TAG Pty Ltd, Chatswood, NSW, Australia

OBJECTIVES: The atypical antipsychotic drugs are rapidly replacing the older typical therapies for the treatment of schizophrenia. The two most widely prescribed atypicals, olanzapine and risperidone, now account for $US4.9 billion in global health care sales per annum (2001) and hence analyses on their respective efficacies are important. METHODS: Several randomised controlled trials have compared these two drugs directly, but there is some inconsistency in the reported relative efficacy. The 8 week study by Conley and Mahmoud (2001) suggested that risperidone is more effective than olanzapine. By contrast, the 28-week trial by Tran et al. (1997) suggested that olanzapine is more effective than risperidone. Two smaller, medium- to long-term trials also showed significant improvements in a variety of efficacy rating scales for patients treated with olanzapine compared with those receiving risperidone (Purdon et al. 2000, Gureje et al. 2002). These trials ran for 52 and 30 weeks, respectively. In order to explore why there was a difference in the findings of the four trials, we examined the mean change in PANSS total score over time with olanzapine and with risperidone in the Tran et al. (1997) study. The original trial dataset was provided by the trial sponsor (Eli Lilly) and the mean change in PANSS total score was plotted for both study arms over the duration of the study. RESULTS: These results suggest that olanzapine and risperidone have similar efficacy in the short-term (up to about eight weeks), after which time olanzapine offers superior effectiveness to risperidone. This is an important finding, which may explain the different outcomes in the four comparative trials. CONCLUSIONS: Since schizophrenia is a chronic condition, understanding the long-term differences between antipsychotic treatments is critical both to the selection of appropriate therapy and to the allocation of antipsychotic drug budgets.




PCOS6: THE BURDEN OF SLEEP DISTURBANCES AMONG JAPANESE GRADUATE STUDENTS

Pallos H, Yamada N, Okawa M, Shiga University of Medical Science, Otsu, Shiga-ken, Japan

OBJECTIVES: The socioeconomic impact and the burden of sleep disturbances have not yet been systematically investigated in Japan. We planned our study to describe the burden of sleep disturbances and estimate the proportion of graduate students to be associated with direct and indirect costs related to their sleep disturbances.
METHODS: We conducted an exploratory epidemiological survey at 15 university graduate schools in Kyoto, Japan to estimate the prevalence of sleep disturbances and the burden related to them; the consultation rate for sleep difficulties and the hypnotic medication use rate. Two hundred nineteen graduate students (158 males and 61 females), aged 22-39 completed the self-reported Pittsburgh Sleep Quality Index questionnaire, together with specific questions designed for the purpose of the study. RESULTS: The overall rate of insomnia was 14.6%, while 10.5% had difficulty initiating sleep and 6.9% had difficulty maintaining their sleep. Excessive daytime sleepiness was present in 4.1% of the students. These rates were similar to the rates for the general young adult population, except for the lower rate of excessive daytime sleepiness. Meanwhile, 29.8% of them reported fatigue, 9.6% health problems, 5% absenteeism, and 3.2% accidents at universities as consequences of their sleep problems, occurring indirect costs; only 2.3% reported consultations with physicians and 0.9% had used hypnotic medication for their problems, occurring direct costs. CONCLUSIONS: Results suggest that the prevalence rates of consequences are higher for the general young adult population than for the less sleep deprived graduate students. Since the general young adult population is important part of the active work force, this indicates a significant loss of productivity. Despite the high prevalence rates of sleep disturbances and their consequences, the consultation rate for sleep problems was low. Increased awareness of preventive measures may decrease the prevalence rates of consequences of sleep problems.


PCOS7: LIFE EXPECTANCY; WHAT IS IT AND CAN WE PREDICT IT?

Wilson JRM1, MacDonagh R1, Ewings P1, O'Boyle C2, 1Taunton and Somerset Hospital, Taunton, Somerset, United Kingdom; 2Royal College of Surgeons of Ireland, Dublin, Ireland

OBJECTIVES: To determine whether Consultant Urologists, Specialist Registrars and Oncologists can accurately predict the life expectancy (LE) of prostate cancer patients using a newly developed LE measure. Patients with prostrate cancer that are perceived by the clinician to have a greater than 10 year life expectancy would be considered for potentially curative treatments. Although in clinics the assessment of LE in is commonly random and inconsistent. METHODS: We are developing a measure for assessing LE using evidence based actuarial statistics centered on co-morbidities. A sum of an individual’s disease mortality ratios is produced; using this figure a co-morbidity attuned age for the patient is generated. A probability of surviving 10 years is then formed, which is very specific for each patient. In this study we generated 70 paper patients with credible past medical history scenarios and asked four consultants, four registrars and two oncologists what percent chance of living to ten years they felt the patients had. The clinician’s figures were compared to the score predicted by our measure using Bland-Atman plots. RESULTS: Our results show that all clinicians were variable in their ability to determine LE. Most were good at predicting LE when LE was good, but most were inconsistent when predicted survival was poor. Using statistical analysis we determined that clinicians significantly overestimate LE when LE was low and underestimate LE when it is high. CONCLUSIONS: In general the clinicians studies were not good at predicting the life expectancy. With our tool, we propose to produce simple computer software enabling clinicians in a clinic setting to generate a rapid, accurate estimate LE using patient demographics and co-morbidity data and thereby improve quality of patient care.





PCOS8: ANALYSIS OF ASTHMA CARE AT PRIMARY CLINIC BASED ON NATIONAL INSURANCE DATABASE

Lee S1, Lee EK2, Park EJ2, Bae EY2, 1Sookmyung University, Seoul, South Korea; 2Korea Institute for Health and Social Affairs, Seoul, South Korea


OBJECTIVES: Asthma is a chronic inflammatory disease of the airway and the prevalence rate is increasing. As the burden of asthma to the society is significant due to the increasing hospital admissions and emergency visits, National Heart, Lung and Blood Institute (NHLBI, USA) and the World Health Organization (WHO) have developed comprehensive guidelines to help clinicians and patients make appropriate decisions about asthma care. The aim of study was to analyze the pattern of asthma prescriptions based on the national asthma guidelines for the patients visiting primary health care providers. METHODS: Prescription data for asthma were obtained from the Korean National Health Insurance claims database of January 2002. Ten percent of the primary health care providers were sampled based on their specialty areas, and 20% of the claim cases were randomly chosen. RESULTS: Study results showed that prescription rate for oral beta-2 agonists was 44.3%, and that for oral theophylline was 46.9%. Oral steroids were prescribed for the 28.2% of the claims. Utilization of inhalers was low for both bronchodilators (20.3%, inhaled beta-2 agonists), and steroids (8.4% inhaled steroids). Bronchodilators were more preferred to the long-term anti-inflammatory controllers among the primary health care providers. Prescription rate for antibiotics was 46.0% for asthmatic patients. Also gastrointestinal drugs were prescribed for 59.0%, antitussives 65.3%, antihistamines 25.3% and analgesics 29.4% respectively. CONCLUSION: This study presented that the prescribing pattern of the primary health care providers for the asthma was quite different from the national and international guidelines. More efforts need to be made to reduce the gap between the present pattern of asthma prescription and the guidelines.


PCOS9: SCREENING AND TREATMENT OF HYPERLIPIDEMIA IN WOMEN WITH OR AT RISK FOR CORONARY HEART DISEASE

Simonson JK1, Minta B2, 1Pfizer Inc, Astoria, NY, USA; 2Oxford Health Plan, White Plains, NY, USA


OBJECTIVE: The purpose of this review was to examine the quality of lipid management in women with coronary heart disease (CHD) or at risk for CHD. More
specifically, this review focused on cholesterol screening rates, treatment and LDL goal attainment in these high-risk patients. METHODS: Included for analysis were female patients enrolled in Oxford Health Plan with any of the following: 1) CHD; 2) other cardiovascular disease (CVD); 3) hypertension; and 4) age > 55 5) nicotine use. Patients were then reviewed for the presence of cholesterol screenings within the last 2 years, lipid panel results and whether or not they received cholesterol-lowering medications. RESULTS: There were 61,835 patients included for analysis; 23% had CHD, 9% had CVD, 42% had two or more CHD risk factors and 26% had only one CHD risk factor. Approximately 20-30% of patients lacked cholesterol screenings for the last 2 years, including patients with established heart disease, risk equivalents for CHD and risk factors for heart disease. Patients with target LDL levels <160 mg/dL and <130 mg/dL achieved goal at least two times more frequently than patients requiring LDL levels <100 mg/dL. Less than 25% of patients with CHD or CVD taking cholesterol-
lowering therapy actually achieved LDL goal. For CHD/CVD patients not receiving cholesterol-lowering therapy, 40% were not at LDL goal. CONCLUSION: Overall, cholesterol screening rates, treatment and LDL goal attainment appeared to require improvement. Very few female patients requiring primary prevention for CHD reached LDL goal on cholesterol treatment indicating potential adherence deficiencies or a necessity to improve cholesterol-lowering regimens. Many high-risk patients were not at LDL goal nor on cholesterol therapy indicating a need to initiate cholesterol management in these patients. Currently, targeted strategies to improve cholesterol adherence, screening and prescribing practices are being examined at Oxford Health Plan.





PCOS10: EVALUATION OF CLOPIDOGREL USE IN MEDICAL PATIENTS OF A GENERAL TEACHING HOSPITAL

Lee VW, Lau CC, Lau CS, Mo CL, Chan TY, The Chinese University of Hong Kong, Shatin, Hong Kong

OBJECTIVES: Clopidogrel is a new antiplatelet drug indicated for various cardiological and neurological conditions. However, its use is limited due to the high cost. In the year 2000/01, the total drug expenditure on clopidogrel (including both inpatient and outpatient uses) had risen from HK $300,000 (US$38,460) (1 US$=7.8 HK$) to
HK$ 1 million (US$128,205) which was 0.5% of the total drug expenditure for 2002/03. The current study was conducted at the Prince of Wales Hospital (PWH), which is a local public teaching hospital in Hong Kong. The aims of the study were to examine the prescribing pattern of clopidogrel at PWH, to determine the side effect profile of clopidogrel in Chinese patients and to analyze its cost for outpatient uses. METHODS: It was a retrospective study performed in patients who were prescribed with clopidogrel from April 2000 to November 2002. Only discharge prescriptions from the cardiology and neurology wards and prescriptions from Specialty Out-Patient Clinic were studied. Data collected included demographic data, indications, dosage, treatment duration, treatment plan, and side effects. RESULTS: A random sample of 96 patients was studied. Approximately 94% of cases were found to be appropriately prescribed according to the guideline in PWH. Clopidogrel was prescribed to 88% of patients to whom percutaneous coronary intervention (PCI) was planned. Seven percent of the use was for secondary prevention of cerebral vascular accident (CVA). Nine percent of patients experienced side effects. Skin rash (3.6%) and minor bleeding (3.6%) were the most common ones. Most cost was attributed to patients who had undergone PCI (47.6%) and patients with CVA (46.5%). CONCLUSION: In this drug use evaluation, use of clopidogrel at PWH was in general appropriate. Clopidogrel was well tolerated.


PCOS11: CHANGE IN CLINICAL STATUS AND FUNCTIONING OVER THE FIRST SIX MONTHS OF TREATMENT: RESULTS FROM THE SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES (SOHO) STUDY

Edgell ET1, Novick D1, Haro JM2, Wright P1, Ratcliffe M1, on behalf of the SOHO Study Group3, 1Eli Lilly and Company, Windlesham, UK; 2Centre De Salut Mental-Gavà, Sant Joan De Deu-SSM, Barcelona, Spain; 3Alonso J (ES), Gasquet I (FR), Kristensen H (DK), Jones PB (UK), Knapp M (UK), Lepine JP (FR), Mavreas V (GR), Murray D (IE), Naber D (DE), Pancheri P(IT), Slooff CJ(NL), Teixeira JM(PO)

OBJECTIVE: To describe changes in clinical and functional status over the first six months of treatment across antipsychotics in outpatient settings. METHODS: SOHO is a 3-year, prospective, outpatient, Pan-European, observational study. Mean change in positive, negative, depressive, and overall symptoms from baseline to six months as measured using Clinical Global Impressions–Schizophrenia (CGI-SCH) scale was assessed for patients enrolled in the SOHO study. Change in functional status was examined by comparing the proportion of patients socializing with friends and family at baseline and 6 months. RESULTS: Mean change in positive symptoms on the CGI-SCH range from -0.68±1.40 for quetiapine patients to -1.71±1.55 for 2+ atypical antipsychotics (AP) patients. Mean change in negative symptoms was greater for clozapine (-1.10±1.21) and olanzapine (-1.04±1.22) patients than other cohorts (ranged from -0.51±1.07 for depot typical agents to -0.97±1.43 for 2+ APs). Social functioning improved across all cohorts with the biggest improvements seen in olanzapine and clozapine. CONCLUSIONS: Substantial improvements in clinical status were seen from baseline to six months across all antipsychotics. Quetiapine patients experienced the smallest reductions in positive symptoms. Olanzapine and clozapine patients experienced larger reductions in negative symptoms, which may explain the greater improvements in social functioning compared with other cohorts.





PCOS12: THE TREATMENT OF SCHIZOPHRENIA ACROSS EUROPE: BETWEEN COUNTRY BASELINE DIFFERENCES IN SERVICE USE IN THE SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES (SOHO) STUDY

Haro JM1, Knapp M2, Fernandez J2, Novick D3, Edgell ET3, on behalf of the SOHO Advisory Board4, 1Centre de Salut Mental-Gavà, Sant Joan De Deu-SSM, Barcelona, Spain; 2Personal Social Services Research Unit, London School of Economics, Centre for the Economics of Mental Health, Institute of Psychiatry, London, UK; 3European Health Outcomes Research, Eli Lilly and Company, Windlesham, UK; 4Alonso J(ES), Gasquet I(FR), Kristensen H(DK), Jones PB(UK), Knapp M(UK), Lepine JP(FR), Mavreas V(GR), Murray D(IE), Naber D(DE), Pancheri P(IT), Slooff CJ(NL), Teixeira JM(PO)


OBJECTIVE: SOHO is a 3-year, prospective observational study of health outcomes associated with antipsychotic treatment conducted across 10 European countries (Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, and the United Kingdom). The aim of the study is to describe between country differences in service use for schizophrenia across Europe in the context of the Schizophrenia Outpatient Health Outcomes (SOHO) study. METHODS: Patients were enrolled in SOHO upon initiation of or change to a new antipsychotic in actual outpatient treatment settings. Service utilization patterns were examined within and between participating countries. The association of service use with a range of patient characteristics (age, gender, symptoms, quality of life, duration of illness, care history, etc.) was assessed. RESULTS: Total enrolment was 10,972 patients. Eight countries had sufficient enrolment for analyses. In the six-month period prior to the study, 33% of patients were admitted to hospital ranging from 17% in Greece to 40% in Germany. Day-hospital use was highest in Italy (39% of patients), and lowest in Greece (4%). The average number of outpatient visits in the 6 months prior to enrolment ranged from a mean of 4 visits in the United Kingdom to 13 visits in Germany. While strong associations between patient characteristics and utilization intensity were found, utilization differences among countries persisted after controlling for patient characteristics.
CONCLUSION: European countries show important differences in patterns of care for schizophrenia. The reasons behind these differences as well as their impact on long-term outcomes require examination. Policy makers would benefit from a better understanding of the pattern of schizophrenia care in Europe in order to improve the access to current delivery arrangements. Comparative data on resource utilization is an important factor for any future research on access to health care provision.




 
COST STUDIES

COST STUDIES -
ARTHRITIS



PCSA1: MEDICAL COSTS FOR CARE OF RHEUMATOID ARTHRITIS IN JAPAN

Mithal A1, Yamanaka H2, Tanaka EI2, Nakajima A2, Kamatani N2, 1Institute for Clinical Outcomes Research and Education, Woodside, CA, USA; 2Tokyo Women's Medical University, Tokyo, Japan

OBJECTIVES: Rheumatoid arthritis (RA) is among the most common rheumatic diseases in Japan. There are no large studies of costs of care of RA in Japan. We report results from the first and only large, long-term outcome study of RA in Japan.
METHODS: J-ARAMIS is a prospective non-interventional observational cohort study of consecutively enrolled patients with rheumatoid arthritis seen at the Institute of Rheumatology in Tokyo. Physician and patient self-report data on outcomes, medication use, adverse events and satisfaction with care is collected using the validated J-HAQ. Outpatient costs of care are calculated from billing records of IOR. Costs for hospitalizations are estimated by using a per-day cost of JPY 20,970 (based on "Survey of Medical Care Activities Public Health Insurances", Ministry of Health, Labor and Welfare, Japan, 2000). RESULTS: The J-ARAMIS program has averaged patient response rates of over 98% to date. A total of 5,666 patients have been enrolled, with a total observation time of 8489.5 patients-years. The average age is 56.4 years (SEM 0.17), with mean disease duration of 9.6 years (SEM 0.12). The mean Body Mass Index is 21.5 (SEM 0.07) and the average disability index is 0.75 (SEM 0.01), both significantly below the numbers seen in the Western countries. The average direct cost of medical care in RA patients is JPY 417,134 per year (SEM JPY 32040). Medications account for 55.4% of these costs, with laboratory and radiology investigations accounting for 22.5%, hospitalizations 13.9%, physician visits 7.2% and rehabilitation 1%. CONCLUSIONS: The medical costs of care of RA patients in Japan are similar to the previously published estimates from the US, but the distribution of costs is significantly different from that seen in the US. RA patients in Japan also have lower levels of disability compared to patients with similar levels of disease duration in the US.


PCSA2: MEDICAL COSTS ARE SIGNIFICANTLY ASSOCIATED WITH DISABILITY LEVELS IN RHEUMATOID ARTHRITIS IN JAPAN

Yamanaka H1, Mithal A2, Tanaka EI1, Nakajima A1, Kamatani N1, 1Tokyo Women's Medical University, Tokyo, Japan; 2Institute for Clinical Outcomes Research and Education, Woodside, CA, USA


OBJECTIVES: The costs of medical care of rheumatoid arthritis are likely to be a function of the disability level of the patient, since disability may be linked to more frequent utilization of health care resources. Aggressive early management of RA is likely to reduce disability and may produce significant costs savings. Yet, this relationship has not been adequately studied. METHODS: The J-ARAMIS program is a prospective non-interventional observational cohort study of consecutively enrolled patients with rheumatoid arthritis seen at the Institute of Rheumatology in Tokyo. Physician and patient self-report data is collected using the validated J-HAQ. Outpatient costs of care are calculated from billing records of IOR for each patient. Costs for hospitalizations are estimated by using a per-day cost of JPY 20,944 (based on "Survey of Medical Care Activities Public Health Insurances", Ministry of Health, Labor and Welfare, Japan, 2000). RESULTS: A total of 5666 patients (8489.5 patients-years of observation) have been enrolled in the J-ARAMIS program. The average age is 56.4 years (SEM 0.17), the disease duration 9.6 years (SEM 0.12). The mean Body Mass Index is 21.5 (SEM 0.07) and the average disability index is 0.75 (SEM 0.01), both significantly below the numbers seen in the Western countries. The average direct cost of medical care in RA patients is JPY 417,134 per year (JPY SEM 32040). After controlling for age, gender, disease duration and BMI, there was a strong association of total costs of care with the disability index (0 – 3, where 0 is no disability, 3 is completely disabled) (p<0.001).
For every unit increase in Disability Index, the costs of care increased by over 33%.
CONCLUSIONS: Disability level is a strong predictor of costs of care in patients with RA. A therapeutic agent which reduces disability substantially might prove less expensive over the long-term than an initially less expensive agent with little effect on disability levels.





PCSA3: COST IMPACT OF USING SPECIFIC CYCLOOXYGENASE II INHIBITORS IN ORTHOPEDIC OUTPATIENTS AT LERDSIN HOSPITAL

Phosri J, Kulsomboon V, Kiatying-Angsulee N, Chulalongkorn University, Bangkok, Thailand


OBJECTIVE: The purposes of this study were to characterize the pattern of Specific Cyclo-oxygenase Inhibitors (C2I) use, and to determine cost impact of C2I use among patients who were at low risk for gastrointestinal adverse events compared with Non-steroidal anti-inflammatory drug (NSAIDs) use at Lerdsin Hospital, the Special Institution for Orthopedics of Ministry of Public Health, Bangkok, Thailand. METHODS: Retrospective data from medical charts of patient receiving C2I or NSAIDs when visiting orthopedic outpatient clinic were reviewed. Data were collected during November and December 2002. Sample size of patients receiving C2I and NSAIDs was calculated based on the proportion of high and low risk of gastrointestinal adverse events from our pilot study. The National Institute for Clinical Excellence of the United Kingdom Guidances for C2I use was employed to determine whether the patients receiving C2I were at high risk. Drug cost was calculated based on drug acquisition cost. RESULTS: Of the 1113 patient medical records, which were reviewed, 40.1 % of 519 patients receiving C2I and 19% of 594 patients receiving NSAIDs were considered to be at high risk. Of the patients receiving C2I, 112 (21.6%) received C2I alone and 159 (30.6%) received gastro-protective agents in addition to C2I. Prescribing C2I among low risk resulting in excessive expenditure were 2.4 million Baht/year compared with NSAIDs in actual practice. Compared with each of the three highest volumes of NSAIDs used in the hospital (diclofenac, Voltaren ®, and ibuprofen 400 mg), excessive expenditures were 3.4, 1.7, and 3.2 million Baht/year, respectively. CONCLUSION: Cost impact of C2I use among patients who were at low risk for gastrointestinal adverse events compared with NSAIDs at Lerdsin Hospital was 2.4 million Baht/year. Because of the high cost impact of C2I use, it is necessary to employ clinical practice guideline for prescribing restriction in low risk patients.


PCSA4: COST-EFFECTIVENESS ANALYSIS OF SELF INJECTION VS AMBULATORY CARE OF ANTI-RHEUMATOID BIOLOGICS (ETANERCEPT)

Igarashi A1, Tsutani K2, Fukuda T1, Miyasaka N3, 1University of Tokyo, Bunkyo, Tokyo, Japan; 2University of Tokyo, Bunkyo-ku, Japan; 3Tokyo Medical & Dental University, Tokyo, Japan


OBJECTIVE: To compare economic value of two administration methods (self-injection and ambulatory care) of anti-rheumatoid biologics (etanercept) by application of cost-effectiveness analysis (CEA). METHODS: From societal perspective, we gathered cost data and outcome data. We developed decision tree model and applied Markov-model analysis. To estimate transitional probability, we used following data. Cost data: 1) direct cost: first visit fee and at-home care guidance fee (from health insurance fee schedule), drug costs (hypothetical costs - since etanercept is not admitted by Ministry of Health, Labor and Welfare (MHLW) yet), ambulatory cost (including transportation expenses. Data will be gained from "Rheumatoid tomonokai", RA patients organization in Japan) and teaching cost of self-injection. (To estimate teaching cost, we developed a questionnaire for health care provider); 2) indirect cost: productivity loss. (Gained from MHLW) Outcome data: ACR20 (gained from 3rd phase of clinical trial data of etanercept in the US) and safety issues subject to self-injection (delayed finding ADR, accidentally impale needles to other people, and so on. Data will be gained from case report form (CRF)) as this is short-time analysis, we did not apply discount rate. We applied sensitivity analysis on 1) incidence of ADR; 2) safety data; and 3) indirect costs.




COST STUDIES - CANCER


PCSC1: THE COST- EFFECTIVENESS ANALYSIS OF BONE MARROW TRANSPLANTATION COMPARED WITH CONVENTIONAL CHEMOTHERAPY IN JAPAN

Nakahara N1, Yanagisawa S1, Kamae I1, Masaoka T2, 1Kobe University, Kobe, Japan; 2Osaka Medical Center for Cancer and Cardiovascular Diseases, Hospital, Osaka, Japan


OBJECTIVE: To assess the cost-effectiveness of bone marrow transplant (BMT) compared with conventional chemotherapy on leukemia, malignant lymphoma, multiple myeloma, and children solid tumors in Japan. METHODS: We reviewed direct medical costs in 3 years for BMT undertaken in domestic clinical trials with 40 patients (26 adults and 14 children). Additional data for costs, including probabilities, were employed from published literature in Japan. A decision analytic model with decision trees was used to estimate the average direct medical cost in three years. Regarding therapeutic effectiveness, we used the Declining Exponential Approximation of Life Expectancy (DEALE) method to estimate the expected life years of survival. The cost estimation included the direct medical cost and the mortality cost. Sensitivity analyses were performed to test the results. RESULTS: As a result of review, the average costs in 3 months associated with the domestic clinical trials were estimated to be JPY\ 6,072,866 for adults and JPY\ 5,276,643 for children with respect to BMT. Consequently, the total costs in 3 years with the decision analytic model were estimated as JPY\ 26,760,804 per patient for BMT and JPY\ 23,296,564 per patient for chemotherapy. The life expectancies were 6.28 years per patient for BMT, whereas 4.25 years per patient for chemotherapy. The cost-effectiveness ratios (cost per life year gained) were JPY\ 4,261,274 for BMT in contrast with JPY\ 5,355,532 for chemotherapy. Since the incremental cost was JPY\ 3,464,240 comparing BMT with chemotherapy, the incremental cost-effectiveness ratio was eventually estimated to be JPY\ 1,794,943. CONCLUSION: The cost-effectiveness analysis was conducted based on the cost data in Japan. It is concluded that BMT was more cost-effective than conventional chemotherapy.


PCSC2: THE COST OF ILLNESS OF HEPATOCELLULAR CARCINOMA IN TAIWAN

Liu CY, Lin CY, National Health Research Institutes, Taipei, Taiwan


OBJECTIVE: Hepatocellular carcinoma (or HCC, Hepatoma) has been the first leading causes of death in Taiwan for recent years. HCC patients need similar treatment options (e.g., chemotherapy, radiotherapy, surgery°Ketc.), and generally require long-term medical care. This study, based on the evidences of National Health Insurance (NHI) database, evaluates the cost of illness (CoI) of HCC in Taiwan. METHOD: We analyzed the 2001 NHI data whose ICD-9-CM codes equal to 155.0, which stand for primary liver carcinoma. We calculated the CoI of HCC from two main cost sources: outpatient and inpatient. We calculated the outpatient CoI from four cost sources (including the cost of drugs, treatment, diagnosis and drug services), and the inpatient CoI from 17 cost sources (including the cost of surgery, beds, diagnosis, drugs, administrations°Ketc.). Also, we applied Cochran-Mantel-Haenszel (CMH) test to test the independence between gender and ages on HCC CoI. RESULTS: From the contingency table between gender and ages on HCC CoI, we may see the males who are 50-54 years old, males who are 35-39 years old and males who are over 65 years are the first 3 high HCC CoI groups. According the CMH statistics, the gender and ages are independent on HCC CoI (CMH p-value<0.0001) and the HCC CoI of males is significantly higher than females. The HCC CoI occupied the Taiwanese GNP about 1.41% in 2001. CONCLUSION: The three high HCC CoI groups could be a reference for further HCC clinical research about high HCC risk objectives. The HCC CoI evaluation can be a good index to show the state of the art of HCC treatment in Taiwan.





PCSC3: THE COST EFFECTIVENESS OF IMATINIB FOR THE TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOURS

De Abreu Lourenco R, Wonder M, Novartis Pharmaceuticals Australia Pty Ltd, North Ryde, NSW, Australia

OBJECTIVE: Imatinib is a novel targeted therapy that has shown high early efficacy in patients with unrespectable and/or metastatic malignant c-kit positive gastrointestinal stromal tumors (GIST). Allocation of health care resources to its use in this indication depends in part on its cost-effectiveness. We evaluated the cost-effectiveness of imatinib versus no active therapy for the treatment of patients with GIST. METHODS: Data on the use of imatinib in patients with GIST were drawn from an ongoing phase II study. Data for similar patients who received no active treatment were obtained from a separate retrospective review. A Markov modeling approach with monthly cycles for a period of ten years was used. Continuing treatment with imatinib depended on an absence of disease progression. Transition rates for death (both patient groups) and disease progression (imatinib group) were based on those observed for the two groups. Costs of treatment included drug therapy (imatinib group) and medical and hospice care (both groups) for surviving patients. Costs and benefits were discounted at 5% p.a. All costs were stated in AUS$ at 2003 prices. All analyses were conducted from the perspective of the Australian health care system. RESULTS: Reported median survival for untreated patients with advanced GIST is 18.9 months. After a median of 25 months of follow-up, 78% of patients treated with imatinib were still alive. It was estimated that treatment with imatinib offers, on average, an additional 3.0 years of survival (discounted), at an incremental lifetime cost of a $168,229 per patient. The cost per life year gained was estimated to be a $56,376 (discounted). CONCLUSION: The cost per life year gained of treatment with imatinib of patients with GIST is consistent with what has previously been accepted as cost-effective. Further analysis of imatinib’s cost-effectiveness is recommended as longer term survival data become available.


PCSC4: COST EFFECTIVENESS ANALYSIS OF TESTING FOR HER2 OVEREXPRESSION USING FISH IN METASTATIC BREAST CANCER

Nonaka A1, Fukuda T2, Ohashi Y1, 1University of Tokyo, Bunkyo-ku, Japan; 2University of Tokyo, Bunkyo, Tokyo, Japan


OBJECTIVE: Two most commonly used tests for HER2 overexpression in metastatic breast cancer are immunohistochemistry(IHC) and flourescene in situ hybridization(FISH). For the proper use of trastuzumab, it would be ideal to analyze the level of HER2 expression by FISH. We performed an economic evaluation of using FISH for testing for the presence of HER2 overexpression in metastatic breast cancer patients, through cost effective analysis comparing the only-IHC, only-FISH, and combined IHC and FISH methods. METHODS: We compared costs and effectiveness in six scenarios by using the decision tree model; “Doing HER2 testing only by FISH” (scenario 1), “Doing HER2 testing only by IHC” (scenario 2) (“patients with IHC3+ are considered to have HER2 overexpression” (scenario 2-1), “patients with IHC3+/2+ are considered to have HER2 overexpression” (scenario 2-2)), “Doing HER2 testing by IHC, and for patients that were not found to have HER2 overexpression by IHC, doing HER2 testing by FISH” (scenario 3). (HER2 testing by FISH was done for the patients “that were scored as IHC2+” (scenario 3-1), “that were scored as IHC2+/1+” (scenario 3-2), “that were scored as IHC2+/1+/0” (scenario 3-3). For the six scenarios we estimated the expected cost, the expected effectiveness(median time to progression) and the incremental cost effectiveness ratio. RESULTS: The expected cost and expected effectiveness of scenario 1 were larger than those of scenario 2 and scenario 3. The incremental cost effective ratio of scenario 1 was higher than that of scenario 3-1 and that of scenario 3-2. CONCLUSION: It is suggested that HER2 testing by only FISH is not necessarily cost-effective at present. This information is considered to be beneficial on therapy selection for metastatic breast cancer patients.




COST STUDIES - CARDIOVASCULAR DISEASE


PCSCD1: COST-EFFECTIVENESS OF STATINS AFTER REVISION OF NCEP ATPIII: COMPARISON BETWEEN ATORVASTATIN AND SIMVASTATIN

Cheng CW, You JH, The Chinese University of Hong Kong, Hong Kong, China

The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) was updated in 2002. The effects of the revised guidelines on lipid profile control in clinical setting are yet to be determined. OBJECTIVE: To investigate the cost-effectiveness of statins in patients with high risk for coronary heart disease (CHD) from the perspective of a public health organization. METHODS: A retrospective cohort study was conducted at the outpatient clinics of a teaching hospital in Hong Kong. Statins were only prescribed to those patients with a 10-year CHD risk > 20 % or CHD risk equivalent per hospital policy. Patients newly started on atorvastatin or simvastatin from 1 October to 31 December 2002; with documented baseline lipid profile and at least one lipid profile measurement done before March 31, 2003 were identified. Costs per member per month (PMPM) was estimated from the costs of drug, clinic visit and lipid profile tests. Clinical outcomes assessed were low-density lipoprotein (LDL) reduction and the rate of target LDL achieved per NCEP ATPIII. Cost-effectiveness ratios were calculated from PMPM and rate of target LDL achieved. RESULTS: The medical records of 56 patients were reviewed. Nineteen patients were started on atorvastatin while 37 patients were started on simvastatin. Mean PMPM cost of atorvastatin was HK$700 ± 199 (1 USD=7.8 HKD); and that of simvastatin was HK$856 ± 476 (p=0.092). Average LDL reduction by atorvastatin was 1.9 ± 0.8 mmol/L; and that by simvastatin was 1.3 ± 0.9 mmol/L (p=0.038). Rate of goal achieved was 68% for atorvastatin and 62% for simvastatin (p=0.651). The cost (per patient per month) per patient achieved target LDL for atorvastatin and simvastatin were HK$1023.78 and HK$1376.41, respectively. CONCLUSIONS: Atorvastatin appears to be more cost-effective than simvastatin as a lipid-lowering monotherapy in high CHD risk patients, with lower cost and improved outcomes.


PCSCD2: ASSESSMENT OF THE INCIDENCE OF DVT IN ASIA FOLLOWING MAJOR ORTHOPAEDIC SURGERY (THE AIDA STUDY): COST OF MANAGEMENT IN 6 ASIAN COUNTRIES: AN INTERIM ANALYSIS

Lee K, Piovella F, Turpie A, Planes A, Wang C, Lee W, Houshan L, Lee L, Perdriset G, Rouillon A, Nguyen T, Gallus A, The Chinese University of Hong Kong, Hong Kong, China

OBJECTIVE: The incidence of post-operative venous thromboembolism (VTE) events - deep vein thrombosis (DVT) and pulmonary embolism (PE)- is traditionally thought to be low in Asia and the routine use of thromboprophylaxis remains controversial. The primary objective of the AIDA study was to assess the incidence of DVT after orthopedic surgery without prophylaxis. The pharmacoeconomic part aimed to estimate the cost of illness of VTE in the six Asian participating countries (Indonesia, Korea, Malaysia, Philippines, Taiwan and Thailand). METHODS: Patients who underwent major orthopedic surgery in 8 study hospitals had a post-operative bilateral venography. All direct medical costs associated with the management of DVT and/or PE including hospitalization, medications, laboratory tests, procedures and clinic visits were recorded and adjusted to 2002 USD. Costs were determined from the hospital perspective. RESULTS: A total of 407 patients were enrolled in the study. In the interim analysis, based on 103 patients who completed the 3-month follow-up, 47 patients had a radiological DVT according to the local evaluation. In Indonesia, Korea and Malaysia, hospitalization stay appeared to be the major cost driver constituting 37.2%, 63.7% and 63.1% of the overall cost, respectively. A higher percentage was spent on medications to treat DVT in the Philippines (77.7%) than in other countries. Four cases of PE were identified in Korea, Thailand and Taiwan. The cost of PE represented a major part of the overall VTE cost in Thailand and Taiwan, increasing by three-fold compared to DVT costs. CONCLUSION: Distribution of cost items amongst countries greatly varied depending on the healthcare system and medical care (no/no no). In some countries, significant amount of resources were consumed by patients who developed DVT or PE, the no-prophylaxis strategy therefore could have the potential of incurring extra healthcare cost.





PCSCD3: COST-MINIMIZATION ANALYSIS IN HYPERTENSION WITH CORONARY ARTERY DISEASE BASED ON JAPAN MULTICENTER INVESTIGATION FOR CARDIOVASCULAR DISEASE DATA: NIFEDIPINE RETARD VERSUS ACE-INHIBITOR

Fujikawa K1, Yui Y2, Kawai C2, Jmic B3, 1Bayer Yakuhin Ltd, Osaka, Osaka, Japan; 2Kyoto University Hospital, Kyoto, Kyoto, Japan; 3JMIC-B Investigators, Kyoto, Kyoto, Japan


OBJECTIVES: The major objective in treating hypertension is to reduce the risk of cardiovascular complications. Despite increasing societal interest in the cost-effectiveness of hypertension therapy, no pharmacoeconomic analysis, based on large-scale clinical data, has been conducted in Japan. In this study, we conducted an economic analysis based on the results of the Japan Multicenter Investigation for Cardiovascular Diseases (JMIC) study, the first large-scale clinical trial in hypertensive Japanese patients with coronary artery disease, in which 1888 patients were randomly assigned to nifedipine retard or an angiotensin converting enzyme inhibitor (ACEI) for 3-years of follow up. METHODS: The results of the JMIC study demonstrated that the incidence of cardiac events, including cardiac mortality, did not differ significantly between nifedipine retard and ACEI therapy (Relative risk 1.05, 95% CI 0.81-1.37, p=0.70). Based on this result, we conducted a cost-minimization analysis by estimating the drug cost associated with hypertension treatment, from the perspective of insurers. RESULTS: The mean dose of nifedipine retard administered during the JMIC study period was 31.9} 10.7 mg (mean} standard deviation), while the ACEI used were enalapril (5.3} 2.5 mg), captopril (39.4} 17.9 mg), or lisinopril (9.9} 3.9 mg). The total cost to treat hypertension, including concomitant medications, was lower with nifedipine retard than with an ACEI (156,000 yen/patient/3 years, and JPY 174,000/patient/3 years, respectively). MonteCarlo simulation indicated that nifedipine retard therapy would be cost saving in 85% of cases, if used as the first line therapy. CONCLUSIONS: The results of this study indicate that hypertension treatment using nifedipine retard is cost-effective compared to ACEI, i.e., lower health care costs and similar effectiveness. Potential savings to the overall drug budget in Japan, from the wider use of nifedipine retard to manage hypertension with coronary artery disease, are more than JPY 10 billion over 3 years.


PCSD4: THE COST-EFFECTIVENESS OF IRBESARTAN IN THE TREATMENT OF HYPERTENSIVE PATIENTS WITH TYPE 2 DIABETIC NEPHROPATHY IN CHINA AND TAIWAN RESEARCH

Nguyen T1, Palmer A2, Yang WC3, Annemans L4, Hou C5, 1Sanofi, Gentilly, Paris, France; 2CORE Center for Outcomes Research, Basel, Switzerland; 3National Yang-Ming University, Taipei, NA, Taiwan; 4University of Ghent, Meise, Belgium; 5Sanofi, Shanghai, China

OBJECTIVES: Macroalbuminuria is very common among hypertensive diabetic patients in Taiwan and China, with respective figures of 30% and 17%. In the Irbesartan in Diabetic Nephropathy Trial (IDNT), a 3-year treatment with irbesartan demonstrated a 23% and 20% reduction compared to amlodipine and control, respectively, in the combined endpoint of doubling of serum creatinine (DSC), end-stage renal disease (ESRD) or death in patients with type-2 diabetes, hypertension, and overt nephropathy (T2DHN). A Markov model was developed to project the health consequences and long-term costs of IDNT in Taiwan and China. METHODS: The model simulated progression from nephropathy to DSC, ESRD and death in T2DHN patients with baseline age 59 years (mean age in IDNT). Treatment-specific progression and mortality probabilities were derived from IDNT. Management and cost of ESRD were obtained from published local sources. A variable time horizon up to 20 years was used, discounting future costs and effects at 3% per year. Univariate and probabilistic sensitivity analyses were performed. RESULTS: In Taiwan, predicted improvements with irbesartan in life expectancy, on average per patient, were 0.421 years versus amlodipine and 0.573 years versus control after 20 years. In China, respective figures were 0.175 to 0.403, given lower reported mortality rates from ESRD. Irbesartan was associated with cost savings per patient of US$5,496 and US$1,166 in Taiwan, and US$19,385 and US$9,581 in China, versus amlodipine and control respectively. The larger savings in China are explained by the larger yearly cost of dialysis (US$31600 versus US$18300 in Taiwan). Break-even occurred respectively after 6 and 4 years in Taiwan and China. Results were robust under a wide range of assumptions, even with 20% less mortality and 20% reduced cost while on dialysis. CONCLUSIONS: Treating T2DHN patients with irbesartan is cost saving and extends life expectancy compared to amlodipine and control.





PCSCD5: FACTORS ASSOCIATED WITH USE OF EMERGENCY DEPARTMENT SERVICES IN ELDERLY PATIENTS WITH CONGESTIVE HEART FAILURE

Chen G, Teuschler H, Wake Forest University Health Sciences, Winston-Salem, NC, USA

OBJECTIVE: Congestive heart failure (CHF) affects more than 4 million Americans with 550,000 new cases reported each year. It is a leading cause of death, morbidity, and use of acute care services among elderly patients. There are little studies that investigate use of emergency department (ED) in elderly patients with CHF. This study examines factors associated with use of emergency department in elderly patients with CHF. METHOD: Using claims data of Medicare Current Beneficiary Survey (1998), 1252 elderly patients aged 65 years or older with CHF (ICD-9-CM code=428.xx) were identified. The use of emergency department (ED) was measured by number of ED visits. The claim data were linked with MCBS survey data to get information on patient socio-demographic characteristics, self-perceived health status, co-existing medical conditions and other factors. A multivariate count regression model was used in the analysis. RESULTS: Of 1252 patients, 61% were female; 87% were white; and 59% were current smokers. The average number of ED visits was 0.27 per patient (SD=0.66). There were 20% of the patients who had at least one emergency department visits. The results from the multivariate regression model shows that patients who had higher ED use were current smokers, poor in self-perceived health status, living in non-urban area, with difficulties in activity of daily living, and having cardiovascular diseases. Gender, race, education, living arrangement, Medicaid insurance status were not significant factors to predict ED visits while controlling other factors. CONCLUSION: The study shows smoking cessation and improvement management of CHF patients in non-urban areas may reduce preventable ED visits.

COST STUDIES -
DIABETES


PCSD1: COST OF TYPE 2 DIABETES CARE IN AUSTRALIA – THE DIABCOST STUDY

Davey P1, Colagiuri S2, Conway B3, Grainger D4, Colagiuri R5, Graham-Clarke P6, FitzGerald P1, Le Reun C7, Price N1, 1M-TAG Pty Ltd, Chatswood, NSW, Australia; 2Prince of Wales Hospital, Sydney, NSW, Australia; 3Diabetes Australia Ltd, Canberra, ACT, Australia; 4Eli Lilly Australia Pty Ltd, Sydney, NSW, Australia; 5Australian Center for Diabetes Strategies, Sydney, NSW, Australia; 6Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 7MTAG Pty Ltd, Chatswood, NSW, Australia


OBJECTIVES: The primary objective of the DiabCost study was to determine the cost of type 2 diabetes in Australia. Additional objectives were to collect data on quality of life, health service use and indirect costs for people with type-2 diabetes, and to improve understanding of the burden on careers. METHODS: A paper-based questionnaire was used to collect cross-sectional survey data. Approximately 25,000 questionnaires were mailed to people from a national diabetes database and responses were received from 10,652 people. Respondents were asked to self-report three months’ retrospective data. Questions covered demographic information, health status (including history of microvascular and macrovascular complications), health service utilization, cost to people with diabetes, lost productivity and quality of life (using the EQ-5D instrument). A separate questionnaire filled in by careers covered carer burden. Costs were derived from numerous public sources such as government reimbursement schedules, hospital cost reports, drug price lists and government pension rates. RESULTS: The mean annual cost per individual with type-2 diabetes was a $7565. These comprised direct costs of AUS$5325 (including AUS$4261 in health care and AUS$1064 in non health care costs), self-reported indirect costs of AUS$94 (comprising AUS$32 in lost patient wages and AUS$62 in lost carer wages) and AUS$2146 in career costs. The overall cost of type-2 diabetes in Australia is predicted to be AUS$3.1 billion. CONCLUSIONS: type-2 diabetes impacts significantly on affected individuals and their careers. It also has a significant impact on Australia’s health care expenditure.


PCSD2: ECONOMIC BURDEN OF TREATING TYPE 2 DIABETES AND ITS COMPLICATIONS IN URBAN CHINA

Chen X1, Tang L1, Tan AW2, Zhao PL3, Hu S1, 1Fudan University, Shanghai, China; 2Glaxo SmithKline, Shanghai, China; 3ISIS Research Co, Shanghai, China

OBJECTIVE: To evaluate the economic burden of treating T2DM and it’s complications in urban China in 2002. METHODS: A prospective study involving 200 endocrinologists filling 4000 diabetes patient diary forms and over 1000 direct patient interviews. The cost components included direct medical, direct non-medical and indirect costs per patient year leading to cost per capita income and household income. Patients were divided into four broad categories according to their diabetic complication; no complications, only microvascular complications, only macrovascular complications and both microvascular and macrovascular complications. RESULTS: The total medical cost was RMB 23.38 billion per year (US$2.83 billion), the direct medical cost is RMB 18.75 billion (3.94% of China healthcare expenditure), the direct non-medical cost is RMB 2.28 billion, the indirect cost is RMB 2.35 billion. Diabetes prevalence rate was 4.8% in urban China with only 30% are diagnosed of which 40% are being treated. 46.7% of patients had no complication, 53.3% had at least one complication, and with 13.3% having macrovascular only, 22.3% having microvascular only and 17.7% having both microvascular and macrovascular complications. The annual direct medical cost of patient with complications was 3.71 times compared to those without complications but increased by up to 10.35 times for patients with both complications. CONCLUSION: T2DM and its complications create a heavy economic burden on the patient and society. Diabetic complications account for approximately 80% of the total direct medical cost. Reducing diabetic complications is the key to reducing cost for treating T2DM.





COST STUDIES -
INFECTIOUS DISEASES


PCSID1: COST UTILITY ANALYSIS OF HEMODIALYSIS AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS IN END STAGE RENAL DISEASES PATIENTS IN THAILAND

Cheawchanwattana A1, Limwattananon C1, Tangcharoensathien V2, Sirivongs D1, Pongskul C1, Limwattananon S1, 1Khon Kaen University, Khon Kaen, Thailand; 2International Health Policy Program, Thailand, Nonthaburi, Thailand

OBJECTIVE: To determine lifetime costs and outcomes in term of quality-adjusted life-years (QALYs) for patients with end stage renal diseases who received renal replacement therapy either hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD). METHODS: Cost utility analysis of HD and CAPD used Markov model with one-year cycle. Data on direct medical costs and utilities were derived from results of the studies conducted in Thailand, and effectiveness was abstracted from the 2002 annual data reported by U.S. Renal Data System (USRDS). Both costs and outcomes occurring in the future were discounted at 3% per year. RESULTS: For HD and CAPD, lifetime costs per patient were Baht 4.54 million (US$106,619) and Baht 5.36 million (US$125,892); life expectancy was 3.16 and 3.59 years; and QALYs were 1.28 and 1.42 years, respectively. An incremental cost-effectiveness ratio (ICER) of CAPD as compared with HD was Baht 1.90 million (US$44,677) per life year saved and Baht 6.15 million (US$144,666) per QALY. By adding direct non-medical costs and indirect costs, ICER of CAPD decreased to Baht 1.00 million (US$23,553) per QALY. Adding costs associated with treatments due to complications, ICER increased Baht 1.31 million (US$30,780) per QALY for every Baht 10,000 (US$235) of the higher cost of CAPD. When the utility of HD was greater than CAPD by 0.10, CAPD became economically dominated by HD. CONCLUSION: CAPD was slightly more effective than HD in term of QALY, ICER of CAPD as compared with HD were beyond US$100,000 per QALY, which was considered not very cost-effective technology.


PCSID2: COST-BENEFIT OF PARENTERAL-ORAL DRUG SWITCHING INTERVENTIONS FOR HOSPITALIZED PATIENTS

Muenpa R1, Limwattananon C1, Limwattananon S1, Tangcharoensathien V2, 1Khon Kaen University, Khon Kaen, Thailand; 2International Health Policy Program, Thailand, Nonthaburi, Thailand

OBJECTIVE: To determine the optimal weekly work schedule for pharmacist’s medication review on potential parenteral-oral drug switching that maximizes the net benefit per intervention. METHODS: Medication charts of patients over one year of age who were prescribed intravenous (IV) drugs in a tertiary care hospital were reviewed prospectively by two clinical pharmacists during a 14-day period in 2003. Candidates for the switching were identified for detailed drugs and dosage regimens used. Net benefits were calculated based on potential savings due to the difference in costs between IV and oral drugs minus the labor cost of pharmacist man-hours. Detailed daily cost information was used to simulate models for five patterns of weekly work schedule.
RESULTS: Of a total of 8825 patient-days of medication chart reviews, 37.0% was
prescribed for the targeted IV drugs. According to the switching guideline, 308 patients were identified as the candidates for parenteral-oral drug switching. The switching candidates accounted for 878 patient-days of prescribed drugs, which were 26.9% of the cases with IV drugs. The IV antimicrobials were prescribed most frequently (51.0%). The rest was antisecretory drugs, antiepileptics, and steroids. Most switching candidates were admitted to surgery wards (45.1%) and medical wards (26.6%). Potential net cost savings during 14 days of pharmacist’s review accrued to the total of Baht 157,430. The net benefits per month estimated by a simulation of various work schedules were Baht 98,504 for the 7-day a week schedule; Baht 80,454 for the 5-workday schedule; Baht 79,960 for the three-day a week schedule; Baht 59,738 for the twice a week schedule; and Baht 37,008 for the once a week schedule. CONCLUSION: The parenteral-oral drug switching intervention by pharmacist’s prospective medication chart review is a cost-saving program. The net benefit is maximized when the pharmacist works in the patient care wards on a daily basis.





PCSID3: THE IMPACT ON PHARMACEUTICAL COST OF HEALTH INSURANCE COVERAGE AMONG CHRONIC HEPATITIS B (CHB) INPATIENTS

Dong Z, Guan Z, National Institute For Social Insurance, P. R. China, Beijing, Beijing, China


OBJECTIVES: With 10% of the population infected by hepatitis B virus (HBV), hepatitis B is the top infectious disease in China. It is estimated that pharmaceutical cost accounts for about 60% of the medical cost for CHB. This study aims to analyze the possible differences in the amount and composition of the pharmaceutical cost between insured and uninsured CHB inpatients. METHODS: We examined 549 inpatient medical records of CHB from hospitals in Beijing, Harbin and Mudanjiang. The time spans from 1999 to 2002. We studied following variables: general information, health insurance status, occupation, state of illness (symptom, physical sign, and complication), usage of pharmaceuticals, prices of pharmaceuticals, etc. The samples were divided into two groups according to different disease states: compensated cirrhosis group and decompensated cirrhosis group. RESULTS: Pharmaceutical cost accounts for 68% of the total inpatient cost. In the comp. cirr. group, the pharmaceutical cost per insured patient is 87% higher than that of noninsured patient, while in the decomp. cirr. group, pharmaceutical cost per insured patient is twice as high as that of noninsured patient. The average hospital stay is 37 days in insured compared with 23 days in noninsured. There is no difference in average daily pharmaceutical cost between the insured and noninsured in the comp. cirr. Group, while in the decomp. cirr. group, the daily pharmaceutical cost of insured is 31% higher than that of noninsured. The frequency of using high-cost medicines in the insured is also significantly higher than that in the noninsured. CONCLUSIONS: Health insurance coverage does have influences on the costs of pharmaceuticals among CHB inpatients. The influences lie in the following three aspects: extending hospital duration, increasing daily cost and enhancing the frequency of using high cost medicines.


PCSID4: COST-EFFECTIVENESS ANALYSIS OF PEGINTERFERON ALFA-2B PLUS RIBAVIRIN FOR NAIVE PATIENTS WITH CHRONIC HEPATITIS C IN TAIWAN

Tarn Y, Tang S, National Defense University/National Defense Medical Center, Taipei, Taiwan

OBJECTIVE: To provide cost-effectiveness evidence among: 1) no antiviral treatment; 2) interferon £\-2b (IFN) 3MU, plus ribavirin (RBV) >10.6 mg/kg/day; 3) peginterferon £\-2b (PEG-IFN) 1.5 £gg/kg, plus RBV >10.6 mg/kg/day for 24 weeks for the treatment of patients with Chronic Hepatitis C. METHODS: A two-year decision-tree modeling technique was used. Direct medical costs were collected using local physician practice patterns and reimbursed price. Outcome measure was sustained virological responder gained. RESULTS: For overall genotyping, the 2-year average costs of IFN a-2b plus RBV therapy was US$ 3859. The efficacy data from Taiwan indicated that for overall genotyping, the sustained virological response (SVR) of IFN a-2b plus RBV and PEG-IFN a-2b plus RBV was 63.6% and 67.1%, respectively. In genotype-1 patients the data was 41.0% and 65.8%, and in genotype 2/3 patients it was 86.8% and 68.4%, respectively. The efficacy data were different between Taiwan and international society. The study used the incremental cost of US$ 12,500 per sustained virological responder gained (ICER) as the criterion for judging the cost effectiveness. In Taiwan, for overall patients or differentiate between genotype 1 or 2/3 patients, combination therapy for 24-week all showed cost-effective than no antiviral therapy. In genotype-1 and for overall patients, PEG-IFN combination therapy for 24 weeks showed cost-effective than IFN combination therapy; however, in genotype 2/3 patients, IFN combination therapies for 24 weeks showed cost-effective than PEG-IFN combination therapy. For patients with good drug compliance, both combination strategies showed cost effectiveness. From overall patients, the data indicated that PEG-IFN/IFN cost ratio may reaches 4, and in genotype 1 patients, the cost ratio may reaches 9 could still have ICER value less than US$12,500. CONCLUSION: PEG-IFN plus RBV treatment modality is a cost-effective strategy for the treatment of naïve patients with chronic hepatitis C, especially type-1 patient.




 
PCSID5: COST OF MANAGEMENT OF HEPATITIS B AND ITS COMPLICATIONS IN HONG KONG CHINESE

Lee K, Lee V, Kwong K, Wong I, Kung N, Leung W, Chan H, Chan F, Sung J, The Chinese University of Hong Kong, Hong Kong, China


OBJECTIVE: Hong Kong, with a population close to 7 million, is an endemic area for hepatitis B virus infection (HBV) with about 10% of the population estimated as carrier. The cost of management of chronic hepatitis B (CHB) can therefore be an enormous burden to the healthcare budget, yet few studies have been performed to assess its potential impact. The present study aims to estimate the direct medical cost in the management of HBV and its complications from a public health organization's perspective. METHOD: The medical history of 488 patients with HBV who received medical services over 5 years from 2 major public hospitals in Hong Kong - Prince of Wales Hospital and United Christian Hospital, were studied. Cost items included hospitalization, professional fees, medications, investigational procedures, surgeries, clinic visits etc. Costs were analyzed according to five disease states: CHB, compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC) and liver transplantation (LT). All costs were calculated in 2000 values. RESULTS: Per patient total annual cost increased with the severity of the disease - from HK$6,318 (US$810) for CHB, HK$10,304 (US$1,321) for CC, HK$58,428 (US$7,490) for DC to HK$121,822 (US$15,618) for HCC. Each case of LT was estimated to cost HK$514,498 (US$65,961). Based on local epidemiological data and assuming 50% of the CHB patients were symptomatic, the estimated total cost of management of HBV in Hong Kong was HKD2.6billion (USD3.3M) per year, or about 4% of the 2000-01 actual government healthcare expenditure. The average annual medical cost per patient in this population was HKD3,600 (US$462), with 68% attributable to hospital stay, which therefore appears to be the major cost driver. CONCLUSION: This study confirms HBV and its complications are a significant burden to the healthcare budget of Hong Kong. Public awareness should be enhanced. Slowing disease progression to the more advanced and costly health states should be cost saving.

 
PCSID6: TOTAL MEDICAL COSTS OF HEPATITIS B IN KOREA

Yang BM1, Kim JY1, Kim CH2, 1Seoul National University, Seoul, South Korea; 2Inje University Seoul Paik Hospital, Seoul, South Korea


OBJECTIVE: Hepatitis B (HBV) infection is endemic in Korea. 5.79-10.87% of males and 1.51-4.44% of females aged over 20 years are carriers of HBV (Ahn YO, 1999) and it is estimated that 25% of carriers will develop serious complications of HBV (Zuckerman A, 1997). Even under government vaccination programs, there will be significant morbidity due to HBV for the next 15-30 years until the real benefit of the vaccination programs take effect. METHODS: We estimated the direct medical costs for chronic infection, compensated cirrhosis; decompensated cirrhosis, hepatocellular carcinoma, liver transplant, and liver transplant after first year were estimated. We used four sources of information for treatment patterns and annual quantities of resources used: the National Health Insurance Corporation (NHI) database, a sampling of patients' medical charts, expert opinion, and patient survey data. RESULTS: HBV related morbidity and mortality are a significant cost burden to the Korean healthcare system. The study results showed that in 2001, the total medical costs of six HBV related disease states were US$208.6m. Annual treatment costs per patient for the six disease categories ranged from KRW297, 392 (Korean Won) for chronic HVB, (equivalent to US$248), to KRW80, 587,018 for transplantation (equivalent to US$67,156). The cost of treatment rose continuously with disease progression. The decompensated cirrhosis and carcinoma categories consumed a large amount of resources as well. Among service types, the main cost driver was hospital days (including surgery). CONCLUSION: The results suggest that successful prevention of HBV infection, as well as effective treatment, will help to considerably save economic resources in the future. These economic benefits could be augmented if disease progression is prevented or delayed among those currently infected, not to mention the obvious gain of improved health for the infected. Such developments, among many others, will provide substantial clinical and economic benefits to the whole Korean society.





PCSID7: COMPARISON OF TREATMENT COSTS FOR AIDS PATIENT RECEIVING AND NOT RECEIVING TRIPLE ANTIRHETROVIRAL THERAPY AT BUMRASNARADOON HOSPITAL, THAILAND

Kulsomboon V1, Thanaviriyakul S1, Pinyowiwat V2, 1Chulalongkorn University, Bangkok, Thailand; 2Ministry of Public Health, Nonthaburee, Thailand


OBJECTIVE: Triple antirhetroviral therapy (ARV) has been demonstrated to be cost-effective and is widely accepted as standard treatment for HIV/AIDS. Because of the substantial costs of ARV and the high prevalence of HIV in Thailand, it was necessary to compare the treatment costs of patients receiving and not receiving ARV before the Thai government would include ARV for their Universal Health Coverage Program. METHODS: Retrospective data from medical charts of AIDS patients receiving and not receiving ARV were reviewed during July - November 2002. For the ARV group, only the patients treated with triple ARV more than one year were included. One-year treatment costs including medication, laboratory, and hospital admission and out patient department (OPD) costs were analyzed and compared. RESULTS: The average annual treatment cost for the 93 patients in the ARV group was Baht 87,168
(US$2,075), which was 7.9 times greater than the average cost of the 91 patients in the non-ARV group (US$264). The average ARV drug cost per day was Baht 223.5
(US$5.3). ARV drug costs contributed 93.6% to the overall treatment of the ARV group. For the non-ARV group, the major cost was hospital admission and OPD costs, which were 97.5% of treatment costs. Although hospital admission and OPD costs of the ARV group was only 6.4% of those in the non-ARV group, saving these costs in ARV group could not compensate the ARV drug cost. CONCLUSIONS: Cost of ARV drug did not out weight cost saving from hospital admissions and OPD costs. Only a decrease in ARV costs could improve patients’ access to ARV. A one dollar per day triple ARV, GPO-VIR®, produced by the Thai government might lead to government subsidization of ARV for all AIDS patients in Thailand.


PCSID9: COST OF MANAGEMENT OF HEPATITIS B AND ITS COMPLICATIONS IN CHINA
Guan Z, Dong Z, National Institute For Social Insurance, P. R. China, Beijing, Beijing, China


OBJECTIVES: With 10% of the population infected by hepatitis B virus (HBV), hepatitis B is the top infectious disease in China. The direct medical cost of CHB was totaled to CNY 26 billion in 2001, accounting for 5.5% of the total national medical expenditure. This study aims to estimate the direct medical cost in the management of HBV and its complications. METHODS: We made a retrospective study by investigating medical records of 868 patients with CHB in two prestigious hospitals in Beijing -- Peking University First Hospital and Cancer Institute & Hospital, Chinese Academy of Medical Sciences. The information spans 3 years, from 1999 to 2002. We studied the items including hospital duration, professional fees, medications, laboratory tests, surgeries, clinic visits etc. The samples were divided into four groups according to different disease states: chronic hepatitis B (CHB), compensated cirrhosis (CC), decompensated cirrhosis (DC) and hepatocellular carcinoma (HC). RESULTS: The samples comprise 207 patients with CHB, 133 with CC, 252 with DC and 276 with HC, 49.8% of them coming from Beijing and 50.2% coming from other provinces of China. The average annual treatment cost increases according to the severity of the disease: CNY1173.46 (US$142.24) for CHB, CNY1527.16 (US$185.11) for CC, CNY14038.09 (US$1701.59) for DC, and CNY39109.28 (US$4740.52) for HC. Compared with the annual income per capita CNY4560 (US$553) in China, or CNY12464 (US$1511) in Beijing, the disease really brings economic burden to the patients. CONCLUSION: Chronic HBV and its complications bring about a significant financial burden to the patients, as well as to the national health budget. More attention should be paid to the prevention and treatment of the diseases.





PCSID10: A COST ANALYSIS OF CHRONIC HEPATITIS B INFECTION & ITS ASSOCIATED COMPLICATIONS IN SINGAPORE

Ong SC, Lim SG, Yeoh KG, Li SC, National University of Singapore, Singapore, Singapore


OBJECTIVES: To estimate the direct treatment cost for patients with chronic hepatitis B (HBV) infection and the associated complications, including cirrhosis (compensated & decompensated), hepatocellular carcinoma (HCC) and liver transplantation (LT). METHODS: Relevant diagnostic data were collected from medical and financial records of HBV infected patients at the National University Hospital, the major hospital in Western Singapore. Each patient was followed up to five years. Clinical data collected included clinical diagnosis, laboratory investigations, ultrasound, and CT and liver biopsy results. Medical resource utilisation considered included the cost of consultation, outpatient care, medication, inpatient stays, and surgery and laboratory tests. The treatment costs due to chronic HBV infection and its related complications were specifically differentiated from those due to other medical conditions. Costs were annualized according to the years of follow up. In the estimation of every resource used, the cost was calculated by multiplying annual frequency and cost per item. The total annual direct cost for each patient (at 2003 value) was obtained by summing up all the defined items. RESULTS: During the data collection period (October 2002 until early April 2003), the case notes of 157 patients (116 chronic HBV, 13 compensated cirrhosis, 5 decompensated cirrhosis, 3 HCC, and 20 LT) were evaluated. The estimated average annual treatment cost of the different categories of patients was: chronic HBV: Sing$718.15 (range: $80.11-$4,690.05); compensated cirrhosis: Sing$1,194.79 (range $316.60-$2,203.60); decompensated cirrhosis: Sing$13162.55 (range: $7065.40-$25,638.80); and HCC: Sing$6628.97 (range: $4580.41-$8819.91) For LT cases, the estimated average cost during the hospitalization of the LT procedure only was Sing$73,673.10 (range: $47,435.48-$186,708.56) CONCLUSION: The results show that chronic HBV infection and its associated complications impose a significant financial burden to the health care system in Singapore. These data would provide valuable information for healthcare planners and providers in the management of HBV infection especially in the area of allocating resources.


PCSID11: MONTE CARLO SIMULATION FOR COST COMPARISON OF INFLUENZA VACCINATION TOWARD SCHOOL-AGED CHILDREN IN JAPAN

Cai L1, Nakajo K1, Nishimura K2, Yanagisawa S1, Aino H1, Inoue H1, Kamae I1, 1Kobe University, Kobe, Japan; 2Harvard University, Boston, MA, USA

The strategy toward influenza vaccination is currently on individual-initiated basis in Japanese school. Although our former analysis on the issue suggested mandatory vaccination in Japanese school has substantial cost savings, there still exist controversies on the alternatives for the vaccination. OBJECTIVE: Using multivariate analysis with the Monte Carlo simulation, we evaluate cost-consequences of the controversial strategies for influenza vaccination to compare with no vaccination for healthy school-aged children in Japan. METHOD: A cost-consequence analysis was performed by decision analytic modeling using data from the literature. The decision tree was employed to make a healthy school-aged child facing the alternatives toward influenza: 1) individual-initiated voluntary vaccination; 2) mandatory vaccination in school; or 3) no vaccination. Direct costs such as medical cost for vaccination, physician visits, and treatments were taken into account including indirect costs as lost productivity of the parents burdened by taking care of their children. The multivariate analysis in use of the Monte Carlo simulation was performed to compare the total cost of each scenario with that of no vaccination consequence. RESULTS: Considering two covariates, i.e., vaccination effect and prevalence of influenza, the analysis was able to make us reconfirm the similar conclusion as the suggestion in the past study that the total cost of mandatory scenario had a marginal saving of US$50 (JY6000) comparing with the voluntary one. The results were quite robust towards multi-way sensitivity analysis in the computer simulation. CONCLUSION: Mandatory policy for influenza vaccination for school-aged children is favorable with substantial cost savings in the societal perspective of Japan.





PCSID13: THE COST COMPARISON OF VALACICLOVIR AND ACICLOVIR FOR THE TREATMENT OF HERPES ZOSTER IN IMMUNOCOMPETENT PATIENTS OVER 50 YEARS OF AGE IN JAPAN


Nakahara N1, Yanagisawa S1, Kamae I1, Miyazaki H2, Kawashima M3, 1Kobe University, Kobe, Japan; 2Juntendo University, Tokyo, Japan; 3Tokyo Women's Medical University, School of Medicine, Tokyo, Japan

OBJECTIVE: To assess the cost-consequence of Valaciclovir (VACV) compared with Acyclovir (ACV) in immunocompetent patients aged 50 years or older with herpes zoster in Japan. METHODS: The cost-consequence analysis was conducted based on the published analytical model developed in UK. Clinical outcomes data were employed from the results of a phase III trial, pivotal, double blind randomized with VACV vs. ACV for 7 days of medication. Direct medical costs and indirect costs were estimated based on clinical data collected in hospitals in Japan, and on statistical data published by the Japanese Ministry of Health, Labor and Welfare. Direct medical costs consist of drug acquisition costs for the antiherpes and pain relief agents, visits to special physicians, hospitalizations, severe ocular complications and costs of treating long-term pain mainly due to post herpes zoster neuralgia (PHN). Indirect costs were also estimated as lost earnings for patients still in paid employment. In addition to discounting of 5% for cost data, sensitivity analyses were performed to test the results. RESULTS: For the baseline case, total direct medical costs per patient were JPY 261,058 for ACV and
JPY 197,941 for VACV, representing a cost saving of JPY 63,117 (24.2%) for treatment with VACV. The mean work days lost were equivalent to a saving of JPY 7,839 (25.0%) across all patients including those who are not employed. The total saving for treatment including indirect costs with VACV was JPY 70,956 (24.3% of total costs) compared with ACV. CONCLUSION: Seven day VACV treatment of acute herpes zoster is cost saving compared with 7-day ACV treatment in terms of direct medical costs and productivity losses in days impaired by PHN. It is strongly suggested that the advantage of prophylactic treatment for PHN with VACV should be emphasized not only in clinical effect but also socioeconomic impact.


PCSID14: PERTUSSIS VACCINATION IN ADOLESCENTS: COSTS AND CONSEQUENCES OF NEW PROPOSED VACCINATION PROGRAMMES IN FOUR CANADIAN PROVINCES

Iskedjian M1, Walker J2, De Serres G3, Hemels MEH4, Maturi B1, Einarson T4, 1PharmIdeas Research and Consulting Inc, Oakville, ON, Canada; 2Brock University, St. Catharines, ON, Canada; 3Direction de sante publique de Quebec, Beauport, QC, Canada; 4University of Toronto, Toronto, ON, Canada


OBJECTIVES: Despite frequently causing serious illness in adolescents, immunization programmes against pertussis have been restricted to children <7. We estimated the economic impact of introducing a booster dose of acellular pertussis vaccine in four Canadian provinces (Manitoba, Ontario, Québec, and Saskatchewan) using different vaccination schedules. METHODS: We conducted a cost-effectiveness analysis using a predictive spreadsheet model with adolescent’s aged 12 (cohorts of 17,400; 144,000; 88,000; and 16,000) over a 10-year horizon, from provincial Ministry of Health (MoH) and societal perspectives. For Québec, costs and benefits of adding acellular pertussis to combined diphtheria-tetanus vaccine (DacPT) in schools were compared to the current practice [diphtheria-tetanus vaccine (DT) only]. In Ontario, we assumed the new vaccine would be administered in school, compared to DT in physicians’ offices. In Manitoba and Sakatchewan, all vaccinations would be done in school, compared to 80%-90% presently. Efficacy and utilization data (vaccination, managing pertussis infection and hospitalization) were derived from the literature. Productivity loss of
parents and older adolescents was estimated. Standard cost lists were used (CAD$),
discounted at 3%. RESULTS: MoH perspective: the expected additional cost of DacPT/adolescent >10 years ranged from $3.98 (Ontario) to $10.57 (Québec);
incremental cost-effectiveness ratios ranged from $127-$337/case avoided. Societal
perspective: 10-year results ranged from $6.66 savings to an incremental cost of $7.47/adolescent. Manitoba and Saskatchewan results fell between those of Ontario and Québec. CONCLUSION: This study suggests that administering a booster dose of DacPT at age 12 may reduce the burden of program implementation was lower in Ontario than other provinces, assuming additional savings by shifting vaccine administration from physicians to schools.

COST STUDIES -
MENTAL HEALTH


PCSMH1: TREATMENT OF CHRONIC REFRACTORY SCHIZOPHRENIA WITH ATYPICAL ANTIPSYCHOTIC AGENTS - A COST-UTILITY ANALYSIS

You JH1, Law FL2, Ng FS2, 1The Chinese University of Hong Kong, Hong Kong, China; 2Tai Po Hospital, N.T, Hong Kong, Hong Kong


OBJECTIVES: Atypical antipsychotic agents such as risperidone and olanzapine have better side effect profiles comparing to typical antipsychotics. The atypical agents also improve the patients' quality of life. The present study was to compare the quality-adjusted life-years (QALYs) gained by risperidone and olanzapine and the corresponding cost in treating patients with chronic schizophrenia who are refractory or intolerant to typical antipsychotics from the perspective of a public health organization. METHODS: Medical records of patients with chronic refractory schizophrenia were reviewed retrospectively over one year. Utilization of healthcare resources and the proportion of outpatient time during treatment with olanzapine or risperidone were retrieved. The utility scores ranging from 0 to 1 of two statuses of schizophrenia, inpatient and outpatient, were rated through a survey conducted on 71 nurses and physicians who have been working at the psychiatric unit for at least 1 year by the method of Standard Gamble. The direct medical cost and QALYs gained by risperidone and olanzapine were estimated. RESULTS: Fifty patients' medical records were reviewed. Olanzapine was administered for 26.2 patient-years and risperidone was administered for 10.0 patient-years. The percentages of outpatient-time were 56% and 51% for patients receiving olanzapine and risperidone, respectively. The utility score of the outpatient status was 0.53 while the inpatient status score was 0.49. It was estimated that it cost HK$324, 283 (1US$=7.8HK$) per QALY gained for olanzapine and HK$ 336,482 per QALY gained for risperidone. CONCLUSION: Olanzapine appeared to dominate risperidone for the treatment of chronic refractory schizophrenia from the perspective of a Hong Kong public health organization.


PCSMH2: THE COST OF TREATING ANXIETY: THE MEDICAL AND DEMOGRAPHIC CORRELATES THAT IMPACT TOTAL MEDICAL COSTS

Marciniak MD1, Lage MJ2, Bowman L1, Landbloom R1, Dunayevich E1, Levine L1, 1Eli Lilly and Company, Indianapolis, IN, USA; 2HealthMetrics Outcomes Research, L.L.C, Groton, CT, USA


OBJECTIVE: The purpose of this retrospective, multivariate analysis is to examine how medical conditions and demographic characteristics affect the cost of treating individuals diagnosed with anxiety. METHODS: Data from MarketScan Databases® were used to identify individuals with new episodes of anxiety. Multivariate analysis was used with the dependent variable being the log of total medical costs. This analysis controlled for demographic characteristics, medical comorbidities, type of anxiety, and prior resource utilization. A smearing estimate is used to calculate the total medical costs for all anxiety patients (AAP), GAD, Panic Disorder (PD) and PTSD. RESULTS: Results indicate that the total medical costs for AAP is $6,474.72, GAD $4,025.86, PD $3,772.71, and PTSD $6,231.24. The multivariate model indicates that controlling for demographics and other disease states, GAD, PD, and PTSD result respectively in a 42%, 37%, and 77% increase in the total medical costs associate with AAP (p<0.0001). The incremental impact of depression, other anxiety disorders, and prior mental health diagnoses on the total medical costs were 38%, 37%, and 30% respectively (p<0.0001).
CONCLUSION: Individuals with the highest costs, and therefore the greatest need for intervention, are anxious patients with depression, other common anxiety diagnoses, and comorbid medical conditions.





PCSMH3: THE COST OF ANXIETY DISORDER TO EMPLOYERS: A CASE-CONTROL STUDY

Marciniak MD1, Lage MJ2, Landbloom R1, Dunayevich E1, Bowman L1, 1Eli Lilly and Company, Indianapolis, IN, USA; 2HealthMetrics Outcomes Research, L.L.C, Groton, CT, USA

OBJECTIVE: The purpose of this retrospective, case-control study is to examine the medical and productivity costs for individuals who have been diagnosed with anxiety. METHODS: This study uses an employer database that collected medical, absenteeism, short-term disability, and worker compensation records during 1999 from 6 major employers. Patient diagnosed with anxiety disorder (based on ICD-9 codes of 300.0, 300.00, 300.01, 300.02 or 300.21) (N=601) were matched at a 1:2 ratio to patients not diagnosed with anxiety disorder (N=1202) based upon age, sex, and metropolitan statistical area. Chi-square and t-statistics were used to compare the anxiety population to the control group. RESULTS: Employees diagnosed with anxiety disorder are significantly more likely to have additional diagnoses, use more medical and psychiatric services and are more likely to be hospitalized or visit the emergency room compared to the control group. Furthermore, employees diagnosed with anxiety disorder have significantly higher medical costs ($5447 vs. $2344; p<0.0001), productivity costs ($2366 vs. $1438; p<0.0001) and total costs ($7813 vs. $3782; p<0.0001) compared to the control group. CONCLUSION: Results indicate employed individuals diagnosed with anxiety disorder have significantly higher medical and productivity costs. Further examination of costs attributed to anxiety disorder and those resulting from comorbidities is warranted.


PCSMH4: COMPARISON OF COST-EFFECTIVENESS BETWEEN
ESCITALOPRAM, CITALOPRAM, FLUOXETINE, SERTRALINE AND VENLAFAXINE FOR THE TREATMENT OF DEPRESSION IN THE UNITED KINGDOM


Wade AG1, McCrone P2, Anderson I3, François C4, Muldoon C5, Rikke Jørgensen T6, 1CPS Clinical Research Centre, Glasgow, United Kingdom; 2Institute of Psychiatry, London, United Kingdom; 3University of Manchester, Manchester, United Kingdom; 4H. Lundbeck A/S, Paris, France; 5Lundbeck Group Limited, Milton Keynes, United Kingdom; 6H. Lundbeck A/S, Copenhagen- Valby, Denmark

Major depressive disorder (MDD) is a major public health issue. A Japanese community study showed prevalence as high as 20% compared to 17.1 % in the UK. MDD is largely under-diagnosed and under-treated in Japan as well as in Europe. Selective serotonin reuptake inhibitors (SSRIs) are effective treatment options for MDD. Given the scarcity of health resources, the evaluation of a new drug is not solely based on efficacy and safety, but also on its cost-effectiveness versus standard alternatives. OBJECTIVES: To assess the cost-effectiveness of escitalopram versus generic citalopram and fluoxetine, sertraline and venlafaxine in the treatment of depression in the United Kingdom. METHODS: A two-path decision analytic model with a 6-month horizon was used. Patients start on the primary path, and can be referred to specialist care on the secondary care path. Model inputs include drug-specific probabilities from comparative trials data, database analysis, the literature, and a panel of experts. The main outcome measure is success (remission), and costs of treatment (total and drug costs). RESULTS: The expected success rate was 62.7% for escitalopram, compared to 57.6% for citalopram, 57.6% for fluoxetine, 57.4% for sertraline and 60.0% for venlafaxine. Average expected total direct costs per patient were lower for escitalopram (£518) compared to generic citalopram (£579), generic fluoxetine (£591), venlafaxine (£585) and sertraline (£625). Budgetary impact shows a decrease in total Healthcare Budget estimated at £68 million 5 years after the introduction of escitalopram. CONCLUSION: Escitalopram can be considered to be the most cost-effective treatment alternative and