Mathematical Modeling and Pharmaceutical Pricing: Analyses Used to Inform In-Licensing and Developmental Go/No-Go Decisions

In the face of significant real healthcare cost inflation, pressured budgets, and ongoing launches of myriad technology of uncertain value, payers have formalized new valuation techniques that represent a barrier to entry for drugs. Cost-effectiveness analysis predominates among these methods, which involves differencing a new technological interventions marginal costs and benefits with a comparators, and comparing the resulting ratio to a payers willingness-to-pay threshold. In this paper we describe how firms are able to model the feasible range of future product prices when making in-licensing and developmental Go/No-Go decisions by considering payers use of the cost-effectiveness method. We illustrate this analytic method with a simple deterministic example and then incorporate stochastic assumptions using both analytic and simulation methods. Using this strategic approach, firms may reduce product development and in-licensing risk.The FDA in the United States or the EMEA in Europe. Coverage and reimbursement decision making for new technology entering European markets occurs at the country-level     

Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies

Rationale. Modafinil is a first-line wake-promoting medication and a useful therapeutic alternative to psychostimulant medications for excessive daytime sleepiness. Objective. This 5-week, randomized, open-label study evaluated three strategies for switching patients from methylphenidate, a commonly used psychostimulant, to modafinil. Methods. Patients (n=40) with excessive daytime sleepiness related to narcolepsy, who had received previous treatment with methylphenidate, were switched from methylphenidate to modafinil (200 mg/day followed by 400 mg/day) without a washout period between treatments, with a 2-day washout period between treatments, or by using a taper-down/titrate-up protocol. Adverse events were recorded throughout the study, and Epworth Sleepiness Scale scores were determined at the end of the study. Results. The majority of patients (95%) were successfully switched to modafinil. At the study end point, mean Epworth Sleepiness Scale scores were <12 for each treatment group. All three switching strategies were well tolerated, with adverse events mild or moderate in nature. Adverse events most frequently reported during modafinil treatment were among those seen previously in large-scale, placebo-controlled studies. There were no meaningful differences among the treatment groups in the frequency or severity of adverse events or in their relationship to modafinil treatment. Only one patient discontinued modafinil treatment because of a treatment-related adverse event (i.e. moderate headache); another patient discontinued due to insufficient efficacy. Conclusions. Switching from methylphenidate to modafinil was well tolerated with or without a washout period or when the methylphenidate dose is gradually tapered during initiation of modafinil therapy. Daytime wakefulness was maintained in patients who have switched from methylphenidate to modafinil. These data suggest that patients with narcolepsy may be switched from methylphenidate to modafinil with few complications and inconveniences. Electronic Publication     

The Relation Between Conditionally Heteroskedastic Factor Models and Factor GARCH Models

The factor GARCH model of Engle (1987) and the latent factor ARCH model of Diebold and Nerlove (1989) have become rather popular multivariate volatility parametrizations due to their parsimony, and the commonality in volatility movements across different financial series. Nevertheless, there is some confusion in the literature between them. The purpose of this paper is to make clear their similarities and differences by providing a formal nesting of the two models, which can be exploited to analyse their statistical features in a more general context. At the same time, their differences may be important in the interpretation of empirical results.     

Provider networks and health plan premium variation

ObjectiveTo examine how plan premiums are associated with physician network breadth, hospital network breadth, and hospital network quality on the Affordable Care Act''s Health Insurance Marketplaces in all 50 states and the DC in 2016.Data SourcesData on plan premiums and characteristics came from 2016 Robert Wood Johnson Foundation Health Insurance Exchange (HIX) Compare. Provider network information was obtained from Vericred. Hospital characteristics were obtained from CMS Hospital Compare and the American Hospital Association (AHA) survey.Study DesignWe analyzed how plan premiums were associated with variations in physician network breadth, hospital network breadth, and hospital network quality using ordinary least square regressions with state‐rating area fixed effects and carrier fixed effects.Principal FindingsPlan premiums were positively associated with physician network breadth and hospital network breadth. We find the following statistically significant results: a one standard deviation increase in physician network breadth was linked to a premium increase of 2.8 percent or $101 per year; a one standard deviation increase in hospital network breadth was linked to a premium increase of 2.4 percent or $86 per year. There was no significant association between premiums and hospital network quality, as measured by hospital star ratings and the inclusion of teaching hospitals or the top‐20 hospitals nationwide.ConclusionsPhysician network breadth and hospital network breadth contributed positively to plan premiums. The roles of the two types of provider network breadth are quantitatively similar. Premiums appear to be insensitive to hospital network quality.     

探索科学合理的医用耗材定价机制简

介绍了我国医用耗材市场主要存在的问题和发达国家的定价机制,阐述了新形势下建立科学合理的医用耗材定价机制的必要性,同时探讨我国该如何建立科学有效的医用耗材定价机制,为决策者下一步制定定价机制提供参考依据。     

2010年上海市15岁及以上居民饮酒行为研究

目的 研究2010年上海市15岁及以上居民饮酒行为现状.方法 采用分层多阶段整群随机抽样的方法,利用2010年“上海市慢性病及其危险因素监测”部分资料,研究上海市15岁及以上居民饮酒现状、饮酒频率、饮酒类型、每日酒精消费量及分级.结果 15岁及以上居民饮酒率为26.1％,男性为43.9％,女性为8.0％.饮酒者中酒精摄入量为34.3 g/d,男性为37.7 g/d,女性为14.9 g/d.不同年龄组中,男性45 ～ 59岁年龄组饮酒率和每日酒精摄入量最高（53.9％和42.6 g/d）,女性18～44岁年龄组饮酒率最高为9.6％,45 ～ 59岁年龄组酒精摄入量最高为16.5 g/d;中心城区和非中心城区的饮酒率分别为22.9％和28.5％,酒精摄入量分别为28.5g/d和37.8 g/d.男性饮酒者中,饮酒频率以几乎每天饮酒的比例最高（35.5％）,3～6d/周的比例最低（13.0％）;饮酒类型中,以饮黄酒、啤酒为主,比例为62.0％和42.8％,饮低度白酒的比例最低为9.8％;过量饮酒、危险饮酒和有害饮酒的比例分别为20.0％、9.2％和20.6％,单次大量饮酒比例为24.6％.结论 2010年上海地区15岁及以上居民饮酒率较高,不同性别、年龄和地区间饮酒行为存在差异.     

以药养医机制对医院合理用药的影响及对策

本文综述了以药养医机制对医院合理用药的影响,通过数据深入分析当前医药卫生体制改革亟需解决的问题,提出了建立健全更加合理的药品价格形成机制、政府财政投入机制、补偿机制,逐步推行医药分业制度等措施,建议用更加合理的新机制取代以药养医的旧机制,促进医院合理用药。     

基于价值定价的多适应证药品医保支付国际经验及启示

目的:为完善我国多适应证药品基于价值定价的医保支付提供参考.方法:梳理多适应证药品价值定价的理论基础和实现流程,分析法国、德国、英国、意大利和瑞典的价值评估指标和基于价值定价的医保支付策略,为我国多适应证药品医保支付提出建议.结果与结论:价值定价的实现首先需要制定一个价值框架以定义、测量、整合价值,再通过建立模型将总价...