Annual Treatment Costs Research Articles

Short-term cost-effectiveness of oral semaglutide versus empagliflozin, sitagliptin, and liraglutide in the treatment of Type 2 diabetes in Greece

Diabetes is a significant global health concern, affecting more than 540 million people worldwide and imposing a substantial financial burden on health systems and societies. This study evaluates the cost per patient of achieving treatment targets with oral semaglutide compared to empagliflozin, sitagliptin, and liraglutide in patients with Type 2 diabetes in Greece. The analysis focuses on seven outcomes, including hemoglobin A1C levels, avoidance of hypoglycemia, and weight loss, with costs calculated in 2024 EUR, excluding patient copayments. The annual treatment costs were EUR 1,210.04 for oral semaglutide, EUR 528.04 for empagliflozin, EUR 260.51 for sitagliptin, and EUR 1,542.87 for liraglutide. Although a higher proportion of patients achieved treatment goals with oral semaglutide, it was associated with a higher cost of control across most outcomes compared to empagliflozin (mean probabilistic sensitivity analysis [PSA] difference: EUR 839.45) and sitagliptin (mean PSA difference: EUR 1,041.50). In contrast, oral semaglutide demonstrated a consistently lower cost of control compared to liraglutide across all treatment targets (mean PSA difference: EUR −3,779.23). This analysis confirms that the cost of control of oral semaglutide varies significantly depending on the treatment target, suggesting that, without changes in its list or net price, it may not be the most cost-effective option compared to empagliflozin and sitagliptin in Greece.

PSVI-1 Supplemented milk replacer improves feed transition of dairy bull-calves

Abstract Neonatal calves are affected by pathogenic infections, compounded by stress, leading to enteric and respiratory disorders accounting for about 7.8% mortality rate and annual treatment costs exceeding $250 million. Federal restrictions on antibiotic use due antimicrobial resistance in humans has opened the door for viable alternatives like rumen enhancements which have been reported to aid the establishment of beneficial rumen flora leading to improved health and performance. It is hypothesized that nutritional formulation of milk replacers to help the calf prevent or cope with diarrhea can provide a leeway that will ensure better animal performance and transition to solid feed. The objective of study was to evaluate the performance of dairy bull-calves fed nutritionally supplemented milk replacers. Three milk replacers were tested with or without supplementation of metabolic enhancements (Control: no metabolic enhancer; Added: milk replacer with metabolic enhancer added at the time of mixing milk in shuttle; Composite: produced along with metabolic enhancer. Dairy bull-calves (n = 60; 2 to 5 d-old) were grouped into three treatments of milk replacers. The study lasted for 10 wk; 6 wk of milk-feeding and 4 wk of calf starter feeding. Body weights (BW) were taken on a weekly basis, while calf starter intake was measured daily and data were analyzed using one-way analysis of variance. Calves fed milk replacer with composite metabolic enhancer recorded the greatest intake and final BW over the 10-wk period. Calves fed milk replacer with added metabolic enhancer at the point of milk mixing recorded the poorest data in terms of BW gain and final BW. Calves fed metabolic enhancer, either added or composite recorded a better weaning and transition to solid feed from milk feeding. Calves fed control milk replacer experienced a poor transition from milk feeding to solid feed. It is concluded that composited rumen metabolite enhancers in milk replacer supported greater starter intake, average daily gain and better transition of calves to solid feed, and is recommended for the feeding of neonatal calves.

Evaluating the impact and costs of conversional or revisional metabolic bariatric surgery on obstructive sleep apnea: Insights from a French nationwide cohort

BackgroundThis study assesses the effectiveness of 5 main conversional or revisional metabolic bariatric surgery sequences after sleeve gastrectomy, adjustable gastric banding and gastric bypass on reimbursement and cost of continuous positive airway pressure therapy, the first line treatment for obstructive sleep apnea, in France. MethodsThis nationwide observational population-based cohort study analyzed data from the French National Health Insurance database. It included all patients who had undergone primary metabolic bariatric surgery in France between January 1, 2012, and December 31, 2014, and followed until December 31, 2020. The study assessed continuous positive airway pressure therapy reimbursement discontinuation and costs of reimbursed continuous positive airway pressure therapy across 5 different conversional or revisional metabolic bariatric surgery sequences. ResultsDuring follow-up, 6,396 patients underwent the following sequences: sleeve gastrectomy–gastric bypass (n = 2,400), adjustable gastric banding–sleeve gastrectomy (n = 2,277), adjustable gastric banding–gastric bypass (n = 1,173), sleeve gastrectomy–sleeve gastrectomy (n = 546), and gastric bypass–others (n =332), with a rate of obstructive sleep apnea of 15.2%, 12.4%, 15.5% 12.8%, and 9.9% in the year before conversional or revisional metabolic bariatric surgery. The rates of patients who had a discontinuation of continuous positive airway pressure were at 2 and 4 years: 41.1%, 41.9%, 46.4%, 29.3%, and 33.3%; 62.3%, 57.0%, 78.2%; 57.5%, and 44.4%, respectively. At 4 years, the mean annual costs (euros) of obstructive sleep apnea treatment per patient were significantly lower (P < .01) than the costs in the year before conversional or revisional metabolic bariatric surgery for each sequence: 526.9 ± 414.4 vs 257.4 ± 349.7; 368.0 ± 247.5 vs 230.9 ± 288.4; 433.7 ± 326.0 vs 116.8 ± 238.3; 540.7 ± 275.3 vs 248.0 ± 308.4 and 501.2 ± 254.0 vs 281.1 ± 287.0, respectively. ConclusionsOur study underscore the effectiveness of conversional or revisional metabolic bariatric surgery in significantly reducing the need and associated costs of continuous positive airway pressure therapy for patients with obstructive sleep apnea postprimary metabolic bariatric surgery over a 4-year period.

The Annual Cost of Cancer Screening in the United States.

Cancer has substantial health, quality-of-life, and economic impacts. Screening may decrease cancer mortality and treatment costs, but the cost of screening in the United States is unknown. To estimate the annual cost of initial cancer screening (that is, screening without follow-up costs) in the United States in 2021. Model using national health care survey and cost resources data. U.S. health care systems and institutions. People eligible for breast, cervical, colorectal, lung, and prostate cancer screening with available data. The number of people screened and associated health care system costs by insurance status in 2021 dollars. Total health care system costs for initial cancer screenings in the United States in 2021 were estimated at $43 billion. Approximately 88.3% of costs were attributable to private insurance; 8.5% to Medicare; and 3.2% to Medicaid, other government programs, and uninsured persons. Screening for colorectal cancer represented approximately 64% of the total cost; screening colonoscopy represented about 55% of the total. Facility costs (amounts paid to facilities where testing occurred) were major drivers of the total estimated costs of screening. All data on receipt of cancer screening are based on self-report from national health care surveys. Estimates do not include costs of follow-up for positive or abnormal screening results. Variations in costs based on geography and provider or health care organization are not fully captured. The $43 billion estimated annual cost for initial cancer screening in the United States in 2021 is less than the reported annual cost of cancer treatment in the United States in the first 12 months after diagnosis. Identification of cancer screening costs and their drivers is critical to help inform policy and develop programmatic priorities, particularly for enhancing access to recommended cancer screening services. None.

Utilization and affordability of health insurance coverage for rare disease drugs in a first-tier city in Northeast China from 2018 to 2021: a study based on the health insurance claims database

ObjectiveThe accessibility issue of orphan drugs in China is prominent. Based on real-world data from a tier-one city in Northeast China, this study aims to analyze the current usage and affordability of orphan drugs for rare diseases.MethodsThe data was sourced from the health insurance claims data of a certain city from 2018 to 2021, including a total of 16 orphan drugs. The utilization of orphan drugs is assessed using four indicators: frequency of medical insurance claims, medication cost, defined daily doses (DDDs), and defined daily drug cost (DDDc). Affordability is measured using the concept of catastrophic health expenditure (CHE).ResultsBetween January 2018 and December 2021, there were a total of 2,851 medical insurance claims in the city, with a total medication costs of $3.08 million. Overall, during the study, there was a year-on-year increase in the utilization frequency of individual rare disease drugs in the city, with DDDs rising from 140.22 in 2018 to 3983.63 in 2021. Additionally, the annual medication costs of individual drugs showed a consistent upward trend, increasing from $10,953.53 in 2018 to $120,491.36 in 2021. However, the DDDc of individual drugs decreased from $398.12 in 2018 to $96.65 in 2021.The number of sales and the amount of sales for orphan drugs in community pharmacies have significantly increased. Prior to medical insurance coverage, out of the 16 orphan drugs, 9 drugs had annual treatment costs exceeding CHE for urban residents, and 15 drugs had annual treatment costs exceeding CHE for rural residents. After medical insurance coverage, there were no drugs with out-of-pocket costs exceeding CHE for urban residents, while 8 drugs had out-of-pocket costs exceeding CHE for rural residents. Furthermore, both before and after medical insurance coverage, the four treatment drugs for idiopathic pulmonary arterial hypertension were more affordable compared to the four treatment drugs for multiple sclerosis.ConclusionThe usage frequency of orphan drugs in a certain city increased gradually, but the disease burden remained heavy. More policy support should be provided to the priority rare disease populations, and the rare disease medical security and diagnosis and treatment systems should be improved.

Impact of smoking on cost-effectiveness of 10-48 years of periodontal care.

The study aims were (1) to explore whether "periodontal treatment" consisting of surgical therapy (flap, resective, or regenerative) or scaling and root planing treatment with long-term periodontal maintenance treatment, is cost-effective in terms of preventing periodontitis-attributable tooth extraction and replacement by implant-supported crowns ("extraction/replacement"); (2) to assess the effect of cigarette smoking on this cost-effectiveness. Data for this observational retrospective study were collected from dental charts of patients who had received periodontal therapy and at least annual follow-up visits for >10 years were analyzed by linear regression generalized estimating equations and generalized linear models. Among 399 adults (199 males, 200 females), those with the least mean annual treatment cost experienced the greatest mean annual costs for extraction/replacement, indicating general cost-effectiveness. Cigarette smoking adversely impacted this cost-effectiveness, with current heavy smokers experiencing no cost-effectiveness. Former smokers with Grade C periodontitis benefitted most, whereas smoking did not influence cost-effectiveness for Grade B periodontitis. Assessed by mean annual costs of "extraction/replacement," periodontal treatment was cost-effective, which decreased in a dose-response manner by former and current smoking intensity. Cigarette smoking should be factored into treatment planning and cost-effective analyses of periodontal treatment. Smoking cessation should be encouraged.

Diabetic ketoacidosis resolution: From the traditional way to guideline-based management in the MICU at University Medical Center, Lubbock, Texas

Diabetes is a chronic, metabolic disease characterized by hyperglycemia which eventually can cause serious organ damage. The prevalence of diabetes has steadily increased over the past few decades, and approximately 1.4 million Americans are diagnosed with diabetes every year. Diabetes was the seventh leading cause of death in the United States in 2019. Diabetic ketoacidosis (DKA) is a serious complication of diabetes that can be life-threatening. It occurs more frequently in the patients with type 1 diabetes but can also develop in people with type 2 diabetes. It was determined that the average cost per DKA episode was $6,444, and that the annual cost of medical treatment in a diabetic patient with a prior episode of DKA was 2.67 times higher than a diabetic patient with no history of DKA. The criteria for DKA resolution at University Medical Center (UMC) in Lubbock, Texas, are different from current American Diabetes Association (ADA) guidelines. At UMC, a plasma bicarbonate ≥18 mEq/L, a venous pH &gt; 7.3, and anion gap ≤12 mEq/L must be recorded twice (4 hours apart) before bridging to subcutaneous long-acting insulin administration. This time requirement could contribute to a longer time for DKA resolution and longer intensive care unit and hospital stays.Keywords: Diabetic ketoacidosis, DKA resolution

Charting the Etanercept Journey: Tracing Cost Dynamics in Poland's Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly.

To evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market. We conducted a comprehensive, retrospective analysis of ETN market competition, specifically changes in tender price based on shifts in market monopoly, including the effects on cost evolution, in the off-patent market in Poland. We included a total of 473 tenders for ETN purchase in dedicated biologic drug reimbursement programs, covering both pre-filled syringes and automatic injectors. This study covers the timeframe from November 2017 to December 2023, throughout which we evaluated a unique setting of ETN market re-monopolization from the perspective of payer, hospital and patient benefits resulting from changing cost calculations. Between 2017 and 2022, Erelzi was recorded as having the largest total tender volume (59%), with a mean price [per ETN daily defined dose (DDD)] of €7.28, followed by Enbrel (31%, €8.34) and Benepali (10%, €9.45), respectively. Over the last 6 months of waning market competition, the mean price for winning bids was estimated at €5.69. After market re-monopolization by an ETN biosimilar, the mean price of winning bids increased to €8.09, and continued to increase (€9.71) in the last 6 months of available follow-up. In contrast to the competitive era, no significant relationship between tender volume and winning price was recorded after re-monopolization. In the most recent tenders, mean ETN prices increased up to €15.82, nearly tripling the lowest prices of the competitive market period. In the early re-monopolization market, mean annual treatment cost per patient is estimated at over €3800, which exceeds therapy costs in the prior competitive market years, and is expected to increase to over €6200 based on the most recent tenders. On a healthcare system level, this corresponds to over €3.42 million excess costs due to market monopoly. Higher ETN prices resulted in downstream failure of regulatory incentives to promote affordable biologics. Due to higher pricing, hospitals lost over an estimated €2.52 million, with possible risk of treatment restrictions. For the same reason, the public payer achieved comparable savings, allowing for partial coverage of higher reimbursement expenses. This nation-level scenario of market re-monopolization by a biosimilar drug confirms net loss and excess costs for the healthcare payer, as can be expected from economic theory. The upwards drug repricing and restriction of treatment availability occurs much more rapidly than the decrement in a period of market competition.

The annual cost of cancer screening in the U.S.

11051 Background: Cancer screening can decrease cancer incidence, mortality, and treatment costs. However, the annual cost of screening to the U.S. healthcare system is unknown. Methods: We used data from national healthcare surveys and standard costing sources to model the healthcare system cost of breast, cervical, colorectal, lung, and prostate cancer screening in the U.S. in 2021. Models projected the number of individuals in the U.S. eligible for each screening test based on current guidelines/recommendations; the number of eligible individuals screened by insurance status; and the costs associated with screening (in 2021 US dollars). Multiple sensitivity analyses were performed to examine the effects of changing model population parameters and costs on projected outcomes. Results: Total 2021 cancer screening costs to the U.S. healthcare system were estimated to be $57 billion; approximately 88% of the costs were attributable to private insurance, 9% to Medicare, and 3% to Medicaid, other government programs, and uninsured individuals. Most screened individuals had private insurance except for lung cancer screening, where a majority of individuals screened had Medicare coverage. Individuals with private insurance accounted for the majority of costs for each screening modality. Screening for colorectal cancer represented approximately two-thirds of the total cost; screening colonoscopy was approximately 60% of the total cost of cancer screening. Breast and cervical cancer screening represented the second and third largest screening costs, 15.4% and 14.7% (respectively) of total screening costs. Facility costs (amounts paid to facilities where testing occurred) were generally larger components of the total estimated costs of screening than were physician costs. Cost estimates were robust to a range of variations in eligible populations and screening costs. Conclusions: The $57 billion estimated annual cost for cancer screening in the U.S. in 2021 is similar to the estimated annual cost of cancer treatment in the U.S. in the first 12 months following diagnosis. Screening may have been suboptimal in 2021, with higher screening rates and costs in subsequent years. Identification of cancer screening costs and their drivers is critical to help inform policy and develop programmatic priorities. The model can be used to estimate the increased costs of enhanced access to recommended cancer screening services among underscreened populations, which would provide population-wide benefits.

The Clinical and Economic Burdens of Obesity and the Value of Weight Loss for an EMR-Derived US Cohort: A Modeling Study.

Obesity-related comorbidities (ORCs) cause significant economic and clinical burdens for people with obesity and the US health care system. A reduction in weight at the population level may reduce incident ORC diagnoses and associated costs of treatment. The aim of this work is to describe obesity burden in the United States through the prevalence and direct treatment costs of ORCs, as well as the clinical and economic value of 15% weight loss in a population of adults with obesity. The IQVIA Ambulatory US electronic medical record database was used to create a cohort (7,667,023 individuals 20-69 years of age, body mass index of 30-50 kg/m2), utilized to characterize the prevalence of 10 ORCs. Direct treatment costs were collected from literature reports. A risk model was leveraged to estimate the number and cost of additional ORC diagnoses over 5 years from baseline through two scenarios: stable weight and 15% lower body weight at baseline for all members of the population. Prevalence, incidence, and cost data were scaled down to a representative subset of 100,000 individuals. In 2022, the annual treatment costs for all 10 ORCs exceeded $918 million for the representative cohort. In a stable-weight scenario, these costs were estimated to increase to ≈$1.4 billion by 2027. With 15% lower body weight at baseline, $221 million in cumulative savings was estimated, corresponding to $2205 in savings/patient over 5 years. Consequently, weight loss in this population may correspond to significantly reduced numbers of incident ORC complications translating to substantial cost savings.

An Early Cost-Utility Model of mRNA-Based Therapies for the Treatment of Methylmalonic and Propionic Acidemia in the United Kingdom.

Novel messenger RNA (mRNA)-based therapies, currently in development, are emerging as a promising potential treatment modality for a broad range of life-threatening and life-limiting inherited liver diseases, including methylmalonic acidemia (MMA) and propionic acidemia (PA). However, owing in part to their complexity, they are likely to come at considerable financial cost to healthcare systems. The objective of this research was to synthesize available evidence on the costs and clinical consequences associated with MMA and PA for the purpose of exploratory economic evaluation of novel mRNA-based therapies using an early cost-utility model from the United Kingdom payer perspective. A Markov model was constructed to simulate the costs and outcomes associated with novel mRNA therapies, compared with a combination of dietary management and organ transplantation (standard of care) among hypothetical cohorts of new-born patients with MMA and PA. Key model drivers were identified, and a price threshold analysis was performed to estimate value-based price ranges for future mRNA therapies given willingness-to-pay thresholds for orphan diseases. mRNA therapy was associated with an additional 5.7 and 1.3 quality-adjusted life-years (QALYs) gained per patient lifetime among patients with MMA and PA, respectively. Key drivers of cost-effectiveness were relative improvement in utility among patients who receive mRNA-based therapy and transplantation, and the cost of mRNA therapy. Assuming a willingness to pay range of £100,000-£300,000 per QALY gained, the model demonstrated mRNA therapy to be cost-effective in MMA and PA at an annual treatment cost of £70,452-£94,575 and £31,313-£36,695, respectively. Despite the lack of a strong evidence base in MMA and PA, this model provides a useful tool to estimate the cost-effectiveness, and inform value-based pricing, of new mRNA-based therapies. Our analyses also identified areas for research that will have the greatest value in reducing uncertainty in future health economic evaluations of such treatments.

Annual epidemiological and health insurance disease burden of hip osteoarthritis in Hungary based on nationwide data

BackgroundHealth services utilization related to hip osteoarthritis imposes a significant burden on society and health care systems. Our aim was to analyse the epidemiological and health insurance disease burden of hip osteoarthritis in Hungary based on nationwide data.MethodsData were extracted from the nationwide financial database of the National Health Insurance Fund Administration (NHIFA) of Hungary for the year 2018. The analysed data included annual patient numbers, prevalence, and age-standardized prevalence per 100,000 population in outpatient care, health insurance costs calculated for age groups and sexes for all types of care. Patients with hip osteoarthritis were identified using code M16 of the International Classification of Diseases (ICD), 10th revision. Age-standardised prevalence rates were calculated using the European Standard Population 2013 (ESP2013).ResultsBased on patient numbers of outpatient care, the prevalence per 100,000 among males was 1,483.7 patients (1.5%), among females 2,905.5 (2.9%), in total 2,226.2 patients (2.2%). The age-standardised prevalence was 1,734.8 (1.7%) for males and 2,594.8 (2.6%) for females per 100,000 population, for a total of 2,237.6 (2.2%). The prevalence per 100,000 population was higher for women in all age groups. In age group 30–39, 40–49, 50–59, 60–69 and 70 + the overall prevalence was 0.2%, 0.8%, 2.7%, 5.0% and 7.7%, respectively, describing a continuously increasing trend. In 2018, the NHIFA spent 42.31 million EUR on the treatment of hip osteoarthritis. Hip osteoarthritis accounts for 1% of total nationwide health insurance expenditures. 36.8% of costs were attributed to the treatment of male patients, and 63.2% to female patients. Acute inpatient care, outpatient care and chronic and rehabilitation inpatient care were the main cost drivers, accounting for 62.7%, 14.6% and 8.2% of the total health care expenditure for men, and 51.0%, 20.0% and 11.2% for women, respectively. The average annual treatment cost per patient was 3,627 EUR for men and 4,194 EUR for women.ConclusionsThe prevalence of hip osteoarthritis was 1.96 times higher (the age-standardised prevalence was 1.5 times higher) in women compared to men. Acute inpatient care was the major cost driver in the treatment of hip osteoarthritis. The average annual treatment cost per patient was 15.6% higher for women compared to men.

Variables affecting new drug prices in South Korea's pricing system.

Objective: The price of pharmaceuticals is important from the economic and industrial perspectives but as well as patients' access to treatment. This study aimed to analyze the variables affecting the prices of new drugs in South Korea's pricing system. Methods: Data on 192 new drugs listed in South Korea from 2012 to 2022 were collected from the official website of the Health Insurance Review and Assessment Service. The independent variables included drugs for severe diseases, alternatives, number of patients, number of advanced 7 countries listed, budget impact, and listing period. The dependent variables included annual treatment cost and the price ratio to the advanced 7 country's average adjusted price. Descriptive statistics of variables, linear correlations between quantitative independent and dependent variables, and associations between independent and dependent variables were analyzed. Results: The mean annual treatment cost and price ratio to the advanced 7 country's average adjusted price were higher for drugs for severe diseases and those with no alternatives. Annual treatment cost and price ratio to the advanced 7 country's average adjusted price were negatively correlated with the number of patients and positively correlated with the number of advanced 7 countries listed. Annual treatment cost was affected by the variables drugs for severe diseases, alternatives, number of patients, number of advanced 7 countries listed, and budget impact. The price ratio to the advanced 7 country's average adjusted price was affected by drugs for severe diseases, alternatives, and the number of patients. Conclusion: This study revealed the effect of different variables on the prices of new drugs in South Korea, allowing for the development of a more effective assessment system to evaluate the prices of new drugs while ensuring profitability for pharmaceutical companies, sustainability of public insurance, and accessibility to drugs by patients.

Parabolic trough concentrator design, characterization, and application: solar wastewater purification targeting textile industry dyes and pharmaceuticals—techno-economic study

AbstractSolar energy, along with other renewable resources, has the potential to be a major contributor to solving environmental issues in the future, as illustrated by the most recent advancements in solar photocatalytic technology. Indeed, wastewater treatment using a parabolic solar collector for industrial processes is gaining ground owing to improved system performance and economic benefits. The fabricated parabolic trough collector (PTC) incorporates reflective, parabolic panels that focus solar energy onto a transparent tube positioned along the parabolic focal line, where solar-powered photochemical reactions occur. This study investigated the design, implementation, and effectiveness of a concentrated sunlight system for removing industrial dyes and emerging large-use pharmaceutical contaminants in the presence of H2O2 at a small demonstrator scale (10 L/h). A spectrophotometric assessment revealed that subjecting Remazol Brilliant Blue (RBB, 60 ppm) and ciprofloxacin (CIP, 10 ppm) to irradiation in the presence of 0.1 M H2O2 (RBB) or 0.01 M H2O2 (CIP) for 3 h resulted in a degradation rate exceeding 60% and 80%, respectively. Furthermore, the total organic content (TOC) analysis indicates a very high total removal yield for RBB. On these bases, a techno-economic analysis is produced, and economic viability is discussed. The data reveal that the annual costs for water treatment, considering investment, electricity, and catalyst expenses over a 12-month period are significantly lower for our PTC-based prototype than for a comparable artificial UV-based equipment.

An Analysis of the Distribution of Direct Cost of Diabetes Care in Selected Districts in Italy.

This study aims to define the distribution of direct healthcare costs for people with diabetes treated in two healthcare regions in Italy, based on number of comorbidities and treatment regimen. This was a retrospective analysis using data from two local health authority administrative databases (Campania and Umbria) in Italy for the years2014-2018. Data on hospital care, pharmaceutical and specialist outpatient and laboratory assistance were collected. All people with diabetes in 2014-2018 were identified on the basis of at least one prescription of hypoglycemic drugs (ATC A10), hospitalization with primary or secondary diagnosis of diabetes mellitus (ICD9CM 250.xx) or diabetes exemption code (code 013). Subjects were stratified into three groups according to their pharmaceutical prescriptions during the year: Type1/type2 diabetes (T1D/T2D) treated with multiple daily injections with insulin (MDI), type2 diabetes on basal insulin only (T2D-Basal) and type2 diabetes not on insulin therapy (T2D-Oral). We identified 304,779 people with diabetes during the period for which data was obtained. Analysis was undertaken on 288,097 subjects treated with glucose-lowering drugs (13% T1D/T2D-MDI, 13% T2D-Basal, 74% T2D-Oral). Average annual cost per patient for the year2018 across the total cohort was similar for people with T1D/T2D-MDI and people with T2D-Basal (respectively €2580 and €2254) and significantly lower for T2D-Oral (€1145). Cost of hospitalization was the main driver (47% for T1D/T2D-MDI, 45% for T2D-Basal, 45% for T2D-Oral) followed by drugs/devices (35%, 39%, 43%) and outpatient services (18%, 16%, 12%). Average costs increased considerably with increasing comorbidities: from €459 with diabetes only to €7464 for a patient with four comorbidities. Similar trends were found across all subgroups analysis. Annual cost of treatment for people with diabetes is similar for those treated with MDI or with basal insulin only, with hospitalization being the main cost driver. This indicates that both patient groups should benefit from having access to scanning continuous glucose monitoring (CGM) technology which is known to be associated with significantly reduced hospitalization for acute diabetes events, compared to self-monitored blood glucose (SMBG) testing.

Comparative evaluation of efficacy of Pippalyadi Agada as an adjuvant drug vs. standard drug therapy in the management of acute food poisoning: A Study Protocol

Antimicrobial resistance, a pressing challenge in modern medicine, arises from excessive antibiotic use in veterinary and human care. Underreporting and complex links between food contamination and illnesses have led to underestimating foodborne disease impacts. The World Bank’s 2019 analysis projected $15B annual treatment costs and $95.2B productivity loss in low- to middle-income countries due to foodborne diseases. “Agada” refers to symptom-relieving medications, like “Vishaghnakalpa.” Pippalyadi Agada, from Vishaghana plants, treats “Dooshivisha Chikitsa,” e.g., Kitibha, rashes, shwas. It has anti-inflammatory, antioxidant properties, aiding acute food poisoning with nausea, vomiting, fever, diarrhea. It is a carminative, curbing prolonged diarrhea, and anti-toxic. Pippalyadi Agada pacifies imbalanced Vata and Kapha, promising better relief than Agni and Pittastana interventions. As an Ayurvedic remedy, it is administered as Vati, 500mg twice daily with Anuapan Honey for 7 days. This study aims to comparatively evaluate the effectiveness of Pippalyadi Agada as an adjunct to standard drug therapy in managing acute food poisoning. Following a comprehensive drug analysis, a total of 60 eligible participants will be selected and assigned to two groups, each comprising 30 individuals. Group A will receive standard drug therapy, while Group B will receive standard drug therapy alongside Pippalyadi Agad, administered twice daily for 7 days. Assessments will occur on days 0, 3, 5, and 8, both before and after the intervention. The study anticipates that the use of Pippalyadi Agada as an adjunct to standard drug therapy will lead to improved symptom relief and faster recovery in individuals with acute food poisoning, as demonstrated by significant reductions in symptoms such as nausea, vomiting, fever, and diarrhea. The observed outcomes will contribute to a more comprehensive understanding of the potential benefits of Ayurvedic interventions in managing foodborne illnesses.

A comprehensive clinical evaluation of HER2-TKIs in patients with previously treated HER2-positive metastatic breast cancer.

Human epidermal growth factor receptor 2-tyrosine kinase inhibitors (HER2-TKIs) have been extensively utilized for treating HER2-positive metastatic breast cancer (MBC), with numerous clinical trial reports available. We aim to systematically perform a comprehensive clinical evaluation on HER2-TKIs, provide a reference for the clinical rational use of drugs, and serve for the decision-making of the national drug policy. We performed comprehensive clinical evaluation in six dimensions including safety, effectiveness, economy, suitability, accessibility, and innovation through meta-analysis, literature review, drug administration websites, and other relevant medication data to analyze HER2-TKIs in treating HER2-positive MBC. For safety, the risk of ≥ grade 3 adverse events among pyrotinib, lapatinib, and neratinib is not significantly different. Furthermore, pyrotinib and neratinib were found to be higher in the risk of ≥ grade 3 diarrhea than lapatinib, however the risk could be reversed and prevented with loperamide. Regarding effectiveness and economy, pyrotinib was confirmed to have the best efficacy and cost-utility value, neratinib the second, and lapatinib the third. As regards innovation and suitability, pyrotinib showed better than other HER2-TKIs. In addition, pyrotinib received a higher recommendation than other HER2-TKIs in patients with HER2-positive MBC. The accessibility of pyrotinib was found to be the best with better urban, rural, and national affordability and lower annual treatment costs. Pyrotinib is more valuable in clinics with better safety, effectiveness, economy, suitability, accessibility, and innovation in HER2-positive MBC. This study could provide references for the clinical application of HER2-TKIs in treating HER2-positive MBC.

Extending the dosing intervals of nivolumab: model-based simulations in unselected cancer patients.

Reducing nivolumab dose intensity could increase patients' life quality and decrease the financial burden while maintaining efficacy. The aims of this study were to develop a population PK model of nivolumab based on data from unselected metastatic cancer patients and to simulate extended-interval regimens allowing to maintain minimal effective plasma concentrations (MEPC). Concentration-time data (992 plasma nivolumab concentrations, 364 patients) were modeled using a two-compartment model with linear elimination clearance in Monolix software. Extended-interval regimens allowing to maintain steady-state trough concentrations (Cmin,ss) above the MEPC of 2.5 mg/L or 1.5 mg/L in >90% of patients were simulated. Increasing 3-times the dosing interval from 240 mg every two weeks (Q2W) to Q6W and 2-times from 480 mg Q4W to Q8W resulted in Cmin,ss above 2.5 mg/L in 95.8% and 95.4% of patients, respectively. 240 mg Q8W and 480 mg Q10W resulted in Cmin,ss above 1.5 mg/L in 91.0% and 91.8% of patients, respectively. Selection of a 240 mg Q6W regimen would decrease by 3-fold the annual treatment costs compared to standard regimen of 240 mg Q2W (from 78,744€ to 26,248€ in France). Clinical trials are warranted to confirm the non-inferiority of extended-interval compared to standard regimen.

Analysis of affordability differences for rare diseases in China: a comparison across disease types and regions

BackgroundChina has implemented policies to make rare diseases more affordable. While previous studies evaluated overall affordability, few have examined affordability differences across regions and disease types. Given the vastness of China and varying medical policies across cities, this study assesses the affordability of rare diseases based on China’s First List of Rare Diseases (CFLRD), National Reimbursement Drug List (NRDL), and outpatient chronic and special disease policies in each prefecture.MethodSix rare diseases were selected and the average annual treatment cost of all relevant drugs in NRDL was calculated for each disease. Based on the WHO/HAI standardized approach, the study analyzed 289 cities with outpatient chronic and special disease policies, measured the security levels by the actual reimbursement ratio of Basic Medical Insurance (BMI) and affordability by the ratio of individual expenses after reimbursement to the annual disposable income of urban residents in the province. The security levels and affordability differences across disease types and provinces were analyzed using the Mann-Whitney U test and the K-W test.ResultThe affordability of rare diseases varied significantly on the disease types and annual treatment cost. Diseases with an annual treatment cost below 100 000 yuan are affordable to all prefectures even with low reimbursement rates, while those with a higher treatment cost were not affordable in at least 80% of prefectures even though the reimbursement ratio is high. The affordability of the same disease varies significantly across provinces and municipalities. Outpatient chronic and special diseases insurance and critical illness insurance, and the inconsistencies between them, result in regional differences.ConclusionAlthough China has made progress in improving the affordability of rare diseases, significant differences persist between cities and diseases. The study suggests the optimization of the BMI system and explores independent funds and innovative insurance models to enhance the affordability of rare diseases, particularly those with extremely high treatment costs.

Cost-benefit evaluation of advanced therapy lines in metastatic triple-negative breast cancer in Germany

BackgroundTriple-negative breast cancer (TNBC) is responsible for 10–20% cases of breast cancer and is resulting in rising healthcare costs. Thus, health-economic evaluations are needed to relate clinical outcomes and costs of treatment options and to provide recommendations of action from a health-economic perspective.MethodsWe investigated the cost-benefit-ratio of approved treatment options in metastatic TNBC in Germany by applying the efficiency frontier approach. These included sacituzumab-govitecan (SG), eribulin, vinorelbine, and capecitabine. Clinical benefit was measured as (i) median overall survival (mOS) and (ii) health-related quality of life (HRQoL) in terms of time to symptom worsening (TSW). To assess medical benefits, literature was systematically reviewed in PubMed for (i) and (ii), respectively. Treatment costs were calculated considering annual direct outpatient treatment costs from a statutory healthcare payer perspective. It was intended that both, (i) and (ii), yield an efficiency frontier.ResultsAnnual direct outpatient treatment costs amounted to EUR 176,415.21 (SG), EUR 47,414.14 (eribulin), EUR 13,711.35 (vinorelbine), and EUR 3,718.84 (capecitabine). Systematic literature review of (i) and statistical analysis resulted in OS values of 14.3, 9.56, 9.44, and 7.46 months, respectively. Capecitabine, vinorelbine, and SG are part of the efficiency frontier including OS. The highest additional benefit per additional cost was determined for vinorelbine, followed by SG. Systematic review of (ii) revealed that no TSW data of TNBC patients receiving vinorelbine were available, preventing the presentation of an efficiency frontier including HRQoL.ConclusionsVinorelbine is most cost-effective, followed by SG. Health-economic evaluations support decision-makers to assess treatment options within one indication area. In Germany, the efficiency frontier can provide decision support for the pricing of innovative interventions. Results of our analysis may thus guide reimbursement determination.