Arthritis

AR1
COST-UTILITY ANALYSIS OF LINGZHI AND SEN MIAO SAN FOR THE TREATMENT OF RHEUMATOID ARTHRITIS

Lee VWY, Lee KK, Li EK, Chu KY, Law CL, Ng TM, Tam LS
The Chinese University of Hong Kong, Shatin, Hong Kong, China

OBJECTIVE: To evaluate the utilization of Lingzhi & Sen Miao San on the Quality of Life in Chinese Rheumatoid Arthritis (RA) patients in economic aspect. METHODS: This project consisted of 2 part of study including a 24-week double-blinded, placebo controlled clinical trial and a retrospective, observational cost utility analysis comparing adjunctive therapy of Lingzhi and Sen Miao San with placebo to the traditional treatment was performed in Chinese RA patients for 24 weeks. Cost utility was analyzed to calculate net cost per quality-adjusted life year (QALY) gained in two treatment models. The Chinese (HK) version of the SF-36 health survey questionnaire was used to study the quality of life and preferences of the patients. Patient compliance was assessed. RESULTS: 59 patients with RA were included (83% female, median age 49 years old). In the 24-week study period, no significant difference was found on the quality-adjusted life years gained between Lingzhi and placebo treatment arms. The median treatment cost of placebo arm was HK$ 8, 096.54, and that of Lingzhi arm was HK$ 15, 542.70, which was significantly higher (p<0.001). The cost per QALY gained between both treatment arms did not show significant difference. CONCLUSIONS: This study did not show any significant differences between two treatment arms. However, Lingzhi is a generally safe, well-tolerated herbal medicine that may have potential benefits on RA patients. This study can be regarded as pioneer to pave way for further clinical studies with longer study duration, larger sample size to demonstrate the full effect of Lingzhi.


AR2
WHAT HEALTH DOMAINS & ITEMS ARE IMPORTANT TO PATIENTS WITH KNEE OSTEOARTHRITIS? A FOCUS GROUP STUDY IN A MULTIETHNIC URBAN ASIAN POPULATION

Xie F1, Li SC1, Fong KY2, Lo NN2, Yeo SJ2, Yang KY2, Thumboo J2
1National University of Singapore, Singapore, Singapore, 2Singapore General Hospital, Singapore, Singapore

OBJECTIVE: To determine important health-related quality of life (HRQoL) domains and items within each domain affected by knee OA, and identify ethnic variations in the importance of these domains and items among three ethnic groups in a multiethnic urban Asian population in Singapore. METHODS: Focus groups were conducted among subjects with knee OA categorised by gender, ethnicity, and language spoken. All focus groups were audio-taped and transcribed verbatim, with subsequent translation into English for groups conducted in other languages. Data analysis was performed by combining the key elements of grounded theory and content analysis with the assistance of the qualitative software ATLAS/ti 5.0. RESULTS: Five domains (pain, physical disability, other symptoms of OA, mental health, and social health) were identified from the 74 items reported as important by at least one subject. These domains were important for subjects from all ethnic groups with the exception of social health, which was more often important for Malay subjects. Items more commonly reported as important in the pain, physical disability, and other symptoms of OA domains were generally similar across ethnic groups, In contrast, important items in the mental and social health domains differed among ethnic groups. CONCLUSIONS: The impact of knee OA on HRQoL is broadly similar in both Asian and Western socio-cultural contexts. Both similarities and differences in important domains and items were identified among subjects with knee OA from 3 major Asian ethnic groups.

AR3
COST-EFFECTIVENESS ANALYSIS OF CELECOXIB ON AN AVOIDANCE OF GASTROINTESTINAL EVENTS IN PATIENTS WITH OSTEOARTHRITIS

Limwattananon S, Limwattananon C, Srisuk P, Loengpirom S
Khon Kaen University, Amphoe Muang, Khon Kaen, Thailand

OBJECTIVE: To determine whether the use of celecoxib instead of a conventional non-steroidal antiinflammatory drug (NSAID) combined with either histamine-2 receptor antagonists (H2RA) or proton pump inhibitors (PPI) is cost-effectiveness in reducing gastro-intestinal (GI) side effects. METHODS: Expected values of effectiveness in terms of number of GI events avoided and health care cost in Thai Baht (40 Baht = 1 USD) were estimated for a six-month time horizon using a decision analysis model. An incremental cost-effectiveness ratio (ICER) for celecoxib was determined based on health care provider perspective. Data on the likelihood of GI disturbance for celecoxib and NSAID were obtained from Celecoxib Outcomes Measurement Evaluation Tools (COMET) study. Components of direct health care costs associated with the use of celecoxib and NSAID comparators were based on Thai health care context using a gastro-enterology expert opinion. Unit prices for the competing drugs were abstracted from electronic drug dispensing databases of 18 provincial hospitals located in all four regions of Thailand. RESULTS: For a reference case analysis, use of celecoxib instead of NSAID (diclofenac) plus H2RA (ranitidine) in 1000 hypothetical patients would incur an incremental cost of approximately 4.6 million Baht and reduce a total of 40.2 events of any GI side effects. This is equivalent to the ICER of 114,975 Baht per GI event avoided for celecoxib. Compared with NSAID plus PPI (omeprazole), ICER for celecoxib was as much as 948,611 Baht for an event avoided, equivalent to an incremental cost of 3.4 million Baht for lowering 3.6 GI events in 1,000 patients. These cost-effectiveness ratios were very sensitive to the unit price of celecoxib and GI-event risk categories. CONCLUSIONS: Use of celecoxib in Thailand was deemed not cost-effective unless concerned parties were willing to pay such a high amount for avoiding any GI events caused by the conventional NSAID.

AR4
ABATACEPT LEADS TO RAPID AND SUSTAINED IMPROVEMENTS IN MULTIPLE ASPECTS OF QUALITY OF LIFE IN RHEUMATOID ARTHRITIS PATIENTS WITH INADEQUATE RESPONSES TO METHOTREXATE

Li T1, Becker JC1, Emery P2
1Bristol-Myers Squibb, Princeton, NJ, USA, 2University of Leeds, Leeds, United Kingdom

OBJECTIVE: Health-related quality of life (HRQOL) and the ability to function in daily activities are significantly impaired in patients with rheumatoid arthritis (RA). Improving physical function and well-being is an important treatment goal for RA. The effects of a biologic agent, abatacept, on patient HRQOL were examined in a Phase III trial, AIM (Abatacept in Inadequate responders to Methotrexate [MTX]). METHODS: AIM was a 1-year, double-blind, placebo-controlled trial evaluating a fixed dose of abatacept versus placebo on a background of methotrexate (MTX). Study drugs were given by monthly IV administration. A battery of pre-specified measures on multiple aspects of HRQOL were assessed: general quality of life including both physical and mental health by the SF-36, physical function by the Health Assessment Questionnaire (HAQ), and sleep quality by the Medical Outcomes Study Sleep Module (MOS-sleep), and fatigue by a 100 mm Visual Analog Scale. Analysis of covariance adjusting for baseline value was used to compare the treatment groups. RESULTS: In this study, 433 and 219 patients were treated with abatacept and placebo respectively. After 1 month of treatment, significant greater improvements from abatacept were observed in 5 out of 8 SF-36 subscales (bodily pain, role physical, general health, vitality, and social functioning) and fatigue compared to placebo. By 6 months, significant differences in favor of abatacept were seen in all HRQOL measures: physical function (HAQ), all 8 subscales of the SF-36, PCS and MCS, sleep quality, and fatigue. The improvements were deemed to be clinically meaningful using established criteria. The effects were sustained and further improved to the end of the study at 1 year. CONCLUSION: Abatacept demonstrated significant and consistent improvements in a broad range of HRQOL dimensions. These data suggest abatacept has the potential to provide real-life benefits to RA patients.

Cardiovascular Disease

CV1
CHOLESTEROL GOAL ATTAINMENT AMONG CHD PATIENTS IN HONG KONG

Lee VWY1, Alemao E2, Yin D2, Cook J3, Lee KK1
1The Chinese University of Hong Kong, Shatin, Hong Kong, China, 2Merck and Co, Whitehouse Station, NJ, USA, 3Merck and Co, Blue Bell, PA, USA

OBJECTIVE: While treatment guidelines recommend lowering cholesterol to target levels appropriate for CHD patients, many remain above goal on current lipid lowering therapy and hence unable to get the maximum benefit of cholesterol reduction. For these patients, a recently published clinical trial showed that ezetimibe co-administration with existing statin therapy gets 72% of patients to NCEP II goal versus 19% among patients continuing on existing therapy. The objective here is to assess cost effectiveness of Ezetimibe 10mg (EZ10) co-administration in CHD patients not attaining goal (LDL-C > 2.59mmol/dL) while on statin therapy (atorvastatin, and simvastatin). METHODS: Decision-analytic model was developed to project lifetime costs and benefits of lipid therapy. Clinical trial data were used to estimate LDL-C reductions for different treatment strategies. Effect of lipid reductions on CHD event rates was estimated using Framingham risk equations and Hong Kong national statistics on nonCHD-related mortality. Direct costs of CHD events and prices for lipid lowering therapy in Hong Kong were used to project lifetime costs. The model was run for a population consisting of all patients on simvastatin and atorvastatin in an observational lipid lowering treatment study in Hong Kong involving patients initiated on a statin and had not reached goal at the first lipid measurement after treatment. RESULTS: Mean age of study cohort of 67 CHD patients was 64.7 (SD10.8) years and 30% were female with mean LDL-C of 3.23mmol/L and TC of 4.85mmol/L. EZ10 co-administered with statin compared to statin titration is projected to increase life expectancy in this patient cohort by 0.45 years with C/LY of $7,387 and C/QALY of $7,362. CONCLUSIONS: Based on the model, treatment with ezetimibe co-administered with statin for CHD patients not at goal is a cost-effective alternative to statin titration and is well below the $45,000 cost/QALY threshold commonly used in these analyses.

CV2
LOW-HDL CHOLESTEROL IN SOUTH ASIAN POPULATION, IS IT A MAJOR CONTRIBUTING RISK FACTOR FOR HIGH CORONARY HEART DISEASE

Pathan AN, Syed SH
Pfizer Laboratories Limited, Karachi, Sindh, Pakistan

OBJECTIVE: Cardiovascular disease is a leading cause of death in developing countries including India & Pakistan. Steady increase in affluence, urbanization, sedentary lifestyle associated with lipid abnormalities, metabolic syndrome and smoking appear to offer additional explanations. Risk factor studies have shown that urban Pakistanis have high triglycerides and low HDL-Cholesterol levels but these findings are inconclusive. The present study was undertaken to investigate the changes in lipid profile in this population. METHODS: A retrospective meta-analysis of relevant English articles retrieved by key word searches of Pfizer Local Intranet, Google, Medline, Medscape, CPSP, JPMA, PJMS, IHJ (January 1995 to date) and cited references. Only ten of the ninety-nine studies evaluated met the following inclusion criteria: (1) Prospective cohort study including clinical trial on South Asian Subjects with age-range 20-72 years. (2) measuring lipid profile HDL-C, LDL-C, TGs & TC. (3) not using adjuvant antihyperlipidemic drugs. Simple statistical calculations were done. Values were expressed as Mean + SD. Differences among different groups were tested using Student's t-test. RESULTS: Of the 3986 subjects, Mean + SD concentrations of total cholesterol, HDL-Cholesterol, LDL-Cholesterol, and triglycerides were found to be 185.31 + 3.83 mg/dl (p<0.0001), 39.26 + 0.86 mg/dl, 121.82 + 15.42 mg/dl, and 141.08 + 2.98 mg/dl (p=0.014), respectively. Serum triglycerides were seen significantly high in patients with hypertension 195.61 + 8.91 (p<0.0001) and raised in diabetic & CHD patients 175.48 + 18.01 & 157.26 + 86.99 respectively but not statistically significant. Similarly HDL-Cholesterol was seen significantly low in patients with CHD, hypertension & diabetes mellitus, 36.01 + 1.99 (p=0.02, CI 35.94 – 36.07). CONCLUSIONS: High levels of serum triglycerides & low levels of HDL-Cholesterol are the most prominent abnormalities that may contribute to the higher prevalence of coronary heart disease in South Asian Population.

CV3
DISEASE MANAGEMENT: IMPACT ON USAGE OF EVIDENCE-BASED MEDICINES FOR THE TREATMENT OF HEART FAILURE; HEALTHCARE UTILISATION AND CLINICAL OUTCOMES IN PATIENTS ENROLLED IN THE NHG HEART FAILURE DISEASE MANAGEMENT PROGRAMME

Tan HN1, Ng K2, Wong LM1, Cheah J1
1National Healthcare Group, Singapore, Singapore, 2The Heart Institute @Tan Tock Seng Hospital, Singapore, Singapore

OBJECTIVE: This retrospective study aims to investigate the impact of disease management on:a) increasing awareness among clinicians to prescribe evidence-based medicines for the treatment of heart failure (HF); b) reducing healthcare utilisation; and c) improving clinical outcomes, for patients enrolled in the NHG Heart Failure Disease Management Programme. METHODS: HF patients with LVEF < 50% and/or documented diastolic dysfunction, and who fulfilled the inclusion criteria were recruited into the Programme. These patients received education and close monitoring by case managers, through telemanagement and follow-up at HF Clinic. The rate of prescription for ACE Inhibitors (ACEI)/ARB and beta-blockers were tracked at regular intervals after the implementation of the Programme. Average length of hospital stay (ALOS), percentage of outlier episodes, average outlier days, and cost per inpatient episode were compared in patients who were enrolled in the Programme and those who were not. Analysis was also conducted on the rate of improvement in patients' clinical outcomes 6 months after their enrolment into the Programme. RESULTS: A total of 1313 patients were enrolled into the Programme from October 2002 – June 2005. Interim evaluation revealed an upward trend in the usage of ACEI/ARB from 88.9% in March 2003 to 93.8% in June 2005, while beta-blocker usage remained constant (79.0% and 77.6% respectively). Patients who were managed in a disease management programme achieved better results than patients who were managed in the usual manner, in: a) ALOS (4.7 days versus 5.3 days); b) Percentage of Outlier Episodes (6.6% versus 9.0%); c) Average Outlier Days (6.8 days versus 7.0 days); and d) Cost per Inpatient Episode (12.6% lower). 76.7% of the patients showed improvement in their NYHA Class Status, 6 months after enrolment. CONCLUSIONS: Disease management has proven to be an effective approach in the management of HF patients in the National Healthcare Group, Singapore.


CV4
LONG-TERM COST-EFFECTIVENESS OF CLOPIDOGREL IN ACUTE CORONARY SYNDROMES – CURE MODEL TAIWAN ADAPTATION

Tarn TH
Taipei City Hospital, Taipei, Taiwan, Lin WA
National defence medical center, Taipei, Taiwan

OBJECTIVE: The CURE trial established that adding clopidogrel to standard therapy (including aspirin) provides a 20% relative risk reduction in the composite outcome of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndromes (ACS). The purpose of this analysis was to assess the long-term cost-effectiveness of adding clopidogrel to aspirin in Taiwan using the CURE trial results. METHODS: A cost-effectiveness analysis was conducted from the societal perspective and incremental cost-effectiveness ratios (ICER) were estimated using a long-term Markov model. Outcomes data were derived from the CURE trial and resource use data were collected locally: hospital costs and length of stays (LOS) were obtained from the inpatient expenditure by admissions claimed in the Bureau of National Health Insurance (BNHI) database between 1999 and 2001; drug costs were obtained from the Taiwan Pharmaceutical Benefit Scheme (2000); and indirect costs were estimated by multiplying the LOS (days) by the mean daily Taiwanese salary obtained from the Taiwanese government. Cost-effectiveness was expressed in terms of costs (New Taiwanese Dollars) per life-year gained (LYG). (1Euro≈NTD39.5). RESULTS: The base-case model resulted in a longer survival in the clopidogrel on top of aspirin strategy compared to the aspirin alone strategy (9.77 LYG vs. 9.65LYG; incremental LYG=0.117). The model also yielded higher direct costs (NTD252,011 vs. NTD248,344; incremental cost=NTD3,666) and lower indirect costs for the clopidogrel on top of aspirin strategy (NTD1,011 vs. NTD1,264; incremental cost=-NTD253). The resulting total ICER for the clopidogrel on top of aspirin strategy was 29,133NTD/LYG (≈ 737 Euros). This estimate is comparatively lower than estimates from Sweden (1,365Euros/LYG for direct costs). CONCLUSIONS: This model indicated that adding clopidogrel to standard therapy in patients with ACS results in a favorable cost-effectiveness ratio in Taiwan.

Diabetes

DB1
THE METABOLIC EFFECTS OF ORLISTAT AND ROSIGLITAZONE ON INSULIN ACTION IN A GROUP OF CHINESE PATIENTS AFFECTED BY THE METABOLIC SYNDROME

Loh SC1, Tomlinson B2, Chan JC3, You JH4, Lee KK2
1The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, 2The Chinese University of Hong Kong, Shatin, China, 3The Chinese University of Hong Kong, Hong Kong, China, 4The Chinese University of Hong Kong, Shatin, Hong Kong

OBJECTIVES: To examine the effects of orlistat and rosiglitazone and assess the changes of cardiovascular risk factors in a group of Chinese patients affected by the metabolic syndrome. METHODS: In a prospective, six-months randomized single-blinded placebo-controlled study, 63 Chinese participants with type 2 diabetes or impaired glucose tolerance, aged > 18 years with a BMI ≤ 23kg/m2 were administered orally 120 mg orlistat three times daily, rosiglitazone 2mg twice daily or placebo three times daily. Changes in clinical and metabolic parameters indicative of the metabolic syndrome were monitored, including body weight, glycaemic control, lipid levels and drug tolerability. RESULTS: There were 20 individuals in the rosiglitazone group and 19 individuals in both the orlistat and placebo groups. The orlistat group demonstrated improved lipid profiles, especially on the reduction of total cholesterol (12% p ≤ 0.0005) and LDL (21%, p = 0.0002). This was accompanied by an improvement in the body fat (p=0.008) and BMI (p=0.008) when compared with control. In comparison, the rosiglitazone group exhibits maximum improvements in the glycaemic indices e.g. fasting insulin (p = 0.004), 2hr-post OGTT insulin (p = 0.004) and HOMA scores (p = 0.005). However, there is an increase from baseline in the LDL levels (12%), body fat (3.7%) and hip circumference (1.5%). CONCLUSIONS: To prevent progression to type 2 diabetes mellitus and its complications, early detection and implementation of appropriate treatment strategies for the metabolic syndrome is crucial. Other than dietary therapy and exercise, rosiglitazone's use as a primary prevention to treat metabolic syndrome is ideal, since most of its problems derived from insulin resistance. On the other hand, orlistat, with its effects on weight, lipids and glucose, may be a useful treatment modality, especially in obese patients.


DB2
THE RELATIONSHIP BETWEEN HOSPITAL COMPETITION AND PRESCRIBING BEHAVIORS - A CASE STUDY OF ORAL HYPOGLYCEMIC AGENTS IN AMBULATORY CARE

Ou HT, Liu YM, Yang Kao YH
National Cheng Kung University, Tainan, Taiwan

OBJECTIVE: 1) To estimate the relationship between hospital competition and prescribing oral hypoglycemic agents (OHAs). 2) To estimate the relationship between hospital competition of three accreditation levels; medical, regional, and district hospitals, and prescribing OHAs under various market structures. METHODS: Major data were obtained from National Health Insurance (NHI) Research Database during the period 1997 to 2001 and the ATC 7- digit coding system of NHI Pharmaceutical Subsidy. Hospital market was defined by geographic boundary, and hospital competition was measured by Herfindahl-Hirschman index. Two types of prescribing behaviors are defined: prescribing new OHAs implied higher prescribing quality and prescribing the OHAs with higher risk of hypoglycemic effect implied poor prescribing quality. RESULTS: There were 2110 observations of hospitals and 158,655 observations of outpatient visits documented with diabetes in six years. There was a positive relationship between hospital competition and prescribing poor quality OHAs in overall hospital markets (Adj. R2 0.40, p <0.05). Identifying the competition of each accreditation level of hospital, there was a negative relationship between regional or district hospital competition and prescribing poor quality OHAs in the market distributed three accreditation levels of hospitals (Adj. R2 0.27, p <0.01; Adj. R2 0.29, p <0.05). However, there was a positive relationship between regional hospital competition and prescribing poor quality OHAs in the market distributed regional and district hospitals (Adj. R2 0.43, p <0.01). CONCLUSIONS: We found the negative impact of hospital competition on the prescribing quality in general hospital markets. In addition, our result implied market mechanism may improve the prescribing quality of regional and district hospitals in the market distributed three levels of hospitals. We presumed there might be abundant medical resources in the market distributed three levels of hospitals, likely being able to provide more pharmaceutical services and information for alleviating asymmetric information.

DB3
THE CORE DIABETES MODEL – SIMULATING LONG-TERM EFFECTS OF IMPLEMENTING HEALTH POLICIES FOR MANAGEMENT OF DIABETES
Ray JA, Palmer A, Valentine WJ, Lurati FM, Foos V, Minshall ME, Roze S


DB4
STATIN UTILIZATION IN PRIMARY PREVENTION IN PATIENTS WITH DIABETES MELLITUS IN HONG KONG

Lee VWY, Chan WS, Ho IC, Tam KY, Lee KK
The Chinese University of Hong Kong, Shatin, Hong Kong, China

OBJECTIVE: Diabetes mellitus (DM) is associated with a 2-4 fold increase in the risk of both coronary heart disease (CHD) and stroke, emphasizing the importance of primary prevention in this high-risk patient group. Management of dyslipidemia with the use of lipid-lowering agents as primary prevention was found to be beneficial. This study was designed to describe the current lipid control patterns and related resources allocation in local diabetic patients. METHODS: Patients who were diagnosed with DM with no prior history of CHD or strokes and were followed up at both Ruttonjee Hospital and Tung Wah Eastern Hospital during January 1, 2002 to December 31, 2003 were recruited. Retrospective chart review was conducted for a period of 2 years, starting from the date of hospital admission. Patients' demographics, baseline and follow-up cholesterol laboratory values and statins treatment data were collected. Patients were then divided into 2 groups: those receiving lipid lowering agents (LLA) and those who were not. RESULTS: A total of 222 patients were included. Only 33. 8% of patients received one or more LLA for primary prevention. In contrast, nearly 50% of patients who were not treated with LLA had dyslipidemia problems (i.e. low density lipoprotein concentration [LDL-C] > 2.6 mmol/L). The most commonly prescribed LLA for primary prevention was statin. Only 21.2% patients attained target LDL-C level. The overall incidence of cardiovascular complications was 11.7% that was slightly higher in those prescribed with LLAs. Absence of routine screening of risk, suboptimal utilization and inadequate dosage titration of LLAs were identified and might contributed to the cardiovascular events. CONCLUSIONS: Primary prevention of cardiovascular complication with LLA should be reinforced. There is room for improvement of the use of LLA for primary prevention in DM patients. Development and implementation of local guidelines could be considered to promote the use of LLA in primary prevention.

Health Care Use & Policy Studies I

HP1
INCOME INEQUALITY IN HEALTH CARE UTILIZATION : EMPIRICAL DATA OF NATIONAL HEALTH INSURANCE IN TAIWAN.

Liang LY1, Li PC2, Huang SM2, Lan CF1
1Yang Ming University, Taipei, Taiwan, 2Department of Health, Taipei, Taiwan

OBJECTIVE: Based on the empirical data of Taiwan's National Health Insurance (NHI) program, this study intends to analyze health care utilization at the individual level among five quintiles and to test the following hypotheses: a) Per capita medical care expenditure (MCE) increases with income, and b) Under-utilization among dependent people (under age 14 and over 65) occurs primarily in the lower income quintile. METHODS: Since 1995, a compulsory social health insurance scheme is implemented and has covered about 97% of the total Taiwan population. This study linked the survey of family income and expenditure data (year 2004) from the Directorate-General of Budget Accounting and the insurance claim data (2004) from the Bureau of NHI by identification number to analyze the relationship between MCE and income. RESULTS:There are 91.8% beneficiaries who used at least once outpatient service which accounts for 73% of total MCE, and 8.02% beneficiaries who used inpatient service. The per capita poorest spent the largest (US$ 623) MCE for outpatient service, and the per capita richest spent the largest (US$ 2306) MCE for inpatient service. The MCE disparity ratio of inpatient and outpatient service from the poorest to the riches was 2.6, 3.5, 3.8, 5.2 and 5.6, respectively. After age 60, the poorest and richest quintile spent 74.1% and 38.5% of total inpatient MCE among five quintiles. Under age 45, the per capita inpatient MCE increases with income. The gender ratio of inpatient service from the poorest to the richest was 1.21, 1.09, 0.95, 0.96 and 0.99, respectively. CONCLUSIONS: The poorest suffered from Diabetes Mellitus, cardiovascular diseases and liver cirrhosis.

HP2
DYNAMIC FINANCIAL MODELS OF EMERGENCY CARE IN THAILAND

Srijariya W, Riewpaiboon A, Chaikledkaew U
Mahidol University, Bangkok, Thailand

OBJECTIVE: To constructs, validate and dynamically simulate a financial model of emergency care. METHODS: 199,334 data have been assembled during a period of 2002-2004 of the 30 baht scheme (Universal Coverage) – the biggest of a three major health insurance systems that cover 75 percents of all Thai citizens. The National Health Security Office (NHSO), an independent body of the Ministry of Public Health takes a major responsibility for implementing and managing this scheme. Data were categorized into 2 groups: group I, model building data set and group II, validation data set. Multiple linear regression technique was used to determine of explanatory variables relative to emergency care budget of NSHO. Although the emergency care claim system is based on DRGs method for inpatient and capitation method for outpatient, the question arises whether it is possible to predict a budget for NSHO to managing emergency fund. So, STELLA software was used to simulate effect of changing health care factors. RESULTS: Factors affecting emergency patient cost are patient type (OPD/IPD), medical procedure, length of stay, accident, hospital type, age, and hospital location. The power of analysis is 76.62. Sensitivity analysis of this regression model, the STELLA software showed that useful for the explicit recognition of scheme's operations by gives dynamic financial models the power to illustrate the links between strategies and results. CONCLUSIONS: These models make a unique contribution to the analytical tools available for performing budgeting analysis for NHSO. Dynamic financial models are valuable in effectively dealing with the complex interrelationships of variables relevant to insuring scheme future results.


HP3 WITHDRAWN



HP4
HEALTH FINANCING AND ACCESS TO HEALTH CARE IN RURAL CHINA

Gericke CA, Meng H, Busse R
Berlin University of Technology, Berlin, Germany

OBJECTIVE: Description and analysis of the development of access to health services in Chinese villages during the period 1985-2002 in relation to changes in health care financing arrangements. Identification of major problems in accessing and financing health care, and formulation of recommendations to improve the observed inequities in health care in rural China. METHODS: Comparison of health care financing arrangements and access to health services in rural China compared to urban China in the period 1985 to 2002 and a description of population health in the same period using routine data and data from published research. RESULTS: In 1998, 87% of health services in rural China were financed out-of-pocket compared to 44% in urban China. Detailed analysis according to the type of village demonstrates more pronounced inequity in access and financing in more remote and poor rural areas for both preventive and curative health services. Access measures comprise both comparisons of health care infrastructure and utilisation rates. Official health status measures reflect these inequalities between rural and urban, as the difference in life expectancy is more than 10 years and infant mortality rates are up to four times higher in rural areas. However official data do not reveal any deterioration of inequalities since 1985. CONCLUSIONS: The inequalities in financing and accessing health care between urban and rural China have massively increased during the last 20 years. So far no measurable effect on official health status can be seen. It is therefore suggested that alternative ways of financing health care have to be been found for the rural population. A number of policy measures to improve the current health inequalities in rural China are proposed.


Methods & Concepts

MC1
NONPARAMETRIC ANALYSIS OF INCREMENTAL NET BENEFITS: STATISTICAL OPTIMALITIES

Jiang JG
Cephalon, Inc, Frazer, PA, USA

For analyzing cost-effectiveness data, Stinnett and Mullahy (1998) proposed the use of incremental net benefits by presenting point and interval estimates as a function of threshold ratio graphically. When the underlying distributions are non-normal or unknown, they proposed a nonparametric confidence interval for the incremental net benefits using bootstrapping techniques, based on the empirical joint distribution of costs and effectiveness for different treatments. This presentation examines its statistical optimalities and its connection to the bootstrap version of Fieller's interval. We illustrate these approaches by applying them to a numerical example.

MC2
APPLYING EXPECTANCY-VALUE MODEL TO UNDERSTAND HEALTH PREFERENCE- AN EXPLORATORY STUDY

Zhang XH1, Xie F1, Wee HL2, Thumboo J2, Li SC1
1National University of Singapore, Singapore, Singapore, 2Singapore General Hospital, Singapore, Singapore

OBJECTIVE: To investigate factors influencing health preference with expectancy-value model (EVM). METHODS: EVM, a model widely used to explore underlying factors of attitudes, was applied to study health preference, which was categorized as attitude in psychology. The factors include attitudinal attributes (AAs) and external variables. AAs are measured in a sum of multiplications of one's subjective probability (expectancy) and perceived value of attributes. In one-to-one interviews, four AAs were identified in focus group discussion, namely, reduction in quality of life (RQoL), burden to family (BTF), dependence on others (DOO) and inability to work (ITW) were assessed using 7-point Likert scales to measure expectancy and value of each attribute. Health preference was measured using visual analogue scales (VAS, range 0-100). Univariate analyses were used to identify external variables (age, gender, ethnicity, education, housing, marital status, and concurrent chronic diseases) that cause significant difference in VAS. Multiple linear regression model (MLR) was used to investigate the explanative power of AAs and possible significant external variable(s) separately or in combination. RESULTS: Twenty-five Chinese and 21 Indians (mean (SD) age: 45.0 (15.55) years, 55.6% female) were interviewed. Ethnicity was identified as the only independent variable causing significant difference in VAS (p<0.05). RQoL, BTF, DOO, ITW were found to explain the variation of VAS of 26.5%, 27.2%, 23.2%, 17.1% respectively in separate MLR models (p<0.05). Combining ethnicity together with the sum of AAs explained up to 27.3% of the variation in VAS, while a model with ethnicity alone only accounted for 10.7% (p<0.05). When MLR was done to examine different predicting power of AAs by ethnicity, ITW failed to predict VAS of Indians (0.3%,p=0.80) while the other 3 AAs moderately explained from 9.1% to 22.9% of the variation (p<0.05). CONCLUSIONS: EVM may be helpful in explaining the variations in health preference and predicting important factors.


MC3
DEVELOPING THE GUIDELINES FOR ECONOMIC EVALUATION OF PHARMACEUTICALS IN KOREA

Bae EY
Health Insurance Review Agency, Seoul, South Korea

OBJECTIVE: To draft the guidelines for economic evaluation of pharmaceuticals which are intended to be listed on the benefit schedule. METHODS: MOHW of Korea decided to amend Official Notification to stipulate the use of economic evidence in the reimbursement decision in 2001. Health Insurance Review Agency (HIRA) has been in charge of developing draft guidelines for economic evaluation of pharmaceuticals. At the outset of drafting the guidelines, HIRA reviewed the existing international guidelines and other research papers to screen the key issues. Then, named individuals were invited to discuss the theoretically and practically controversial issues of this area and determine the direction of guidelines. After five consultation meetings, HIRA drafted the guidelines and asked advice from academia and industry. A Second draft was openly discussed at the workshop which was hosted by HIRA and the Korean Association of Health Economics and Policy. RESULTS: The guidelines comprise two parts, guidance and explanatory notes. According to the guidelines, all the pharmacoeconomic studies submitted to the HIRA should be done with social perspectives. With regard to the productivity cost, HIRA recommends excluding it in a base case analysis, and doing a sensitivity analysis or presenting the results including the productivity cost separately. CEA and CUA are the recommended approaches, and the final outcomes such as LYs or QALYs are welcomed. Uncertainty and generalizability are also important issues in HIRA guidelines. CONCLUSIONS: HIRA guidelines will be the first official pharmacoecnomic guidelines in Asia. For the upcoming two or three years, it will be voluntary for the companies to submit the economic evidence and practicability of the guidelines will be tested. With growing experience and theoretical development in this area, HIRA guidelines will be revised periodically.



MC4
VALUE OF INFORMATION: AN APPLICATION IN HEALTH ECONOMIC EVALUATION OF RENAL REPLACEMENT THERAPY IN THAILAND

Teerawattananon Y
International Health Policy Program, Nonthaburi, Thailand

OBJECTIVE: Calculation of the expected value of perfect information(EVPI) in health economic modelling has been an increasing interest in examining the need for further research to reduce uncertainty in making decisions, and quantifying the value of obtaining further information on chosen parameters. This study aims to demonstrate how EVPI calculation can be performed using data from the economic evaluation of palliative management vs. peritoneal dialysis(PD) and haemodialysis(HD) in Thailand. METHODS: A probabilistic Markov model applied to end-stage renal disease patients aged 20-70 years was developed using the societal viewpoint. Input parameters were extracted from a national cohort and systematic reviews where possible. The Monte Carlo simulation technique was carried out to evaluate effects of sampling uncertainty around input parameters and to obtain overall and partial EVPI. All processes were conducted using a widely available software, Microsoft Excel. RESULTS: The results presented in cost-effectiveness acceptability curves suggest that for ceiling ratio below 450,000 and higher than 900,000 Baht/QALY the model can confidently conclude which method was the most cost-effective. However, for the ceiling ratio between 450,000 and 900,000 Baht/QALY there was no confident conclusion and then the expected opportunity loss of making a wrong decision can be identified. The overall EVPI was 30,000 million Baht for the next 10 years at a ceiling ratio of 650,000 Baht/QALY. The medical cost of PD and HD were the first and second most important parameter requiring further research to collect perfect information. Utility values for patients treating by PD and HD, costs of treated co-morbidity, and survival function were among the following important parameters. CONCLUSIONS: Illustrative worked examples of EVPI calculation will further encourage analysts to present such results that are comprehensive to handle real-life situation faced by policy decision-makers who need to make a judgment under sub-optimal information.


PODIUM SESSION II:

GI Disorders

GI1 WITHDRAWN




GI2
COST-EFFECTIVENESS AND BUDGET IMPACT ANALYSIS OF SACRAL NERVE STIMULATION (SNS) WITH INTERSTIM ® IN FAECAL INCONTINENCE (FI) PATIENTS IN SPAIN.

Navarro A1, Muñoz A1, Brosa M2, Rodriguez JM3, Serrano-Contreras D4, Minda K5
1Hospital Mutua de Terrassa, Terrassa, Barcelona, Spain, 2Oblikue Consulting, Barcelona, Spain, 3Medtronic Iberica, Madrid, Spain, 4Medtronic Iberica, Madrid, Madrid, Spain, 5Medtronic S.A, Tolochenaz, Morges, Switzerland

Interstim® therapy has shown a higher effectiveness and safety compared to surgical procedures like dynamic graciloplasty or artificial anal sphincter in patients with intact anal sphincter (IAS) and before Sphincteroplasty in patients with structural deficient anal sphincter (SDAS), a condition with a high impact on psychological and social life in healthy people. OBJECTIVE: To assess the cost-effectiveness of two FI management scenarios, with and without SNS, and to estimate the potential budget impact of its progressive introduction in the Spanish setting. METHODS: A decision analytic model was developed, representing the possible clinical paths for each of the scenarios (with and without SNS), as well as its clinical and economical consequences in mid-long term with a Markov model. Clinical and resource use data were retrieved from literature and validated by a clinician expert's panel. Efffectiveness was measured with both QALYs and symptom free years (SFY). A 3% discount rate was used for future costs and benefits (time horizon= 5 years). Prevalence figures where combined with Interstim sales forecasts to estimate the total number of patients to receive therapy the next years and the associated budget impact. RESULTS: The introduction of Interstim® in the therapeutic management of FI has an associated cost-effectiveness of 22,910€ (IAS patients) and 22,546€ (SDAS patients) per QALY gained. The progressive introduction of Interstim® in 150 to 250 patients/year will have an estimated budget impact of 320,049€, 490,550€ and 667,824€ for next three years (net increase of 0.3% to 0.5% of total costs in patients with IF). CONCLUSIONS: Introducing Interstim® in the management of FI in IAS and SDAS patients in the Spanish setting, has shown to be an efficient measure with a C/E rate below the accepted Spanish threshold (30,000€/QALY), and with a relatively low additional cost for the Spanish NHS.


GI3
COMPARATIVE EFFECTIVENESS OF LAMIVUDINE MONOTHERAPY FOR PATIENTS WITH CHRONIC HEPATITIS B

Sun X1, Zhou R2, Li P2, Li Y3, Guyatt G4
1The Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, China, 2West China Hospital, Sichuan University, Chengdu, Sichuan, China, 3Chinese Evidence-Based Medicine Center, West China Hospital, Chengdu, Sichuan, China, 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

OBJECTIVE: To investigate effectiveness of lamivudine monotherapy compared to other antivirals for patients with chronic hepatitis B. METHODS: Systematic review and meta-analysis of randomized trials were conducted. Medline, Cochrane Trial Register, Current Contents, SCI-E and CBMdisc were searched. Complementary screening of references of included studies was also conducted. Randomized trials that compared lamivudine monotherapy with single use of other antivirals for patients with chronic hepatitis B were eligible. Studies that included patients with co-infection of HCV and HIV, and with decompensate liver diseases were excluded. Outcomes measures were loss of HBeAg, seroconversion, loss of HBV-DNA, and normalization of ALT. Egger's regression and funnel plot were used to identify publication bias. Meta-regression, subgroup analysis and sensitivity analysis were used to investigate heterogeneity. Type of comparison, duration, doses, and ethnicity were considered for heterogeneity. RESULTS: A total of eleven included trials formed thirteen comparisons, without publication bias identified (coefficient=-1.52, 95%CI: -3.85-0.81). Of these, seven compared with interferon-alpha, five with nucleic analogues, and one with thymocin-alpha. Seven of eleven trials (63.6%) were moderate in quality, and three trials (27.3%) were high. Lamivudine was inferior to other antivirals in loss of HBeAg (OR=0.45, 95%CI: 0.30-0.67), without heterogeneity identified (chi-square=5.47, df=6, p=0.485). Although heterogeneous across trials in loss of HBV-DNA (chi-square=47.33, df=11, p=0.000), no specific factors were identified. It showed that lamivudine was comparable to other antivirals (OR=1.39, 95%CI=0.67-2.88). The comparison of lamivudine with interferon also identified no significant difference. Ethnic difference was the prognostic factor for addressing heterogeneity in normalization of ALT (coefficient=2.56, 95%CI=0.62-4.51, P=0.015). Lamivudine could produce more significant normalization of ALT than other antivirals in Chinese. Lamivudine was comparable to other antivirals in seroconversion. CONCLUSIONS: There was advantage of lamivudine in normalization of ALT. However, it was clinically inferior to other antivirals in decreasing HBeAg.



GI4
OUTCOMES AND COSTS OF GENERIC AND TRADE RANITIDINE USE IN THE UNITED STATES AND JAPAN

Kamae I1, Yanagisawa S1, Oderda GM2, Otsuka M3, Jorgenson J4, Otsuka K1, Brixner D2
1Kobe University, Kobe, Japan, 2University of Utah College of Pharmacy, Salt Lake City, UT, USA, 3Musashino University, Nishi-Tokyo, Japan, 4University of Utah Hospital and Clinics, Salt Lake City, UT, USA

Generic drugs are available in the United States and Japan. In the US between 40% and 50% of all prescriptions are generic products. Although the cost advantage of generic drugs is recognized in Japan, physicians are still concerned about the potential for a difference in outcomes from generic vs trade name products. OBJECTIVE: To investigate whether the outcomes in patients taking generic vs. trade name Ranitidine differ in the United States and, based on the results of the study in the US, to assess the difference of treatment costs in generic vs. trade Ranitidine in Japan. METHODS: In the US, Medstat MarketScan (commercial claims) 2000-2001 data was used. Patients 18 and older with at least one prescription for oral Ranitidine were identified. The first Ranitidine prescription fill was the index date. Incidence of GI perforations ulcers or bleeds (PUB) or Other GI events (OGI, e.g. gastritis), and costs were determined for patients with generic or trade name therapy. In Japan, a decision analytic model was introduced to evaluate the costs assuming the same outcomes as in the US. RESULTS: In the US 97,387 generic and 5,117 trade patients were identified. Drug costs ($2538 vs. $4070) and total costs ($9647 vs. $12,501) were lower for generic vs. trade patients. There was no difference in mpr (medication possession ratio) or the incidence of PUB (1.9%). Other GI events were higher (19.7%, 17.7%) for generic Ranitidine. The higher proportion in OGI reduced the advantage of a lower cost generic drug by 10.7% ($51 to $46), estimating the average treatment costs per patient of gastritis/duodenitis for four-week follow-up in Japan. CONCLUSIONS: US Patients on generic ranitidine had lower costs, a similar incidence of PUB and somewhat higher OGI incidence. Also, the higher incidence in OGI reduced the value of generic Ranitidine therapy in Japan.


Health Care Use & Policy Studies II

HP5
CATASTROPHIC AND POVERTY IMPACTS OF OUT-OF-POCKET HEALTH PAYMENTS BEFORE AND AFTER THE UNIVERSAL HEALTH CARE COVERAGE IMPLEMENTATION IN THAILAND

Limwattananon S
Khon Kaen University, Amphoe Muang, Khon Kaen, Thailand, Prakongsai P
International Health Policy Program, Amphoe Muang, Nonthaburi, Thailand, Tangcharoensathien V
International Health Policy Program, Nonthaburi, Thailand

OBJECTIVE: To determine the impacts of out-of-pocket (OOP) health payments on household economic status before and after an implementation of the universal health care coverage (UC) policy in Thailand. METHODS: Analysis of socio-economic surveys on consumption expenditures of national representatives of households during 2000 (N=24,747), 2002 (N=34,785) and 2004 (N=34,843). RESULTS: Proportion of households whose OOP payments for health care deemed catastrophic (i.e., above 10% of total consumption expenditure) reduced from 5.4% in 2000 (pre-UC period) to 3.3 and 2.8% in 2002 and 2004 (post-UC periods), respectively. For the beneficiaries of Low-Income Card (LIC) and Voluntary Health Card (VHC) schemes, the health care catastrophe appeared in 4.7% of the households during the pre-UC period. The catastrophic incidence reduced to 3.2% and 2.6% among the UC beneficiaries during the post-UC periods. The percentage of households impoverished by the OOP health payments reduced after the UC implementation, from 4.4% in 2000 to 2.5% and 1.8% in 2002 and 2004. The post-OOP poverty incidence among the poorest quintile households reduced substantially from 18.3% to 10.3% and 8.0% over the same periods. An increase in the poverty headcounts (using national poverty line) as a result of OOP payments dropped from 2.1 percentage points during the pre-UC period to 0.8 and 0.5 percentage points during the post-UC periods. For the post-OOP impoverished households, an increase in the poverty gap reduced slightly from 0.7 percentage points in 2000 to 0.4 and 0.2 percentage points in 2002-2004. CONCLUSIONS: Reduction in the health care catastrophe and household impoverishment due to OOP payments is evident after the implementation of UC policy that provides comprehensive coverage of health care with a very small nominal fee of 30 Baht (or 0.75 USD) upon a visit or admission to health care facility for a comprehensive range of health services.

HP6 WITHDRAWN


HP7
SURVEILLANCE OF ANTIMICROBIAL RESISTANCE AND USE IN THE COMMUNITY: A TIME-SERIES STUDY.

Thatte UM1, Kulkarni RA2, Holloway KA3, Sørensen TL4, Koppikar GV2, Shinkre NN2, Chaudhury RR5
1BYL Nair Charitable hospital, Mumbai, Maharashtra, India, 2BYL Nair Ch hospital, Mumbai, Maharashtra, India, 3World Health Organisation, Geneva, geneva, Switzerland, 4Bispebjerg Hospital, Bispebjerg, Netherlands, Netherlands, 5Delhi Society for Promotion of Rational Use of Drugs, Delhi, Delhi, India

OBJECTIVE: To determine resistance to antibiotics in E. coli isolated from stools of patients from a specified area of Mumbai and use of these same antimicrobials by prescribers in these facilities and chemist shops with the objective of developing a surveillance system for AMR and drug use in the community. METHODS: Prospective, time series study over 24 months. Setting: 1 hospital, 9 municipal dispensaries, 10 GP clinics and 10 chemist shops randomly selected each month in ‘E' ward of Mumbai. Study Population: 4800 (200 per month) stool samples of patients with or without diarrhoea attending various facilities were collected. E. coli isolates from these were tested for antimicrobial susceptibility using standard methods. 7200 antibiotic containing prescriptions (300 per month) for all clinical conditions were collected from patients attending the same facilities. Consumption data from the municipal facilities was also examined. Outcome Measures: % patients prescribed antimicrobials, % patients prescribed specific antimicrobial, No. DDD's of antimicrobial consumed per catchment population, % resistance of E. coli to specified antimicrobials. RESULTS: Across facilities, 25-30% of medicines prescribed were antibiotics. Commonly used antimicrobials in municipal facilities was Cotrimoxazole (7.27 & 20.67% respectively), Amoxicillin and Quinolones at GPs and chemists (8.7 & 7.84%-amoxicillin; 8.64 & 9.17%-quinolones). DDD of Co-trimoxazole, Amoxycillin, Cephalexin and Quinolones was 463.45, 102.98, 18.95, 82.24 mg/1000 inhabitants/day respectively at municipal facilities and 56.87, 92.63, 3.02, 136.12 mg/1000 inhabitants/day respectively at GPs. Resistance of E. coli to Cotrimoxazole, Amoxycillin, Quinolones and Cephalosporins varied between 24-66%, 22-68%, 22-87% and 2-53% respectively over time. Antimicrobial resistance patterns correlated with use patterns. There was high E. coli sensitivity to cefotaxime, which was less used in the community. CONCLUSIONS: This study demonstrates a system of surveillance of AMR and use in the community that can be used to monitor interventions to improve antimicrobial use and contain resistance.



HP8
OPTIMAL CONTRACT DESIGN UNDER PRICE-VOLUME AGREEMENTS

Zhang H, Zaric GS
The University of Western Ontario, London, ON, Canada

OBJECTIVE: Price-volume contracts between public payers and drug manufacturers are seen as one way of controlling drug expenditures. However, the manufacturer may have more information than the payer regarding the eventual market size. Thus, price volume agreements may not entirely reduce the financial risks faced by a payer. METHODS: We developed a mathematical model of the contract design problem. We modeled the contract design process from the perspectives of both the payer and the manufacturer. We assumed a sequence of events as follows: the payer determines a rebate schedule; then the manufacturer submits sales forecasts as part of a formulary submission; then the payer either accepts or rejects the submission; and finally the manufacturer determines the appropriate level of marketing effort. We applied game theoretic tools to identify an optimal contract from the perspective of the payer. The sequence of events was resolved through Stackleberg equilibrium methods. RESULTS: An optimal contract exists for both the payer and the manufacturer. The manufacturer's marketing effort is positively related with anticipated demand. Although the manufacturer may have private information about market size and future marketing effort, the payer can design the contract so that it is in the manufacturer's best interest to reveal any private information. CONCLUSIONS: In an optimal contract the payer can infer any private information held by the manufacturer regarding anticipated market size or marketing effort. Thus, a payer can eliminate uncertainty regarding market size through a carefully designed contract. In this way, a carefully designed price-volume agreement can be used to reduce a payer's risk.


Infection

IN1
ADVERSE EVENTS OF ANTIRETROVIRAL THERAPIES CONTAINING NEVIRAPINE OR EFAVIRENZ BASED ON INTENSIVE ADR MONITORING DATABASE

Kulsomboon V1, Maleewong U1, Suwankaesawong V2, Jameekornkul C2
1Chulalongkorn University, Bangkok, Thailand, 2Food and Drug Administration Office, Nonthaburee, Thailand

OBJECTIVE: Nevirapine-based triple combination antiretroviral (ARV) therapy has been used as first line drug for HIV patients in Thailand. However, negative consequence from adverse events is of concern when compared to the Efavirenz-based ARV. The aim of this study is to compare the incidence of Nevirapine-based and Efavirenz-based therapy. METHODS: Nineteenth general hospitals were recruited in the Intensive Adverse Drug Reaction (ADR) Monitoring program. One or two pharmacists from each of these hospitals were trained to understand the concept of pharmacoepidemiology, pharmacologic measure, and how to complete adverse event reports and antiretroviral drug utilization data. Adverse event data of the hospital completely reporting utilization of ARV within six months period from January to June, 2005, were used for the study. The incidences of adverse events of Nevirapine-based and Efavirenz-based ARV therapy were calculated and compared. RESULTS: Six hospitals (31.6%) completed the drug utilization report. Of the 1,185 patients using Nevirapine-based ARV, 39 cases had adverse event. Of the 369 patients usingh Efavirenz-based therapy, nine cases had adverse event. The ADR incidence of Nevirapine and Efavirenz was 3.29 and 2.44 per 100 persons per six months. Sixteen cases (1.35%) had to quit Nevirapine and three cases (0.81%) had to quit Efavirenz. Six cases (0.51%) in Nevirapine-based ARV group had severe and life-threatening ADR resulting in hospitalization including Steven Johnson Syndrome, oedema, dyspneoa, and skin exfoliation. Within Efavirenz-based group, only one case (0.27%) had Fixed Eruption and was hospitalized. CONCLUSIONS: For overall ADR, Nevirapine-based ARV had the ADR incidence higher than Efavirenz-based ARV. The serious or life threatening ADR seems to be greater in Nevirapine group. Data from Intensive ADR monitoring program could be used for assessing the ADR incidence which could be incorporated in pharmacoeconomic calculation.

IN2
PRODUCTIVITY COSTS AND CARER BURDEN OF HOME PARENTERAL ANTIBIOTIC THERAPY

Neilson GS, Neilson JS, Whitby M
Princess Alexandra Hospital, Brisbane, Queensland, Australia

OBJECTIVE: The aim of the study is to measure productivity in both home parenteral antibiotic patients and their carers and carer burden. The model of drug delivery to early discharged hospital patients is self-administration of home parenteral antibiotics. Productivity and carer burden have not previously been examined in this group of patients. METHODS: A labour questionnaire has been designed to collect individual patient employment information and data concerning the return to normal activities to enable the inclusion of a value for household duties and leisure. Employment was stratified according to the Australian Bureau of Statistics'(ABS) Australian Standard Classification of Occupations. This enabled the use of the ABS gender-specific average weekly wages for nine major work groups. Data from the multidimensional Caregiving Distress Scale (CDS) was collected to measure carer burden. Further, data concerning employment and leisure loss by carers was collected to measure loss of productivity. The labour questionnaire and the CDS instruments were mailed to patients on completion of therapy. RESULTS: A total of 123 patients completed the employment survey and 60 carers completed carer burden surveys. A total of 73% of patients who were employed prior to hospitalisation returned to work during home parenteral antibiotic treatment for a total of 299 days with a value of $AUD 47,864. For the remainder of the patients, the value of leisure time and a return to normal daily activities was $AUD 140,982. For carers, 23% lost employment time for a total of 115 days with a value of $AUD 19,187. The value of lost leisure or time for normal daily activities was $AUD 83,767. The average score for the CDS was 21 (95% CI, 17.3-24.8) which indicates that carer burden was low. CONCLUSIONS: Productivity gains of home parenteral antibiotic patients exceeded the lost productivity of carers. Carer burden was low.


IN3
ECONOMIC EVALUATION OF VACCINATION AGAINST POLIOMYELITIS IN MALAYSIA: ORAL POLIO VACCINE (OPV) VS INACTIVATED POLIO VACCINE (IPV)

Aljunid SM
Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia

OBJECTIVE: To conduct an economic evaluation of switching from the current regime using combination of DTwcPHib + OPV to new combined vaccine DTwcPHib + IPV(monovalent) and DTacPHibIPV(combination). METHODS: Incremental cost-effectiveness approach was used in the methodology. Cost of the vaccination programmes includes price of vaccines, cost of vaccine wastage, cost of transportation and maintenance of cold chain, cost of vaccines administration and cost of managing adverse events. The outcomes measured in this study are the number of cases of Vaccine Associated Paralytic Polio (VAPP) and other adverse events avoided such as mild fever, high fever and convulsions. A time-motion survey was conducted in one government health centre to obtain the human resource cost of vaccine administration. Cost of VAPP was estimated from an expert group discussion while the cost of other adverse events (high fever and mild fever) was obtained from interviews with 400 mothers and children attending three government clinics. The cost of managing convulsions was obtained from a survey of 46 patients admitted to HUKM and Hospital Kuala Lumpur. RESULTS: The current program at the cost of RM 77.14 per dose of DTwcPHib +OPV vaccine would cost the country of RM115 million annually. At RM 91.98 per dose of DTwcPHib +IPV (monovalent), the total cost of program would incur RM137 million and at RM 85.94 per dose of the DTacPHib IPV, the total cost of program was RM128 million. Incremental cost effectives ratio when switching from current programme to DTwcPHib +IPV cost RM 11 million per case of VAPP avoided. However, the incremental cost effectiveness ratio when switching form current programme to DTacPHibIPV cost only RM three million per case of VAPP avoided. CONCLUSIONS: Switching from the current programme to DTacPHib IPV (combination) is more cost-effective as compared to DTwcPHib +IPV (monovalent).


IN4
MODELING ECONOMIC BENEFITS OF SUPPRESSING VIRAL REPLICATION IN CHRONIC HEPATITIS B (CHB) PATIENTS IN CHINA: A COST-EFFECTIVENESS ANALYSIS OF ENTECAVIR AND LAMIVUDINE BASED ON A PHASE III CLINICAL TRIAL

Yuan Y1, Iloeje U2, Li H3, Hay J4, Bi Yao GB5
1Bristol-Myers Squibb Company, Plainsboro, NJ, USA; 2 Bristol-Myers Squibb Company, Wallingford, CT, USA; 3 Bristol-Myers Squibb Co, Wallingford, CT, USA; 4 University of Southern California, Los Angeles, CA, USA; 5 Jin An District Hospital & Shanghai Fudan University, Shanghai, China

OBJECTIVE: Of estimated 112 million persons infected with CHB in China, 15-40% will eventually develop liver complications. Most of the patients do not actively seek antiviral agents for treatment probably due to high cost and uncertain long-term outcomes. Entecavir is a new therapeutic option for CHB patients and the purpose of this study was to evaluate the cost effectiveness of entecavir treatment in China, based upon estimated clinical benefits. METHODS: We took the perspective of the Chinese Social Security program. Multivariate-adjusted relative risks with viral load (VL) categories were estimated from a published Taiwan CHB cohort with 42,115 person-years of follow-up, and applied to patients enrolled in a randomized phase III trial in China in which HBV DNA was a primary endpoint after 48 weeks of therapy with either entecavir or lamivudine monotherapy. Entecavir and lamivudine daily prices were assumed RMB yuan 40 and 16.71, respectively. Life expectancy tables were based on China vital statistics. Direct medical cost of and utility scores for different phases of CHB were estimated from published China specific data, and costs were adjusted to year 2005 value using Chinese Consumer Price Index information. Probabilistic sensitivity analyses were conducted to evaluate parameter uncertainty on event distribution and treatment failure rates beyond trial period. RESULTS: 519 subject started double-blind treatment; males (82%); HBeAg+ (87%); mean age 30 years. Entecavir was superior to lamivudine as the proportion of subjects who achieved HBV DNA<300 copies/ml by PCR assay at Week 48, 78.7% versus 46.7%, respectively, (P<0.05). In the base case, compared with lamivudine, one year of entecavir therapy yielded a net cost saving of 2123 yuan and 0.71 quality-adjusted life year (QALY) gain, with 98.5% of 1000 Monte Carlo simulation estimates below 5000 RMB/QALY. CONCLUSIONS: Entecavir is a highly cost effective choice of treating hepatitis B patients in China.

Mental Health

MH1 Withdrawn


MH2
THE IMPACT OF SCHIZOPHRENIA ON CAREGIVERS: BURDEN OF ILLNESS AND QUALITY OF LIFE

Adams J1, Nand V2, Le Reun C3, Mudge M1, Crowley S4, Eggleston A2, Schrover R5, Brown A1
1Medical Technology Assessment Group, Chatswood, NSW, Australia, 2Janssen-Cilag Pty Ltd, North Ryde, NSW, Australia, 3M-TAG Pty Ltd, Chatswood, Australia, 4University of Melbourne, North Ryde, NSW, Australia, 5Janssen-Cilag Pty Ltd/University of Melbourne, North Ryde, NSW, Australia

OBJECTIVE: To determine the burden of illness and health related quality of life (HRQL) of carers for people with schizophrenia. METHODS: Carers of people with schizophrenia were recruited through a Schizophrenia Fellowship in Australia. Participants completed a mail out questionnaire that included questions about the carer, the person they care for, time spent caring, costs associated with caring, impact of caring on paid employment and unpaid activities (n=73). Carers valued their HRQL using the Assessment of Quality of Life (AQoL) multi-attribute utility instrument. RESULTS: The mean age of carers was 61 years and the majority were females caring for their son or daughter. Respondents spent 5.3 days per week caring. On these days, the average time spent caring was 5.4 hours. Costs incurred by carers included purchasing food (mean: AUD$36.80/week), living expenses (mean: $27.40/week), travel expenses ($13.90/week) and cigarettes ($14.05/week). Of those who were in paid employment (45%), 28% indicated that they were less able to carry out their work due to caring on average 5.8 days/month. Carers that had reduced their work hours and/or changed job (22%) in the past year because of caring for someone with schizophrenia, had their income reduced by an average $84/week. Of the carers that had taken part in unpaid activities during the last month (67%), 26% had to reduce the amount of unpaid work due to caring for someone with schizophrenia. The mean AQoL utility value of the carers included in this study was 0.64±0.25 (SD). CONCLUSIONS: This study shows that caring for someone with schizophrenia has a substantial impact on the carers' life. Caring is associated with both direct and indirect costs. The results from the AQoL suggest that the HRQL of the carer is markedly lower than a person in normal health.



MH3
THE QUALITY OF LIFE IN DEPRESSED OUTPATIENTS: 6 MONTH FOLLOW-UP STUDY IN SHANGHAI, CHINA

Ji JL1, Chen XB2, Tan-Mulligan A3, Sheng F3
1Zhongshan Hospital, Fudan University, Shanghai, China, 2Fudan University, Shanghai, China, 3GlaxoSmithKline Pharmaceuticals China, Shanghai, China

OBJECTIVE: The aim of this study was to assess the quality of life of patients with depression using Paroxetine at baseline, three months and six months. METHODS: It is a multi-center collaborative QOL follow-up study conducted in six general hospitals and 1 mental health center in Shanghai. The patients were treated with Paroxetine (10-20mg/day) for six months and assessed with HAMD-17, HAMA-14 and SF-36 at baseline, three-month and six-month. RESULTS: 1) A total of 196 outpatients met the diagnostic criteria of major depression in accordance with the DSM-IV participated in the study at baseline,180 patients finished six months follow-up, including 54 pure depression patients and 126 co-morbidity patients. 2) At baseline, co-morbidity patients had a higher impaired quality of life compared with pure depression patients, especially in PF, VT, SF and MH (p<0.05). 3) After three months treatment, co-morbidity patients had more improvement in QOL, especially in RP, RE and GH (p<0.05). 4) After six months treatment, co-morbidity patients had further improvement in QOL, especially in RP, BP and RE (p<0.05). 5) Paroxetine is an effective anti-depressant which let 59% of patients were free of depressive symptoms (HAMD<8 score) and 88% of cases were free of anxiety symptoms (HAMA<8 score) after six-month treatment. CONCLUSIONS: 1) Depression imposed a huge humanistic burden on the patients, whose quality of life were impaired badly; 2) Paroxetine significantly improved patients' Quality of Life, both in pure depression and co-morbidity patients; 3) Co-morbidity patients have more improvement in Quality of Life compared with pure depression patients; 4) Longer treatment with Paroxetine showed a higher improvement in Quality of Life.


MH4
PHARMACOECONOMIC EVALUATION OF RELAPSED AND NON-RELAPSED GENERALISED ANXIETY DISORDER PATIENTS

Jorgensen TR1, J François C2, Despiegel N2
1H. Lundbeck A/S, Valby, Copenhagen, Denmark; 2 H. Lundbeck A/S, Paris, France

OBJECTIVE: Assess the impact of relapse and non-relapse on patient reported outcomes (PRO) and resource utilisation in patients with Generalised Anxiety Disorder (GAD). METHODS: An economic evaluation conducted alongside a double-blind, placebo-controlled, 6-month relapse prevention clinical trial compared PRO and costs of relapsed and non-relapsed GAD patients (n=195). Relapse was defined as an increase in HAM-A score to 15 or more. PRO was assessed using the SF-36 quality of life (QoL) scale at randomization (week 12), weeks 36, 60 and 88 or at early termination for relapsed and non-relapsed patients. Resource utilisation was assessed at the same time points. RESULTS: Patients reported significant improvement in QoL during the 12-week open-label period of escitalopram treatment (p>0.0001). After randomization, relapsed patients reported significantly lower QoL scores than non-relapsed patients in all SF-36 mental health dimensions (p<0.001). On the SF-36 physical dimensions, relapsed patients reported significant worsening in general health (p>0.001) and role physical dimensions (p>0.0.15) but no change in the physical functioning or bodily pain dimensions. The difference in cost (including medication cost) between patients experiencing relapse and those that did not was €2363 over 76 weeks. CONCLUSIONS: Relapsed GAD patients reported significantly lower QoL as assessed by the SF-36 scale compared with non-relapsed patients. The difference was 10 to 33 points in the mental health dimensions, which is superior to the accepted clinically relevant 10-point difference. Relapsed patients cost significantly more than non-relapsed patients. This highlights the need for long-term treatment with drugs that are effective in preventing relapse in GAD patients.

Urinary/Kidney Disorders

UK1
A REGIONAL ASIAN ANALYSIS OF THE COST-EFFECTIVENESS OF EARLY IRBESARTAN TREATMENT VERSUS CONVENTIONAL ANTIHYPERTENSION TREATMENT, AND LATE IRBESARTAN TREATMENT IN PATIENTS WITH TYPE 2 DIABETES HYPERTENSION AND KIDNEY DISEASE

Annemans L1, Demarteau N2, Hu S3, Lee TJ4, Morad Z5, Thanom S6, Yang WC7
1IMS Health and Ghent University, Brussels, Belgium, 2 IMS Health, Brussels, Belgium, 3Fudan University (former Shanghai Medical University), Shanghai, China, 4College of Medicine, Hallym University, Chuncheon, South Korea, 5Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, 6Phramongkutklao Army Hospital, Bangkok, Thailand, 7Veteran General Hospital and National Yang-Ming University, School of Medicine, Taipei, Taiwan

OBJECTIVE: The prevalence of type 2 diabetes, often leading to diabetic nephropathy, increases around the world and even more in Asia. Irbestartan has been shown to slow down progression of kidney disease in clinical trials conducted at early (microalbuminaria) and late (proteinuria) stages of nephropathy in hypertensive type 2 diabetic patients. A Markov model based on these results has demonstrated that in Western regions (US, Europe) early irbesartan results in significant clinical (life year gained - LYG) and economic (savings) benefits compared to conventional therapy or late irbesartan. The objective of this study was to adapt this analysis to the Asian context. METHODS: The 25 years time horizon model was developed in MSExcel and adapted to China, Malaysia, Thailand, South-Korea and Taiwan from a health care perspective. The effectiveness parameter was LYG. All costs were converted to 2005US$ using official exchange rates and price indexes. Local data were sought for costs data, and for transplantation, dialysis, and death probabilities. Upon local availability, official databases or published data were used. Probabilities regarding disease progression with the investigated drugs were extracted from 2 published clinical trials. A probabilistic analysis provided mean values and 95% confidence intervals
(95%CI). RESULTS: Early irbesartan gave the largest clinical and economic benefits, reducing the need for dialysis by 62% versus conventional treatment in all regions, and total costs by 6% (95%CI [-32%;20%] (Thailand) to 41%[-67%;-6%] (Taiwan), and increasing LYG by 0,5 years (range 0.47[0.09;0.84] to 0.56[0.12;0.98]). The second best alternative, late irbesartan, also led to higher LYG and lower cost, as compared to conventional treatment in all regions, although to a lower extent (total costs in Taiwan reduced by 16% versus conventional treatment). CONCLUSIONS: Although absolute results vary in different settings (Western countries, Asia), reflecting differences in epidemiology, management and costs, early irbesartan remains a cost-effective alternative.


UK2
ESTIMATED ANNUAL COST OF OVERACTIVE BLADDER IN THAILAND

Prasobsanti K1, Ponprasit K2
1Chulalongkorn University Hospital, Bangkok, Thailand; 2 Pfizer Thailand Ltd, Bangkok, Thailand

OBJECTIVE:To estimate the annual direct and indirect costs of overactive bladder (OAB) in indigenous Thai people aged 18 years and over, attending a Urology Clinic in Bangkok in 2005 METHODS: Epidemiologically based models using diagnostic and treatment algorithms from clinical practice guidelines and current disease prevalence data were used to estimate direct and indirect costs of OAB. Prevalence and event probability estimates were obtained from the literature, national data sets, and expert opinion. Costs were estimated from a small survey using a cost questionnaire and from unit cost.Sensitivity analyses were performed on all variables. RESULTS: The annual cost of OAB in Thailand is estimated as 4.2 billion USD which includes 3.25 billion USD for direct medical costs, 0.82 billion USD for direct, non-medical costs and 0.13 billion USD for indirect costs of lost productivity. Costs for women were greater than the costs for men. The largest costs category was direct treatment costs of comorbidities associated with OAB followed by costs of transportation. The more patients were treated, the less direct treatment costs of OAB consequences would be. Costs of OAB medication accounted for 7% of the total costs of OAB. It is estimated that 1.2 billion USD per year could be saved if all OAB patients were treated. Costs were most sensitive to change in OAB prevalence. CONCLUSIONS: OAB is a costly condition. It is estimated to consume 2.46% of national GDP. Based on information from direct and indirect costs of OAB, it is recommended that physicians increase their level of appreciation of the disease and initiate early treatment so as to reduce the impact of the higher cost of treating co morbidities conditions associated with OAB. It may also be beneficial that a more humanistic approach to the problem would help improve quality of life of these patients.

UK3
ETHICAL DIMENSION OF RESOURCE ALLOCATION: THE CASE OF SCALING UP ACCESS TO RENAL REPLACEMENT THERAPY IN THAILAND

Tangcharoensathien V1, Prakongsai P2, Kasemsup V3, Teerawattananon Y4
1International Health Policy Program, Nonthaburi, Thailand, 2International Health Policy Program, Amphoe Muang, Thailand,
Mahidol University, Bangkok, Thailand, 3International Health Policy Program - Thailand, Nonthaburi, Thailand

OBJECTIVE: To investigate policy options for the introduction of access to renal replacement therapy (RRT) under universal coverage (UC) in Thailand. METHODS: Literature reviews, secondary data analysis, in-depth interviews with stakeholders and the analysis of policy options based on the WHO manual on ethical dimensions of health resource allocation. RESULTS: The incidence rate of end-stage renal diseases (ESRD) patients requiring RRT ranges from 100 to 300 per million populations. Forecasting indicates demand for RRT would exceed 50,000 cases in year five, and 100,000 cases in year ten, if universal access to RRT is adopted. The program requires 5.5% and 24% of total UC budget in year 1 and 15, respectively. By year 15, RRT would cost 7.7% of total national health expenditure, if neither strategy to reduce the costs for RRT nor case selection is in place. This huge forecast outlay is not affordable by the country. Analysis indicates neither hemodialysis nor peritoneal dialysis was cost-effective, as their cost per life year saved were greater than 5.2 times of GNI per capita. Though not cost-effective, protecting households against financial catastrophe justifies public funding; and to be financially feasible, rationing is unavoidable. This study advocates prevention of ESRD and providing RRT to every patient, up to an age cut-off, or to every patient with a fix number of RRT years by providing more years to the younger patients is financially feasible (due to discontinuation of RRT beyond the cut off point) while observes ethical principles of providing equal chance to all patients. CONCLUSIONS: The proposed options will go through a process of national consensus in 2006, with a series of public hearing, in order to solicit public opinion on rationing through dis-continuation in view of financial constraints.


UK4
ECONOMIC ANALYSIS OF ORAL CARBONACEOUS ADSORBENT AST-120 IN DELAYING THE INITIATION OF DIALYSIS TREATMENTS AMONG PATIENTS WITH CHRONIC RENAL FAILURE

Kang HY1, Cho WH1, Lee SM2, Kim HJ3, Woo TW4
1Yonsei University, Seoul, South Korea, 2Yonsei University, Graduate School, Seoul, South Korea, 3Pochon CHA University, Pochon, Kyoung-gi, South Korea, 4CJ Corp, Seoul, South Korea

OBJECTIVE: To enable comprehensive evaluation as a treatment option for patients with chronic renal failure (CRF), an economic assessment of oral adsorbent AST-120 was carried out. METHODS: We sought to evaluate the economic value of AST-120 by estimating cost savings due to its effect of delaying the initiation of dialysis. A decision analytic model was developed with conventional treatments for CRF accompanied by AST-120 therapy as 'a treatment choice' and conventional treatments only as 'an alternative choice.' Direct medical and non-medical costs and productivity loss costs were considered. Information regarding the effects of AST-120 was obtained from results of earlier clinical studies. Cost information was derived from administrative data for 40 hemodialysis (HD) and 20 peritoneal dialysis (PD) patients from two dialysis centers located in Seoul, Korea. By computing the weighted average for the cases delaying the initiation of HD and PD, the expected per-capita cost savings due to the use of AST-120 by a patient with CRF was obtained. RESULTS: Depending on the probability of AST-120 showing the effect of delaying the initiation of dialysis (52.3-68.1%) and the duration of the delay (1, 2, or 4 years), the present value of cumulative cost savings per patient with CRF from societal perspective would be 12,476,000-19,940,000, 24,361,000-38,938,000 or 46,469,000-174,271,000 Korean Won. CONCLUSIONS: The cost savings estimated to be resultant from AST-120 therapy confirm that its effect of delaying the initiation of dialysis has considerable economic value.