Risk sharing in managed entry agreements—A review of the Swedish experience

BackgroundIn 2014 managed entry agreements (MEA) between Swedish health care payers (county councils), the reimbursement authority (the Dental and Pharmaceutical Benefits Agency (TLV)) and pharmaceutical companies were introduced to facilitate early and equal access to treatments. MEAs complement the value-based pricing system for out-patient drugs and enables stake-holders to negotiate risk-sharing agreements.AimThe aim of the study was to review existing agreements, describe the type of uncertainty dealt with, and to analyze incentives created using the literature on performance-based reimbursement schemes in Sweden.MethodA document review of all agreements made in the period January 2015 to August 2019 was conducted, classifying agreements by the type of uncertainty dealt with.ResultsAgreements were made for 56 products during the studied time period (45 ongoing), mainly in the fields of hepatitis C (n = 10) and oncology (n = 14). Uncertainties addressed in ongoing agreements included size of treated population (10), treatment duration (13), and effectiveness (9). The mechanism for risk-sharing was limited to refunds based on patient numbers, duration or just flat-rate refunds. The estimated refund in 2018 was 50 % of total sales.DiscussionThis review show that the main driver behind risk sharing in Sweden so far have seem to be affordability rather than managing uncertainty.     

An evaluation of the Public Health Responsibility Deal: Informants’ experiences and views of the development,implementation and achievements of a pledge-based,public–private partnership to improve population health in England

ObjectivesThe Coalition Government's Public Health Responsibility Deal (RD) was launched in England in 2011 as a public–private partnership designed to improve public health in the areas of food, alcohol, health at work and physical activity. As part of a larger evaluation, we explored informants’ experiences and views about the RD's development, implementation and achievements.MethodsWe conducted 44 semi-structured interviews with 50 interviewees, purposively sampled from: RD partners (businesses, public sector and non-governmental organisations); individuals with formal roles in implementing the RD; and non-partners and former partners. Data were analysed thematically: NVivo (10) software was employed to manage the data.ResultsKey motivations underpinning participation were corporate social responsibility and reputational enhancement. Being a partner often involved making pledges related to work already underway or planned before joining the RD, suggesting limited ‘added value’ from the RD, although some pledge achievements (e.g., food reformulation) were described. Benefits included access to government, while drawbacks included resource implications and the risk of an ‘uneven playing field’ between partners and non-partners.ConclusionsTo ensure that voluntary agreements like the RD produce gains to public health that would not otherwise have occurred, government needs to: increase participation and compliance through incentives and sanctions, including those affecting organisational reputation; create greater visibility of voluntary agreements; and increase scrutiny and monitoring of partners’ pledge activities.     

Bargaining for health: A case study of a collective agreement-based health program for manual workers

This paper examines the short- and medium-term effects of the PensionDanmark Health Scheme, the largest privately administered health program for workers in Denmark, which provides prevention and early management of work-related injuries. We use a difference-in-differences approach that exploits a natural variation in the program rollout across collective agreement areas in the construction sector and over time. The results show only little evidence of an effect on the prevention of injuries requiring medical attention in the first 3 years after the program was introduced. Despite this, we find evidence of significant positive effects on several labor market outcomes, suggesting that the program enables some work-injured individuals to maintain their work and earnings capacity. In view of its low costs, the program appears to be cost-effective overall.     

英国患者用药可及性方案实施经验及对我国的启示

风险分担协议在提高患者对药品的可及性、降低药品成本效果的不确定性和控制医保基金财务风险等方面取得了显著成效,受到各国政府或保险人的广泛关注。本文系统梳理了英国患者用药可及性方案,包括方案的起源、分类、应用流程、实施效果等。指出我国已基本具备了实施风险分担协议的条件,但仍需进一步明确风险分担协议实施主体,构建风险分担协议标准化流程,同时加强卫生技术评估在卫生资源配置中的应用,以逐步推进风险分担协议的实施等建议,以期完善我国药品谈判制度,提高药品谈判的科学性和效率。     

Harnessing trade and investment agreements to promote public health

There is an underlying tension between the goals of trade liberalisation and a nation's sovereign right to regulate on matters of public health. In terms of trade in goods, Article XX(b) of the General Agreement on Tariffs and Trade (GATT) allows for measures necessary to protect human health, as one of the general exceptions. The increasing proliferation of comprehensive Free Trade Agreements (FTA) also contains general exception clauses to protect human health. International Investment Agreements contain provisions carving out an exception for tobacco products, from the scope of Investor State Dispute Settlement (ISDS) claims against the host State. The aim of this article is to examine if the public health exceptions in FTAs differ from those under the GATT, and whether they can be used as an avenue for effective regulation. In the context of investment, the article examines if a ‘carve-out’ from ISDS is a feasible option. The article concludes by observing that it may be difficult for FTAs to provide for broader regulatory autonomy to States, given the resort to the World Trade Organization (WTO) jurisprudence in FTA dispute settlement. Effectively, measures to regulate alcohol for the protection of public health may have to be designed and structured in a WTO compatible manner. In terms of ISDS, a ‘carve-out’ from dispute settlement may provide increased regulatory space but would depend on whether consensus can be achieved in this regard. States should approach the regulation of alcohol in a comprehensive manner addressing potential challenges under the trade and investment regimes.     

Trade and health: how World Trade Organization (WTO) law affects alcohol and public health

Aims The alcohol field is becoming more aware of the consequences of world trade law for alcohol policies. However, there is a need for greater clarity about the different effects of trade on alcohol‐related harm. Methods A comprehensive review of all literature on alcohol and world trade [including World Trade Organization (WTO) disputes on alcohol], supported by a more selective review of other relevant cases, academic reports and the grey literature on trade and health. Results The burden of WTO law on alcohol policies depends upon the type of policy in question. Purely protectionist policies are likely to be struck down, which may lead to increases in alcohol‐related harm. Partly protectionist and partly health‐motivated policies are also at risk of being struck down. However, purely health‐motivated policies are likely to be defended by the WTO—and to the extent that policy makers misunderstand this, they are needlessly avoiding effective ways of reducing alcohol‐related harm. Conclusions WTO agreements contain genuine and substantial risks to alcohol policies, and various ways of minimizing future risks are suggested. However, the ‘chilling effect’ of mistakenly overestimating these constraints should be avoided. Health policy makers should decide on which policies to pursue based primarily on considerations of effectiveness, ethics and politics rather than legality. As long as any effect of these policies on trade is minimized, they are overwhelmingly likely to win any challenges at the WTO.     

Mental health CPR: Peer contracting as a response to potential suicide in adolescents

Contracting has been used as a response to individuals at risk of suicide for over thirty years. In the present study almost 400 high school students were given a survey about their experiences with suicide. It found that they were unlikely to initiate contact with traditional counselors during a suicidal crisis, but over half of them admitted they would probably tell a friend. Training in No harm agreements, a form of peer contracting, was given to half the students. After training, these experimental subjects were significantly more likely than control subjects to recognize symptoms of suicide, to intervene appropriately, and to arrange for professional follow-up. They were also less likely to consider suicide an acceptable option. Greater recognition of two suicidal symptoms and increased likelihood of getting a promise not to commit suicide without talking with a counselor or minister were still present in the experimental group at seven weeks after the training. Responses about questions of safety with this method were promising but still need further attention.