Efficiency of Diagnostic Testing for Helicobacter pylori Infections-A Systematic Review.

BACKGROUND: The most recommended treatment for a Helicobacter pylori infection is high doses of combined antibiotics. The objective of this article is to perform a systematic review of the economic evaluation studies applied to assess the efficiency of diagnostic testing for H. pylori infections, so that their main characteristics can be identified and to learn from the literature how the antimicrobial resistance (AMR) issue is incorporated into these economic evaluations. METHODS: We conducted a systematic review to compare the costs and clinical effectiveness of diagnostic strategies for H. pylori infections. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and extracted the items from the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: We found thirteen articles that were of good quality according to CHEERS: six studies focused on diagnostics of Helicobacter pylori infections associated with dyspepsia and four on duodenal ulcers. Testing was found to be the most cost-effective strategy in eight articles. Four studies considered AMR. CONCLUSIONS: Testing was more cost-effective than empirical treatment, except in cases of high prevalence (as with developing countries) or when patients could be stratified according to their comorbidities. The introduction of AMR into the model may change the efficiency of the testing strategy.

Diagnostic Testing for Sepsis: A Systematic Review of Economic Evaluations.

INTRODUCTION: Sepsis is a serious and expensive healthcare problem, when caused by a multidrug-resistant (MDR) bacteria mortality and costs increase. A reduction in the time until the start of treatment improves clinical results. The objective is to perform a systematic review of economic evaluations to analyze the cost-effectiveness of diagnostic methods in sepsis and to draw lessons on the methods used to incorporate antimicrobial resistance (AMR) in these studies. MATERIAL AND METHODS: the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed, and the Consolidated Health Economic Evaluation Reporting standards (CHEERS) checklist was used to extract the information from the texts. RESULTS: A total of 16 articles were found. A decision model was performed in 14. We found two ways to handle resistance while modelling: the test could identify infections caused by a resistant pathogen or resistance-related inputs, or outcomes were included (the incidence of AMR in sepsis patients, antibiotic use, and infection caused by resistant bacterial pathogens). CONCLUSION: Using a diagnostic technique to detect sepsis early on is more cost-effective than standard care. Setting a direct relationship between the implementation of a testing strategy and the reduction of AMR cases, we made several assumptions about the efficacy of antibiotics and the length-of-stay of patients.

The Use of Risk-Sharing Contracts in Healthcare: Theoretical and Empirical Assessments.

OBJECTIVE: The aim of this review is to provide a summary of the literature on risk-sharing agreements, including conceptual, theoretical and empirical (number of agreements and their achievements) perspectives, and stakeholders'  perceptions. METHODS: We conducted a systematic literature search in MEDLINE from 2000 to April 2019, following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology, and completed it with a manual search of other publications (mainly grey literature). The search was restricted to publications with English abstracts; the initial identification of articles was restricted to the title, abstract and key words fields. The geographical scope was not restricted. RESULTS: Over 20 studies proposed different taxonomies of risk-sharing contracts, which can be summarised as financial and paying-for-performance agreements. Theoretical studies modelling the incentives to implement risk-sharing agreements are scarce; they addressed different types of contracts and regulatory contexts, characterizing the drug prices and the optimal strategies of the involved agents. Empirical studies describing specific agreements are abundant and referred to different geographical contexts; however, few articles showed the economic results and assessed the value of such contracts. Stakeholders' perceptions of risk-sharing contracting were favourable, but little is known about the economic and clinical advantages of specific agreements. Whether risk-sharing contracts have yielded the desired results for healthcare systems remains uncertain. CONCLUSION: Risk-sharing contracts are increasingly used, although the lack of transparency and aggregated registries makes it difficult to learn from these experiences and assess their impact on healthcare systems.

Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists.

BACKGROUND: Concerns about financial sustainability of health systems have promoted the adoption of risk-sharing agreements. Nevertheless, few insights have been derived, due to their confidentiality. The purpose of this study is to analyze to what extent these agreements have been implemented in Spain and the importance of several clinical and management variables concerning their use. We also explore whether risk-sharing agreements promote the adoption of personalized medicine. We give a descriptive analysis based on a questionnaire sent to members of the Spanish Society of Hospital Pharmacy, asking about the implementation of risk-sharing contracts in their hospitals. RESULTS: There were 80 replies. Implementation of risk-sharing agreements was high (90%), being oncology, neurology, dermatology and infectious diseases the main specialties. The most relevant variables were the number of units of medication per year (89%) in price-volume agreements, and the efficacy and uncertainty of treatments (over 75%) in pay-for-performance agreements. Price-volume agreements were suitable for both conventional and personalized medicine and pay-for-performance more specific for personalized medicine. Paying for performance promotes genetic testing (85%). CONCLUSIONS: The results suggest health authorities should encourage the assessment of financial and health outcomes of real-world contracts of conventional and personalized medicine to better know the variables influencing their use.

Personalized Medicine and Pay for Performance: Should Pharmaceutical Firms be Fully Penalized when Treatment Fails?

In this article, we model the behavior of a pharmaceutical firm that has marketing authorization for a new therapy believed to be a candidate for personalized use in a subset of patients, but that lacks information as to why a response is seen only in some patients. We characterize the optimal outcome-based reimbursement policy a health authority should follow to encourage the pharmaceutical firm to undertake research and development activities to generate the information needed to effectively stratify patients. Consistent with the literature, we find that for a pharmaceutical firm that does not undertake research and development activities, when the treatment fails, the total price of the drug must be returned to the healthcare system (full penalization). By contrast, if the firm undertakes research and development activities that make the implementation of personalized medicine possible, treatment failure should not be fully penalized. Surprisingly, in some cases, particularly for high-efficacy drugs and small target populations, the optimal policy may not require any penalty for treatment failure. To illustrate the main results of the analysis, we provide a numerical simulation and a graphical analysis.

Implementing personalized medicine with asymmetric information on prevalence rates.

Although personalized medicine is becoming the new paradigm to manage some diseases, the economics of personalized medicine have only focused on assessing the efficiency of specific treatments, lacking a theoretical framework analyzing the interactions between pharmaceutical firms and healthcare systems leading to the implementation of personalized treatments. We model the interaction between the hospitals and the manufacturer of a new treatment as an adverse selection problem where the firm does not have perfect information on the prevalence across hospitals of the genetic characteristics of the patients making them eligible to receive a new treatment. As a result of the model, hospitals with high prevalence rates benefit from the information asymmetry only when the standard treatment is inefficient when applied to the patients eligible to receive the new treatment. Otherwise, information asymmetry has no value. Personalized medicine may be fully or partially implemented depending on the proportion of high prevalence hospitals.

[Impact of the Royal Decree-Law 16/2012 on the number of prescriptions and pharmaceutical expenditures]. / Impacto del Real Decreto-Ley 16/2012 sobre el copago farmacéutico en el número de recetas y en el gasto farmacéutico.

BACKGROUND: this research aims to understand if the consequences on drug expenditures and number of prescriptions of Royal Decree-Law 16/2012 as estimated by the Ministry of Health, Social Services and Equality (MHSSE) are similar to those found by using common statistical approaches. In addition, several models have been built to forecast the evolution of both variables for the period September 2013-December 2014. METHODS: the Box-Jenkins methodology and the Box-Tiao intervention analysis were applied to data of the period 2003-13 to forecast the monthly values of the number of prescriptions and pharmaceutical expenditures. Forecasts were used in a counter-factual analysis to be compared to the actual values of prescriptions and drug expenditures. Moreover, forecasts for the period September 2013 to December 2014 were obtained to observe the impact of the policy in the future. RESULTS: the counterfactual analysis estimated a decrease in the number of prescriptions of 12.18% and 12.83% in the pharmaceutical expenditure; these figures were 12,75% and 14,03% respectively, when the intervention analysis was used. CONCLUSION: the estimated reduction in the number of prescriptions for the period June 2012-August 2013 was similar to the figure offered by the MHSSE, while the reduction in the drug expenditure series was smaller. The Box-Jenkins methodology generated low forecast errors (less than 3%) what makes this procedure useful to reliably anticipate future consumptions.

Should the patent system for pharmaceuticals be replaced? A theoretical approach.

This paper acknowledges the difficulties of providing access to innovative drugs in some jurisdictions under the patent system and it contributes to the current debate on mechanisms aimed at facilitating such access. We employ a highly stylized static model of two markets (North and South) to analyse the conditions under which a new system based on royalty payments would be preferred to a patent system for pharmaceuticals. In the welfare calculations we have considered explicitly the influence of marketing activities by the patent owner as well as the shadow price of public funds needed to finance the royalties. The bargaining power of the firm in terms of obtaining higher compensation is also considered. The result: are not unambiguously conclusive being heavily dependent on the relevant values of the parameters. Nevertheless, it seems that for realistic parameter values, the new system could be preferred by all the parties involved.

Methodological reviews of economic evaluations in health care: what do they target?

INTRODUCTION AND OBJECTIVES: An increasing number of published studies of economic evaluations of health technologies have been reviewed and summarized with different purposes, among them to facilitate decision-making processes. These reviews have covered different aspects of economic evaluations, using a variety of methodological approaches. The aim of this study is to analyze the methodological characteristics of the reviews of economic evaluations in health care, published during the period 1990-2010, to identify their main features and the potential missing elements. This may help to develop a common procedure for elaborating these kinds of reviews. METHODS: We performed systematic searches in electronic databases (Scopus, Medline and PubMed) of methodological reviews published in English, period 1990-2010. We selected the articles whose main purpose was to review and assess the methodology applied in the economic evaluation studies. We classified the data according to the study objectives, period of the review, number of reviewed studies, methodological and non-methodological items assessed, medical specialty, type of disease and technology, databases used for the review and their main conclusions. We performed a descriptive statistical analysis and checked how generalizability issues were considered in the reviews. RESULTS: We identified 76 methodological reviews, 42 published in the period 1990-2001 and 34 during 2002-2010. The items assessed most frequently (by 70% of the reviews) were perspective, type of economic study, uncertainty and discounting. The reviews also described the type of intervention and disease, funding sources, country in which the evaluation took place, type of journal and author's characteristics. Regarding the intertemporal comparison, higher frequencies were found in the second period for two key methodological items: the source of effectiveness data and the models used in the studies. However, the generalizability issues that apparently are creating a growing interest in the economic evaluation literature did not receive as much attention in the reviews of the second period. The remaining items showed similar frequencies in both periods. CONCLUSIONS: Increasingly more reviews of economic evaluation studies aim to analyze the application of methodological principles, and offer summaries of papers classified by either diseases or health technologies. These reviews are useful for finding literature trends, aims of studies and possible deficiencies in the implementation of methods of specific health interventions. As no significant methodological improvement was clearly detected in the two periods analyzed, it would be convenient to pay more attention to the methodological aspects of the reviews.

Should health authorities offer risk-sharing contracts to pharmaceutical firms? A theoretical approach.

In this paper, we characterise the risk-sharing contracts that health authorities can design when they face a regulatory decision on drug pricing and reimbursement in a context of uncertainty. We focus on two types of contracts. On the one hand, the health authority can reimburse the firm for each treated patient regardless of health outcomes (non risk-sharing). Alternatively, the health authority can pay for the drug only when the patient is cured (risk-sharing contract). The optimal contract depends on the trade-off between the monitoring costs, the marginal production cost and the utility derived from treatment. A non-risk-sharing agreement will be preferred by the health authority, if patients who should not be treated impose a relatively low cost to the health system. When this cost is high, the health authority would prefer a risk-sharing agreement for relatively low monitoring costs.

Healthy vs. unhealthy food: a strategic choice for firms and consumers.

In this paper, we carry out a theoretical analysis of the strategic choice made by firms regarding the type of food they market when they face consumers who care about the healthy/unhealthy attributes of the product but incur in emotional/health costs when the food they consume has unhealthy attributes. We consider a two-stage game. In the first stage, one of the firms chooses the unhealthy content of its product. In the second stage, both firms simultaneously decide their prices. We find that, depending on the parameters of the model, product differentiation can be maximal or less than maximal. The firm that produces the unhealthy food charges a higher price and obtains a larger share of the market unless the emotional/health costs and the unhealthy food production costs are relatively high. We also find that educational campaigns will not always reduce the demand for the unhealthy food or the degree of the unhealthy attribute.JEL Classification:I10, I18, L11.

Transferability indices for health economic evaluations: methods and applications.

In this paper, we have elaborated an index in two phases to measure the degree of transferability of the results of the economic evaluation of health technologies. In the first phase, we have considered the objective factors (critical and non-critical) to derive a general transferability index, which can be used to measure this internal property of the studies of economic evaluation applied to health technologies. In the second phase, with a more specific index, we have measured the degree of applicability of the results of a given study to a different setting. Both indices have been combined (arithmetic and geometric mean) to obtain a global transferability index. We have applied the global index to a sample of 27 Spanish studies on infectious diseases. We have obtained an average value for the index of 0.54, quite far from the maximum theoretical value of 1. We also found that 11 studies lacked some critical factor and were directly deemed as not transferable.

Utilización de un impuesto sobre ventas de tabaco en la fase minorista destinado a la financiación de la farmacoterapia para la deshabituación tabáquica / Use of a retail sales tax on tobacco to fund drug therapy for smoking cessation

Objetivos: Se analiza la capacidad de generar ingresos fiscals de un potencial impuesto sobre el tabaco en la fase minorista y sus efectos sobre la salud pública, si los ingresos fuesen destinados a financiar programas de cesación tabáquica. Métodos: Tras una revisión de la legislación de la capacidad jurídica de las comunidades autónomas de establecer y recaudar impuestos especiales, se describe un nuevo impuesto sobre las ventas de tabaco en la fase minorista. Se calculan la potencial recaudación de impuestos mediante un modelo de simulación de la imposición indirecta –el modelo SINDIEF (Simulador de Imposición Indirecta del Instituto de Estudios Fiscales)– y se estima el número potencial de fumadores que abandonaría el consumo de tabaco. Se han empleado variables epidemiológicas y clínicas de las terapias farmacológicas existents para la obtención de los resultados. Resultados: Para la tasa mayor (20 céntimos de euro por cajetilla), se estima que 1.078.000 fumadores abandonarían anualmente el consumo de tabaco. Los resultados sugieren que el nuevo impuesto se podría considerar como una forma de promocionar la farmacoterapia aplicada a los fumadores. Conclusiones: La corresponsabilidad fiscal para financiar los programas de cesación podría basarse en un impuesto sobre las ventas de tabaco en la fase minorista similar al establecido para los hidrocarburos. Las simulaciones para diferentes valores del gravamen muestran el gran potencial del impuesto para generar ingresos, ya que el impuesto se aplica anualmente a 4.600 millones de cajetillas de cigarrillos (AU)

Objectives: To analyze the revenue-generating potential of a new retail sales tax on tobacco and its effects on public health if the tax revenues were allocated to finance smoking cessation programs. Methods: We provide an extensive review of the legislation on the authority of autonomous communities to order the levy and collection of special taxes and describe the new tobacco retail sales tax. We calculated collected tax revenues with a simulation model of indirect taxation -the SINDIEF (Simulador de Imposición Indirecta del Instituto de Estudios Fiscales) model– and determined the potential number of smokers who would quit smoking. Epidemiological and clinical variables from existing pharmacological therapies were used to obtain the results. Results: For the highest tax rate (20 eurocents per pack), we found that 1,078,000 smokers yearly would give up smoking, suggesting that the new tax could be considered as a way to promote pharmacotherapy in smoking behavior. Conclusions: Fiscal corresponsability to finance smoking cessation programs could be based on a tobacco retailing sales tax, similar to that levied on hydrocarbons. Simulations for different tax rates show the huge potential of the tax to yield revenues, as the tax is levied yearly on 4.6 billion cigarette packs each year (AU)