The increasing costs of medicines and their implications for patients, physicians and the health system.

Most new medicines entering the market are high-cost speciality drugs. These drugs can cost tens to hundreds of thousands of dollars per course of treatment and in some cases millions of dollars per dose. Approximately half of all spending on medicines is projected to target only 2-3% of patients, raising important questions about resource allocation. While there is no doubt that breakthrough innovations have transformed clinical care in some disciplines, it is also true that cost is becoming one of the primary barriers to treatment access and that many new medicines do not provide value commensurate with their prices. This article examines pricing trends, the reasons for high prices and their implications for access and clinical practice.

Optimal power-heat-carbon scheduling strategy for interconnected heterogeneous multi-microgrid considering hydrogen fuel cell vehicles.

The scale of multi-microgrid (MMG) and hydrogen fuel cell vehicles (HFCVs) is increasing dramatically with the increase in the new energy penetration ratio, and developing an integrated energy system containing a multi-microgrid for hydrogen fuel vehicles brings great challenges to power grid operation. Focusing on the difficulties of the access of multiple microgrids for the low-carbon and economic operation of the system, this paper proposes an optimal interconnected heterogeneous multi-microgrid power-heat-carbon scheduling strategy for hydrogen-fueled vehicles. Firstly, an HFCV model is established, and then an optimal scheduling model is constructed for the cooperative trading of power-heat-carbon in a multi-microgrid, on the basis of which the low-carbon economic operation of the multi-microgrid is realized. The results of the case study show that the scheduling strategy in this paper reduces carbon emissions by about 7.12% and costs by about 3.41% compared with the independent operation of the multi-microgrid. The degrees of interaction of each multi-microgrid are also analyzed under different HFCV penetration rates.

Out-of-Pocket Costs and Payments in Autologous and Implant-Based Breast Reconstruction: A Nationwide Analysis.

BACKGROUND: Many factors influence a patient's decision to undergo autologous versus implant-based breast reconstruction, including medical, social, and financial considerations. This study aims to investigate differences in out-of-pocket and total spending for patients undergoing autologous and implant-based breast reconstruction. METHODS: The IBM MarketScan Commercial Databases were queried to extract all patients who underwent inpatient autologous or implant-based breast reconstruction from 2017 to 2021. Financial variables included gross payments to the provider (facility and/or physician) and out-of-pocket costs (total of coinsurance, deductible, and copayments). Univariate regressions assessed differences between autologous and implant-based reconstruction procedures. Mixed-effects linear regression was used to analyze parametric contributions to total gross and out-of-pocket costs. RESULTS: The sample identified 2079 autologous breast reconstruction and 1475 implant-based breast reconstruction episodes. Median out-of-pocket costs were significantly higher for autologous reconstruction than implant-based reconstruction ($597 vs $250, P < 0.001) as were total payments ($63,667 vs $31,472, P < 0.001). Type of insurance plan and region contributed to variable out-of-pocket costs (P < 0.001). Regression analysis revealed that autologous reconstruction contributes significantly to increasing out-of-pocket costs (B = $597, P = 0.025) and increasing total costs (B = $74,507, P = 0.006). CONCLUSION: The US national data demonstrate that autologous breast reconstruction has higher out-of-pocket costs and higher gross payments than implant-based reconstruction. More study is needed to determine the extent to which these financial differences affect patient decision-making.

Association of food insecurity with health, access to care, affordability of care, financial burden of care, and financial hardships among US adults during the COVID-19 pandemic.

OBJECTIVES: To examine the associations between food insecurity and health, access to care, affordability of care, financial burden of care, and financial hardships among US adults during the COVID-19 pandemic and examine whether the associations were less pronounced among adults with safety nets. STUDY DESIGN: We conducted a retrospective longitudinal cohort study using the 2020-2021 Medical Expenditure Panel Survey. METHODS: Linear probability models were used to assess the associations between food insecurity in one year and the outcomes of interest in the following year while adjusting for baseline characteristics. We performed the analyses for the entire population and then conducted stratified analyses for adults with and without Supplemental Nutrition Assistance Program (SNAP) benefits or Medicaid coverage. RESULTS: Compared with food-secure adults, food-insecure adults were 9.1 percentage points less likely to report life satisfaction and 9.9, 10.2, and 13.2 percentage points more likely to experience delays in getting medical care, postpone or forgo medical care because of cost, and struggle with paying medical bills. Food-insecure adults were 30.4, 27.2, and 23.5 percentage points more likely to face challenges in affording necessities, paying utility bills, and meeting rent or mortgage payments on time than food-secure adults. Notably, the strengths of these associations were attenuated among adults with SNAP benefits or Medicaid coverage. CONCLUSIONS: Food insecurity was associated with poor health, limited access to and affordability of care, and a greater financial burden of care among US adults during the pandemic. Nevertheless, safety net programs can play a critical role in alleviating adverse consequences.

Modeling and simulating the multi-generation product sales, production and inventory system within the context of quality upgrades.

The rapid development of science and technology has led to an increasing number of high-tech enterprises offering new products through successive generations of product upgrades. This trend presents a new challenge for the sustainable operations of enterprises. Based on the Norton-Bass model, this study begins by constructing a multi-generation product diffusion model within a single enterprise in the context of a monopoly under the quality upgrade scenario. Subsequently, a supply model is established based on this foundation, and these two models are seamlessly integrated using product sales volume as an interface, culminating in a comprehensive sales-supply system. This study analyzes the effects of new-product pricing, quality levels, initial stock, and production capacity on the performance of this system. The system dynamics (SD) method was used to simulate and solve the system in the decentralized and centralized decision-making modes, and the two decision-making modes were compared and analyzed. The research reveals several key findings. i) Comprehensive decision optimization yields enhanced profitability through joint optimization calculation of the multi-generation product diffusion system and the supply adjustment system. ii) consumer price sensitivity significantly affects product quality upgrades and profits. A negative correlation exists between consumer price sensitivity and both factors. The upgrades of product quality should be carefully traded off with consideration of pricing and quality costs. iii) Maximizing profits by maintaining a certain order level of backlog or stock shortage is beneficial for overall enterprise profitability. Additionally, optimal production capacity has been identified as a crucial element in efficient operational inventory management. This study expands the multi-generation product diffusion operational theory and provides valuable theoretical support and decision-making foundations for the sustainable management of enterprises.

Shifting from techno-economic to socio-ecological priorities: Incorporating landscape preferences and ecosystem services into the siting of renewable energy infrastructure.

This study examines the siting scenarios for renewable energy installations (REI) in a mountainous region of Europe (Switzerland), incorporating the external costs of ecosystem services and, innovatively, social preferences. This approach challenges the prevalent techno-economic siting paradigm, which often overlooks these externalities. To minimize the external costs of the scenarios while maximizing energy yield, Marxan, an optimization software, was employed. The energy target for all scenarios is set at 25 TWh/a, stemming from the energy gap anticipated due to the phase-out of Swiss nuclear reactors by 2050. This target is met using renewable energy infrastructure such as wind, roof-mounted photovoltaic, and ground-mounted photovoltaic systems. By integrating social preferences into the optimization, this study showcases a promising implementation that transcends the software's intended applications. It complements techno-economic approaches and offers alternative decision-making avenues. The conventional "roof first" strategy proved ineffective in preventing extensive land use for the development of new renewable energy infrastructure. Strategies incorporating ground-mounted photovoltaic infrastructure were more spatially, ecologically, and socially efficient than those without. The strategy optimized for energy yield exhibited the highest spatial efficiency but incurred significant ecosystem service costs and, surprisingly, had low social costs. In contrast, the strategy prioritizing ecosystem services was the most efficient in terms of ecosystem service costs but had elevated social costs and was spatially less efficient than other strategies. The strategy optimized for social preferences incurred the lowest social costs and excelled in spatial efficiency and ecosystem service costs. Notably, this strategy employed a limited number of planning units linked to both high ecosystem service and social costs. The findings underscore that incorporating social preferences significantly enhances the evaluation of siting options. This inclusion allows for the social acceptance of investments to be factored into costs, facilitating more informed and inclusive decisions.

Mapping the global geography of cybercrime with the World Cybercrime Index.

Cybercrime is a major challenge facing the world, with estimated costs ranging from the hundreds of millions to the trillions. Despite the threat it poses, cybercrime is somewhat an invisible phenomenon. In carrying out their virtual attacks, offenders often mask their physical locations by hiding behind online nicknames and technical protections. This means technical data are not well suited to establishing the true location of offenders and scholarly knowledge of cybercrime geography is limited. This paper proposes a solution: an expert survey. From March to October 2021 we invited leading experts in cybercrime intelligence/investigations from across the world to participate in an anonymized online survey on the geographical location of cybercrime offenders. The survey asked participants to consider five major categories of cybercrime, nominate the countries that they consider to be the most significant sources of each of these types of cybercrimes, and then rank each nominated country according to the impact, professionalism, and technical skill of its offenders. The outcome of the survey is the World Cybercrime Index, a global metric of cybercriminality organised around five types of cybercrime. The results indicate that a relatively small number of countries house the greatest cybercriminal threats. These findings partially remove the veil of anonymity around cybercriminal offenders, may aid law enforcement and policymakers in fighting this threat, and contribute to the study of cybercrime as a local phenomenon.

Access to essential medicines for diabetes care: availability, price, and affordability in central Ethiopia.

BACKGROUND: Diabetes is a major global public health burden. Effective diabetes management is highly dependent on the availability of affordable and quality-assured essential medicines (EMs) which is a challenge especially in low-and-middle-income countries such as Ethiopia. This study aimed to assess the accessibility of EMs used for diabetes care in central Ethiopia's public and private medicine outlets with respect to availability and affordability parameters. METHODS: A cross-sectional study was conducted in 60 selected public and private medicine outlets in central Ethiopia from January to February 2022 using the World Health Organization/Health Action International (WHO/HAI) standard tool to assess access to EMs. We included EMs that lower glucose, blood pressure, and cholesterol as these are all critical for diabetes care. Availability was determined as the percentage of surveyed outlets per sector in which the selected lowest-priced generic (LPG) and originator brand (OB) products were found. The number of days' wages required by the lowest paid government worker (LPGW) to purchase a one month's supply of medicines was used to measure affordability while median price was determined to assess patient price and price markup difference between public procurement and retail prices. RESULTS: Across all facilities, availability of LPG and OB medicines were 34.6% and 2.5% respectively. Only two glucose-lowering (glibenclamide 5 mg and metformin 500 mg) and two blood pressure-lowering medications (nifedipine 20 mg and hydrochlorothiazide 25 mg) surpassed the WHO's target of 80% availability. The median price based on the least measurable unit of LPG diabetes EMs was 1.6 ETB (0.033 USD) in public and 4.65 ETB (0.095 USD) in private outlets. The cost of one month's supply of diabetes EMs was equivalent to 0.3 to 3.1 days wages in public and 1.0 to 11.0 days wages in private outlets, respectively, for a typical LPGW. Thus, 58.8% and 84.6% of LPG diabetes EMs included in the price analysis were unaffordable in private and public outlets, respectively. CONCLUSIONS: There are big gaps in availability and affordability of EMs used for diabetes in central Ethiopia. Policy makers should work to improve access to diabetes EMs. It is recommended to increase government attention to availing affordable EMs for diabetes care including at the primary healthcare levels which are more accessible to the majority of the population. Similar studies are also recommended to be conducted in different parts of Ethiopia.

Online Tools to Decrease Out-of-Pocket Prescription Costs for Patients: A Practical Guide for Urologists.

INTRODUCTION: Patients who seek urologic care have recently reported a high degree of financial toxicity from prescription medications, including management for nephrolithiasis, urinary incontinence, and urological oncology. Estimating out-of-pocket costs can be challenging for urologists in the US because of variable insurance coverage, local pharmacy distributions, and complicated prescription pricing schemes. This article discusses resources that urologists can adopt into their practice and share with patients to help lower out-of-pocket spending for prescription medications. METHODS: We identify 4 online tools that are designed to direct patients toward more affordable prescription medication options: the Medicare Part D Plan Finder, GoodRx, Amazon, and the Mark Cuban Cost Plus Drug Company. A brief historical overview and summary for patients and clinicians are provided for each online resource. A patient-centered framework is provided to help navigate these 4 available tools in clinic. RESULTS: Among the 4 tools we identify, there are multiples tradeoffs to consider as financial savings and features can vary. First, patients insured by Medicare should explore the Part D Plan Finder each year to compare drug plans. Second, patients who need to urgently refill a prescription at a local pharmacy should visit GoodRx. Third, patients who are prescribed recurrent generic prescriptions for chronic conditions can utilize the Mark Cuban Cost Plus Drug Company. Finally, patients who are prescribed 3 or more chronic medications can benefit from subscribing to Amazon RxPass. CONCLUSIONS: Prescription medications for urologic conditions can be expensive. This article includes 4 online resources that can help patients access medications at their most affordable costs. Urologists can provide this framework to their patients to help support lowering out-of-pocket drug costs.

Ruminations on sustainable and safe food: Championing for open symbiotic cultures ensuring resource efficiency, eco-sustainability and affordability.

Microbes are powerful upgraders, able to convert simple substrates to nutritional metabolites at rates and yields surpassing those of higher organisms by a factor of 2 to 10. A summary table highlights the superior efficiencies of a whole array of microbes compared to conventionally farmed animals and insects, converting nitrogen and organics to food and feed. Aiming at the most resource-efficient class of microbial proteins, deploying the power of open microbial communities, coined here as 'symbiotic microbiomes' is promising. For instance, a production train of interest is to develop rumen-inspired technologies to upgrade fibre-rich substrates, increasingly available as residues from emerging bioeconomy initiatives. Such advancements offer promising perspectives, as currently only 5%-25% of the available cellulose is recovered by ruminant livestock systems. While safely producing food and feed with open cultures has a long-standing tradition, novel symbiotic fermentation routes are currently facing much higher market entrance barriers compared to axenic fermentation. Our global society is at a pivotal juncture, requiring a shift towards food production systems that not only embrace the environmental and economic sustainability but also uphold ethical standards. In this context, we propose to re-examine the place of spontaneous or natural microbial consortia for safe future food and feed biotech developments, and advocate for intelligent regulatory practices. We stress that reconsidering symbiotic microbiomes is key to achieve sustainable development goals and defend the need for microbial biotechnology literacy education.

EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ("EFFECT-BACK"): study protocol for a randomized controlled trial.

INTRODUCTION: Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior to cognitive behavioral therapy (CBT) in reducing perceived limitations of movement. The current study aims to further compare the efficacy of both treatment methods and identify those patient groups that particularly benefit from EXP. METHODS: The general objective of this randomized multicenter clinical trial (targeted N = 380) is to improve and expand the range of treatments available to patients with chronic back pain. As the primary objective of the study, two different psychological treatments (EXP and CBT) will be compared. The primary outcome measure is a clinically significant improvement in pain-related impairment, measured by the QPBDS, from baseline to 6-month follow-up. Secondary outcome measures are absolute changes and clinically significant improvements in variables coping, psychological flexibility, depressiveness, catastrophizing, exercise avoidance and fear of exercise, and intensity of pain. Participants are recruited in five psychological and medical centers in Germany and receive ten sessions of manualized therapy by trained licensed CBT therapists or clinical psychologists, who are currently in their post-gradual CBT training. Potential predictors of each treatment's efficacy will be explored with a focus on avoidance and coping behavior. CONCLUSION: This study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it should gain more attention and be further disseminated. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294081. Registered on 02 March 2022.

Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review.

Introduction: While biosimilar medicines can contribute to the sustainability of healthcare systems, their utilization rate varies across European countries. This study aims to identify and systematize policy measures and instruments used in European countries to increase biosimilar market share. Methods: A systematic review was conducted according to PRISMA 2020 recommendations. Medline-PubMed, Web of Science and ScienceDirect databases were searched using inclusion criteria that required full articles published in English between January 2006 and November 2023. Reviews, letters, reports, editorials and comments or opinion articles were excluded from this study. Results: Of the 1,137 articles, only 13 met the eligibility criteria for analysis, which covered a total of 28 European countries. Pricing regulation measures were found in 27 of these countries with tendering, price-linkage and internal reference price being the most used. Tendering was used by 27 countries to procure biosimilars in inpatient setting. Prescribing guidelines and recommendations were the widely used instrument. Some European countries adopted physician incentives, quotas, and prescription by international non-proprietary name. Conclusion: Automatic substitution was not commonly recommended or applied. Interchangeability and switching will become increasingly relevant issues. It is important that the positive results from some countries serve as an example for the future of these medicines in the European market. Systematic review registration: https://inplasy.com/, Identifier INPLASY2023120032.

Tackling medicine shortages during and after the COVID-19 pandemic: Compilation of governmental policy measures and developments in 38 countries.

In response to increasing shortages of medicines, governments have implemented legislative and non-legislative policy measures. This study aimed to map these policies across high-income countries in Europe and beyond as of 2023 and to analyse developments in governmental approaches since the beginning of the pandemic. Information was collated from 38 countries (33 European countries, Australia, Brazil, Canada, Israel and Saudi Arabia) based on a survey conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in 2023. 34 countries requested pharmaceutical companies to notify national registers of upcoming shortages and 20 countries obliged manufacturers and/or wholesalers to stock supply reserves of critically needed medicines. Further common measures included export bans for defined medicines (18 countries), regulatory measures to facilitate import and use of alternative medicines (35 countries) and multi-stakeholder coordination (28 countries). While the legislation of 26 countries allows imposing sanctions, particularly for non-compliance to reporting requirements, fines were rather rarely imposed. Since 2022, at least 18 countries provided financial incentives, usually in the form of price increases of some off-patent medicines. Overall, several policies to address medicine shortages were taken in recent years, in some countries as part of a comprehensive package (e.g., Australia, Germany). Further initiatives to secure medicine supply in a sustainable manner were being prepared or discussed.

Usability of Health Care Price Transparency Data in the United States: Mixed Methods Study.

BACKGROUND: Increasing health care expenditure in the United States has put policy makers under enormous pressure to find ways to curtail costs. Starting January 1, 2021, hospitals operating in the United States were mandated to publish transparent, accessible pricing information online about the items and services in a consumer-friendly format within comprehensive machine-readable files on their websites. OBJECTIVE: The aims of this study are to analyze the available files on hospitals' websites, answering the question-is price transparency (PT) information as provided usable for patients or for machines?-and to provide a solution. METHODS: We analyzed 39 main hospitals in Florida that have published machine-readable files on their website, including commercial carriers. We created an Excel (Microsoft) file that included those 39 hospitals along with the 4 most popular services-Current Procedural Terminology (CPT) 45380, 29827, and 70553 and Diagnosis-Related Group (DRG) 807-for the 4 most popular commercial carriers (Health Maintenance Organization [HMO] or Preferred Provider Organization [PPO] plans)-Aetna, Florida Blue, Cigna, and UnitedHealthcare. We conducted an A/B test using 67 MTurkers (randomly selected from US residents), investigating the level of awareness about PT legislation and the usability of available files. We also suggested format standardization, such as master field names using schema integration, to make machine-readable files consistent and usable for machines. RESULTS: The poor usability and inconsistent formats of the current PT information yielded no evidence of its usefulness for patients or its quality for machines. This indicates that the information does not meet the requirements for being consumer-friendly or machine readable as mandated by legislation. Based on the responses to the first part of the experiment (PT awareness), it was evident that participants need to be made aware of the PT legislation. However, they believe it is important to know the service price before receiving it. Based on the responses to the second part of the experiment (human usability of PT information), the average number of correct responses was not equal between the 2 groups, that is, the treatment group (mean 1.23, SD 1.30) found more correct answers than the control group (mean 2.76, SD 0.58; t65=6.46; P<.001; d=1.52). CONCLUSIONS: Consistent machine-readable files across all health systems facilitate the development of tools for estimating customer out-of-pocket costs, aligning with the PT rule's main objective-providing patients with valuable information and reducing health care expenditures.