The economic value of insulin glargine 300 U/mL (Gla-300) in people ≥18 years of age with type 2 diabetes mellitus: a value-based economic model from a U.S. payer perspective.

AIMS: This study aimed to evaluate the value and affordability of insulin glargine 300 U/mL (Gla-300) in a budget impact model from a United States (U.S.) payer perspective by leveraging recent real-world evidence (RWE) studies and incorporating the recent insulin price caps where applicable. MATERIALS AND METHODS: An economic model for a hypothetical one million U.S. health-plan population was developed to assess the budgetary impact of therapeutic interchanges in either direction between the two long- and longer-acting basal insulins (BIs) for patients with type 2 diabetes over a three-year model horizon. The utilization of long-acting BIs, longer-acting BIs, biosimilar BIs, and insulin degludec (IDeg-100) were informed by IQVIA data and internal forecasting at Sanofi. The DELIVER-2 and DELIVER-naïve studies provided healthcare resource utilization (HCRU) parameters. In the model base case, 24% of patients switched from long-acting BIs to insulin glargine biosimilars, IDeg-100, and other longer-acting BIs (Gla-300) by projected year 3. RESULTS: The base case total costs were $10,145 per patient per year (PPPY) in year 3 for the cumulative population. When all patients switched to Gla-300, the total costs in year 3 were $8,799, reflecting a net savings of -$660 PPPY compared to the budget increase of $686 PPPY in the base case. However, the longer-acting to long-acting BIs reversal scenario demonstrated a budgetary decrease of $676 PPPY over the model horizon. The reduction in incremental PPPY cost of $93 was observed using net drug costs rather than wholesale acquisition costs (WAC). LIMITATIONS: The market shares for years 1-3 were based on expectations supported by the clinicians' expert opinions and were not obtained from real-world data. CONCLUSIONS: The economic value of increased utilization of Gla-300 was driven by the reduction in HCRU, costs and market shares assumptions. Budgetary reductions were achieved by switching patients from long-acting BIs to Gla-300.

Type 2 Diabetes (T2D) is a chronic and debilitating condition that can lead to severe macro or microvascular complications. To mitigate these complications, it is crucial to effectively manage blood glucose levels. When other treatments prove ineffective in achieving adequate glucose control, insulin-based therapy becomes necessary. However, insulin-based treatments often come with the risk of hypoglycemic episodes, which can lead to increased utilization of healthcare resources (HCRU) and have a negative impact on costs.This study aimed to assess the budgetary impact of higher market shares of longer-acting basal insulins (specifically insulin glargine Gla-300) compared to long-acting basal insulins, insulin glargine biosimilars, and insulin degludec (IDeg) in the treatment of T2D. The perspective taken was that of a U.S. payer, taking into account the recent insulin price caps where applicable.The economic benefit of increased utilization of Gla-300 was driven by reductions in HCRU, costs, and market share assumptions. This resulted in a budgetary increase of $686 per patient per year (PPPY). In an alternative scenario where all patients transitioned to Gla-300, it led to a net savings of $660 PPPY.These findings provide valuable insights for decision-makers and healthcare professionals when making choices related to formulary placement and treatment utilization.

Clinical and economic outcomes associated with use of anti-arrhythmic drugs versus ablation in atrial fibrillation.

Aim: To evaluate the clinical and economic impact of antiarrhythmic drugs (AADs) compared with ablation both as individual treatments and as combination therapy without/with considering the order of treatment among patients with atrial fibrillation (AFib). Materials & methods: A budget impact model over a one-year time horizon was developed to assess the economic impact of AADs (amiodarone, dofetilide, dronedarone, flecainide, propafenone, sotalol, and as a group) versus ablation across three scenarios: direct comparisons of individual treatments, non-temporal combinations, and temporal combinations. The economic analysis was conducted in accordance with CHEERS guidance as per current model objectives. Results are reported as costs per patient per year (PPPY). The impact of individual parameters was evaluated using one-way sensitivity analysis (OWSA). Results: In direct comparisons, ablation had the highest annual medication/procedure cost ($29,432), followed by dofetilide ($7661), dronedarone ($6451), sotalol ($4552), propafenone ($3044), flecainide ($2563), and amiodarone ($2538). Flecainide had the highest costs for long-term clinical outcomes ($22,964), followed by dofetilide ($17,462), sotalol ($15,030), amiodarone ($12,450), dronedarone ($10,424), propafenone ($7678) and ablation ($9948). In the non-temporal scenario, total costs incurred for AADs (group) + ablation ($17,278) were lower compared with ablation alone ($39,380). In the temporal scenario, AADs (group) before ablation resulted in PPPY cost savings of ($22,858) compared with AADs (group) after ablation ($19,958). Key factors in OWSA were ablation costs, the proportion of patients having reablation, and withdrawal due to adverse events. Conclusion: Utilization of AADs as individual treatment or in combination with ablation demonstrated comparable clinical benefits along with costs savings in patients with AFib.

A value-based budget impact model for dronedarone compared with other rhythm control strategies.

Aim: The budgetary consequences of increasing dronedarone utilization for treatment of atrial fibrillation were evaluated from a US payer perspective. Materials & methods: A budget impact model over a 5-year time horizon was developed, including drug-related costs and risks for long-term clinical outcomes (LTCOs). Treatments included antiarrhythmic drugs (AADs; dronedarone, amiodarone, sotalol, propafenone, dofetilide, flecainide), rate control medications, and ablation. Direct comparisons and temporal and non-temporal combination scenarios investigating treatment order were analyzed as costs per patient per month (PPPM). Results: By projected year 5, costs PPPM for dronedarone versus other AADs decreased by $37.69 due to fewer LTCOs, treatment with dronedarone versus ablation or rate control medications + ablation resulted in cost savings ($359.94 and $370.54, respectively), and AADs placed before ablation decreased PPPM costs by $242 compared with ablation before AADs. Conclusion Increased dronedarone utilization demonstrated incremental cost reductions over time.

Are There Racial and Ethnic Health Disparities Among Outcomes After Anterior Cranial Fossa Surgery? A Propensity Score-Matched American College of Surgeons National Surgical Quality Improvement Program Study.

BACKGROUND: Race-based health care outcomes remain to be described in anterior cranial fossa (ACF) surgery. OBJECTIVE: To determine whether race predicts worse outcomes after ACF surgery. METHODS: A retrospective cohort study was performed using the American College of Surgeons National Surgical Quality Improvement Program data for 2005 to 2020. Current Procedural Terminology and International Classification of Diseases-9 codes were used to identify ACF tumor cases. Propensity score matching was performed to compare White and minority patients to assess the robustness of unmatched findings. A subanalysis of pituitary adenoma (PA) resections was also performed. RESULTS: In an unmatched analysis of 1370 patients who underwent ACF surgery (67.9% White, 17.4% Black, 6.6% Asian/Pacific Islander, and 6.3% Hispanic), minority groups had higher rates of comorbidities. Unmatched multivariate analysis found Hispanic patients bore a 1.86 odds ratio (OR) of minor complications, Black and Asian and Pacific Islander patients bore 1.49 and 1.71 ORs, respectively, for extended length of stay, and Black patients bore a 3.78 OR for urinary tract infection (UTI). Matched analysis found that minority patients had higher UTI rates ( P = .02) and a 4.11 OR of UTI. In PA cases specifically, minority groups had higher comorbidities and length of stay in addition to extended length of stay odds (1.84 OR). CONCLUSION: Although most ACF surgery outcomes were unaffected by race, minority groups had more minor postoperative complications than White patients, particularly UTI. Similar disparities were observed among PA cases. Higher rates of comorbidities may also have led to longer hospital stays. Further study is needed to understand what actions might be necessary to address any race-associated health disparities in ACF surgery.

Breast Cancer Stage Is Associated With Exceeding Target Price in the Oncology Care Model.

PURPOSE: To explore mean difference between Oncology Care Model (OCM) total costs and target price among breast cancer episodes by stage under the Centers for Medicare and Medicaid Services OCM payment methodology. METHODS: Breast cancer episodes from OCM performance period 1-4 reconciliation reports (July 1, 2016-July 1, 2018) were linked with health record data from a large, academic medical center. Demographics, total cost of care (TCOC), and target price were measured by stage. Adjusted differences between TCOC and target price were compared across cancer stage using multivariable linear regression. RESULTS: A total of 539 episodes were evaluated from 252 unique patients with breast cancer, of which 235 (44%) were stage I, 124 (23%) stage II, 33 (6%) stage III, and 147 (27%) stage IV. About 37% of episodes exceeded target price. Mean differences from target price were -$1,782, $2,246, -$6,032, and $11,379 all in US dollars (USD) for stages I through IV, respectively. Stage IV episodes had highest mean TCOC ($44,210 USD) and mean target price ($32,831 USD) but also had higher rates of chemotherapy, inpatient admission, and novel therapy use. After adjusting for covariates, stage IV and ≥ 65-year-old patients had the highest mean difference from target price ($17,175 USD; 95% CI, $12,452 to $21,898 USD). CONCLUSION: Breast cancer episodes in older women with distant metastases most frequently exceeded target price, suggesting that target price did not adequately account for complexity of metastatic cancers. A metastatic adjustment introduced in PP7 represents a promising advancement in the target price methodology and an impact evaluation will be needed.

Assessment of Pharmacokinetics and Metabolism Profiles of SCH 58261 in Rats Using Liquid Chromatography-Mass Spectrometric Method.

5-Amino-7-(2-phenylethyl)-2-(2-furyl)-pyrazolo(4,3-e)-1,2,4-triazolo(1,5-c) pyrimidine (SCH 58261) is one of the new chemical entities that has been developed as an adenosine A2A receptor antagonist. Although SCH 58261 has been reported to be beneficial, there is little information about SCH 58261 from a drug metabolism or pharmacokinetics perspective. This study describes the metabolism and pharmacokinetic properties of SCH 58261 in order to understand its behaviors in vivo. Rats were used as the in vivo model species. First, an LC-MS/MS method was developed for the determination of SCH 58261 in rat plasma. A GastroPlus™ simulation, in vitro microsomal metabolic stability, and bile duct-cannulated studies were also performed to understand its pharmacokinetic profile. The parameter sensitivity analysis of GastroPlus™ was used to examine the factors that influence exposure when the drug is orally administered. The factors are as follows: permeability, systemic clearance, renal clearance, and liver first-pass effect. In vitro microsomal metabolic stability indicates how much the drug is metabolized. The extrapolated hepatic clearance value of SCH 58261 was 39.97 mL/min/kg, indicating that the drug is greatly affected by hepatic metabolism. In vitro microsomal metabolite identification studies revealed that metabolites produce oxidized and ketone-formed metabolites via metabolic enzymes in the liver. The bile duct-cannulated rat study, after oral administration of SCH 58261, showed that a significant amount of the drug was excreted in feces. These results imply that the drug is not absorbed well in the body after oral administration. Taken together, SCH 58261 showed quite a low bioavailability when administered orally and this was likely due to significantly limited absorption, as well as high metabolism in vivo.

The Evolution of Disease State Management: Historical Milestones and Future Directions.

Twenty-five years ago, the Journal of Managed Care Pharmacy introduced its readers to disease state management, which attempted to break the siloed culture of the U.S. health care system. Disease state management has been transformed, in part, to population health management. This shift was marked by 3 main inflection points: the rise of the web-enabled smartphone, the Patient Protection and Affordable Care Act (ACA), and the adoption of artificial intelligence (AI). The introduction of smartphones filled the communication gap through improved patient engagement and accessible mobile applications, giving patients access to their clinical data. In addition, through the ACA, bundled payment models moved away from a volume-based to a value-based payment approach and attempted to incorporate population health concerns, such as the social determinants of health. The advancement of AI will allow the health care system to collect comprehensive health data and to predict the population at higher risk. Despite these advancements, some challenges from 25 years ago remain, yet rapid technology advancements may expedite the next wave of change. DISCLOSURES: No funding contributed to the writing of this article. The authors have nothing to disclose with respect to research, authorship, and/or publication of this article.

Assessment of lifestyle effects on the levels of free oxygen radicals in the korean population.

BACKGROUND: As many studies revealed that oxidative stress due to the imbalance of reactive oxygen species (ROS) and antioxidant capacity is related with pathologic processes such as cardiovascular diseases, diabetes, as well as aging and obesity, the relationship between lifestyle and oxidative stress has recently gained much medical attention. However, little information exists on the effects of lifestyle on ROS in Korea. In this study, we investigated the effects of lifestyle on free oxygen radical levels in men and women in Korea. METHODS: A total of 138 adults participated in this study from September 2007 to June 2010 at a health promotion center and department of family medicine. Information on the lifestyle of each participant was obtained by questionnaire. Biochemical markers and a free oxygen radical test (FORT) were also measured. RESULTS: The average age was 47.28 ± 10.85 years and 79.7% were male. High sensitivity C-reactive protein (hs-CRP; r = 0.418, P = 0.012), triglycerides (r = -0.243, P = 0.008), hemoglobin (r = -0.445, P < 0.001), total protein (r = 0.210, P = 0.036), creatinine (r = -0.294, P = 0.001), fruit intake per day (P = 0.047), and smoking (P = 0.003) were related to the FORT levels in univariate analysis. Multiple linear regression analysis showed that hs-CRP (P = 0.039) was an independent predictor of serum FORT values. This statistical model can explain 78% of the variance in FORT values. CONCLUSION: This result suggests that hs-CRP showed a statistically significant positive association with FORT values. Further studies on the relationship between lifestyle and antioxidant capacity as well as ROS seem to be warranted to evaluate the overall effect of oxidative stress.