A new entity for the negotiation of public procurement prices for patented medicines in Mexico

Problem

As countries expand health insurance coverage, their expenditures on medicines increase. To address this problem, WHO has recommended that every country draw up a list of essential medicines. Although most medicines on the list are generics, in many countries patented medicines represent a substantial portion of pharmaceutical expenditure.

Approach

To help control expenditure on patented medicines, in 2008 the Mexican Government created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), whose role, as the name suggests, is to enter into price negotiations with drug manufacturers for patented drugs on Mexico’s list of essential medicines.

Local setting

Mexico’s public expenditure on pharmaceuticals has increased substantially in the past decade owing to government efforts to achieve universal health-care coverage through Seguro Popular, an insurance programme introduced in 2004 that guarantees access to a comprehensive package of health services and medicines.

Relevant changes

Since 2008, the CCPNM has improved procurement practices in Mexico’s public health institutions and has achieved significant price reductions resulting in substantial savings in public pharmaceutical expenditure.

Lessons learnt

The CCPNM has successfully changed the landscape of price negotiation for patented medicines in Mexico. However, it is also facing challenges, including a lack of explicit indicators to assess CCPNM performance; a shortage of permanent staff with sufficient technical expertise; poor coordination among institutions in preparing background materials for the annual negotiation process in a timely manner; insufficient communication among committees and institutions; and a lack of political support to ensure the sustainability of the CCPNM.     

The redistributive effect of health care finance in twelve OECD countries.

The OECD countries finance their health care through a mixture of taxes, social insurance contributions, private insurance premiums and out-of-pocket payments. The various payment sources have very different implications for both vertical and horizontal equity and on redistributive effect which is a function of both. This paper presents results on the income redistribution consequences of the health care financing mixes adopted in twelve OECD countries by decomposing the overall income redistributive effect into a progressivity, horizontal inequity and reranking component. The general finding of this study is that the vertical effect is much more important than horizontal inequity and reranking in determining the overall redistributive effect but that their relative importance varies by source of payment. Public finance sources tend to have small positive redistributive effects and less differential treatment while private financing sources generally have (larger) negative redistributive effects which are to a substantial degree caused by differential treatment.     

Mapping variability in allocation of Long-Term Care funds across payer agencies in OECD countries

IntroductionLong-term care (LTC) is organized in a fragmented manner. Payer agencies (PA) receive LTC funds from the agency collecting funds, and commission services. Yet, distributional equity (DE) across PAs, a precondition to geographical equity of access to LTC, has received limited attention. We conceptualize that LTC systems promote DE when they are designed to set eligibility criteria nationally (vs. locally); and to distribute funds among PAs based on needs-formula (vs. past-budgets or government decisions).ObjectivesThis cross-country study highlights to what extent different LTC systems are designed to promote DE across PAs, and the parameters used in allocation formulae.MethodsQualitative data were collected through a questionnaire filled by experts from 17 OECD countries.Results11 out of 25 LTC systems analyzed, fully meet DE as we defined. 5 systems which give high autonomy to PAs have designs with low levels of DE; while nine systems partially promote DE. Allocation formulae vary in their complexity as some systems use simple demographic parameters while others apply socio-economic status, disability, and LTC cost variations.Discussion and conclusionsA minority of LTC systems fully meet DE, which is only one of the criteria in allocation of LTC resources. Some systems prefer local priority-setting and governance over DE. Countries that value DE should harmonize the eligibility criteria at the national level and allocate funds according to needs across regions.     

OECD国家的医学技术评估借鉴

医学技术评估作为一个新生事物，其重要性和实用性已越来越被各国所重视，成为一项国际性活动。主要以OECD国家为例，探计他们在利用干预机制影响医学技术的发展、传播及使用方面的一些经验教训。     

The price of innovation: new estimates of drug development costs

The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per new drug is 403 million US dollars (2000 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 11% yields a total pre-approval cost estimate of 802 million US dollars (2000 dollars). When compared to the results of an earlier study with a similar methodology, total capitalized costs were shown to have increased at an annual rate of 7.4% above general price inflation.     

经合组织国家医疗改革的过程及其趋势

医疗服务是世界各国共同面临的一个难题，没有哪个国家的民众对本国医疗服务系统感到特别满意。为了满足公平、效率和控制医疗费用等一系列内在冲突的目标，各国的医疗服务系统都在不断地改革、调整，以适应不同的价值目标的要求。二战后经合组织（Organization of Economical Cooperation and Development，OECD）国家的医疗服务改革，大体上经历了三个阶段。笔者主要从政府角色、提供方式、补偿制度等维度，对此进行了考察，以期为我国医疗服务制度建构提供借鉴。     

The effects of drug safety warnings on drug sales and share prices

Current regulations require that when seeking approval for new drugs, pharmaceutical companies must demonstrate their short- but not long-term safety and efficacy. Instead, post-approval, clinicians report adverse reactions to regulators, who may issue additional safety warnings. We investigate the incentives this creates for pharmaceutical companies to seek approval for new drugs with unknown long-term effects. We first construct models predicting that (1) long-run effects can be reasonably approximated from observational follow-up of short-term randomized control trials, and (2) companies will trade-off short-term sales against possible later adverse demand effects. We then test whether regulator warnings over diabetic, analgesic, analeptic, or psychoanaleptic drugs sold in the US and UK hospital and retail sectors affect the sales of individual drugs or the share prices of companies that sell them. With some exceptions, we find that pharmaceutical companies generally face no adverse market reaction in sales or share price from newly issued warnings in these four drug categories.     

Enchancing effect of patented whey protein isolate (Immunocal) on cytotoxicity of an anticancer drug

To determine the enhancing effect of a whey protein isolate on the cytotoxicity of a potential anticancer drug, baicalein, the human hepatoma cell line Hep G2 was assigned to grow in different media for four days, and cell growth and apoptosis were investigated. The control group was grown in normal medium; the other three groups were grown in whey protein isolate (Immunocal) medium, baicalein medium, and a combination of Immunocal and baicalein. As indicated by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide assay, survival rate was significantly lower in cells grown in baicalein + Immunocal than in cells grown in baicalein alone. In contrast, there was no significant difference in survival rate of the cells grown in Immunocal. In the investigation of apoptosis, cells grown in baicalein + Immunocal showed a higher phosphatidylserine exposure, lower mitochondrial transmembrane potential, and nearly 13 times more cells undergoing apoptosis than cells grown in baicalein alone. We also demonstrated that Immunocal reduced glutathione (GSH) in Hep G2 cells by 20-40% and regulated the elevation of GSH, which was in response to baicalein. In conclusion, Immunocal seemed to enhance the cytotoxicity of baicalein by inducing more apoptosis; this increase in apoptotic cells may be associated with the depletion of GSH in Hep G2 cells. This is the first study to demonstrate, in vitro, that Immunocal may function as an adjuvant in cancer treatments.     

七个经合组织国家全球卫生战略比较研究

全球化对健康产生了广泛而深刻的影响,挑战了原有的国际卫生体系,推动了全球卫生概念的提出,开拓了全球卫生治理的新局面。经济合作与发展组织中的七个国家已经发布并实施了国家全球卫生战略。本文比较研究了这些国家出台全球卫生战略的背景、目标利益,指导价值理念、重点领域及战略的制定过程等,并对七国战略的共同点及不同特色进行了总结提炼,发现尊重和维护健康权、积极承担国际责任并发展合作伙伴的能力是共同的价值理念;维护和改善本国人民的健康并为改善全球健康做出贡献、促进国家利益的实现是共同的目标;基于本国比较优势满足发展中国家卫生合作的需求是确定重点领域的关键;加强全球卫生治理、影响健康的全球治理,以及影响全球的卫生治理的思想贯穿战略的始终;多部门和全社会参与战略制订的过程。在借鉴上述国家全球卫生战略核心思想和经验的基础上,提出对中国制订国家全球卫生战略的建议。     

Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries

Background

Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value.

Objective

To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment.

Methods

A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) ‘Responsibilities and structure of HTA agencies’; (2) ‘Evidence and evaluation criteria considered in HTAs’; (3) ‘Methods and techniques applied in HTAs’; and (4) ‘Outcomes and implementation of HTAs’. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts.

Results

All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional ‘social value judgements’ (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making.

Conclusion

More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness.

     

Evaluation of new medicines in Spain and comparison with other European countries

ObjectiveTo compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany.MethodFor each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions.ResultsResults are presented as a summary of the HTA landscape for P&R of new medicines in each country. Comparisons are made between Spain and other countries regarding the procedure and implementation of HTA.ConclusionsBased on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions.     

药品价格调整及集中招标采购对患者药品费用负担的影响

中国医科大学附属第一医院2002年7月－9月间药品实际销售金额为3780．4万元，按2001年6月1日时政策允许的最高零售价格计算可销售4167．2万元，药品实际销售金额降低了9．3％（386．8万元／6167．2万元），其中政府调价因素致药品零售总额下浮4．0％（1671万元／4167．2万元），统一招标采购因素致药品零售总额下浮4．3％（179．8万元／4167．2万元），其他因素致药品零售总额下浮0．95％（39．9万元／4167．2万元。这一结果证实了政府调价及集中招标采购政策的实施已在一定程度上减轻了社会的药品费用负担，但评估降低药品零售价格的措施对降低社会总药品费用的影响程度是一个复杂的过程，参与因素较多，单纯以某类或某品牌药品价格降低的幅度并不能准确反映社总药品费用减轻的程度。     

Does size matter? The impact of caseload and expertise concentration on AMI 30-day mortality—A comparison across 10 OECD countries

Objective

To examine the variability of hospital performance within and across countries, using 30-day acute myocardial infarction (AMI) mortality, and to study the impact of hospital characteristics on performance.

The welfare cost of violence across countries

The cost of violence goes beyond its material dimension, including also the welfare loss due to higher mortality. A given mortality, and its distribution across age groups, determines a reduction in life expectancy that can be valued using the marginal willingness to pay approach. We estimate the health dimension of the welfare cost of violence for 73 countries. On average, 1 year of life expectancy lost to violence is associated with a yearly social cost of 3.8% of GDP. The health dimension increases the estimated social costs of violence by 40% in the United States and by 57% in Latin America.     

A note on the impact of hours worked on mortality in OECD countries

We investigate whether an increase in hours worked per employed person raises the total mortality rate in a sample of 23 OECD countries. We build on earlier research but extend the analysis by introducing the number of hours worked per employed as an additional regressor. Contrary to our expectations, we found that an increase in the number of hours worked actually has significantly negative effect on mortality rate, even controlling for income. Although one explanation may be that fluctuations in hours of work is in fact in this setting more a measure of the capacity use rate of the economy than a measure of how stressful work is for individuals who are working, more research on the topic is needed to find a plausible explanation for the observed phenomenon.     

The impact of DRG-based payment systems on quality of health care in OECD countries

Ever since DRG-based payment systems were first introduced in the United States in 1983, the medical community has expressed concern about the potential impact of these price control systems on the quality of care. Several research studies have examined the impact of DRG-based payment systems on the quality of care within a single state in the United States, or within a specific country. We have not identified any attempts in the literature to examine the impact of DRG-based payment systems on the quality of health care across different countries. In this article we contribute to the debate by (1) providing a unique identification of DRG adoption status for each of 35 countries, (2) refining an international case mix index, and (3) applying it to examine whether DRG-based payments impact the quality of health care across national and cultural boundaries. We find some evidence for Organization for Economic Cooperation and Development countries that, compared with non-adopters, adoption of DRG-based payment systems is associated with faster hospital case mix increases and slower quality gains with respect to patient mortality from surgical and medical misadventures.     

我国药品价格管理的对策探讨——基于“药品降价令”的思考

通过文献研究,阐述了我国药品价格管理现状;采用比较、归纳法,总结国际药品价格管理经验;最后从制度、利益、市场层面提出了完善药品价格管理体系建设、加强流通环节管理等治理对策。     

The impact of minimum wages on population health: evidence from 24 OECD countries

This study examines the relationship between minimum wages and several measures of population health by analyzing data from 24 OECD countries for a time period of 31 years. Specifically, I test for health effects as a result of within-country variations in the generosity of minimum wages, which are measured by the Kaitz index. The paper finds that higher levels of minimum wages are associated with significant reductions of overall mortality rates as well as in the number of deaths due to outcomes that have been shown to be more prevalent among individuals with low socioeconomic status (e.g., diabetes, disease of the circulatory system, stroke). A 10% point increase of the Kaitz index is associated with significant declines in death rates and an increase in life expectancy of 0.44 years. Furthermore, I provide evidence for potential channels through which minimum wages impact population health by showing that more generous minimum wages impact outcomes such as poverty, the share of the population with unmet medical needs, the number of doctor consultations, tobacco consumption, calorie intake, and the likelihood of people being overweight.