The Checklist for Standard Methodological Requirements and Reporting of Economic Evaluation of Medicines in Slovakia.

OBJECTIVES: We have developed a scientifically well-grounded, methodological, and reporting checklist for economic evaluation (EE) of medicines in the Slovak health technology assessment process, which serves as a supplement to the Slovak pharmacoeconomic guidelines. METHODS: The checklist was developed using an iterative process in which items were generated and gradually added to the baseline checklist based on shortcomings identified in an analysis of Slovak EEs, using relevant published checklists, and Slovak, as well as international, methodological guidance that was identified in the systematic literature review. The selection of checklist recommendations, their clarity, and relevance to the Slovak setting were validated in the online survey. RESULTS: From the sample of 151 price and reimbursement submissions published between January 2018 and July 2021, almost half of them (n = 73) received at least 1 request from the Ministry of Healthcare to justify or modify the methodology used in the EE; and in 18 proceedings, a negative opinion was issued because of shortcomings identified in the EE. The 25-items preliminary checklist, resulting from an iterative working process, has been validated in an online survey conducted among members of ISPOR Chapter Slovakia. After incorporating relevant comments, the final proposal for the Slovak checklist consists of 55 recommendations. CONCLUSIONS: The research represented the first attempt to create a Slovak EE checklist, which serves as a part of ISPOR Slovakia pharmacoeconomic guidelines. Implementation of the checklist allows checking whether EE meets legislative and methodological requirements and thus helps in improving the appropriateness and standardization of EEs in Slovakia.

Explaining the decline in coronary heart disease mortality rates in the Slovak Republic between 1993-2008.

OBJECTIVE: Between the years 1993 and 2008, mortality rates from coronary heart disease (CHD) in the Slovak Republic have decreased by almost one quarter. However, this was a smaller decline than in neighbouring countries. The aim of this modelling study was therefore to quantify the contributions of risk factor changes and the use of evidence-based medical therapies to the CHD mortality decline between 1993 and 2008. METHODS: We identified, obtained and scrutinised the data required for the model. These data detailed trends in the major population cardiovascular risk factors (smoking, blood pressure, total cholesterol, diabetes prevalence, body mass index (BMI) and physical activity levels), and also the uptake of all standard CHD treatments. The main data sources were official statistics (National Health Information Centre and Statistical Office of the Slovak Republic) and national representative studies (AUDIT, SLOVAKS, SLOVASeZ, CINDI, EHES, EHIS). The previously validated IMPACT policy model was then used to combine and integrate these data with effect sizes from published meta-analyses quantifying the effectiveness of specific evidence-based treatments, and population-wide changes in cardiovascular risk factors. Results were expressed as deaths prevented or postponed (DPPs) attributable to risk factor changes or treatments. Uncertainties were explored using sensitivity analyses. RESULTS: Between 1993 and 2008 age-adjusted CHD mortality rates in the Slovak Republic (SR) decreased by 23% in men and 26% in women aged 25-74 years. This represented some 1820 fewer CHD deaths in 2008 than expected if mortality rates had not fallen. The IMPACT model explained 91% of this mortality decline. Approximately 50% of the decline was attributable to changes in acute phase and secondary prevention treatments, particularly acute and chronic treatments for heart failure (≈12%), acute coronary syndrome treatments (≈9%) and secondary prevention following AMI and revascularisation (≈8%). Changes in CHD risk factors explained approximately 41% of the total mortality decrease, mainly reflecting reductions in total serum cholesterol. However, other risk factors demonstrated adverse trends and thus generated approximately 740 additional deaths. CONCLUSION: Our analysis suggests that approximately half the CHD mortality fall recently observed in the SR may be attributable to the increased use of evidence-based treatments. However, the adverse trends observed in all the major cardiovascular risk factors (apart from total cholesterol) are deeply worrying. They highlight the need for more energetic population-wide prevention policies such as tobacco control, reducing salt and industrial trans fats content in processed food, clearer food labelling and regulated marketing of processed foods and sugary drinks.

Drug Policy in Slovakia.

Slovak law sets clear rules and timelines in the process of approving the price and reimbursement of drugs. During the last decade, the Ministry of Health adopted several cost-containment measures in the price and reimbursement policy. The most effective measures were the implementation of the external referencing of drug prices in 2008 and the reimbursement law in 2011. The new act introduced several regulations such as making stricter rules for the referencing of prices, setting cost per quality-adjusted life-year threshold, and defining new rules for the setting of reimbursements. On one side, implementation of these measures helped to achieve visible cost savings, but, on the other side, cost-containment policies have had some unintended consequences. In recent years, Slovakia has been facing a decreased availability of drugs because of parallel exports. As a result of the government's effort, Slovakia is the only country in the European Union that implemented a legal ban on the re-export of medicines. During the decade before 2011, many innovative drugs were included in the reimbursement system. Because of stricter legal conditions introduced in 2011, there has been a gradual shift in reimbursing innovative drugs from the standard reimbursement system to reimbursement by way of exceptions of health insurance companies. Recently, there has been an ongoing discussion on possible changes to the reimbursement law.