Development of a core evaluation framework of value-added medicines: report 2 on pharmaceutical policy perspectives.

BACKGROUND: A core evaluation framework that captures the health care and societal benefits of value added medicines (VAMs, also often called repurposed medicines) was proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes across countries and to create incentives for manufacturers to invest into incremental innovation. However, this can be impactful only if the framework can be adapted to heterogeneous health care financing systems in different jurisdictions, and the cost of evidence generation necessitated by the framework takes into account the anticipated benefits for the health care system and rewards for the developers. AREAS COVERED: The framework could potentially improve the pricing and reimbursement decisions of VAMs by adapting it to different country specific decision-contexts such as deliberative processes, augmented cost-effectiveness frameworks or formal multi-criteria decision analysis (MCDA); alternatively, some of its domains may be added to current general evaluation frameworks of medicines. The proposed evaluation framework may provide a starting point for practices based on which VAMs can be exempted from generic pricing mechanisms or can be integrated into the reimbursement and procurement system, allowing for price differentiation according to their added value. Besides evidence from RCTs, pricing and reimbursement decision processes of VAMs should allow for ex-ante non-RCT evidence for certain domains. Alternatively, relying on ex-post evidence agreements-such as outcome guarantee or coverage with evidence development-can also reduce decision uncertainty. CONCLUSIONS: The core evaluation framework for VAMs could trigger changes in the existing pricing, reimbursement and procurement practices by improving the appraisal of the added value created by incremental innovation.

Development of a core evaluation framework of value-added medicines: report 1 on methodology and findings.

BACKGROUND: Medicines that are based on known molecules and are further developed to address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers are called value-added medicines (VAMs). The evaluation process of VAMs is heterogeneous across countries, and it has been primarily designed for originator pharmaceuticals with confirmatory evidence collected alongside pivotal clinical trials. There is a mismatch between evidence requirements by public decision-makers and evidence generated by manufacturers of VAMs. Our objective was to develop a core evaluation framework for VAMs. METHODS: Potential benefits offered by VAMs were collected through a systematic literature review and allocated to separate domains in an iterative process. The draft list of domains and their applicability were validated during two consecutive virtual workshops by health policy experts representing countries with different economic statuses, geographical and decision-making contexts. RESULTS: Based on 158 extracted studies, the final consensus on the evaluation framework resulted in 11 value domains in 5 main clusters, including unmet medical needs, health gain (measured by health care professionals), patient-reported outcomes, burden on households, and burden on the health care system. CONCLUSIONS: The proposed framework could reduce the heterogeneity in value assessment processes across countries and create incentives for manufacturers to invest in incremental innovation. However, some domains may not be equally relevant or accepted in all countries, therefore the core framework needs thorough adaptation in specific jurisdictions.

The self-reported prevalence and disease burden of asthma in Greece.

OBJECTIVES: The primary objective was to estimate the self-reported prevalence of asthma in Greece. The secondary one was to assess the impact of asthma control on patients' health related Quality-of-Life (HRQoL), productivity loss, daily activities and psychological distress. METHODS: A population-based, random-digit dialing, telephone nationwide survey was conducted to recruit patients with asthma. Among the responders, 3,946 met the age criterion (≥18 years) and completed the screening questions regarding asthma. Of them, 353 subjects reported that they had been diagnosed with asthma sometime in their life and completed the survey. Data on demographic and lifestyle characteristics, asthma control, comorbidities, limitations in daily activities, psychological distress, productivity loss, as well as HRQoL, were collected through telephone interview. RESULTS: The lifetime self-reported prevalence of asthma was found to be 9.10% (95% CI:8.14%-9.94%). Sixty three percent of patients had well-controlled (WC) asthma. Asthma control was associated with gender, age, and specific comorbidities. Moreover, patients with not well-controlled (NWC) asthma were more likely to have missed work and reduced productivity during the past 12 months due to their asthma (p < 0.01). Patients with NWC asthma were more likely to declare psychological distress and limitations in their daily living activities. Patients' HRQoL with NWC asthma was significantly worse (0.65 ± 0.24) compared to those with WC asthma (0.86 ± 0.17, p ≤ 0.001). CONCLUSIONS: The results of this survey revealed the link between the asthma control and burden of disease demonstrating the need for the implementation of programs aiming at the management of chronic symptoms related to this condition.

European Society of Cardiology: Cardiovascular Disease Statistics 2017.

Aims: The European Society of Cardiology (ESC) Atlas has been compiled by the European Heart Agency to document cardiovascular disease (CVD) statistics of the 56 ESC member countries. A major aim of this 2017 data presentation has been to compare high-income and middle-income ESC member countries to identify inequalities in disease burden, outcomes, and service provision. Methods and results: The Atlas utilizes a variety of data sources, including the World Health Organization, the Institute for Health Metrics and Evaluation, and the World Bank to document risk factors, prevalence, and mortality of cardiovascular disease and national economic indicators. It also includes novel ESC-sponsored survey data of health infrastructure and cardiovascular service provision provided by the national societies of the ESC member countries. Data presentation is descriptive with no attempt to attach statistical significance to differences observed in stratified analyses. Important differences were identified between the high-income and middle-income member countries of the ESC with regard to CVD risk factors, disease incidence, and mortality. For both women and men, the age-standardized prevalence of hypertension was lower in high-income countries (18% and 27%) compared with middle-income countries (24% and 30%). Smoking prevalence in men (not women) was also lower (26% vs. 41%) and together these inequalities are likely to have contributed to the higher CVD mortality in middle-income countries. Declines in CVD mortality have seen cancer becoming a more common cause of death in a number of high-income member countries, but in middle-income countries declines in CVD mortality have been less consistent where CVD remains the leading cause of death. Inequalities in CVD mortality are emphasized by the smaller contribution they make to potential years of life lost in high-income countries compared with middle-income countries both for women (13% vs. 23%) and men (20% vs. 27%). The downward mortality trends for CVD may, however, be threatened by the emerging obesity epidemic that is seeing rates of diabetes increasing across all the ESC member countries. Survey data from the National Cardiac Societies showed that rates of cardiac catheterization and coronary artery bypass surgery, as well as the number of specialist centres required to deliver them, were greatest in the high-income member countries of the ESC. The Atlas confirmed that these ESC member countries, where the facilities for the contemporary treatment of coronary disease were best developed, were often those in which declines in coronary mortality have been most pronounced. Economic resources were not the only driver for delivery of equitable cardiovascular health care, as some middle-income ESC member countries reported rates for interventional procedures and device implantations that matched or exceeded the rates in wealthier member countries. Conclusion: In documenting national CVD statistics, the Atlas provides valuable insights into the inequalities in risk factors, health care delivery, and outcomes of CVD across the ESC member countries. The availability of these data will underpin the ESC's ambitious mission 'to reduce the burden of cardiovascular disease' not only in its member countries but also in nation states around the world.

Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals - an application on improving tender decision making in Indonesia.

BACKGROUND: Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The aim of this study was to develop a Multi-Criteria Decision Analysis (MCDA) framework through a pilot workshop to inform the national procurement of OPPs in Indonesia. METHODS: An initial list of potentially relevant criteria was identified based on previous work and a literature review. In a 2-day pilot policy workshop, twenty local experts representing different stakeholder groups and decision-making bodies selected the final criteria, approved the scoring function for each criterion, and assigned weights to each criterion. RESULTS: An MCDA framework was proposed for OPP drug decision making in developing countries, which included price and 8 non-price criteria. Based on the pilot policy workshop 6 + 1 criteria were considered relevant for Indonesia: pharmaceutical price (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product stability and drug formulation (12.2%), reliability of drug supply (8.4%), real world clinical or economic outcomes, such as adherence or non-drug costs (4.2%) and pharmacovigilance (3.6%). CONCLUSIONS: According to the pilot policy workshop, other criteria apart from price need to be strengthened in the tendering process. The introduction of additional criteria for OPP procurement in an MCDA framework creates incentives for manufacturers to invest into improved manufacturing standards, equivalence proof, product quality, reliability of supply or even additional real-world data collection, which ultimately may result in more health gain for the society.

Cost-utility of ranibizumab versus aflibercept for treating Greek patients with visual impairment due to diabetic macular edema.

BACKGROUND: To conduct a cost-utility analysis of ranibizumab versus aflibercept for the treatment of patients with visual impairment due to diabetic macular edema (DME) in the Greek setting. METHODS: A Markov model was adapted to compare the use of ranibizumab 0.5 mg (pro re nata-PRN and treat and extend-T&E) to aflibercept 2 mg (every 8 weeks after five initial doses) in DME. Patients transitioned at a 3-month cycle among nine specified health states (including death) over a lifetime horizon. Transition probabilities, utilities, as well as DME-related mortality were extracted from relevant clinical trials, a network meta-analysis and other published studies. The analysis was conducted from payer perspective and as such only costs reimbursed by the payer were considered (year 2014). The incremental cost per quality-adjusted life year (QALY) gained and the net monetary benefit was the main outcome measures. RESULTS: Τhe use of PRN and T&E ranibizumab regimens were shown to be cost saving comparing to aflibercept (by €2824 and €22, respectively), and more beneficial in terms of QALYs gained (+0.05) and time without visual impairment (0.031 and 0.034 years), thereby dominating aflibercept. Moreover, ranibizumab used as PRN or T&E resulted in a net monetary benefit of €3984 and €1278, respectively. CONCLUSIONS: Both PRN and T&E ranibizumab regimens were more beneficial and less costly compared to aflibercept for the management of DME. Hence, ranibizumab seems to be a dominant option for the treatment of visual impairment due to DME in the Greek setting.

Economic evaluation of trimetazidine in the management of chronic stable angina in Greece.

BACKGROUND: To evaluate the cost-effectiveness of trimetazidine (TMZ) as add-on therapy to standard-of-care (SoC) compared to SoC alone in patients with chronic stable angina who did not respond adequately to first line therapy with b-blockers, nitrates or calcium channel antagonists in Greece. METHODS: A Markov model with 3-month cycles and 1-year time horizon was developed to assess the comparators. The analysis was conducted from a third-party payer perspective. The clinical inputs and utility values were extracted from the published literature. Resource consumption data were obtained from local experts, using a questionnaire developed for the purpose of the study and were combined with unit cost data (in €2016) obtained from official sources. Cost effectiveness was assessed by calculating the incremental cost effectiveness ratio (ICER). Probabilistic sensitivity analysis (PSA) was performed to account for uncertainty and variation in the input parameters of the model. RESULTS: The analysis showed that the cost of TMZ plus SoC was €1755.57 versus €1751.76 of SoC alone. In terms of health outcomes, TMZ plus SoC was associated with 0.6650 QALYs versus 0.6562 QALYs for SoC alone. The incremental analysis resulted in an ICER of €430.67 per QALY gained. PSA revealed that the probability of TMZ plus SoC being cost-effective over SoC was 89 %, at a threshold of €34,000 per QALY gained. CONCLUSION: The results indicate that TMZ as add -on treatment may be a highly cost-effective option for the symptomatic treatment of patients with chronic stable angina in Greece relative to SoC alone.

Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer.

PURPOSE: The aim of this study was to compare the effectiveness of prophylactic single fixed dose of pegfilgrastim and daily administration of filgrastim on febrile neutropenia (FN), severe neutropenia, treatment delay, and dose reduction in patients with breast cancer receiving dose-dense adjuvant chemotherapy. METHODS: A retrospective cohort study with 1058 breast cancer patients matched by age and chemotherapy was conducted. The primary endpoints were FN, severe (grade 3, 4) neutropenia, dose reduction (>10 % reduction of the dose planned), and treatment delay (dose given more than 2 days later). RESULTS: Eighteen episodes of FN (3.4%) in the filgrastim group and 23 (4.3%) in the pegfilgrastim group (p = 0.500) were recorded. More than half of the total episodes (27/41) occurred during the first 4 cycles of treatment. Patients who received filgrastim were almost three times more likely to experience a severe neutropenia episode and were significantly more likely to experience a dose reduction (18.5%) compared to those who received pegfilgrastim (10.8%) (p < 0.001). The percentage of patients, who received their planned dose on time, was significantly lower in patients receiving filgrastim (58%) compared to those receiving pegfilgrastim (72.4%, p < 0.001). CONCLUSIONS: No significant difference was detected on FN rate between daily administration of filgrastim and single administration of pegfilgrastim. However, patients receiving pegfilgrastim had a significantly lower rate of severe neutropenia, as well as dose reduction and treatment delay, thus, achieving a higher dose density.

Ranolazine for the symptomatic treatment of patients with chronic angina pectoris in Greece: a cost-utility study.

BACKGROUND: To conduct an economic evaluation comparing ranolazine as add-on therapy to standard-of-care (SoC) with SoC alone in patients with stable angina who did not respond adequately to first line therapy, in Greece. METHODS: A decision tree model was locally adapted in the Greek setting to evaluate the cost-utility of ranolazine during a 6-month period. The analysis was conducted from a third-party payer perspective. The clinical inputs were extracted from the published literature. The cost inputs considered in the model reflect drug acquisition, hospitalizations, vascular interventions and monitoring of patients. The resource utilization data were obtained from 3 local experts. All costs refer to the year 2014. Cost-effectiveness was assessed by means of the incremental cost per quality adjusted life year (QALY) gained with the ranolazine as add-on therapy relative to SoC alone (ICER). Probabilistic sensitivity analysis (PSA) was performed. RESULTS: Ranolazine as add-on therapy was more costly compared to SoC alone, as the 6-month total cost per patient was €1170 and € 984, respectively. Patients received ranolazine plus SoC and SoC alone gained 0.3155 QALYs and 0.2752 QALYs, respectively. Ranolazine plus SoC resulted in an ICER equal to €4620 per QALY gained, well below the threshold of €34,000 per QALY gained. The PSA showed that the likelihood of ranolazine plus SoC being cost-effective at the threshold of €34,000 per QALY gained was 100 %. CONCLUSIONS: Τhe results suggest that ranolazine as add-on treatment may be a cost-effective alternative for the symptomatic treatment of patients with chronic stable angina in Greece.

Everolimus plus exemestane versus bevacizumab-based chemotherapy for second-line treatment of hormone receptor-positive metastatic breast cancer in Greece: An economic evaluation study.

BACKGROUND: The objective of our study was to conduct a cost-effectiveness (CE) study of combined everolimus (EVE) and exemestane (EXE) versus the common clinical practice in Greece for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer (BC) progressing on nonsteroidal aromatase inhibitors (NSAI). The combinations of bevacizumab (BEV) plus paclitaxel (PACL) and BEV plus capecitabine (CAPE) were selected as comparators. METHOD: A Markov model, consisting of three health states, was used to describe disease progression and evaluate the CE of the comparators from a third-party payer perspective over a lifetime horizon. Efficacy and safety data as well as utility values considered in the model were extracted from the relevant randomized Phase III clinical trials and other published studies. Direct medical costs referring to the year 2014 were incorporated in the model. A probabilistic sensitivity analysis was conducted to account for uncertainty and variation in the parameters of the model. Primary outcomes were patient survival (life-years), quality-adjusted life years (QALYs), total direct costs and incremental cost-effectiveness ratios (ICER). RESULTS: The discounted quality-adjusted survival of patients treated with EVE plus EXE was greater by 0.035 and 0.004 QALYs, compared to BEV plus PACL and BEV plus CAPE, respectively. EVE plus EXE was the least costly treatment in terms of drug acquisition, administration, and concomitant medications. The total lifetime cost per patient was estimated at €55,022, €67,980, and €62,822 for EVE plus EXE, BEV plus PACL, and BEV plus CAPE, respectively. The probabilistic analysis confirmed the deterministic results. CONCLUSION: Our results suggest that EVE plus EXE may be a dominant alternative relative to BEV plus PACL and BEV plus CAPE for the treatment of HR+/HER2- advanced BC patients failing initial therapy with NSAIs.

Economic evaluation of rivaroxaban in stroke prevention for patients with atrial fibrillation in Greece.

BACKGROUND: To undertake an economic evaluation of rivaroxaban relative to the standard of care for stroke prevention in patients with non-valvular atrial fibrillation (AF) in Greece. METHODS: An existing Markov model designed to reflect the natural progression of AF patients through different health states, in the course of three month cycles, was adapted to the Greek setting. The analysis was undertaken from a payer perspective. Baseline event rates and efficacy data were obtained from the ROCKET-AF trial for rivaroxaban and vitamin-K-antagonists (VKAs). Utility values for events were based on literature. A treatment-related disutility of 0.05 was applied to the VKA arm. Costs assigned to each health state reflect the year 2013. An incremental cost effectiveness ratio (ICER) was calculated where the outcome was quality-adjusted-life year (QALY) and life-years gained. Probabilistic analysis was undertaken to deal with uncertainty. The horizon of analysis was over patient life time and both cost and outcomes were discounted at 3.5%. RESULTS: Based on safety-on-treatment data, rivaroxaban was associated with a 0.22 increment in QALYs compared to VKA. The average total lifetime cost of rivaroxaban-treated patients was €239 lower compared to VKA. Rivaroxaban was associated with additional drug acquisition cost (€4,033) and reduced monitoring cost (-€3,929). Therefore, rivaroxaban was a dominant alternative over VKA. Probabilistic analysis revealed that there is a 100% probability of rivaroxaban being cost-effective versus VKA at a willingness to pay threshold of €30,000/QALY gained. CONCLUSION: Rivaroxaban may represent for payers a dominant option for the prevention of thromboembolic events in moderate to high risk AF patients in Greece.

Cost-effectiveness analysis of liraglutide versus sitagliptin or exenatide in patients with inadequately controlled Type 2 diabetes on oral antidiabetic drugs in Greece.

BACKGROUND: To evaluate the long-term cost-effectiveness of liraglutide versus sitagliptin or exenatide, added to oral antidiabetic drug mono- or combination therapy respectively, in patients with Type 2 diabetes in Greece. METHODS: The CORE Diabetes Model, a validated computer simulation model, was adapted to the Greek healthcare setting. Patient and intervention effects data were gathered from a clinical trial comparing liraglutide 1.2 mg once daily vs. sitagliptin 100 mg once daily, both combined with metformin, and a clinical trial comparing liraglutide 1.8 mg once daily vs. exenatide 10 µg twice daily, both as add-on to metformin, glimepiride or both. Direct costs were reported in 2013 Euros and calculated based on published and local sources. All future outcomes were discounted at 3.5% per annum, and the analysis was conducted from the perspective of a third-party payer in Greece. RESULTS: Over a patient's lifetime, treatment with liraglutide 1.2 mg vs. sitagliptin drove a mean increase in discounted life expectancy of 0.13 (SD 0.23) years and in discounted quality-adjusted life expectancy of 0.19 (0.16) quality-adjusted life years (QALYs), whereas therapy with liraglutide 1.8 mg vs. exenatide yielded increases of 0.14 (0.23) years and 0.19 (0.16) QALYs respectively. As regards lifetime direct costs, liraglutide 1.2 mg resulted in greater costs of €2797 (€1468) versus sitagliptin, and so did liraglutide 1.8 mg compared with exenatide (€1302 [€1492]). Liraglutide 1.2 and 1.8 mg doses were associated with incremental cost effectiveness ratios of €15101 and €6818 per QALY gained, respectively. CONCLUSIONS: Liraglutide is likely to be a cost-effective option for the treatment of Type 2 diabetes in a Greek setting.

Economic evaluation of ivabradine in the treatment of chronic heart failure in Greece.

BACKGROUND: The objective of our study was to assess the cost-effectiveness of ivabradine plus standard care (SoC) in chronic heart failure (CHF) patients with sinus rhythm and a baseline heart rate ≥ 75 b.p.m. in Greece, in comparison with current SoC alone. METHODS: An existing cost-effectiveness model consisting of two health states, was adapted to the Greek health care setting. All clinical inputs of the model (i.e. mortality rates, hospitalization rates, NYHA class distribution and utility values) were estimated from SHIFT trial data. All costing data used in the model reflects the year 2013 (in €). An incremental cost effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was calculated. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. The horizon of analysis was over patient life time and both cost and outcomes were discounted at 3.5% per year. The analysis was conducted from a Greek third party-payer perspective. RESULTS: The Markov analysis revealed that the discounted quality-adjusted survival was 4.27 and 3.99 QALYs in the ivabradine plus SoC and SoC alone treatment arms, respectively. The cumulative lifetime total cost per patient was €8,665 and €5,873, for ivabradine plus SoC and SoC alone, respectively. The ICER for ivabradine plus SoC versus SoC alone was estimated as €9,986 per QALY gained. The PSA showed that the likelihood of ivabradine plus SoC being cost-effective at a threshold of €36,000/QALY was found to be 95%. CONCLUSIONS: Ivabradine plus SoC may be regarded as a cost-effective option for the treatment in CHF patients in Greece.

Economic evaluation of agomelatine relative to other antidepressants for treatment of major depressive disorders in Greece.

BACKGROUND: Major depressive disorder (MDD) constitutes an important public health problem, as it is highly prevalent in the industrialized world and it is associated with substantial economic consequences for patients, health care providers, insurance and social security organizations and employers. To conduct an economic evaluation comparing agomelatine with other commonly used alternatives for treating patients with major depressive disorder (MDD) in Greece. METHODS: An existing international Markov model designed to evaluate the cost-effectiveness of agomelatine was adapted to the Greek setting. It reflects six different health states, in which patients may move on a monthly basis. The analysis was undertaken from a societal perspective. Transition probabilities, utilities and costs assigned to each health state were extracted from the published literature, government sources and expert opinion. Data reflects the year 2012 and was discounted using a rate of 3.5%. Probabilistic analysis was undertaken to deal with uncertainty. RESULTS: Base case analyses revealed that agomelatine is a dominant therapy for MDD relative to escitalopram, fluoxetine and sertraline, and it appeared to be cost-effective compared to venlafaxine (ICER: €547/QALY). Agomelatine remained a dominant treatment against generic sertraline and fluoxetine, and it appeared to be a cost-effective alternative compared to generic venlafaxine and escitalopram (ICER: €1,446/QALY and €3,303/QALY, respectively). Excluding the indirect cost from the analysis, agomelatine remained a cost-effective alternative over all comparators. In the probabilistic sensitivity analysis agomelatine was dominant in 44.5%, 89.6%, 70.6% and 84.6% of simulated samples against branded venlafaxine, escitalopram, fluoxetine and sertraline, respectively. CONCLUSION: The present evaluation indicates that agomelatine is either a dominant or a cost-effective alternative relative to branded or generic alternatives, in Greece.

Survival from breast cancer in relation to access to tertiary healthcare, body mass index, tumor characteristics and treatment: a Hellenic Cooperative Oncology Group (HeCOG) study.

Apart from tumour, treatment and patient characteristics at diagnosis, access to healthcare delivery may as well play a significant role in breast cancer prognosis. This study aimed to assess the additional impact exerted on survival by travel burden-a surrogate indicator of limited access to healthcare- expressed as geographical distance and/or time needed to reach the tertiary healthcare center from the patient's residence. Between 1997 and 2005, 2,789 women participated in therapeutic clinical trials conducted by the Hellenic Cooperative Oncology Group. The effect of geographical distance and travel time between patient's residence and treating hospital on survival was estimated using Cox proportional hazards regression adjusting for age, menopausal status, tumour size/grade, positive nodes (number), hormonal receptor status, HER2 overexpression, surgery type/treatment protocol as well as for body mass index>30 kg/m2. More aggressive tumour features, older treatment protocols and modifiable patient characteristics, such as obesity (HR: 1.27) adversely impacted on breast cancer survival. In addition, less studied indicators of access to healthcare, such as geographic distance>350 km and travel time>4 h were independently and significantly associated with worse outcomes (HR=1.43 and 1.34 respectively). In conclusion, to address inequalities in breast cancer survival, improvements in access to healthcare services related to increased travel burden especially for patients of lower socioeconomic status should be considered, more than ever at times of financial crisis and independently of already known modifiable patient characteristics.

Economic evaluation in cardiology.

For a variety of reasons, the demand and supply of healthcare services is changing daily and expenditure on healthcare services is increasing with rates well above those of the gross domestic product in most countries, regardless of geography, economic development, and population health status. As resources are scarce, it is necessary to ensure that they are allocated in uses that maximize overall health societal benefit. Economic evaluation of healthcare technologies and interventions is a tool designed to assist decision makers in allocating budgets in ways that will maximize value for money spent. This paper explains the economic approach from the perspective of cardiology.

Health technology assessment: what is it? Current status and perspectives in the field of electrophysiology.

Health technology assessment (HTA) is the multidisciplinary field of policy analysis that studies medical, social, ethical, and economic implications of the development, diffusion, and use of health technologies. Its worldwide diffusion needs to be understood in the context of evidence-based healthcare delivery policy, and it is strongly driven by the search for new cost-containment policies by the governments of universal healthcare systems. This article presents the three main pillars of HTA: evaluating comparative effectiveness, cost-effectiveness, and organizational impact. While comparative analysis is more familiar to cardiologists, cost-effectiveness and organizational studies are less widely known because they expand the perspective of the evaluation to institutional settings and society at large and require significant inter-disciplinary work. Sound economic and organizational studies that extend comparative effectiveness studies may facilitate dialogue between medical science and policymaking.

Atrial fibrillation ablation: a cost or an investment?

In the last decade, catheter ablation (CA) became a viable therapeutic approach for symptomatic patients with atrial fibrillation (AF) non-responsive to antiarrhythmic drugs (AAD). The economic analysis of CA is complex due to the presence of several confounding factors, such as the pattern of AF (paroxysmal AF, persistent or long-term persistent AF), the patient population (age, presence/absence of underlying structural heart disease, comorbidities, etc.), the different techniques for ablation (with impact on complexity and cost of the procedure, as well as on efficacy and safety), and the learning curve and experience of an individual centre (with impact on efficacy and cost effectiveness). At present, CA appears to be cost effective mainly in patients with paroxysmal AF who are refractory to AADs, especially if the success of the procedure and, thus, the benefit in quality of life remains >5 years, with a low complication rate. More data are needed on cost effectiveness of CA of persistent and long-term persistent AF or of AF associated with heart failure. Atrial fibrillation ablation is unlikely to be cost effective for patients who have preserved quality of life despite their AF or for patients whose quality of life is not expected to improve substantially despite elimination of AF (e.g. patients with poor quality of life mainly due to other health problems). These observations may help in the selection of candidates for AF ablation.

Device therapy and hospital reimbursement practices across European countries: a heterogeneous scenario.

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.

Self-reported prevalence of atherothrombosis in a general population sample of adults in Greece; a telephone survey.

BACKGROUND: The aim of this study was to estimate the prevalence of selected atherothrombotic risk factors and several clinical manifestations of atherothrombosis, as well as the utilization rates of selected vascular interventions in Greece. METHODS: During December 2009, 3,007 adults (aged 47 ± 16 years, 48.3% men and 51.7% women) recruited in a random-digit dialed telephone survey (response rate: 16%). The sample size was selected following a multistage and stratified by gender, age group, and Greek region procedure in order to be more representative. Data regarding medical history and socio-demographic characteristics of the participants were collected. RESULTS: Overall, 6.5%, 17.7% and 14.0% of participants reported that they had been diagnosed with diabetes mellitus, hypertension and hypercholesterolemia, respectively. In the overall sample, 2.5% of participants reported that they had been diagnosed with angina, 2.0% with myocardial infarction, 1.6% with stroke and 2.5% with peripheral artery disease. Overall, 1.5% of participants reported that they had undergone percutaneous coronary intervention, 1.4% coronary artery bypass grafting, 0.6% angioplasty of a peripheral vessel, and 0.7% surgery of a peripheral vessel. CONCLUSION: Despite the limitations may occur due to the sampling procedure, the findings of the present study indicate that atherothrombosis affects a large portion of the population in Greece and it is expected to impose a significant economic burden. The data of the current study could contribute in obtaining an accurate estimation of the economic burden of atherothrombosis in Greece because people who are aware of their condition/disease are those who use health care resources.