Exploring the impact of clawback on pharmaceutical expenditure: A case study of public hospitals in Greece.

Several European administrations have applied various mechanisms promoting cost containment to stabilise their budgets for pharmaceutical expenditure. Since 2016, Greece has adopted the clawback as a policy to contain the NHS hospitals' pharmaceutical expenditure, which increased significantly in the 2016-2020 period. The present study reviews the impact of this policy on the operation of NHS hospitals, the uninterrupted supply and rational use of their medicines, along with the sustainability of their finances. The trend of pharmaceutical expenditure for the period 2016-2020 is combined with further analysis of detailed drug consumption data of 15 sampled NHS hospitals. The data is classified by Anatomical Therapeutic Category (ATC) and the percentage of clawback distributed to each ATC and pharmaceutical company is calculated. It was found that a large proportion of the clawback is allocated to a few therapeutic categories (ATCs) and consequently, few pharmaceutical companies are particularly burdened. The increased burden on pharmaceutical companies, due to the continuous increase in the excessive pharmaceutical expenditure of the NHS hospitals and their limited budget, endangers the uninterrupted supply of medicines to hospitals and the viability of pharmaceutical companies. This issue was discussed in a scientific consensus group*, in which participants proposed ways to keep the level of pharmaceutical expenditure in line with patients' needs, the country's economic potential, and the sustainability of pharmaceutical companies.

Sustainability of Healthcare Financing in Greece: A Relation Between Public and Social Insurance Contributions and Delivery Expenditures.

The economic crisis in Greece, which began in 2010 and lasted for 10 years, highlighted the serious problems and challenges of the Greek Social Health Insurance system. The reforms that mainly took place during the crisis provided a temporary solution. They focused on establishing a new National Organization for Healthcare Services (named EOPYY) and merging all the old insurance funds. This paper aims to examine whether this social health insurance fund has been sustainable in the long run. An actuarial model was created to project future expenses and revenues. Demographic and economic trends were considered, while it was assumed that medical technology remains unaltered. The assessment of the system solvency was based on the ratio (Revenue/Liabilities) calculated for each year, from 2020 to 2050. The results led to deficits, the amount and the time point in which they appear depends on how optimistic or pessimistic demographic and economic assumptions were. A new financial flow model was proposed to address the deficits. The results show that under the new model, the system remains solvent until 2050. The state subsidy amount on the employees' health insurance premium was estimated as a percentage of the employees' wage.

Blastocyst versus cleavage embryo transfer improves cumulative live birth rates, time and cost in oocyte recipients: a randomized controlled trial.

RESEARCH QUESTION: Does embryo transfer day (day 5 versus day 3) affect cumulative live birth rates (CLBR), time to live birth (TLB) and cost per live birth (CPL) in recipients of donated oocytes? STUDY DESIGN: A single-centre RCT conducted between April 2017 and August 2018. Recipients of donated oocytes were randomized to cleavage-stage (day 3) or to blastocyst-stage (day 5) embryo transfer. Eligible recipients were aged 18-50 years and in their first or second synchronous cycle. Primary outcome was CLBR (12 months from first embryo transfer), and fresh and subsequent cryopreserved transfers were considered; TLB and CPL were also analysed. RESULTS: Recipients (n = 134) were randomized to the day-3 group (n = 69) or to the day-5 group (n = 65). Day-5 transfer resulted in a 15.9% relative increase in CLBR and a significant shorter TLB compared with day-3 transfer. To reach a 50% CLBR, the day-3 group required 6 months more than the day-5 group (15.3 versus 8.9 months, respectively). The average CPL in the day-3 strategy cost 24% more than the day-5 strategy (€14817.10 versus €10959.20). Clinical pregnancy rate was 25% less in the day-3 group. The trial was prematurely stopped after poor initial results in the day-3 arm led to unplanned interim analysis. CONCLUSIONS: The transfer of blastocyst-stage embryos in recipients of donated oocytes is preferred as it leads to a higher clinical pregnancy rate, live birth rate, shorter time to pregnancy and lower costs to achieve live birth, compared with cleavage-stage embryo transfer.

The impact of economic crisis on the Greek hospitals' productivity.

During the recent economic crisis, Greece implemented a comprehensive reform in the health care system. The 2010 health reform occurred under the constraints imposed by the memorandum of understanding that the Greek Government signed with its EU/International Monetary Fund creditors to control its deficit. The objective of the study is to examine the impact of the reform on the efficiency and productivity of public hospitals in Greece. We use the Malmquist productivity index to comparatively examine the potential changes before and after the reform years. We compare productivity, efficiency, and technological changes using panel data of 111 public acute hospitals operating in Greece throughout the recession period of 2009 to 2012. Bootstrapping methods are applied to allow for uncertainty owing to sampling error and for statistical inference for the Malmquist productivity index and its decompositions. The analysis indicates that the productivity has been increased following the policy changes. It appears that the expected benefits from the reform in general have been achieved, at least in the short-term. This result is examined in the light of management and operations activities, which are related with the reform process. Therefore, at a second stage, the Malmquist index is regressed on variables that may potentially be statistically associated with productivity growth.

Primary Care Doctors' Assessment of and Preferences on Their Remuneration.

Despite numerous studies on primary care doctors' remuneration and their job satisfaction, few of them have quantified their views and preferences on certain types of remuneration. This study aimed at reporting these views and preferences on behalf of Greek doctors employed at public primary care. We applied a 13-item questionnaire to a random sample of 212 doctors at National Health Service health centers and their satellite clinics. The results showed that most doctors deem their salary lower than work produced and lower than that of private sector colleagues. Younger respondents highlighted that salary favors dual employment and claim of informal fees from patients. Older respondents underlined the negative impact of salary on productivity and quality of services. Both incentives to work at border areas and choose general practice were deemed unsatisfactory by the vast majority of doctors. Most participants desire a combination of per capita fee with fee-for-service; however, 3 clusters with distinct preferences were formed: general practitioners (GPs) of higher medical grades, GPs of the lowest medical grade, residents and rural doctors. Across them, a descending tolerance to salary-free schemes was observed. Greek primary care doctors are dissatisfied with the current remuneration scheme, maybe more than in the past, but notably the younger doctors are not intended to leave it. However, Greek policy makers should experiment in capitation for more tolerable to risk GPs and introduce pay-for-performance to achieve enhanced access and quality. These interventions should be combined with others in primary care's new structure in an effort to converge with international standards.

Greek National E-Prescribing System: Preliminary Results of a Tool for Rationalizing Pharmaceutical Use and Cost.

BACKGROUND: In Greece, due to the ongoing economic crisis a number of measures aiming at rationalising expenditure implemented. A new e-prescribing system, under a unified healthcare fund was the main pillar of these reforms focus on monitoring and auditing prescribing patterns. OBJECTIVE: Main objective of this study was to document the Greek experience with the new national e-prescribing system. METHODS: We analyse the dispensed prescriptions over the period 2013-2014, stratified into four levels: therapeutic subgroup, patent status, physician's specialty and geographical region. RESULTS: Data analysis offered a comprehensive insight into pharmaceutical expenditure over the timeframe and revealed discrepancies regarding composition of spending, brand-generic substitution within certain therapeutic subgroups, physicians' prescribing behaviour based on medical specialty, therapeutic subgroup as well as regional per capita measures. CONCLUSIONS: E-prescribing system is a valuable tool providing sound information to health policymakers in order to monitor and rationalize pharmaceutical expenditure, in value and volume terms.

Reengineering NHS Hospitals in Greece: Redistribution Leads to Rational Mergers.

The purpose of this study was to record and evaluate existing public hospital infrastructure of the National Health System (NHS), in terms of clinics and laboratories, as well as the healthcare workforce in each of these units and in every health region in Greece, in an attempt to optimize the allocation of these resources. An extensive analysis of raw data according to supply and performance indicators was performed to serve as a solid and objective scientific baseline for the proposed reengineering of the Greek public hospitals. Suggestions for "reshuffling" clinics and diagnostic laboratories, and their personnel, were made by using a best versus worst outcome indicator approach at a regional and national level. This study is expected to contribute to the academic debate about the gap between theory and evidence based decision-making in health policy.

The efficiency of the public dental services (PDS) in Cyprus and selected determinants.

BACKGROUND: Currently there is a dual system of oral healthcare delivery in Cyprus: the public dental system (PDS) run by the Government and the private system provided by private dental practitioners. Although 83% of the population is entitled to free treatment by the PDS only 10% of the population make use of them. As Cyprus faces now the challenges of the introduction of a new health care system and rising healthcare costs in general, surveys that examine, among other things, the efficiency of the PDS become very important as tools to make important cost savings. The aims of this study are to assess trends regarding the number of visits and the age distribution of patients using PDS from 2004 to 2007, to measure the technical efficiency of the PDS and to investigate various factors that may affect it. METHODS: Non-parametric Data Envelopment Analysis (DEA) was employed to assess technical efficiency. Two separate cases were examined. Efficiency was calculated, firstly using as inputs the wages and the working hours of the personnel, and secondly the working hours of the personnel and the cost of the materials. As outputs, in both cases, the treatment offered (divided into primary, secondary and tertiary care) and the numbers of visits were used. In the second stage Tobit analysis was used to explore various predictors of efficiency (time per patient, location, age of dentists, age of patients and age of assistants). RESULTS: The study showed that whilst there was an increase in the number of patients using the PDS from 2004 to 2007, only a small proportion of the population (10%) make use of them. Women, middle and older aged patients, make more use of the PDS. Regarding efficiency, there were large differences between the units. The average Technical Efficiency score was 68% in the first model and 81% in the second. Urban areas and low time per patient are predictors of increased efficiency. CONCLUSION: The results suggest that many of the rural PDS are underperforming. Given that the option of shutting them down is undesirable, measures should be taken to reduce inputs (e.g. by reducing the personnel's working hours) and to increase outputs (remove barriers, make PDS more accessible and increase the number of patients).

Reforming reimbursement of public hospitals in Greece during the economic crisis: Implementation of a DRG system.

OBJECTIVES: Until recently, in-patient NHS hospital care in Greece was reimbursed via an anachronistic and under-priced retrospective per diem system, which has been held primarily responsible for continuous budget deficits. The purpose of this paper is to present the efforts of the Ministry of Health (MoH) to implement a new DRG-based payment system. METHODS: As in many countries, the decision was to adopt a patient classification from abroad and to refine it for use in Greece with national data. Pricing was achieved with a combination of activity-based costing with data from selected Greek hospitals, and "imported" cost weights. Data collection, IT support and monitoring are provided via ESY.net, a web-based facility developed and implemented by the MoH. RESULTS: After an initial pilot testing of the classification in 20 hospitals, complete DRG reimbursement data was reported by 113 hospitals (85% of total) for the fourth quarter of 2011. The recorded monthly increase in patient discharges billed with the new system and in revenue implies increasing adaptability by the hospitals. However, the unfavorable inlier vs. outlier distribution of discharges and revenue observed in some health regions signifies the need for corrective actions. CONCLUSIONS: The importance of this reimbursement reform is discussed in light of the current crisis faced by the Greek economy. There is yet much to be done and many projects are currently in progress to support this effort; however the first cost containment results are encouraging.

Public procurement of health technologies in Greece in an era of economic crisis.

Public procurement is generally an important sector of the economy and, in most countries, is controlled by the introduction of regulatory and policy mechanisms. In the Greek healthcare sector, recent legislation redefined centralized procurement through the reestablishment of a state Health Procurement Committee (EPY), with an aim to formulate a plan to reduce procurement costs of medical devices and pharmaceuticals, improve payment time, make uniform medical requests, transfer redundant materials from one hospital to another and improve management of expired products. The efforts described in this paper began in early 2010, under the co-ordination of the Ministry of Health (MoH) and with the collaboration of senior staff from the International Monetary Fund (IMF), the European Commission (EC) and the European Central Bank (ECB). The procurement practices and policies set forth by EPY and the first measurable outcomes, in terms of cost savings, resulting from these policies are presented. The importance of these measures is discussed in light of the worst economic crisis faced by Greece since the restoration of democracy in 1974, as a result of both the world financial crisis and uncontrolled government spending.

Financial relationships in economic analyses of targeted therapies in oncology.

PURPOSE: A potential financial relationship between investigators and pharmaceutical manufacturers has been associated with an increased likelihood of reporting favorable conclusions about a sponsor's proprietary agent in pharmacoeconomic studies. The purpose of this study is to investigate whether there is an association between financial relationships and outcome in economic analyses of new targeted therapies in oncology. MATERIALS AND METHODS: We searched PubMed (last update June 2011) for economic analyses of targeted therapies (including monoclonal antibodies, tyrosine-kinase inhibitors, and mammalian target of rapamycin inhibitors) in oncology. The trials were qualitatively rated regarding the cost assessment as favorable, neutral, or unfavorable on the basis of prespecified criteria. RESULTS: Overall, 81 eligible studies were identified. Economic analyses that were funded by pharmaceutical companies were more likely to report favorable qualitative cost estimates (28 [82%] of 34 v 21 [45%] of 47; P = .003). The presence of an author affiliated with manufacturer was not associated with study outcome. Furthermore, if only studies including a conflict of interest statement were included (66 of 81), studies that reported any financial relationship with manufacturers (author affiliation and/or funding and/or other financial relationship) were more likely to report favorable results of targeted therapies compared with studies without financial relationship (32 [71%] of 45 v nine [43%] of 21; P = .025). CONCLUSION: Our study reveals a potential threat for industry-related bias in economic analyses of targeted therapies in oncology in favor of analyses with financial relationships between authors and manufacturers. A more balanced funding of economic analyses from other sources may allow greater confidence in the interpretation of their results.

Anti-Müllerian hormone for the assessment of ovarian response in GnRH-antagonist-treated oocyte donors.

Evidence regarding the role of anti-Müllerian hormone (AMH) among oocyte donors is limited and only involves gonadotrophin-releasing hormone (GnRH)-agonist-treated donors. This trial assessed the predictive ability of AMH for ovarian response among 108 oocyte donors treated with an antagonist protocol. In multivariate linear regression analysis, both AMH and age were independently associated with ovarian response (unstandardized coefficients 0.904 and -0.378, respectively). In receiver operating characteristic curve analysis, AMH performed better than age, but was a modest predictive marker for low (≤ 6 oocytes) and excessive (>20 oocytes) ovarian response (area under the curve (AUC) 0.643 and 0.695, respectively). Similarly, a multivariate logistic model including AMH and age was also modest (AUC 0.651 and 0.697 for low and excessive responders, respectively). The predictive ability of AMH did not significantly alter when different thresholds were adopted, such as <4 oocytes for low response and >25 for excessive response (AUC 0.759 and 0.724, respectively). Among oocyte donors treated with a GnRH-antagonist protocol, although AMH was correlated with the number of oocytes retrieved, it demonstrates a modest ability in discriminating women with low or excessive ovarian response. Selection of oocyte donors is of paramount importance for the proper and more cost-efficient functionality of the oocyte donation programme. Despite the extensive literature regarding the efficacy of anti-Müllerian hormone (AMH) for predicting ovarian response among infertile patients, available evidence regarding the role of AMH in oocyte donors is considerably limited and involves only agonist down-regulated cycles. In this trial we assessed whether AMH can be considered a predictive marker for ovarian response among oocyte donors treated with a gonadotrophin-releasing hormone (GnRH)-antagonist protocol. According to our results, among oocyte donors treated with a GnRH-antagonist protocol, although AMH was correlated with the number of oocytes retrieved, the correlation is not strong and it appears that AMH has a modest predictive ability to discriminate women who are likely to demonstrate either impaired or excessive response to ovarian stimulation.

Industry involvement and baseline assumptions of cost-effectiveness analyses: diagnostic accuracy of the Papanicolaou test.

BACKGROUND: Industry involvement has been associated with more favourable cost-effectiveness ratios in cost-effectiveness analyses, but the mechanisms for this association are unclear. We evaluated whether the assumed accuracy of the Papanicolaou (Pap) test was correlated with the features of cost-effectiveness analysis studies. METHODS: We searched PubMed (last updated April 2010) for cost-effectiveness analysis studies in which at least one strategy involved the Pap test for cervical cancer. We assessed the baseline assumed diagnostic sensitivity and specificity of the Pap test in each study and the association of these values with three levels of manufacturer involvement in the study. RESULTS: Among 88 analyzed cost-effectiveness analysis studies, the assumed sensitivity of the Pap test was lower in studies with manufacturer-affiliated authors, manufacturer funding or manufacturer-related competing interests versus studies without (mean sensitivity 60% v. 70%, p < 0.001). The assumed specificity of the Pap test was lower in cost-effectiveness analyses involving new screening tests (mean 93% v. 96%, p = 0.016). The assumed specificity did not differ between trials with manufacturer involvement versus those without (mean 95% v. 95%, p = 0.755). INTERPRETATION: The results of cost-effectiveness analyses may be affected by a downgrading of the assumed diagnostic accuracy of the standard Pap test against which newer tests or interventions are compared. New technology then seems to have more favourable results against a straw-man comparator.