Potential Cost-Savings From the Use of the Biosimilars in Slovakia.

Objectives: To analyse the market shares of biosimilars in Slovakia and to calculate the potential cost-savings from the use of biosimilars in Slovakia based on two different data sources. Methods: National reimbursement lists from the Czech Republic, Hungary, Poland and Slovakia were used for analyzing the availability of biosimilars with public funding. In addition, the reimbursement dossiers of biosimilars, the justifications of reimbursement decisions by the Slovak Ministry of Health, and final reimbursement decrees, which are published on the webpage of the Slovak Ministry of Health, were utilized for this study. Reimbursement decisions regarding biosimilars by the Slovak Ministry of Health from 2006 to August 2019 were considered and the detailed utilization of biosimilars in 2018 was analyzed based on data from the State Institute for Drug Control. The study was validated based on data from the Slovak National Health Information Center. Results: Fifty four biosimilars were approved by the European Medicines Agency (EMA) in August 2019. Of the total group of licensed biosimilars on the market, 29 biosimilars (54%) were available in the Czech Republic, 28 biosimilars (52%) were available in Poland, and 27 biosimilars (50%) were available in Hungary and 24 biosimilars (44%) were available in Slovakia. Our analysis, based on the data provided by distributors of medicinal products to the State Institute for Drug Control, revealed that the health fund in Slovakia could have saved 35 to 50 million euros per year if biosimilars with marketing authorisations had been available on the Slovak market. The calculations assumed a 25-35% price decrease against the original biological medical products, and that there would be no increase in the utilization of biosimilars in Slovakia. Conclusions: To achieve significant improvement in patient access to biosimilars in Slovakia, a top-down approach establishing targets and quotas for the procurement of biosimilars should be applied.

INTRODUCTION OF HEALTH TECHNOLOGY ASSESSMENT FOR MEDICINES IN SLOVAKIA.

OBJECTIVES: The aim of our study was to describe approaches to health technology assessment (HTA) for medicines in the Slovak healthcare system and the related decision-making processes concerning reimbursement for medicines. METHODS: Analysis of the Slovak legislative framework related to HTA and the reimbursement process for medicines was performed. Additionally, current practices of the Working Group for Pharmacoeconomics, Clinical Outcomes and Health Technology Assessment of the Slovak Ministry of Health were evaluated. RESULTS: In Slovakia, there is always at least one treatment available in each determined therapeutic class with no co-payment. HTA is becoming an established method for the evaluation of cost-effectiveness of medicines in Slovak healthcare policy. The majority of decision makers within Slovakia support the idea of increased use of and the quality and efficiency of HTA methods. However, it is crucial to overcome several practical barriers to facilitate progress in the field of HTA in the Slovak Republic. CONCLUSIONS: It can be seen that participation within the European Network for Health Technology Assessment (EUnetHTA JA 2 and EUnetHTA JA 3 projects) has significantly improved the quality of the process of HTA in Slovakia. Further legislative activities in this field are required due to the approved strategy for European Union cooperation on HTA.

Cost-Utility Analysis of Heberprot-P as an Add-on Therapy to Good Wound Care for Patients in Slovakia with Advanced Diabetic Foot Ulcer.

Objectives: To explore whether Heberprot-P (an epidermal growth factor) is a cost-effective option for the treatment of advanced diabetic foot ulcer as an add-on therapy to good wound care (GWC) in Slovakia from the perspective of health care payers. Methods: A Markov model was constructed to compare the costs and effects of Heberprot-P plus GWC to those of GWC alone from the perspective of health care payers. The 52-week clinical trial period was extended to 5- and 10-year time horizons. Transition probabilities were calculated based on a previous clinical trial of Heberprot, utility values were derived from the scientific literature, and cost vectors were collected from the General Health Insurance Fund database in Slovakia. A one-way deterministic sensitivity analysis was employed to explore the influence of uncertainty for each input parameter on the incremental cost-effectiveness ratio (ICER). Results: Based on the ICER threshold of €30,030 per quality-adjusted life year (QALY) recommended by the Slovak Ministry of Health, Heberprot-P therapy plus GWC is not a cost-effective alternative to GWC alone over a 10-year time horizon. The ICER increases if a longer time horizon is applied, as the incremental costs are similar, but the aggregated utility gain from avoided amputation is lower. Based on the sensitivity analysis, the utility multiplier for the health state "no ulcer after small amputation" had the most impact on the ICER; however, the model was robust to changes in all input parameters. Conclusions: Heberprot-P, as an add-on therapy to GWC in the treatment of advanced diabetic foot ulcer, is not a cost-effective alternative to GWC alone. However, if the unit cost of Heberprot-P were to be reduced to <€273, its ICER would be <€30,030.

Polypharmacy in elderly hospitalised patients in Slovakia.

OBJECTIVE: The aims of the present study were to: analyse the prevalence of polypharmacy in a group of older patients; evaluate the influence of hospital stay on the number of drugs taken; assess the most frequently prescribed pharmacological classes; identify risk factors that predisposed the patient to polypharmacy. Setting The study was carried out in the Department of Internal Medicine of a non-university general hospital. METHOD: In the retrospective study, 600 patients aged 65 years or more were enrolled. They were hospitalised in the period from 1st December 2003 to 31st March 2005. Each person taking six or more medications per day was considered to be a patient with polypharmacy. Particular sociodemographic and clinical characteristics, as well as comorbid conditions, were evaluated as factors potentially influencing the prevalence of polypharmacy. MAIN OUTCOME MEASURE: The number and type of medications taken at the time of hospital admission and discharge were recorded and compared for each patient. RESULTS: Polypharmacy on admission and at discharge was observed in 362 (60.3%) and 374 (62.3%) patients, respectively. Hospitalisation led to a significant increase in the number of medications. The spectrum of medications used corresponded to the proportions of diagnoses in the evaluated group, in which cardiovascular diseases were most prevalent. According to the multivariate analysis using a logistic regression model, diabetes mellitus (odds ratio (OR) 2.40; 95% confidence interval (CI): 1.64-3.50), heart failure (OR 2.14; 95% CI: 1.46-3.14), dementia (OR 2.12; 95% CI: 1.26-3.57), living alone (OR 2.00; 95% CI: 1.28-3.10), arterial hypertension (OR 1.63; 95% CI: 1.08-2.44) and cerebrovascular disease (OR 1.58; 95% CI: 1.03-2.44) significantly increased the risk of the presence of polypharmacy. CONCLUSION: Our study confirmed a relatively high prevalence of polypharmacy in Slovak elderly patients. Polypharmacy risk rose especially with the increased prevalence of diseases of advancing age (diabetes mellitus, heart failure, arterial hypertension, dementia and cerebrovascular diseases). The increasing numbers of medications in inpatients indicate the need for the careful re-evaluation of pharmacotherapy during the stay in hospital.