Economic aspects of biosimilar competition in Hungary — The treatment of rheumatic disorders

Biologicals are the fastest growing segment of the global pharmaceutical market, reaching 199 billion USD sales per year with 9.8% 10-year compound annual growth rate (CAGR). Being less costly, yet equally efficacious and safe alternatives to originator reference products, biosimilars drive competition, promise budget savings and the opportunity for better patient-access. This paper examines the key factors and players of biosimilar competition in rheumatology in Hungary. Due to the scarcity of data, the total yearly expenditure on biologicals could only be estimated from different data sources. In 2015 the estimated expenditure on biologicals was around 100 billion HUF. In rheumatology indications the expenditure on biologicals was 10 (8.9-11.2) billion HUF, and the average annual net treatment cost was 1.2 (1.06-1.34) million HUF / per patient / year. The magnitude of societal benefits in terms of budget savings and health gains may result from the joint effort of policy makers, funders, physicians and patients. In rheumatology indications, biosimilar utilization could be increased by a policy supporting physician-driven interchange of the reference product to biosimilars. Also, creating a physician incentive system for broader use should be considered in order to realize the full economic advantages of biosimilars and contribute to sustainable healthcare financing in Hungary

Step-by-step Guideline for disease-specific costing studies in low and middle income countries: a mixed methodology.

__Abstract__ BACKGROUND: Disease-specific costing studies can be used as input into cost-effectiveness analyses and provide important information for efficient resource allocation. However, limited data availability and limited expertise constrain such studies in low- and middle-income countries (LMICs). OBJECTIVE: To describe a step-by-step guideline for conducting disease-specific costing studies in LMICs where data availability is limited and to illustrate how the guideline was applied in a costing study of cardiovascular disease prevention care in rural Nigeria. DESIGN: The step-by-step guideline provides practical recommendations on methods and data requirements for six sequential steps: 1) definition of the study perspective, 2) characterization of the unit of analysis, 3) identification of cost items, 4) measurement of cost items, 5) valuation of cost items, and 6) uncertainty analyses.Please provide the significance of asterisk given in table body. RESULTS: We discuss the necessary tradeoffs between the accuracy of estimates and data availability constraints at each step and illustrate how a mixed methodology of accurate bottom-up micro-costing and more feasible approaches can be used to make optimal use of all available data. An illustrative example from Nigeria is provided. CONCLUSIONS: An innovative, user-friendly guideline for disease-specific costing in LMICs is presented, using a mixed methodology to account for limited data availability. The illustrative example showed that the step-by-step guideline can be used by healthcare professionals in LMICs to conduct feasible and accurate disease-specific cost analyses

Global Pharmaceutical Markets

The high price of patented drugs lies at the heart of a major global public health crisis: the global poor are often denied access to lifesaving drugs due to high cost. Do global drug companies owe ethical or legal duties to make their drug patents available for the world’s low- and medium-income populations? We suggest that they do, through an exploration of the exceptions surrounding the “duty of rescue” - more precisely, the doctrine in US tort law that does not impose a duty to rescue absent special circumstances such as having contributed to the risk and enjoying special relationships to the endangered person. We find that these special circumstances are surprisingly applicable to global pharmaceutical markets, with both legal and ethical implications for global intellectual property law

A Randomized, Controlled Trial on the Effects of Almonds on Lipoprotein Response to a Higher Carbohydrate, Lower Fat Diet in Men and Women with Abdominal Adiposity.

BACKGROUND: Almonds have been shown to lower LDL cholesterol but there is limited information regarding their effects on the dyslipidemia characterized by increased levels of very low density lipoproteins (VLDL) and small, dense low-density lipoprotein (LDL) particles that is associated with abdominal adiposity and high carbohydrate intake. The objective of the present study was to test whether substitution of almonds for other foods attenuates carbohydrate-induced increases in small, dense LDL in individuals with increased abdominal adiposity. METHODS: This was a randomized cross-over study of three 3wk diets, separated by 2wk washouts: a higher-carbohydrate (CHO) reference diet (CHO RESULTS: Relative to the CHO CONCLUSION: Our analyses provided no evidence that deriving 20% E from almonds significantly modifies increases in levels of small, dense LDL or other plasma lipoprotein changes induced by a higher carbohydrate low saturated fat diet in individuals with increased abdominal adiposity. TRIAL REGISTRATION: Clinicaltrials.gov NCT01792648

Tax, Class, Women, and Elder Care

As the fastest-growing urban area in the United States—and due to its emerging national influence in commercial real estate development and leasing through transformational transactions such as Amazon’s recently completed national HQ2 search—the City of Seattle and related Washington State laws addressing the use of dual agency in commercial transactions present a unique backdrop for examining the findings and recommendations from a 2014 commercial real estate conflicts of interest research study and attendant report, described below, more than four years after its publication. In November 2014, a published research study report made a number of key observations about the existence of adverse legal and transactional consequences from conflicts of interest in the representation of commercial tenants by full-service brokerage firms engaged in the commercial real estate services (CRES) sector actively engaged in the practice of “dual agency.” That report, published by the Center for Real Estate and Urban Analysis (CREUA) at The George Washington University School of Business in Washington, D.C., also offered a series of key recommendations for mitigating or eliminating entirely these adverse consequences. In the intervening years since the mid-November 2014 publication of the conflicts of interest research report, the CRES sector has not taken any steps, in the form of industry self-regulation or otherwise, to address—much less ameliorate—these legal issues and the attendant, adverse transactional consequences for commercial tenants. Further, over the same period, (1) there has been increasing consolidation among the five largest CRES full-service brokerage firms (i.e., collectively they represent a larger share of the market for leasing commercial property than in 2014, when the CREUA conflicts of interest research report was conducted); and (2) those firms have gained traction in numerous domestic commercial property markets by taking equity positions in a substantial amount of commercial space available for lease in major markets. These market developments further exacerbate the negative consequences for tenants seeking independent, objective, and professional representation in commercial real estate transactions because they present the prospect that, in a dual agency scenario, the tenant representative may be acting as an undisclosed principal.[3] And even in cases where the tenant representative discloses the existence of a conflict where their firm is a principal in the transaction, the tenant may not be adequately equipped with the knowledge necessary to understand the significance and consequence of the self-dealing present in this transaction. As a consequence, the problems associated with dual agency have become more acute and more pervasive in the world of commercial real estate generally, and in commercial leasing transactions in particular. Under the common law, an agent would owe the following duties to its principal: o Unbroken service and loyalty (the “duty of undivided loyalty”); o Confidentiality; o Full disclosure of information necessary for the principal for to make well-informed decisions; o Acting in the best interest of the principal; o Reasonable care and diligence; and o Accountability to the principal. However, in Washington State, the legislature in 1996 replaced the common law duties agents owe to principals under state common law—such as the duty of undivided loyalty—with a statutory scheme that, at best, causes confusion about the duties an agent owes its principal, particularly in the context of a dual agency representation of the tenant and the landlord in the same transaction

A Study into the Financial Sustainability of Offinso Mutual Health Insurance Scheme

It is widely recognized that a strong financial base is a prerequisite for an effective health care delivery system. Currently, Governments in sub-Saharan Africa are facing serious financial constraints in their attempts to provide basic health services to their people (Abekah-Nkrumah, et.al 2009). The purpose of this research was to determine: the adequacy of funding of Offinso Health insurance scheme; the relationship between revenue trends and claims management from 2006 to 2011; and measures put in place to ensure the financial sustainability of the scheme. In doing so the funding adequacy, revenue trend and claims payment from 2006 to 2011, and financial sustainability strategies of Offinso health insurance scheme was examined. The research was both descriptive and causal. The research strategy was survey and single case holistic. The research philosophy was both positivism and interpretivism. The research also used both deductive and inductive approach. Data was analysed using quantitative techniques like mean, frequency, correlation, standard deviation, and others. The unit of analysis was staff of Offinso Health Insurance Scheme. The total population size of 20 was used. In addition extract from the financial records of the scheme was also used. No specific sampling technique was used since data was collected from the entire population. It was found out that the scheme is not adequately funded; there is a highly positive relationship between revenue and claims payment and that claims payment consumes substantial portion of total revenue; the scheme has adequate defensive strategies; there is poor prudent fund management; and inadequate sourcing strategies. Generally the scheme may be facing financial sustainability problems in the long run as evidenced in the research findings. Keywords: Adequacy of funding, Financial sustainability, Mutual health insurance, Offinso

The Value Driven Pharmacist: Basics of Access, Cost, and Quality 2nd Edition

https://digitalcommons.butler.edu/butlerbooks/1017/thumbnail.jp

Evaluation and design of a novel drug delivery device for treating tumor-related cerebral edema

Thesis (M. Eng.)--Massachusetts Institute of Technology, Dept. of Materials Science and Engineering, 2010.Cataloged from PDF version of thesis.Includes bibliographical references (p. 47-53).Tumor-related cerebral edema is a debilitating medical condition that afflicts tens of thousands of newly diagnosed brain cancer patients in the U.S. each year, where the standard care of treatment indicates the systemic administration of dexamethasone sodium phosphate (DXM) and surgery. The former is associated with toxic side effects, and the latter is an ineffective option. Local drug delivery to the desired site of therapy helps to circumvent the side effects of DXM. In this paper, the design of a novel, local drug delivery device was explored as a means to treat tumor-related cerebral edema. The novel device was then evaluated based on an analysis of the market environment in which it will be sold. This included discussion of the supply chain infrastructure and the challenges associated with the medical industry, an estimate of the addressable market size, growth and valuation, and an estimate of the novel product's cost compared to current edema treatment and the device's potential competitors. The methods by which the device could be commercialized were also discussed, specifically, strategies for obtaining FDA approval, manufacturing the device on a medium scale, protecting intellectual property, integrating the device into the supply chain, and an estimation of the financial investment needed to form a startup company. Finally, the technology that enables its desired application was evaluated, which included an assessment of the barriers to drug delivery, ideal characteristics of a successful drug delivery device, possible routes and means of administration, as well as other considerations pertinent to a successful drug delivery device. After completing the first iteration of the innovation cycle, it was concluded that the device deserves further investigation and investment, as it progresses from the lab bench to the marketplace.by Kamal A. Shair.M.Eng

Regulation for Conservatives: Behavioral Economics and the Case for "Asymmetric Paternalism"

Regulation by the state can take a variety of forms. Some regulations are aimed entirely at redistribution, such as when we tax the rich and give to the poor. Other regulations seek to counteract externalities by restricting behavior in a way that imposes harm on an individual basis but yields net societal benefits. A good example is taxation to fund public goods such as roads. In such situations, an individual would be better off if she alone were exempt from the tax; she benefits when everyone (including herself) must pay the tax