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.     

揿针疗法分经论治神经根型颈椎病的临床研究

目的:观察揿针疗法分经论治神经根型颈椎病的临床疗效及可行性.方法:将70例神经根型颈椎病患者随机分为观察组与对照组,每组35例.对照组采用常规取穴的揿针疗法,观察组采用分经辨证取穴的揿针疗法.在治疗前后对两组患者的视觉模拟量表(VAS)评分及临床症状评分进行评价,并观察两组治疗方案的临床疗效.结果:治疗后,两组患者的VAS评分均较治疗前降低(均P<0.01),且观察组患者VAS评分低于对照组(P<0.01);两组患者的临床症状评分均较治疗前降低(均P<0.01),且观察组患者的临床症状评分低于对照组(P<0.01);观察组的临床总有效率高于对照组(P<0.05).结论:分经辨证取穴的揿针疗法能够降低神经根型颈椎病患者的疼痛评分,改善患者的临床症状,疗效优于常规揿针疗法.     

Explore the Application Law of Disperse Stagnation and Purge Heat with Bitter-Acrid Medicinals in Treating Endogenous Cough

内伤咳嗽以肺失宣肃、肺气上逆为基本病机。“苦辛通降助肺法”即借助药物气味的升降作用以使肺气宣降复常的治法，用于治疗内伤咳嗽可通过苦辛配伍来助肺宣降、调节气机。张之文教授为全国温病学泰斗，提出以“苦辛通降助肺法”治疗内伤咳嗽，临床效果显著。本研究以张老医案为基础，通过数据挖掘来管窥“苦辛通降助肺法”治疗内伤咳嗽的应用规律，为内伤咳嗽的治疗提供新的思路和方法。     

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.     

周亚滨教授运用六经辨证治疗心病证治经验

周亚滨教授从“伤寒最多心病”立意,通过总结《伤寒论》一书对于心病的脉证及遣方用药,指出六经辨证体系对于心病证治具有指导意义。六经辨证是涵盖了八纲以及脏腑经络辨证的学说,能够指导着脏腑经络生理、病理变化的辨证论治。文章整理周亚滨教授在基于六经病证分论的基础上,临证上运用六经辨证思维论治心病的辨证经验,用药上可概括以和、温、补、清、下法为多。     

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.     

Engraftable neural crest stem cells derived from cynomolgus monkey embryonic stem cells

Neural crest stem cells (NCSCs), a population of multipotent cells that migrate extensively and give rise to diverse derivatives, including peripheral and enteric neurons and glia, craniofacial cartilage and bone, melanocytes and smooth muscle, have great potential for regenerative medicine. Non-human primates provide optimal models for the development of stem cell therapies. Here, we describe the first derivation of NCSCs from cynomolgus monkey embryonic stem cells (CmESCs) at the neural rosette stage. CmESC-derived neurospheres replated on polyornithine/laminin-coated dishes migrated onto the substrate and showed characteristic expression of NCSC markers, including Sox10, AP2α, Slug, Nestin, p75, and HNK1. CmNCSCs were capable of propagating in an undifferentiated state in vitro as adherent or suspension cultures, and could be subsequently induced to differentiate towards peripheral nervous system lineages (peripheral sympathetic neurons, sensory neurons, and Schwann cells) and mesenchymal lineages (osteoblasts, adipocytes, chondrocytes, and smooth muscle cells). CmNCSCs transplanted into developing chick embryos or fetal brains of cynomolgus macaques survived, migrated, and differentiated into progeny consistent with a neural crest identity. Our studies demonstrate that CmNCSCs offer a new tool for investigating neural crest development and neural crest-associated human disease and suggest that this non-human primate model may facilitate tissue engineering and regenerative medicine efforts.