External Reference Pricing for Pharmaceuticals-A Survey and Literature Review to Describe Best Practices for Countries With Expanding Healthcare Coverage.

BACKGROUND: Countries with expanding healthcare coverage (CEHCs) increasingly use external reference pricing (ERP) for pharmaceuticals. The ERP policies must aim to optimize efficiency, minimize disturbances, and maximize access to effective therapies for all patients. OBJECTIVE: This research aims to deduce best practices for prudent ERP regulations from past experiences and currently applied policies and to guide policymakers in CEHCs in implementing robust ERP policies. METHODS: The literature was reviewed for methods and effects of ERP for pharmaceuticals. Pharmaceutical pricing experts from Asia, the Middle East, Russia, and South Africa were surveyed for current approaches to ERP in their respective countries. RESULTS: Key determinants of ERP relate to scope, number, and choice of reference countries; price definitions; computation rules; frequency; and stringency of applying ERP. The scarce evidence shows that ERP seems to lead to narrower price windows with the risk of reducing prices in high-price countries and raising prices in low-price countries. Moreover, launch delays and indirect price effects are often observed. The ERP policies in CEHCs are often applied in isolation, not always in a consistent and transparent manner, neglecting its indirect effects. CONCLUSION: Policymakers should consider a set of requirements when introducing ERP, including clear definitions and decision criteria in full transparency. External reference pricing should inform and serve as a benchmark for pricing decisions, rather than being used as the sole pricing mechanism. External reference pricing is primarily a tool to support decisions regarding on-patent pharmaceuticals, and for off-patent products, competition may prove more effective in reducing prices than ERP.

The implementation process of the Workload Indicators Staffing Need (WISN) method by WHO in determining midwifery staff requirements in Greek Hospitals.

INTRODUCTION: One of the greatest challenges in the healthcare field is planning the health workforce under limited financial resources while being fully capable of responding to an affordable, fair and efficient healthcare system. This study aimed to demonstrate the implementation process of the health workforce planning tool 'Workload Indicators of Staffing Needs' introduced by the World Health Organization. METHODS: A descriptive and cross-sectional study was carried out at four (two public and two private) hospitals in Greece, to estimate midwifery staff requirements at ward level during 2015-2016, using the WISN software tool. Focus group discussions, structured interviews and annual service statistics from the hospitals' records were used to obtain data. RESULTS: Results for both private hospitals showed a shortage in the number of midwives. However, after combining the interpretation of the results, as indicated by the WISN methodology and the structured interviews, current and required staffing is in balance in both. On the other hand, both public hospitals indicate a surplus of midwives (1.83 and 1.33 ratios for the General hospitals in Korinthos and Kalamata, respectively). CONCLUSIONS: This study demonstrated the implementation process of the WISN methodology through its application in midwifery staff at four hospitals in Greece and confirmed its usefulness in estimating staffing requirements. The application of the WISN methodology should be viewed as a vital tool in assessing overstaffing and understaffing through the estimation of workload pressure among different categories of health staff, thus providing the basis for effective health workforce redistribution in Greece.

Shaping Pharmaceutical Tenders for Effectiveness and Sustainability in Countries with Expanding Healthcare Coverage.

Policy makers in countries, aiming to build and expand their healthcare systems and coverage, need effective procedures to support the most efficient use of limited financial resources. Tendering is commonly deployed to minimize and fix the purchasing price for the contract duration, especially for off-patent pharmaceuticals. While tenders can reduce acquisition costs, they may also expose the healthcare systems to risks including drug shortages, quality trade-offs, and ultimately, compromised patient health outcomes. Careful planning is therefore required. The effectiveness and impact of tendering were examined in different healthcare settings to establish good tender practices and to develop guidance for tender stakeholders in countries with expanding healthcare coverage for the effective conduct. The literature was reviewed for tender practices and outcomes in all countries, and tender experts from one multi-national pharmaceutical company in 17 countries with expanding healthcare coverage were surveyed on current tender practices. Tendering is a common practice for multisource pharmaceuticals in most countries worldwide. However, countries with expanding healthcare coverage specifically are vulnerable to the risks of defective tendering practices. Risk factors include non-transparent tender practices, a lack of consistency, unclear tender award criteria, a focus on lowest price only, single-winner tendering, and generally, a lack of impact monitoring. If well planned, managed, and conducted, tenders can be advantageous. Countries with expanding healthcare coverage should approach tenders strategically to achieve the desired improvements in healthcare. The good tender practices derived from this study may guide policy makers and purchasers in countries with expanding healthcare coverage on how to expand access to healthcare at an affordable cost. These include the use of multiple selection criteria and performance monitoring. Plain Language Summary Decision makers in countries aiming to expand their healthcare systems must best use the limited money available for healthcare. Tendering is commonly deployed for pharmaceuticals produced by multiple manufacturers (so-called multisource pharmaceuticals), to choose the product with the lowest price. Through tenders, purchasers request offers from suppliers for the needed products.The ultimate purpose of our research was to develop a guidance on robust tender processes. Therefore, we reviewed the literature to examine the effectiveness and impact of current tendering practices. In addition, we conducted a survey among tender experts from one pharmaceutical company in 17 countries with expanding healthcare coverage.In both the survey and the literature review, we confirmed that worldwide, tendering is a common practice for multisource pharmaceuticals. However, defective tendering practices may increase the vulnerability for some risks including abuse due to intransparent processes, lack of consistency, unclear tender award criteria, a focus on lowest price only, single winner tendering, and generally, a lack of impact monitoring after the end of the tender process.Hence, tenders must be well planned, managed, and conducted to be advantageous. Countries with defined and transparent tender frameworks and processes will be better equipped to achieve the desired improvements in the healthcare systems. 'Good tender practices' include the clear definition of requirements to be used as selection criteria in addition to acquisition costs, and for monitoring of the tender success. 'Good tender practices' may help to manage cost and improve healthcare at the same time.

Systematic review of the cost-effectiveness of transcatheter interventions for valvular heart disease.

Transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve repair (TMVR) are increasingly used for managing patients with valvular heart disease to whom surgery presents a high-risk. As these are costly procedures, a systematic review of studies concerned with their economic assessment was undertaken. The search was performed in PubMed and the Cochrane Library and followed recommended methodological steps. Studies were screened and their data were retrieved and were synthesized using a narrative approach. Twenty-four, good to high quality, evaluations were identified, representing different viewpoints, modelling techniques and willingness-to-pay thresholds. Studies show that in high-risk patients with symptomatic aortic stenosis, TAVI may be cost-effective compared with medical management (MM) across many health care settings. In contrast, studies of TAVI compared with surgical aortic valve replacement (SAVR) yield conflicting and inconclusive results. The limited data available show that TMVR may also be cost-effective relative to MM in mitral valve disease. Existing evidence indicates that transcatheter techniques may be cost-effective options, relative to MM, in high-risk patients with valvular disease. Nonetheless, more research is needed to establish their economic value further, to investigate the drives of cost-effectiveness, and to evaluate surgical with transcatheter techniques in aortic valvular disease.

Cost effectiveness of treatments for non-ST-segment elevation acute coronary syndrome.

BACKGROUND: Acute coronary syndrome (ACS) represents the most common subset of cardiovascular heart diseases and relates to high rates of morbidity and mortality worldwide and, consequently, to both the direct and indirect costs to the health system and society. Given the rising healthcare costs combined with budgetary constraints, health care systems and decision makers are faced with challenging decisions and the need to choose alternative treatments that not only improve patient quantity and quality of life but are also economically attractive. OBJECTIVES: To systematically review the published literature and to identify studies evaluating the cost effectiveness of different treatments for patients presenting with non-ST-segment elevation (NSTE) ACS. DATA SOURCES: A literature search was performed using PubMed and the Cochrane Library until October 2013, with no limit on publication date. STUDY SELECTION: The search was conducted using predetermined inclusion and exclusion criteria, limiting articles to those published in the English language and those reporting results of economic evaluations [i.e. cost-effectiveness (CEA), cost-utility (CUA) cost-minimisation (CMA) cost-consequence (CCA) and cost-benefit (CBA) analyses] of the different treatment therapies used for managing patients presenting with NSTE-ACS. Publications such as editorials, letters to the editor, posters, expert opinions, reviews, systematic reviews, or meta-analyses were excluded. STUDY APPRAISAL METHODS: All studies included were assessed for their methodological quality using the British Medical Journal checklist. RESULTS: A total of 39 studies were included, presenting a wide variation in terms of methodological approaches and settings, thus resulting in different ranges of incremental cost-effectiveness ratios for each treatment evaluated. CONCLUSIONS: Evidence from the present systematic review suggests that the majority of the available treatments represent either cost-saving or cost-effective options for NSTE-ACS patients. Moreover, the cost effectiveness of the available treatments was found to be dependent on various factors, particularly the risk profile of patients and the cost of treatment, and hence there is a need to take these into consideration when making decisions and choices.

The cost effectiveness of implantable cardioverter defibrillators: a systematic review of economic evaluations.

BACKGROUND: Sudden cardiac death (SCD) is the most common cause of death in developed countries, with more than 3 million people dying yearly. Implantable cardioverter defibrillators (ICDs) are considered to be an effective treatment in the primary and secondary prevention of SCD; however, their cost is considerable and this poses questions regarding whether they are worth the investment relative to less expensive pharmacotherapy. OBJECTIVE: The aim of this systematic review is to investigate existing evidence regarding the cost effectiveness of ICD therapy and to identify the key drivers of cost effectiveness, for the purpose of informing interested policy and decision makers. METHODOLOGY: A systematic review of the literature concerning the cost effectiveness of ICDs was undertaken. Electronic databases, including PubMed, Cochrane and Health Economic Evaluations Database were searched based on appropriate terms and their combinations. Economic evaluation studies that examined the cost effectiveness of ICDs were selected and 34 were included for evaluation. RESULTS: Findings from the present analysis show that ICD therapy, in properly selected patients who are at high risk of sudden cardiac death, is associated with similar or better cost-effectiveness ratios compared with other well accepted conventional treatments. The cost effectiveness of ICDs is influenced by several factors, including ICD efficacy and safety, impact on patient quality of life, device original implantation cost, frequency and cost of battery replacement, patient demographics and risk profile and analysis time horizon. CONCLUSION: ICDs may represent a cost-effective option relative to pharmacotherapy in appropriately selected patient groups. The cost-effectiveness ratios appear to be at acceptable and comparable levels to other established treatments in cardiovascular and non-cardiovascular diseases. However, cost effectiveness is highly related to several factors and hence economic efficiency is highly dependent on conditions that need to be fulfilled for each individual case in medical practice. The aforementioned factors and technological advances imply that to ensure cost-effective use of ICD therapy, continuous research is needed.

Depressive Symptoms Among Adolescent Students in Greek High Schools.

Depressive symptoms in adolescence have been a subject of considerable controversy in terms of their nature, severity and identification. Therefore, the objective of this study was to examine the presence of depressive symptoms in Greek adolescent high school students and to explore the relationship between depressive symptoms and sociodemographic characteristics. For that purpose, a cross-sectional study design was conducted in two public schools in Megalopolis, Greece, from April 2012 to July 2012, using a self-administered questionnaire based on DSM-IV. The target population involved 222 high school students and the response rate was 74.75%. Data was analyzed using trend χ(2) test, student's t-test and bivariate analysis. The analysis of survey data was conducted using the SPSS (19.0). Main findings demonstrate that 3.6% had symptoms of major depressive episode. Furthermore, depressive symptoms were significantly higher in girls, while statistically significant relationships were found between students' physical (P<0.01) and mental health (P<0.008), students' experiences in school (P<0.02), students' experiences with friends (P<0.008) and the frequency of depressive symptoms. Overall, the study results reveal that depressive symptoms can occur in adolescents. Early diagnosis, as well as the need for psychological care at adolescence is necessary for the prevention of major depressive disorders.

Comprehensive overview: efficacy, tolerability, and cost-effectiveness of irbesartan.

BACKGROUND: Hypertension represents a major health problem, affecting more than one billion adults worldwide. Irbesartan, an angiotensin II receptor blocker, is considered to be a highly effective treatment in the management of hypertension. The purpose of this review is to evaluate the efficacy, safety and tolerability profile, and cost-effectiveness of treatment with irbesartan in hypertension. METHODS: A review of the literature was conducted using the electronic PubMed and Cochrane Library databases and the Health Economic Evaluations Database of search terms relating to irbesartan efficacy, tolerability, and cost-effectiveness, and the results were utilized. RESULTS: Findings from the present analysis show that irbesartan either as monotherapy or in combination with other antihypertensive agents can achieve significant reductions in blood pressure, both systolic and diastolic, compared with alternative treatment options. Irbesartan was also found to have a renoprotective effect independent of its blood pressure-lowering in patients with type 2 diabetes and nephropathy. Furthermore, irbesartan demonstrated an excellent safety and tolerability profile, with either lower or equal adverse events compared with placebo and other alternative treatments. In terms of economic analyses, compared with other antihypertensive therapy alternatives, irbesartan was found to be a preferred option, that is less costly and more effective. CONCLUSION: The evidence indicates that treating patients with hypertension alone or with type 2 diabetes and nephropathy using irbesartan can control hypertension, prolong life, and reduce costs in relation to existing alternatives.