Search Results (235)

Background and Objectives: GLP-1 receptor agonists (GLP-1 RAs; ATC A10BJ) and dual GLP-1/GIP agonist (ATC A10BX16) have expanded rapidly due to strong evidence in type 2 diabetes, obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). Their high acquisition costs and accelerating uptake make them key drivers of pharmaceutical expenditure. This study quantified national utilization and expenditure trends for antihyperglycemic drugs in Croatia (2017–2024), with a focus on GLP-1 RA and dual GLP-1/GIP agonists. Materials and Methods: Aggregate national data on dispensed medicines, valued at wholesale pharmacy prices, were obtained from HALMED’s annual ATC/DDD reports. Utilization was expressed as defined daily doses per 1000 inhabitants per day (DDD/1000/day). We analyzed the total A10 and key subclasses. The dual GLP-1/GIP agonist was only marketed in 2024. Compound annual growth rates (CAGR) were calculated. Results: The total antihyperglycemic utilization increased from 66.9 to 96.8 DDD/1000/day (a 44.7% rise), while the total A10 expenditure increased from EUR 54.2 million to EUR 96.5 million, indicating that expenditure growth outpaced utilization growth. GLP-1 receptor agonist expenditure increased from EUR 5.2 million (2018) to EUR 28.6 million (2024) (CAGR 33.0%), reaching 29.8% of total A10 expenditure in 2024. Expenditure for GLP-1-based agents grew faster than their DDD volume because per-DDD acquisition costs are substantially higher than for SGLT-2 inhibitors. These growth patterns are consistent with trajectories reported in higher-uptake EU health systems, suggesting convergence rather than an outlier position for Croatia. Conclusions: Croatia experienced a rapid shift towards GLP-1 RA-based antihyperglycemic pharmacotherapy, with GLP-1-based therapies exerting a disproportionate budget impact. For payers, these surveillance data support budget forecasting and negotiation of pricing and reimbursement conditions; clinicians can use them to benchmark and optimize evidence-aligned prescribing; and policymakers can apply them to monitor the diffusion and fiscal impact of high-cost therapies. Routine national ATC/DDD analysis, complemented by HZZO claims and primary-care datasets, is essential for guiding future pricing, reimbursement and formulary decisions. Full article

The regulation of new medicine prices must balance financial sustainability with equitable access to innovation. Value-Based Pricing (VBP) strategies seek to align drug prices with their clinical and societal impact. The Pharmaceutical Innovativeness Index (PII) is a transparent and reproducible tool proposed to assess the degree of innovativeness of new medicines, with potential to support pricing decisions within economic regulation frameworks. An exploratory qualitative study was conducted through a focus group study was conducted with experts in health economics and pharmaceutical regulation to evaluate the applicability of the PII and to discuss key domains relevant to the assessment of pharmaceutical innovation. Responses were collected anonymously using an interactive digital platform and analyzed through inductive thematic content analysis. Based on these findings, the research team developed a conceptual pricing model integrating the PII with additional value-based criteria. Two hypothetical case studies were created to explore its practical feasibility. Participants identified Added Therapeutic Value (ATV) and Unmet Therapeutic Need (UTN) as the most relevant domains, while Methodological Quality (MQ) and Study Design (SD) were also recognized as essential to ensure rigor and reduce bias. The PII scores showed strong alignment with expert judgment in the illustrative case studies. The proposed model incorporates international best practices—such as the efficiency frontier approach—and additional dimensions including safety and incremental innovation. Overall, the PII demonstrated potential to enhance transparency, consistency, and regulatory efficiency in drug pricing decisions in Brazil. However, it should currently be regarded as an exploratory framework requiring further empirical validation and regulatory adaptation before implementation. Full article

Background/Objectives: Thyroid hormones, considered safe in therapeutic doses, are used to treat hypothyroidism, a common condition. Due to a combination of factors, including their mechanism of action, availability, and low price, these drugs are used illegally, mainly to improve performance, to assist in weight loss, or for attempting suicide. Their overuse can lead to serious health consequences, including death. Although thyroid hormones are abused, there are no studies assessing the scale, characteristics, and consequences of their illegal use. The aim of this study was to evaluate case reports of thyroid hormone poisoning from the last 30 years, assessing their dynamics and characteristics. Methods: Full-text clinical case studies were obtained by searching PubMed, Google Scholar, MEDLINE, Embase, Web of Science, and Scopus for the following terms: “thyroid hormones”, “thyroxine”, “levothyroxine”, “triiodothyronine”, and “liothyronine”, as well as “intoxication”, “overdose”, and “poisoning”. This study adhered to Preferred Reporting for Systematic Reviews and Meta-analyses (PRISMA) guidelines for systematic reviews. Results: Thyroid hormones are abused particularly by athletes, persons trying to lose weight, or those attempting suicide. There has been an upward trend in thyroid hormone poisoning over the past 30 years, particularly since 2015. The same trend has been observed in cases of thyroid hormone use for doping, among other performance-enhancing drugs. Thyroid hormone use for doping was the most common cause of poisoning with these drugs, with other clinical manifestations from poisonings due to other causes. No upward trend has been observed in the use of thyroid hormones in suicide attempts since 2017, as this number remains stable. Conclusions: Although exploratory in nature, our work indicates that thyroid hormone poisoning, associated mostly with the illegal use of anabolic–androgenic steroids, exhibits an increasing tendency. Moreover, thyroid hormone abuse is an important issue in suicidology. Full article

In this paper, we present the application of Entrepreneurial Separation to Transfer Technologies from federally funded research and the difficulties associated with the transfer of intellectual property. With the increased threat (call) by the government to exercise “march-in” rights, which could limit both the licensing terms and what firms charge for goods (e.g., prescription drugs) that come from intellectual property (IP) resulting from federally funded research, researchers may be disinclined to commercialize their IP. While the government wants to exercise its March-In Rights to help consumers, it may be unintentionally harming them. The government is increasingly more vocal about the threat of march-in rights, in part because of the high consumer prices that have resulted from pandemic-related inflationary pressures. This threat has the potential of rolling back 40 years of gains from the Bayh–Dole Act. We present an overview of Entrepreneurial Separation to Transfer Technology and Entrepreneurial Leave Agreements and how they serve as one tool to support the transfer of early-stage technology. In a Volatile, Uncertain, Complex, and Ambiguous environment, university and federal laboratories need all the tools available to facilitate innovation and its commercialization. We present here why the development of these programs can help support their activities. Full article

Background: Comprehensive data on the economic burden of cervical cancer treatment remain scarce in China’s less developed regions, necessitating this study on hospitalization costs and expenditure trends in these areas. Methods: Employing a multi-stage stratified cluster sampling approach, this study enrolled 10,070 cervical cancer inpatients from 72 healthcare facilities in Gansu Province. Clinical and expenditure data were extracted from hospital information systems. Rank sum tests and Spearman correlation analyses were performed for univariate assessment, while quantile regression and random forest models were applied to identify determinant factors. Results: From 2019 to 2023, the average hospitalization duration for cervical cancer patients in Gansu Province was 16.12 days, with an average hospitalization cost of USD 3862.08 (2023 constant prices, converted from CNY at 1:7.0467). During these five years, the average inpatient costs per hospitalization increased from USD 3473.45 to USD 4202.57, and the average daily hospitalization cost rose from USD 230.53 to USD 241.77. The average drug cost decreased from USD 769.06 to USD 640.16. The main factors influencing hospitalization costs included the length of hospital stay, whether cervical cancer surgery was performed, hospital type, hospital level, and the proportion of medications. Conclusions: Our findings indicate that cervical cancer is a considerable economic burden on both families and society. This highlights the need to control the length of hospital stay and optimize the allocation of medical resources, in addition to strengthening cervical cancer screening and HPV vaccination in underdeveloped areas, in order to enhance the efficiency of prevention and treatment and ensure medical equity. Full article

Objective: This study evaluated the cost-effectiveness of sacituzumab govitecan (SG) compared with single-agent chemotherapy of the physician’s choice (TPC) from the perspective of Taiwan’s National Health Insurance. Methods: A partitioned survival model was developed to assess outcomes in patients with metastatic triple-negative breast cancer (mTNBC). Clinical data were derived from the ASCENT trial, while direct medical costs were obtained from Taiwan’s National Health Insurance Administration (NHIA). Utility values were taken from published literature. The primary outcome was the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were performed to examine parameter uncertainty and test the robustness of the results. Results: In the base-case analysis, SG was associated with an incremental cost of USD 121,836 per QALY gained—exceeding Taiwan’s willingness-to-pay (WTP) threshold of USD 102,120. One-way sensitivity analyses indicated that SG drug cost was the primary driver of ICER variability. Probabilistic sensitivity analysis showed that reducing the price of SG by 50% increased the likelihood of cost-effectiveness. Conclusions: From the NHIA perspective, SG is not cost-effective for patients with advanced or metastatic TNBC at its current price. Substantial price reductions would be required for SG to become cost-effective under the WTP threshold of USD 102,120 per QALY. Full article

Background: Prostate cancer is the second most common malignant cancer among men, and according to the predictions, the estimated number of new cases will substantially grow in the coming years. Therefore, the costs of the disease will increase as well. Methods: We conducted a literature review of the state of knowledge about the costs of treatment and the economic burden of prostate cancer. The vast majority of studies were focused on direct costs only, which clearly shows the literature gap. Results: We focused on the estimates of direct costs, i.e., treatment of prostate cancer, adjuvant and neoadjuvant treatment, and supportive and palliative care, and indirect costs. Cost-effectiveness analyses indicated that docetaxel combined with androgen deprivation therapy (ADT) was the most cost-effective strategy for metastatic hormone-sensitive prostate cancer (incremental cost-effectiveness ratio (ICER): USD 13,647). In contrast, novel therapies such as PARP inhibitors and whole-genome-sequencing-guided treatments were not cost-effective unless drug prices were reduced by 47–70%. In the United States, 5-year cumulative treatment costs ranged from USD 48,000 for conservative management to over USD 91,000 for radiotherapy, while out-of-pocket expenses averaged AUD 1172 in Australia. Indirect costs were also considerable, with Slovakia reporting an increase in sick leave costs from EUR 1.2 million in 2014 to EUR 2.1 million in 2022. Conclusions: Metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer were the most frequent categories for various treatment cost evaluations. A few specific combinations of drugs were cost-effective only under the condition of dropping the unit prices of a medication. Further summarizing, reviewing, and developing a methodology for standardized comparisons are needed. Full article

Triple-negative breast cancer (TNBC) has historically been challenging to treat due to limited therapeutic options. Since 2018, the treatment landscape has evolved substantially with the approval of precision therapies, including immune checkpoint inhibitors, poly (ADP-ribose) polymerase inhibitors, and antibody–drug conjugates. Despite these advancements, the therapeutic benefit remains limited due to various clinical challenges, largely driven by TNBC heterogeneity and an incomplete understanding of drug–tumor crosstalk mechanisms—both contributing to a restricted pool of eligible patients and variable treatment responses. Concurrently, emerging drugs tested in recent pivotal TNBC trials have demonstrated variable outcomes. Additionally, the associated economic burden has become a pressing global concern, as several approved drugs provide insufficient clinical benefit in relation to high expenditures, often driven by drug pricing. The situation is particularly critical in low- and middle-income countries, where TNBC is highly prevalent, yet access to even chemotherapeutic treatment remains limited. These factors collectively hinder real-world patient outcomes. This review provides a comprehensive analysis of TNBC management, integrating clinical advancements with economic perspectives and raising awareness of underdiscussed topics. The overview presented herein highlights the necessity for a global, interdisciplinary approach and patient centered care in TNBC drug development. Full article

Background: Generic drugs account for approximately 40% of the Korean prescription drug market, despite limited generic substitution at the point of dispensing. This suggests that switching between originator and generic drugs often occurs at the point of prescription. Physicians, in fact, have opposed pharmacy-level substitution due to concerns about the clinical equivalence of generics, despite the regulatory confirmation of their bioequivalence. Importantly, multi-source prescription switching (MSPS) may reflect discretionary prescribing behavior, underscoring the need for targeted benefit policies to enhance substitutability and promote effective competition among multi-source drugs. This study aimed to quantify the extent of physician-initiated MSPS among adults with hypertension or diabetes and to identify factors associated with these switching behaviors. Methods: We conducted a retrospective cohort study using Korean National Health Insurance claims data. The studied cohort consisted of patients newly initiated, between January and June 2014, on a pharmaceutically equivalent and bioequivalent antihypertensive or antidiabetic drug. Patients were followed for up to 24 months to identify MSPS episodes occurring during drug therapy courses, which were defined as 12 ± 3 consecutive visits resulting in prescriptions for pharmaceutically equivalent, bioequivalent multi-source drugs. An MSPS episode was defined as a change in product code—uniquely identifying a multi-source drug—within the same pharmaceutically equivalent drug code between any two consecutive prescriptions within the course. We estimated the mean MSPS rate and assessed variation by patient characteristics, drug types, physician practices, and geographic regions. Results: Among 1,325,334 identified drug therapy courses, 17.06% involved at least one MSPS. Switching rates varied substantially (coefficient of variation = 227%) by physician practice setting (e.g., public health center branches: 26%; tertiary hospitals: 15%) and by drug market size (e.g., glimepiride: 29%; cilnidipine: 1%). In contrast, patient age and gender were not associated with switching behavior. Conclusions: In Korea, physicians frequently switch prescriptions between originator and generic drugs, even as generic substitution at the pharmacy level remains uncommon. The substantial variation in MSPS across provider settings and drug markets—but not by patient characteristics—underscores the need for targeted pharmacy benefit policies to promote effective substitutability and competition among multi-source drugs. Full article

China’s healthcare expenditure tripled during 2010–2019, prompting the nationwide implementation of centralized volume-based procurement (CVBP). While effective in reducing drug prices, CVBP introduces sustainability challenges including supply chain vulnerabilities and welfare trade-offs. This study develops a pharmaceutical sector-embedded computable general equilibrium (CGE) model to quantify CVBP’s multidimensional sustainability impacts. Using China’s 2020 Social Accounting Matrix (SAM) with simulated 10–50% price reductions, key findings reveal that (1) >40% price reductions trigger sectoral output reversal; (2) GDP exhibits an inverted U-shape; (3) household income declines despite corporate/government gains; and (4) industrial contraction impairs innovation capacity and employment stability. Our analysis identifies potential sustainability risks, emphasizing the need for rigorous empirical validation prior to implementing aggressive price reduction policies, and underscores the importance of integrating supply chain considerations into procurement policy design. This approach maximizes resource allocation efficiency while advancing socioeconomic resilience in healthcare systems. Full article

The city of Pittsburg, Pennsylvania, remains -the epicenter of aggravated assaults this year. Compared to its pre-pandemic figures, violent crimes saw an upsurge with theft topping the city crime list. This study assessed the trend of crime series, particularly thefts, robberies, and burglaries, in two specific periods, namely from January 1990 to December 2001 and from 1 July 2023 to 30 September 2023, in Pittsburg using the discrete valued time series processes, with some popular innovation distributions that have recently emerged. The upward trend in thefts, robberies, and burglaries was affiliated with a shortage of police, existing police officers’ low morale, the latter’s anti-police demeanours, weak crime laws, gun proliferation, falling inflation rates, a rise in the consumers’ price index, uncomfortable homes, life insecurity, poverty, alcohol, drugs, and a devalued society. Thus, the implications include a need to strengthen existing crime laws, to create a diversion judiciary system offering alternatives to high-cost incarcerations provided that culprits adhere to the programs, and to establish evidence-based policies rooted in effective approaches. Full article

Antimicrobial resistance (AMR) represents a critical global health threat, with inappropriate antibiotic self-medication (ASM) being a key contributor. China—as the world’s largest antibiotic consumer—faces significant challenges despite regulatory efforts, compounded by limited contemporary data during the COVID-19 pandemic. A nationwide cross-sectional study was conducted using the 2021 China Family Health Index Survey (n = 11,031 participants across 120 cities). Trained investigators administered face-to-face questionnaires assessing ASM practices, decision-making factors, and sociodemographic characteristics. Multivariate logistic regression identified determinants of ASM. Overall, ASM prevalence was 33.7% (n = 3717), with no urban-rural difference (p > 0.05). Physician advice (78.2%), drug safety (67.1%), and efficacy (64.2%) were primary selection criteria; rural residents prioritized drug price and salesperson recommendations more than their urban counterparts (p < 0.01). Key predictors included higher ASM odds among females (OR = 1.30, 95%CI:1.18–1.43), middle-aged adults (46–59 years; OR = 1.20, 95%CI:1.02–1.42), those with health insurance (resident: OR = 1.33; commercial: OR = 1.62), and individuals with drinking histories (OR = 1.20, 95%CI:1.10–1.31). Lower odds were associated with primary education (OR = 0.69, 95%CI:0.58–0.81), unemployment (OR = 0.88, 95%CI:0.79–0.98), and absence of chronic diseases (OR = 0.56, 95%CI:0.47–0.67). One-third of Chinese residents engaged in ASM during the pandemic, driven by intersecting demographic and behavioral factors. Despite converging urban-rural prevalence rates, distinct decision-making drivers necessitate context-specific interventions, including strengthened pharmacy regulation in rural areas, tailored education programs for high-risk groups, and insurance system reforms to disincentivize self-medication. Full article

Cancers are problematic for health systems globally, including in Antigua and Barbuda, where understanding the changing extent of common cancers is key to implementing effective prevention and control strategies. This study aimed to assess the relationship between treatment rates and drug treatment costs along with characteristics affecting these costs for patients with female breast, cervical, colorectal and prostate cancers in Antigua and Barbuda from 2017 to 2021. A retrospective observational study design was used. Estimates of age-standardized treatment rates and drug treatment costs were determined using direct standardization and a micro-costing approach, respectively. Linear regression was used to evaluate the relationship between age-standardized treatment rates and drug treatment costs. Model independent variables were assessed for multicollinearity and residuals examined for variance and normality. With a sum of 242 cases identified for this study, each cancer type showed evidence of strong positive correlations and significant associations between treatment costs and age-standardized treatment rates. The mean cost (USD) of drug treatment was highest for female breast (USD 25,009.63) and colorectal (USD 13,317.16) cancers and lowest for prostate (USD 12,528.10) and cervical (USD 5121.41) cancers, with several variables showing significance in the respective final models. An association existed between age-standardized treatment rates and drug treatment costs for the cancers studied. These results offer a basis for encouraging strategies in obtaining affordably priced cancer medicines in Antigua and Barbuda. Full article

Background/Objectives: Metabolic dysfunction-associated steatohepatitis (MASH) has become the leading cause of hepatocellular carcinoma and liver disorders globally. Nevertheless, only one expensive drug, resmetirom (Res), has been approved by the FDA for MASH treatment to date. However, its high price has imposed a heavy financial burden on patients. Methods: In this study, half-dose Res and low-dose metformin (Met) (referred to as RM) were administered in combination to treat MASH models in vitro and in vivo. We utilized transcriptome and lipidomics sequencing to assess the efficacy of RM in improving MASH. Our goal was to systemically compare the therapeutic effects of RM, Met, and Res on MASH and elucidate the underlying mechanisms. Results: Our results demonstrated that RM was comparable to Res and superior to Met in reducing lipid production in vitro, attenuating lipid accumulation, inhibiting inflammation, and improving fibrosis in vivo. Transcriptome and lipidome analyses further revealed that RM regulated the expression of genes and lipids in a manner similar to Res, particularly in pathways related to cholesterol metabolism and inflammation. Further validation showed that RM facilitated cholesterol transformation by robustly promoting the expression of CYP7A1, thereby mitigating MASH. Conclusions: Collectively, our findings highlight that a combination of half-dose Res and Met is equivalent to Res alone in terms of MASH treatment efficacy. This study provides a novel therapeutic strategy that is not only effective for MASH treatment but also reduces the economic burden on patients. Full article

Systemic therapy (ST) and transarterial radioembolization (TARE) are widely used treatments for advanced-stage hepatocellular carcinoma (HCC). This study quantified the significant variability in treatment costs for unresectable HCC from payer and provider perspectives. An Excel-based price analysis model was developed to estimate the prices of ST and TARE over a 21-month time horizon using 2015–2021 data. Median prices were calculated from Medicare Average Sales Price (ASP), provider Wholesale Acquisition Cost (WAC), and Average Wholesale Price (AWP). Sensitivity analyses evaluated price fluctuations associated with a ±10% variation in treatment duration. ST prices demonstrated marked variability across perspectives, with the median ASP at $175,625, WAC at $198,719, and AWP at $262,892. However, TARE prices were stable, ranging from $21,594 to $24,052. Sensitivity analyses revealed that treatment duration variation resulted in price changes of $35,000–$50,000 for ST, compared with ~$5000 for TARE. The variability in ST pricing was driven by treatment duration and drug-specific pricing mechanisms, particularly immunotherapy-based regimens, which accounted for the higher cost range. Conversely, TARE’s consistent pricing is attributed to standardized procedural costs. Substantial variability exists in ST prices compared with the consistent costs of TARE, underscoring the economic advantage of TARE in appropriate clinical contexts. Full article