Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

新疆生产建设兵团第十三师天然草地资源现状及其利用探讨

新疆生产建设兵团第十三师位于在新疆东部哈密市,辖区有8个团场。十三师草场面积占兵团草场面积的15.7%,是兵团草场面积最大的师。十三师草原生态十分脆弱,主要以荒漠、半荒漠草场为主。除了部分与地方乡镇接壤草场以外,草场承包确权工作基本完成。由于超载放牧、基础设施落后、防灾减灾能力弱等原因,导致天然草场退化、沙化,有毒、有害植物增加,产草量和草质量明显下降,影响牧民收入。超载放牧是草场退化的根本原因,本文围绕这个主题,对草场面临的困难和难题进行分析,并提出了建设性的建议。通过异地搬迁、办理贷款及改善牧民生产生活等措施,减少天然草原载畜量,减轻夏草场放牧强度,逐步达到草畜平衡的目标,为十三师畜牧业可持续健康发展提供理论基础。     

The Financial Impact on Reimbursement of Moderately Hypofractionated Postoperative Radiation Therapy for Breast Cancer: An International Consortium Report

AimsModerately hypofractionated breast irradiation has been evaluated in several prospective studies, resulting in wide acceptance of shorter treatment protocols for postoperative breast irradiation. Reimbursement for radiation therapy varies between private and public systems and between countries, impacting variably financial considerations in the use of hypofractionation. The aim of this study was to evaluate the financial impact of moderately hypofractionated breast irradiation by reimbursement system in different countries.Materials and methodsThe study was designed by an international group of radiation oncologists. A web-questionnaire was distributed to representatives from each country. The participants were asked to involve the financial consultant at their institution.ResultsData from 13 countries from all populated continents were collected (Europe: Denmark, France, Italy, the Netherlands, Spain, UK; North America: Canada, USA; South America: Brazil; Africa: South Africa; Oceania: Australia; Asia: Israel, Taiwan). Clinicians and/or departments in most of the countries surveyed (77%) receive remuneration based on the number of fractions delivered to the patient. The financial loss per patient estimated resulting from applying moderately hypofractionated breast irradiation instead of conventional fractionation ranged from 5–10% to 30–40%, depending on the healthcare provider.ConclusionAlthough a generalised adoption of moderately hypofractionated breast irradiation would allow for a considerable reduction in social and economic burden, the financial loss for the healthcare providers induced by fee-for-service remuneration may be a factor in the slow uptake of these regimens. Therefore, fee-for-service reimbursement may not be preferable for radiation oncology. We propose that an alternative system of remuneration, such as bundled payments based on stage and diagnosis, may provide more value for all stakeholders.     

Reimbursement for therapeutic apheresis devices and procedures for using the healthcare insurance system in Japan

The aim of this paper was to explain the insurance coverage status of therapeutic apheresis (excluding CHDF) in Japan, alongside the social system of medical reimbursement and concerns regarding the future sustainability of the healthcare system. Insurance schemes and premiums differed for individuals at different levels in the society (eg, municipal residents, employees, and public servants). Insurance premiums and their rates varied depending on the total household income, the number of people living together, age, and the place of residence. In addition, the medical expense subsidies for children through public expenditure were also described. Japan's generous insurance system and multiple medical expense subsidies provide financial support for patients. With Japan's history of medical expense subsidies based on the policy of supporting intractable diseases, we have established an environment where all citizens can receive therapeutic apheresis when needed if they are affected by a disease for which insurance coverage is indicated.     

英国价值定价理念对我国医保药品报销政策的启示

本文在梳理英国医保药品报销政策的基础上,通过对价值定价理念的深入研究和理解,系统探讨其在报销政策制定过程中对药品目录遴选、价值测算、支付标准确定、医保基金平衡和报销效益评估的作用机制,并深入思考通过价值定价理念建立起的药物警戒体系与药品报销政策间的衔接机制。在此基础上总结价值定价理念的特点、应用阶段和具体操作方法,以期为我国提供借鉴。     

医保投诉的影响因素及方案分析

目的分析医保投诉的影响因素及解决方案。方法选取2016年1月-2016年12月、2018年1月-2018年12月分别为对照阶段、观察阶段,分别采取常规医保管理、常规医保管理联合优化管理方案,在两个阶段内各随机选取医保支付医疗费用的患者3000例,设为对照组及观察组,分析投诉发生情况;在对照组及观察组内各随机选取患者300例,分析不同阶段服务质量。结果观察组投诉率低于对照组(P<0.05);观察组满意度评分高于对照组(P<0.05)。结论了解医保影响因素,并予以对症解决方案,能够降低医保投诉率,提升医院服务质量及患者满意度。     

Telehealth Billing for Nurse Practitioners During COVID-19: Policy Updates

Telehealth is a growing valuable strategy to assist patients accessing needed care when unable to get to a health care setting for one of several reasons. During the coronavirus disease 2019 (COVID-19) pandemic of 2020, many health care practices were forced to implement telehealth services to meet patient and practice needs. In 2020, several temporary waivers, exceptions, and telehealth policy changes emerged across the nation. Many telehealth policies are state or federal specific. This report provides a general overview of essential telehealth policies and legislative updates along with resources and websites to guide and support nurse practitioners with contemporary regulations regarding telehealth billing.     

The Impact of Decision Makers’ Constraints on the Outcome of Value of Information Analysis

Background

When proven effective, decision making regarding reimbursement of new health technology typically involves ethical, social, legal, and health economic aspects and constraints. Nevertheless, when applying standard value of information (VOI) analysis, the value of collecting additional evidence is typically estimated assuming that only cost-effectiveness outcomes guide such decisions.