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Background: Neuromyelitis optica spectrum disorder (NMOSD) is a rare and debilitating disease that has become more widely recognized in China. Legislative measures have been implemented by the government to improve treatment access for rare diseases. Objectives: To investigate the diagnostic journey, treatment status, treatment accessibility, and treatment satisfaction of the NMOSD patients on disease-modifying therapies (DMTs) in China. Design: A patient online survey. Methods: This cross-sectional online survey was conducted between November 2022 and January 2023. Patients over 18 years old and diagnosed with NMOSD were included. The questionnaire consisted of five sections covering demographics, diagnostic and treatment experiences, DMTs availability, cost and affordability, and treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (version II). Patient opinions and demands were also collected at the end of the survey. Results: A total of 375 patients diagnosed with NMOSD were recruited, of which 321 patients used DMTs. It required 1.22 ± 3.22 years and 3.58 ± 4.24 hospital visits for a definitive diagnosis. One-third of the patients still needed to travel for over 2 h to access DMTs. The total treatment expenditure was estimated to be CNY 59,827.00 (USD 8315.95) a year. Drug expenses alone accounted for 52.22% of the average annual household income. The most common challenges perceived were the inability to afford treatment and a lack of effective options. No significant difference was found in treatment satisfaction among DMTs, except that rituximab scored lowest in convenience compared to other DMTs. Patients' age and travel time required to obtain medications were negatively associated with global treatment satisfaction. Conclusion: In China, patients with NMOSD face challenges in obtaining proper treatment due to diagnostic difficulties, distant medication access, and high costs. Policies should prioritize improving disease education and alleviating financial burdens for the patients. [ABSTRACT FROM AUTHOR]

Background: Neuromyelitis optica spectrum disorder (NMOSD) is a rare and debilitating disease that has become more widely recognized in China. Legislative measures have been implemented by the government to improve treatment access for rare diseases. Objectives: To investigate the diagnostic journey, treatment status, treatment accessibility, and treatment satisfaction of the NMOSD patients on disease-modifying therapies (DMTs) in China. Design: A patient online survey. Methods: This cross-sectional online survey was conducted between November 2022 and January 2023. Patients over 18 years old and diagnosed with NMOSD were included. The questionnaire consisted of five sections covering demographics, diagnostic and treatment experiences, DMTs availability, cost and affordability, and treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (version II). Patient opinions and demands were also collected at the end of the survey. Results: A total of 375 patients diagnosed with NMOSD were recruited, of which 321 patients used DMTs. It required 1.22 ± 3.22 years and 3.58 ± 4.24 hospital visits for a definitive diagnosis. One-third of the patients still needed to travel for over 2 h to access DMTs. The total treatment expenditure was estimated to be CNY 59,827.00 (USD 8315.95) a year. Drug expenses alone accounted for 52.22% of the average annual household income. The most common challenges perceived were the inability to afford treatment and a lack of effective options. No significant difference was found in treatment satisfaction among DMTs, except that rituximab scored lowest in convenience compared to other DMTs. Patients' age and travel time required to obtain medications were negatively associated with global treatment satisfaction. Conclusion: In China, patients with NMOSD face challenges in obtaining proper treatment due to diagnostic difficulties, distant medication access, and high costs. Policies should prioritize improving disease education and alleviating financial burdens for the patients. [ABSTRACT FROM AUTHOR]

Background: Although several statistical methods have been developed to inform decision making on reimbursement under uncertainty (e.g., expected net benefit, cost-effectiveness acceptability curves, and expected value of perfect information [EVPI]), those for value-based pricing are limited. This research develops methods for estimating the value-based price and quantifying the uncertainty around it in health technology assessment. Methods: We defined the value-based price of a medical product under assessment as the price at which the incremental cost-effectiveness ratio is just equal to a cost-effectiveness threshold. According to this definition, we derived an explicit form of the value-based price. Using this explicit form, we developed frequentist and Bayesian approaches to value-based pricing under uncertainty. Our proposed methods were illustrated via 2 hypothetical case studies. Results: The value-based price can be expressed explicitly using cost, effectiveness, and a cost-effectiveness threshold and is a linear function of a cost-effectiveness threshold. In the frequentist framework, point estimation, interval estimation, and hypothesis testing for the value-based price are available. In the Bayesian framework, the best estimate of the value-based price under uncertainty is the weighted median value-based price with the weight of the expected consumption volume of a medical product under assessment. This is based on the opportunity loss incurred by a decision error in value-based pricing. This opportunity loss also provides a basis for the calculation of EVPI associated with value-based pricing. These methods provided estimates of the value-based prices of medical products and the uncertainty around them in 2 hypothetical case studies. Conclusions: Our developed methods can improve decision making on value-based pricing in health technology assessment. [ABSTRACT FROM AUTHOR]

This article elaborates on intellectual monopoly theory as a form of predation and rentiership using Amazon as a case study. By analysing Amazon's financial statements, scientific publications and patents, we show that Amazon's economic power heavily relies on its systematic innovations and capacity to centralize and analyse customized data that orients its business and innovations. We demonstrate how Amazon's innovation activities have evolved over time with growing importance of technologies related to data and machine learning. We also map Amazon's innovation networks with academic institutions and companies. We show how Amazon appropriates intellectual rents from these networks and from technological cooperation with other intellectual monopolies. We argue that Amazon, as other data-driven monopolies, predates value from suppliers and third-party companies participating in its platform. One striking characteristic of Amazon is the low rate of reported profits. The centrality of innovations leads us to suggest an alternative calculation that shows that Amazon's profits are not as low as they appear in Annual Reports. We also argue that lower profits are coherent with Amazon's rentiership and predatory strategy since they contribute to the avoidance of accusations of excessive market power. Finally, the paper offers preliminary observations on: (i) the complementarities between financial and intellectual rentierism and (ii) how data-driven intellectual monopoly expands big corporations' political power. Going beyond the specific case of Amazon, we thus contribute to a better understanding of the role of lead firms and power dynamics within innovation networks. [ABSTRACT FROM AUTHOR]

The first ever insurance reimbursement for an artificial intelligence (AI) system, which expedites triage of acute stroke, occurred in 2020 when the Centers for Medicare and Medicaid Services (CMS) granted approval for a New Technology Add-on Payment (NTAP). Key aspects of the AI system that led to its approval by the CMS included its unique mechanism of action, use of robotic process automation, and clear linkage of the system's output to clinical outcomes. The specific strategies employed encompass a first-case scenario of proving reimbursable value for improved stroke outcomes using AI. Given the rapid change in utilization of AI technology in stroke care, we describe the economic drivers of stroke AI systems in healthcare, focusing on concepts of reimbursement for value added by AI to the stroke care system. This report reviews (1) the successful approach used by the first NTAP-approved AI system, (2) economic variables in insurance reimbursement for AI, and (3) resultant strategies that may be utilized to facilitate qualification for NTAP reimbursement, which may be adopted by other AI systems used in stroke care. [ABSTRACT FROM AUTHOR]

The current COVID-19 pandemic has put the problem of equitable access to health technologies in the limelight because governments, even in the economically advanced countries, are struggling to meet the health needs of their populations. Tiered pricing of innovative health technologies, which involves the division of markets into different tiers or groups, provides a legitimate policy tool to alleviate some of the COVID-19 financial burdens on global health systems. Differential pricing denotes the practice of companies to charge different prices for the same product depending on the different classes of purchasers. This paper examines the legality and practical significance of tiered pricing as a price-reducing policy option and discusses some of the key limitations of this important policy tool. This study proposes the adoption of a global framework for sustainable pricing and tiered pricing of innovative health technologies. The proposed global framework will help in achieving a balance between fair access and fair profit levels. [ABSTRACT FROM AUTHOR]

Background. The assessment of value along the clinical development of new biopharmaceutical compounds is a challenging task. Complex and uncertain evidence has to be analyzed, considering a multitude of value preferences from different stakeholders. Objective. To investigate the use of multicriteria decision analysis (MCDA) to support decision making during drug development while considering payer and health technology assessment (HTA) value concerns, by applying the Advance Value Framework in nonalcoholic steatohepatitis (NASH) and testing for the consistency of the results. Design. A multiattribute value theory methodology was applied and 2 rounds of decision conferences (DCs) were organized in 3 countries (England, France, and Germany), with the participation of national key experts and stakeholders using the MACBETH questioning protocol and algorithm. A total of 51 health care professionals, patient advocates, and methodologists, including (ex-) committee members or assessors from national HTA bodies, participated in 6 DCs in the study countries. Target Population. NASH patients in fibrosis stages F2 to 3 were considered. Interventions. The value of a hypothetical product profile was assessed against 3 compounds under development using their phase 2 results. Outcome Measures. DC participants' value preferences were elicited involving criteria selection, options scoring, and criteria weighting. Results. Highly consistent valuation rankings were observed in all DCs, always favoring the same compound. Highly consistent rankings of criteria clusters were observed, favoring therapeutic benefit criteria, followed by safety profile and innovation level criteria. Limitations. There was a lack of comparative treatment effects, early evidence on surrogate endpoints was used, and stakeholder representativeness was limited in some DCs. Conclusions. The use of MCDA is promising in supporting early HTA, illustrating high consistency in results across countries and between study rounds. [ABSTRACT FROM AUTHOR]

In 1993, the Canadian federal government ratified the North American Free Trade Agreement (NAFTA). Prior to ratification, compulsory licensing was eliminated from Canada's Patent Act and intellectual property rights (IPRs) were strengthened. Compulsory licensing allows competitors to produce drugs under patent without the consent of the patent holder, challenging drug monopolies and lowering prices, whereas IPRs lengthen patent protections, shielding patent holders from competition and increasing prices. We perform a critical discourse analysis of key provisions in Chapter 17 of NAFTA in light of industry claims that pharmaceutical innovation requires important investments in research and development, justifying high drug prices. We note that since NAFTA, spending in research and development in Canada has decreased and drug prices have increased, becoming a major barrier to equitable access to critically necessary medications. We argue that by modifying the law, the federal government has wronged the Canadian people by discursively appropriating the language of protecting the public good while in practice legitimizing and consolidating private drug development and production, legalizing exorbitant profits, and excluding well-tested publicly financed alternatives. While NAFTA has now been superseded by the Canada–United States–Mexico Agreement, our analysis offers important lessons moving forward. [ABSTRACT FROM AUTHOR]

Objectives. To examine the impact of the Preferred Drugs Initiative (PDI), an Irish health policy aimed at reducing prescribing variation. Design. Interrupted time series spanning 2012 to 2015. Setting. Health Service Executive pharmacy claims data for General Medical Services (GMS) patients, approximately 40% of the Irish population. Participants. Prescribers issuing preferred drug group items to GMS adults before and after PDI guidelines. Primary Outcome. The percentage coverage of PDI medications within each drug class per calendar quarter per prescriber. Methods. Latent curve models with structured residuals (LCM-SRs) were used to model coverage of the preferred drugs over time. The number of GMS adults receiving medication and the percentage who were 65 years and older at the start of the study were included as covariates. Results. In the quarter following PDI guidelines, coverage of the preferred drugs increased most in absolute terms for proton pump inhibitors (PPIs) (1.50% [SE 0.15], P < 0.001) and selective and norepinephrine reuptake inhibitors (SNRIs) (1.17% [SE 0.26], P < 0.001). Variation between prescribers remained relatively unchanged and increased for urology medications. Prescribers who increased coverage of the preferred PPI also increased coverage of the preferred statin immediately following guidelines (correlation 0.47 [SE 0.13], P < 0.001). Where guidelines were disseminated simultaneously, coverage of one preferred drug did not significantly predict coverage of the other preferred drug in the next calendar quarter. Prescribing of preferred drugs was not moderated by prescriber-level factors. Conclusions. Modest changes in prescribing of the preferred drugs have been observed over the course of the PDI. However, the guidelines have had little impact in reducing variation between prescribers. Further strategies may be necessary to reduce variation in clinical practice and enhance patient care. [ABSTRACT FROM AUTHOR]

Intellectual property rights (IPR) protection for pharmaceuticals has been comprehensive and strict since the establishment of the World Trade Organization in 1995 and the subsequent implementation of the TRIPS Agreement. This study investigated the relationship between the level of IPR and national pharmaceutical expenditure using panel data of 22 OECD countries from 1970 to 2009. The patent index was used to measure the level of national protection for IPR along with other covariates: GDP per capita, the percentage of population aged over 65, number of doctors, proportion of public financing among total pharmaceutical expenditure, under-5 mortality, price index, and period indicators. The regression analysis results showed that the level of IPR protection was significantly correlated with pharmaceutical spending even after controlling for various factors that affect pharmaceutical expenditure. The results were consistent in OLS regression and GLS regression. However, the effect of IPR was stronger and more significant in countries with a relatively small-sized pharmaceutical market than in those with big market. Many developed countries incur a financial burden due to rapidly growing pharmaceutical expenditure; therefore, the results of this study present the possibility that stronger IPR would produce welfare loss in developed countries. [ABSTRACT FROM AUTHOR]

Japan is now the second largest pharmaceutical market in the world. As a unique population, it provides many opportunities for pharmaceutical companies to develop their businesses. However, the market is strictly regulated by the government, and drug prices are determined according to the rules in Japan. Nevertheless, no detailed empirical analyses have been conducted to clarify what opportunities may exist for pharmaceutical companies in the future. In the present article, we reviewed the pros and cons of the Japanese pharmaceutical market including related regulations, discussed our analyses of economic and regulatory science, and provided future perspectives on drug development and the pharmaceutical market in Japan. Specifically, we first clarified the Japanese pharmaceutical market profile using the publically available market database. Second, we reviewed the Japanese pharmaceutical pricing system, and found inconsistencies between the “pricing premium for the promotion of new drug development and the elimination/resolution of off-label use” and “repricing for market expansion” based on our literature review. Finally, we provided future perspectives on the pharmaceutical markets in Japan, as well as the direction of the research and development of new drugs. [ABSTRACT FROM AUTHOR]

This article investigates the post-merger performance effects resulting from mergers and acquisitions (M&As), drawing on a representative sample taken from all Swiss M&As occurring between 2006 and 2008, the majority of which took place between small and medium-sized firms (SMEs). Using this data, the study was able to investigate the impact of M&As on differing measures of economic performance, and also on innovation for the post-merger period of 2008–2010. The study found positive statistically significant performance effects arising from M&As for three of five critical performance indicators utilized. Furthermore, the evidence suggests that growth is a principal motive for external mergers, while efficiency is more influential on internal mergers. [ABSTRACT FROM AUTHOR]

The article discusses research on generic drug prescribing and utilization in Japan. In addition to determining maximum potential of generic drug use, the study also intended to simulate cost reduction strategies within various health care sectors. It also reports study procedures performed including the evaluation of insurance claims submitted to the Japanese National Health Insurance (NHI) from January to March 2010, the calculation of drug usage data, and drug pricing analysis.

Consumer-driven health care (CDHC) plans are a new health insurance paradigm that lets consumers control some of their own health care dollars. It also provides financial incentives to manage medical spending wisely while affording consumers greater choice and control over the types of medical services received. The premise of CDHC is coupling a tax-preferred, personal health account, used to fund day-to-day medical expenses, with a high-deductible health plan to fund care of a catastrophic nature. When individuals enter the medical marketplace, they will spend first from their health savings accounts, health reimbursement arrangements, or flexible spending accounts. Once they reach their deductible, insurance pays all remaining costs. CDHC plans are relatively new to the market, and the market share is still quite small compared to traditional forms of health insurance. CDHC is not for everyone—and not everyone wants to take greater control of health care spending. However, early evidence is encouraging. Virtually all the studies have found that people treat their own money with more care than funds belonging to someone else. Many individuals will appreciate the flexibility in benefits and the added convenience that controlling health care dollars allows. [ABSTRACT FROM PUBLISHER]

A significant difference can be observed between hospice and nonhospice philosophy. Nonhospice units direct its effort to cure and sustain patient's life using disease- modifying therapeutic procedures, while hospice units focus on patient's quality of life. However, despite the differences between the 2 basic philosophies in question, both approaches share 1 aspect in common: the correct diagnosis of the patient. In any case above, laboratory analysis is a valuable tool. This work aims to compare the laboratory utilization between nonhospice cancer and hospice cancer units. Laboratory requests from patients within a 1-year period were evaluated and the hospice laboratory profile was presented. We demonstrated that nonhospice unit had a major volume of requested laboratory test than hospice unit, but for inpatients this difference was not so dramatic. [ABSTRACT FROM AUTHOR]

The article discusses globalization and aspects of public health, including occupational and environmental dimensions, from a global perspective with a special focus on Swedish conditions. The author points out some aspects of how globalization influences public health, particularly, health at work, changing lifestyles, sustainable development, and health systems.

The debate over the impact of the new Medicare prescription drug benefit (Part D) has intensified in anticipation of its implementation. This paper contributes additional information related to the effect of different types of prescription drug coverage plans on use and expenditures among elderly Medicare beneficiaries.Cross-sectional design using data from the 2002 Medical Expenditures Panel Survey (MEPS). The two dependent variables were (1) prescription drug use and (2) expenditures. The main independent variable was the type of drug insurance (Medicare FFS only [no Rx insurance], Medicare FFS + Rx insurance and Medicare HMO). Bivariate and multivariate analyses were used to test the effect of insurance type, and beneficiaries' characteristics, on likelihood and level of drug use, as well as expenditures. The findings showed that average total drug expenditures among Medicare FFS enrollees who had Rx insurance (non-HMO) were higher ($182.51) than that of Medicare FFS enrollees with no Rx insurance. In addition, the former group had a higher likelihood (any use) of using prescribed medications. On the other hand, no differences in the likelihood of use were detected between Medicare HMO and Medicare FFS (no Rx insurance) enrollees. However, Medicare HMO enrollees had a higher level of drug use. In conclusion, The differences in drug use and expenditures by insurance type imply that each party (Medicare, Medicare Advantage plans, employers) will have a different set of dis/incentives for involvement in Medicare Part D. [ABSTRACT FROM AUTHOR]

Purpose. Under the Medicare Prescription Drug Improvement and Modernization Act, beneficiaries remaining in the traditional fee-for-service plan will face a variety of drug benefit options provided by private stand-alone prescription drug plans. Although these plans likely will differ with regard to a number of important attributes, little is known about older adults’ judgment processes in this context. The objectives of this study were to 1) better understand the manner in which drug insurance attributes are weighted in older adults’ judgments of drug benefit suitability, 2) explore variability in judgment strategies among seniors, and 3) assess seniors’ insight into their judgment policies.METHOD:S:. Three focus groups were conducted with 19 older adults to elicit important drug plan attributes. A policy-capturing study with 32 seniors, none of whom had participated in the focus groups, then was employed to quantify the impacts of these attributes on judgments of plan suitability. RESULTS:. Focus group participants reported that copayment, monthly premium, deductible, formulary use, and mail-order pharmacy use were important drug insurance attributes. The policy-capturing study showed that deductibles and premiums were weighted most heavily in judgment formation. However, significant variability in judgment policies was apparent, with 3 distinct groups emerging from cluster analysis. The first emphasized deductibles and copayments, the second premiums and deductibles, and the third use of a mail-order pharmacy and deductibles. Study volunteers exhibited insight into the role of some plan attributes in their judgments, but notm others. CONCLUSION:S:Cost-sharing provisions appear to be most important in older adults’ evaluations of drug benefit plans. However, significant heterogeneity in attribute preferences also was apparent in this study. Older adults may not be cognizant of the manner in which some plan attributes affect their evaluations, suggesting a role for decision aids in this process. [ABSTRACT FROM AUTHOR]

The article presents information on medical malpractice actions against doctors in the U.S. The damage amounts claimed in the actions have increased, which threatens the delivery of medical services. This is known as medical malpractice crisis. Doctors fear these lawsuits, because they adversely affect their reputation and practice. They also spoil the doctor/patient relationships, and the relationships between doctors and lawyers. Job satisfaction of doctors is also lowered.

Physicians sometimes order diagnostic tests to reduce the risk of malpractice liability. The authors develop an expected-utility model that links a rational physician's concerns about malpractice liability to increases in the use of diagnostic tests and use this model to assess the effects of defensive testing on patients' interests. To do so, they adapt the threshold approach to clinical decision making to incorporate the physician's inter ests, focusing on 1) the effect of the physician's expected liability risks and 2) the effect of any expected liability reduction due to diagnostic testing. Surprisingly, the mere existence of liability risks is often sufficient to widen the range of disease probabilities for which diagnostic testing is the preferred clinical strategy. If testing reduces the physician's expected liability risks, the testing range is widened further. For some dis ease probabilities, testing is preferred by the physician even though it is not in the patient's best interests. When tests are performed in such instances, utility is trans ferred from the patient to the physician and the physician's insurer. Although the de fensive use of diagnostic tests improves clinical outcomes for some patients, it worsens clinical outcomes for others. Moreover, defensive testing worsens the expected out comes of all patients whose clinical strategies are changed. Physicians should realize that defensive testing necessarily reduces the overall quality of patient care. Key words: decision analysis; decision threshold; defensive medicine; diagnostic testing; expected utility; malpractice liability. (Med Decis Making 1998;18:19-28) [ABSTRACT FROM PUBLISHER]