Linezolid in South Africa: The regulatory authority’s role in supporting access to improved treatment regimens for drug-resistant tuberculosis

Abstract

The rising incidence of drug-resistant tuberculosis (DR-TB) in South Africa is cause for concern, with doctors having limited treatment options to offer patients who face excruciating side-effects from existing medications, and poor odds of treatment success. With several newer drugs showing efficacy against DR-TB, increased possibilities exist to stem the tide of the epidemic, shorten treatment duration, and improve outcomes. To take advantage of this potential TB treatment revolution, countries must rapidly facilitate access to existing and future drugs. This requires co-ordinated action from governments, and particularly regulatory authorities, in promoting early access to new treatments, tackling intellectual property and price barriers, expediting regulatory approval, adopting and implementing up-to-date TB management policies, and engaging with research and development processes for new regimens. Doctors Without Borders expended great effort to obtain a less expensive version of the drug, linezolid, for its DR-TB pilot program in Khayelitsha, South Africa. This piece describes that experience, and subsequently offers recommendations for policy reforms which could help South Africa more rapidly access other new TB drugs in the future. The South African experience may be of relevance to other countries seeking advice on how to facilitate access to new treatments and tackle their TB epidemics.     

Willingness to participate in future HIV prevention trials in Beira,Mozambique

We conducted an evaluation of healthcare accessibility among patients taking antiretroviral treatment (ART) after they were ‘down-referred’ from hospital-based programmes to primary healthcare (PHC) centres in a rural South African setting. A cross-sectional design was used to study 109 PHC users compared to a randomly selected control group of 220 hospital-based users. Both groups were matched for a minimum duration on ART of six months. Using a comprehensive healthcare-accessibility framework, the participants were asked about availability, affordability and acceptability of their ART care in structured exit interviews that were linked to their ART-clinic record reviews. Unadjusted and adjusted regression models were used. Down-referral was associated with reduced transportation and meal costs (p = 0.001) and travel time to an ART facility (p =0.043). The down-referred users were less likely to complain of long queues (adjusted odds ratio [AOR] 0.06; 95% confidence interval [95% CI]: 0.01–0.29), were more likely to feel respected by health providers (AOR 4.43; 95% CI: 1.07–18.02), perceived lower stigma (AOR 0.25; 95% CI: 0.07–0.91), and showed a higher level of ART adherence (AOR 8.71; 95% CI: 1.16–65.22) than the hospital-based users. However, the down-referred users preferred to consult with doctors rather than nurses (AOR 3.43; 95% CI: 1.22–9.55) and they were more likely to visit private physicians (AOR 7.09; 95% CI: 3.86–13.04) and practice self-care (AOR 4.91; 95% CI: 2.37–10.17), resulting in increased health-related expenditure (p = 0.001). Therefore, the results indicate both gains and losses in ART care for the patients, and suggest that down-referred patients save time and money, feel more respected, perceive lower stigma and show better adherence levels. However, unintended consequences include increased costs of using private physicians and self-care, highlighting the need to further promote the potential gains of down-referral interventions in resource-poor settings.     

成本-效果可支付曲线的理论与应用

目的:从理论和应用角度对一种新兴分析工具——成本-效果可支付曲线进行介绍,以期为我国药品决策研究与实践提供新思路。方法:通过分析成本-效果平面中成本-效果阈值线和可支付线的含义来引出和分析成本-效果可支付曲线,并借助已有实证研究对其含义进行分析和解释。结果:成本-效果可支付曲线结合了可支付线与阈值线二者提供的信息,是成本-效果阈值和预算限制的函数。结论:成本-效果可支付曲线可同时提供经济性与可支付性信息,在给定预算下随成本-效果阈值的变化而变化。     

Food taxes: what type of evidence is available to inform policy development?

Summary Once dispatched to the bottom draw of policy options to address unhealthy eating, food taxes now seem back in the out tray of European policy makers. Even David Cameron made an offhand quip recently suggesting that this is something the British Government might explore. While the purpose of developing food taxes is likely their potential to raise money for national treasuries, governments have justified them on health grounds. But, what evidence is available that can inform policy development in this area from a health perspective? Most obvious are the studies that model different scenarios for taxes. Yet these studies form a relatively small part of the potential evidence‐base. The largest proportion of existing research on food prices has simply measured food prices in the marketplace and drawn hypotheses about the dietary implications. Other studies have estimated the costs of actually consumed diets. Another set of studies have quantified an association between price of specific foods and diet from real world data. Others have likewise taken a quantitative approach, but in experimental settings. A particularly large group of studies are qualitative – those asking consumers if and/or how their food choices are influenced by prices. The final type of study combines qualitative and quantitative methods. This paper examines the relevance of these different types of evidence as information for policy development in this area.     

Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018

ObjectiveBuprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions.MethodsWe first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News.ResultsBrand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation.ConclusionsBrand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.     

农民工社会医疗保险承受力及其改善体制机制

国家为了改善农民工医疗保险的问题制定了系列的政策法规,并最终以社会保险立法的形式加以强制约束。但中国农民工医疗保险仍处于较低的参保状态,说明农民工医疗保险仍然面临较大的压力。改善和提高农民工医疗保险的相关利益主体的承受力,有助于提高并稳定农民工参保。     

Financially independent primary health care drug supply system in Cameroun

The drug supply system in the North-west Province of Cameroun differs from 'simple' health financing projects in three important respects. Firstly, the system does not promote drug sales for cofinancing purposes but aims at supporting the prescribers to provide better medical care, and patients' access to the most essential drugs at fair prices. Secondly, the project guarantees equal prices and services throughout the Province regardless of distance from the central warehouse and sales at a given location. Thirdly, along with the revolving fund-financed drug supply system, a community-based legal framework has been established. Built-in management alert mechanisms helped the project resist common causes of collapse such as uneconomic behaviour and political interference. The drug supply system has gained full independence from subsidies and external authorities. Its strong community participation promotes good governance.