W Wrona

Valuation of EQ‐5D Health States in Poland: First TTO‐Based Social Value Set in Central and Eastern Europe

OBJECTIVE Currently, there is no EQ-5D value set for Poland. The primary objective of this study was to elicit EQ-5D Polish values using the time trade-off (TTO) method. METHODS Face-to-face interviews with visitors of inpatients in eight medical centers in Warsaw, Skierniewice, and Puławy were carried out by trained interviewers. Quota sampling was used to achieve a representative sample of the Polish population with regard to age and sex. Modified protocol from the Measurement and Value of Health study was used. Each respondent ranked 10 health states and valued 4 health states using the visual analog scale and 23 using the TTO. Mean and variance stability tests were performed to determine whether using a larger number of health states per respondent would yield credible results. Modeling included random effects and random parameters models. RESULTS Between February and May 2008, 321 interviews were performed. Modeling based on 6777 valuations resulted in an additive model with all coefficients statistically significant, R(2) equal to 0.45, and value -0.523 for the worst possible health state. Means and variance did not differ significantly for states valued in the middle and at the end of the TTO exercise. CONCLUSIONS This is the first EQ-5D value set based on TTO in Central and Eastern Europe so far. Because the values differ considerably from those elicited in Western European countries, its use should be recommended for studies in Poland. Increasing the number of health states that each respondent is asked to value using TTO seems feasible and justifiable.

Cost-effectiveness of radial vs. femoral approach in primary percutaneous coronary intervention in STEMI – Randomized, control trial

INTRODUCTION AND OBJECTIVES Primary percutaneous coronary intervention infarction became the preferred method of treatment for myocardial ST segment elevation. Improved safety was reported in transradial access (radial) compared to transfemoral access (femoral). The aim of this study was to compare the cost between the two access points in ST segment elevation myocardial infarction. METHODS This is a subanalysis of the OCEAN RACE trial in which 103 myocardial infarction patients were randomized to either the radial (n=52) or femoral (n=51) groups. The clinical safety and efficacy were recorded during the hospital stay. The procedural metrics were meticulously logged, and costs were evaluated using the micro-cost method. The indirect costs were estimated using the human capital approach. RESULTS Clinical success was numerically higher in the radial group (90.4 vs. 80.4%, p=0.123). There were no differences in major adverse cardiac events (9.6% vs. 11.8%, p=0.48) and death (2.0% vs. 6.0%, p=0.31). The average in-hospital cost per patient was 2,740 ± 1,092 EUR. The cost of therapeutic success was lower in the radial group at 3,060 EUR vs. 3,374 EUR. The indirect costs related to absence at work were 138 EUR per patient, which were lower in the radial group compared to the femoral group. CONCLUSIONS The total in-hospital costs were similar between the study groups. The indirect costs were lower in the radial group. Introduction of radial access as the default approach in all centers may significantly reduce the overall financial burden from a social perspective.

PMC24 SELF-ASSESSED HEALTH STATUS IN POLAND: EQ-5D FINDINGS FROM POLISH VALUATION STUDY

PMC22 THE IMPACT OF COMORBIDITY BURDEN ANDAGE ON PREFERENCE-BASED HRQL INTHE UNITED STATES Sullivan PW, Ghushchyan VH University of Colorado Denver, Aurora, CO, USA OBJECTIVES: Gains in life expectancy have lead to aging populations with more chronic comorbidity. This study aims to examine the impact of age and comorbidity on EQ-5D index scores in a nationally representative sample of the U.S. METHODS: The pooled 2001 and 2003 Medical Expenditure Panel Survey (MEPS) was used. MEPS is a nationally representative survey of the U.S. civilian, noninstitutionalized population based on self-report which collects detailed information on sociodemographic characteristics, medical conditions and HRQL. The total number of chronic conditions for each individual was calculated based on ICD-9 codes. Spline regression was used to allow for nonlinear age effects: individuals were separated into 4 quartiles based on age: 18–31; 32–44; 45–58; and >58 years. Censored least absolute deviations (CLAD), Tobit and OLS methods were used to regress EQ-5D index scores on age and chronic comorbidity, controlling for income, gender, race, ethnicity, education, physical activity and smoking status. Interactions between age and chronic conditions were also explored. RESULTS: After controlling for chronic comorbidities and other confounders, age was not statistically significant except for those >58 years and the magnitude of this coefficient was very small (coefficient age >58 years = -0.0006). However, the coefficients for chronic comorbidities were highly statistically significant with large magnitudes for those with 2 chronic conditions (coefficient 2 chronic conditions = -0.16; coefficient 9 chronic conditions = -0.28). Having only one chronic condition was not statistically significant. The interaction between age and chronic comorbidity was significant, but the deleterious impact of their interaction was largely dominated by the existence and number of chronic conditions. CONCLUSIONS: Chronic conditions have a significant deleterious impact on EQ-5D index scores regardless of age. The negative impact of age on EQ-5D index scores may be due to the existence and degree of chronic comorbidity.

The direct and indirect costs of epilepsy in Poland estimates for 2014–2016 years

ABSTRACT Background: According to the current data, around 1% of the Poland population have epilepsy, which comprises about 400,000 people. This group of patients requires life-long therapy including both drug therapy and hospitalization. The character of the epilepsy has a significant impact on the expenses borne by individual patients, and the prevalence of the disease has a significant impact on the health care system. Methods: This article aims to measure the direct and indirect costs of epilepsy in Poland estimates for the years 2014–2016 (top-down approach). We use a modified human capital approach and a unique dataset provided by the number of Polish institutions including National Health Fund, Social Insurance Institution, and Central Statistical Office. Results: Epilepsy burden in Poland is significant. In the years 2014–2016, the total direct cost of epilepsy amounted to, respectively, 355 mln PLN (84 mln EUR), 368 mln PLN (87 mln EUR), and 373 mln PLN (88 mln EUR), but the total indirect cost amounted to 1 bn PLN (239 mln EUR), 949 mln PLN (224 mln EUR), and 848 mln PLN (200 mln EUR). Conclusions: Direct and indirect costs of epilepsy can be a useful input for health technology analyses of drugs or economic impact assessments of public health programs.

PMC6 ASSESSING PRODUCTIVITY AND ACTIVITY IMPAIRMENT DUE TO ILLNESS IN POLAND

lack of an RCT makes formal technology assessment vs. alternative treatment (e.g., best supportive care [BSC]) challenging. In such instances, naïve indirect comparison based on historical controls is typically employed. We present a method for estimating outcomes for untreated patients when appropriate historical controls are not available, by using data from non-responders in an uncontrolled trial. METHODS: Ofatumumab was licensed for fl udarabineand alemtuzumab-refractory chronic lymphocytic leukaemia (FA-Ref CLL) based on results of an uncontrolled trial (Hx-CD20-406). To evaluate the cost-effectiveness of ofatumumab vs. BSC from the UK National Health Service perspective, a partitioned survival analysis model was developed. Progression free survival (PFS) and overall survival (OS) for ofatumumab were estimated by fi tting Weibull survival functions to failure time data for all FA-Ref patients in Hx-CD20-406. Following a literature search, no suitable historical control representing BSC could be identifi ed; therefore hazard ratios for PFS and OS for BSC vs. ofatumumab were estimated by fi tting Cox regression models to data for non-responders vs. all FA-Ref patients. Costs and utilities were taken from both published and unpublished sources. RESULTS: BSC patients (approximated by non-responders) were estimated to achieve 4.7 months PFS, 11.3 months OS, 0.50 QALYs, and expected lifetime costs of £4,876. Ofatumumab patients were estimated to reach 6.5 months PFS, 17.9 months OS, 0.77 QALYs, with expected lifetime costs of £43,828. CONCLUSIONS: The novel approach presented permits a practical alternative for estimating cost-effectiveness when neither an RCT nor appropriate historical control can be identifi ed. Further research should be conducted using established data sets to validate the methodology, and to address potential limitations, e.g. unobserved differences between treatment groups, and potential benefi ts of treatment in patients classifi ed as non-responders.

PMC14 THE COST OF ABSENTEEISM IN POLAND IN 2007—DIFFERENCES WITHIN THE PROVINCES

PMC12 DEVELOPMENT OF COST CATALOGS FOR COST-EFFECTIVENESS ANALYSES IN GERMANY: RESULTS OF A FEASIBILITY STUDY Scheuringer M, Krobot KJ MSD Sharp & Dohme GmbH, Haar, Germany OBJECTIVES: The aim of the review was to evaluate the efficacy and safety of imiquimod 5% cream compared with vehicle for treating superficial basal cell carcinoma. METHODS: The analysis was performed in accordance with the rules of systematic review, based on the Cochrane Collaboration (Cochrane Reviewer’s Handbook) guidelines and the Health Technology Assessment Agency in Poland (AOTM) recommendations. RESULTS: Two multicenter, vehicle-controlled, randomized clinical trials of high quality were identified according to predefined selection criteria. Treatment with imiquimod 5% cream once a day, 3 times per week resulted in significantly greater complete response rate than vehicle in the period of 6 as well as 12 weeks. Probability of achieving the complete response rate (no histological evidence of superficial basal cell carcinoma in the excised post–treatment target tumor tissue) was significantly greater for imiquimod 5% cream than vehicle and amounted to 18.2 (95% CI: 4.19; 84.84) and 146.14 (95% CI: 69.3; 323.75) respectively at 12 and 6 weeks after treatment. The incidence of adverse events during the treatment period such as application site reaction including itching, pain and tenderness at the target tumor site and local skin reaction such as erythema, scabbing, were more frequently recorded in the group of subjects who received imiquimod 5% cream in comparison with the vehicle group. CONCLUSIONS: Imiquimod 5% cream appears to be effective in the treatment of superficial basal cell carcinoma. A 3 times a week dosing demonstrates high efficacy results with acceptable safety profile, during the 6 as well as 12-week period.

PMC38 INFLUENCE OF DEMOGRAPHIC AND CULTURAL PREDICTORS ON EQ-5D VALUE SET IN THE POLISH POPULATION

PMC36 AN INVESTIGATION OF FACTORIAL STRUCTURE OF SF-36V2 INTHE US GENERAL POPULATION—THE APPLICATION OF CONFIRMATORY FACTOR ANALYSISTHROUGH STRUCTURAL EQUATION MODELLING Chuang LH, Kind P University of York,York, UK OBJECTIVES: SF-36 is one of the most popular and extensively used health outcome measures. A large amount of resources have been devoted to examine the psychometric properties of SF-36, such as scale reliability, validity and the use of exploratory factor analysis or principal component analysis to identify the two latent constructs. However, few studies have examined the factor structure of SF-36 using the right tool -confirmatory factor analysis. None of the available studies have examined the factorial validity of SF-36v2. The study here is to investigate the factorial structure (construct validity) of SF-36v2 in the US general population using confirmatory factor analysis through structural equation modelling (SEM). METHODS: A sample consisting of 3844 non-institutionalized adults was drawn from the National Health Measurement Survey in the US and interviewed over the telephone. SF-36v2 was administered along with other health outcome measures. The factorial structure of SF-36 developed in Keller’s paper (1997) was adopted as a point of departure for the other models. The model’s goodness of fit to the data was evaluated using a number of fit indices, including CFI, TLI, SRMR, RMSEA, S-Bx2 Statistic and the corrected CFI. All analyses were performed using Mplus 3. RESULTS: Keller’s model provided an adequate fit to the data. However, other models that allowed for error terms of items to covary improved the model fit dramatically. The most interesting finding was that the model that contained only the measurement part performed best. That is, a hierarchic structure did not improve the model fit to the data regardless of the composition of higher order factors. CONCLUSIONS: The results supported the 8 hypothetical factors structure as proposed by the SF-36 developers. However, there were some doubts regarding the higher hierarchic construct of SF-36v2. Consequently, the use of two summary scores should be taken with caution.

PMS16 ADALIMUMAB, ETANERCEPT AND INFLIXIMAB FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS-BUDGET IMPACT ANALYSIS ON POLISH NATIONAL HEALTH FUND

ADALIMUMAB, ETANERCEPT AND INFLIXIMAB FORTHE TREATMENT OF ANKYLOSING SPONDYLITIS-BUDGET IMPACT ANALYSIS ON POLISH NATIONAL HEALTH FUND Macioch T, Niewada M,WronaW, Golicki D, Hermanowski T Medical University of Warsaw, Department of Pharmacoeconomics, Warsaw, Poland, Medical University of Warsaw, Department of Experimental and Clinical Pharmacology,Warsaw, Poland OBJECTIVES: To evaluate impact of TNF-alfa inhibitors reimbursement (adalimumab, etanercept and infliximab) in the treatment of ankylosing spondylitis (AS) on Polish National Heath Fund’s budget.METHODS: Budget impact from the perspective of public payer (National Heath Fund) in the 3 years time horizon was constructed. The number of patients eligible for treatment was estimated based on epidemiological data on AS prevalence from other European countries and statement of polish experts on minimal availability of biological treatment in Poland (0.4% of AS patients). Costs analyzed: acquisition costs of drugs, drug administration and treatment monitoring costs, adverse events treatment costs including tuberculosis monitoring and treatment costs, and AS hospitalization costs. Health outcomes included quality-adjusted life-year (QALY) and were estimated based on date from systematic review and economic analysis. Multiple sensitivity and scenario analyses were performed. Values are presented in PLN (exchange rate: 1 Euro = 3.40 PLN). RESULTS: In base scenario 184 AS patients were eligible for TNF-alfa inhibitors treatment annually. Assuming equal market share between adalimumab, etanercept and infliximab total one year treatment cost after market share stabilization were calculated for 10.63 mln PLN and comprised 3.38 and 3.87 mln PLN for adalimumab, etanercept and infliximab-based treatments, respectively. Total 3-years treatment costs assuming one year time to cover target population and 2-years time to reach market share stabilization was 27.72mln PLN. Incremental annual cost while comparing base scenario with worse scenario (all patients treated only with standard care and no TNF-alfa inhibitors) ranged from 5.86 to 10.43 mln PLN. Corresponding health benefit represented annual increase in QALY of 90 to 118 years. CONCLUSIONS: The impact of TNF-alfa inhibitors on Polish National Heath Fund’s budget for limited to less than 200 patients population is marginal.