Availability, price and affordability of insulin, delivery devices and self-monitoring blood glucose devices in Indonesia.

Insulin is essential for the survival of people with type 1 diabetes and for better management of people with type 2 diabetes. People with diabetes using insulin also require self-monitoring blood glucose (SMBG) devices (e.g., meters, strips, continuous monitoring systems) for day-to-day management. It is essential to ensure that insulin and these devices are available and affordable. This study aimed to evaluate the availability, price, and affordability of insulin and SMBG devices in Indonesia using an adaptation of the World Health Organization/Health Action International (WHO/HAI) price survey. A total of 34 public health facilities (hospitals, primary healthcare centres/Puskesmas) and 37 private pharmacies were sampled. Information from three major online marketplaces was also collected. Prices were expressed as median patient prices (US$). Affordability was defined as the number of days' wages needed by the lowest paid unskilled government worker (LPGW) to purchase 30 days' supply of insulin, delivery devices and SMBGs. Availability of analogue insulin was slightly higher in public facilities (63.6%) than in the private sector (43.2%), with no human insulin available in both sectors. Conversely, better availability was observed in private facilities for SMBG devices as public sector facilities did not supply devices for self-testing. Median prices for 1000IU analogues varied between the public sector (US$ 5.26) and the private sector (US$11.24). The highest median price of analogues was seen in online marketplaces (US$ 28.65). The least costly median price of SMBG devices were observed in online platforms (meter: US$ 18.37, test strip: US$ 0.27, lancet: US$ 0.02). A low-income person had to work 2-3 days to buy 1000IU of analogues. It required 5-7 days' and 4-5 day's wages to purchase a meter and a month's supply of test strips, respectively. The availability and affordability of insulin and SMBG devices remain important issues in Indonesia requiring holistic approaches for further improvement.

Cost-effectiveness of the tandem t: Slim X2 with control-IQ technology automated insulin delivery system in children and adolescents with type 1 diabetes in Sweden.

AIMS: The present analysis estimated the cost-effectiveness of treatment with the Tandem t: slim X2 insulin pump with Control IQ technology (CIQ) in children with type 1 diabetes in Sweden. METHODS: A four-state Markov model and probabilistic sensitivity analyses (PSA) were used to assess the cost-effectiveness of CIQ use compared with treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII) in conjunction with CGM. Data sources included clinical input data from a recent retrospective, observational study, cost data from local diabetes supply companies and government agencies, and published literature. Outcomes measures were quality adjusted life years (QALYs) at 10, 20 and 30-year time horizons based on cost per QALY and incremental cost-effectiveness ratio (ICER). RESULTS: A total of 84 type 1 diabetes children were included (CIQ, n = 37; MDI, n = 19; CSII, n = 28). For all time horizons, the use of CIQ was a dominant strategy (e.g. more effective and less costly) compared with MDI or CSII use: 10-year ICER, SEK -88,010.37 and SEK -91,723.92; 20-year ICER, SEK -72,095.33 and SEK -87,707.79; and 30-year ICER, SEK -65,573.01 and SEK -85,495.68, respectively. PSA confirmed that CIQ use was less costly compared with MDI and CSII. CONCLUSIONS: Initiation of CIQ use in children with type 1 diabetes is cost-saving, besides previously shown improved glycaemic control, and increased quality of life. Further investigations are needed to more fully elucidate the cost-effectiveness of these technologies in different countries with existing differences in payment models.

Real-time continuous glucose monitoring vs. self-monitoring of blood glucose: cost-utility in South Korean type 2 diabetes patients on intensive insulin.

AIMS: This study investigated the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with type 2 diabetes (T2D) receiving intensive insulin therapy in South Korea. METHODS: The IQVIA Core Diabetes Model (CDM v9.5) was used, with clinical effectiveness data obtained from a large-scale real world study. Costs were obtained from South Korean sources and inflated to 2022 South Korean Won (KRW). A South Korean payer perspective was adopted over a lifetime horizon, with future costs and effects discounted at 4.5% per annum. Baseline characteristics included a mean baseline HbA1c level of 8.6% (71 mmol/mol), and a mean age of 64.4 years. A willingness-to-pay (WTP) threshold of KRW 46.0 million was used. RESULTS: Rt-CGM led to an increase of 0.683 quality-adjusted life years (QALYs) versus SMBG (7.526 QALYs for rt-CGM versus 6.843 QALYs for SMBG). An increase in costs of KRW 16.4 million (from KRW 90.4 million to KRW 106.8 million) was associated with rt-CGM. The incremental cost-utility ratio was KRW 24.0 million per QALY gained, significantly lower than the KRW 46 million threshold. CONCLUSIONS: For individuals with T2D managed by intensive insulin therapy in South Korea, rt-CGM is cost-effective relative to SMBG.

Single-arm, first-in-human feasibility study results for an ultra-low-cost insulin pump.

BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and ß-Hydroxybutyrate were monitored to assess device performance. RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained ß-Hydroxybutyrate < 0.6 mmol/L throughout. CONCLUSION: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.

Health Outcome Changes in Individuals With Type 1 Diabetes After a State-Level Insulin Copayment Cap.

Importance: Many insulin users ration doses due to high out-of-pocket costs. Starting January 2020 with Colorado, 25 states and the District of Columbia enacted laws that cap insulin copayments. Objective: To estimate the association of Colorado's $100 copayment cap with out-of-pocket spending, medication adherence, and health care services utilization for diabetes-related complications. Design, Setting, and Participants: In this cohort study using Colorado's All-Payer Claims Database, nonelderly insulin users with type 1 diabetes were analyzed from January 2019 to December 2020. Outcome changes were compared in the prepolicy and postpolicy period among individuals continuously enrolled in state-regulated and non-state-regulated plans using difference-in-differences regressions. Subgroup analyses were conducted based on individuals' prepolicy spending (low: never ≥$100 out-of-pocket vs high: ≥$100 out-of-pocket cost at least once). Data were analyzed from June 2023 to May 2024. Exposure: Enrollment in state-regulated health insurance plans subject to the copayment cap legislation. Main Outcomes and Measures: Adherence to basal and bolus insulin treatment was evaluated using the proportion of days covered measure, out-of-pocket spending reflected prescription cost for a 30-day supply, and health care utilization for diabetes-related complications was identified using primary diagnosis codes from medical claims data. Results: The panel included 1629 individuals with type 1 diabetes (39 096 person-months), of which 924 were male (56.7%), 540 (33.1%) had 1 or more comorbidities, and the mean (SD) age was 40.6 (15.9) years. Overall, the copayment cap was associated with out-of-pocket spending declines of $17.3 (95% CI, -$27.3 to -$7.3) for basal and $11.5 (95% CI, -$24.7 to $1.7) for bolus insulins and increases in adherence of 3.2 (95% CI, 0.0 to 6.5) percentage points for basal and 3.3 (95% CI, 0.3 to 6.4) percentage points for bolus insulins. Changes in adherence were associated with increases within the prepolicy high-spending group (basal, 9.9; 95% CI, 2.4 to 17.4 percentage points; bolus, 13.0; 95% CI, 5.1 to 20.9 percentage points). The policy was also associated with a mean reduction of -0.09 (95% CI, -0.16 to -0.02) medical claims for diabetes-related complications per person per month among high spenders, a 30% decrease. Conclusions and Relevance: In this cohort study of Colorado's insulin copayment cap among individuals with type 1 diabetes, the policy was associated with an overall decline in out-of-pocket spending, an increase in medication adherence, and a decline in claims for diabetes-related complications only among insulin users who spent more than $100 in the prepolicy period at least once.

Continuous glucose monitoring for self-management of diabetes in people living with type 2 diabetes mellitus on basal insulin therapy: A microsimulation model and cost-effectiveness analysis from a US perspective with relevance to Medicaid.

BACKGROUND: Reducing the risks of complications is a primary goal of diabetes management, with effective glycemic control a key factor. Glucose monitoring using continuous glucose monitoring (CGM) technology is an important part of diabetes self-management, helping patients reach and maintain targeted glucose and glycated hemoglobin (HbA1c) levels. Although clinical guidelines recommended CGM use, coverage by Medicaid is limited, likely because of cost concerns. OBJECTIVE: To assess the cost-effectiveness of FreeStyle Libre CGM systems, compared with capillary-based self-monitoring of blood glucose (SMBG), in US individuals with type 2 diabetes mellitus using basal insulin. METHODS: A patient-level microsimulation model was used to compare CGM with SMBG for a population of 10,000 patients. A 10-year horizon was used, with an annual discount rate of 3.0% for costs and utilities. Model population characteristics were based on US national epidemiology data. Patient outcomes were based on published clinical trials and real-world studies. Annual costs, reflective of 2023 values, included CGM and SMBG acquisition costs and the costs of treating diabetic ketoacidosis, severe hypoglycemia, and diabetes complications. The effect of CGM was modeled as a persistent 1.1% reduction in HbA1c relative to SMBG based on US real-world evidence. Disutilities were based on published clinical trials and other relevant literature. The primary outcome was cost per quality-adjusted life-year (QALY) gained. Sensitivity analyses were performed to test the validity of the model results when accounting for a plausible variation of inputs. RESULTS: In the base case analysis, CGM was dominant to SMBG, providing more QALYs (6.18 vs 5.97) at a lower cost ($70,137 vs $71,809) over the 10-year time horizon. A $10,456 increase in glucose monitoring costs was offset by a $12,127 reduction in treatment costs. Cost savings reflected avoidance of acute diabetic events (savings owing to reductions in severe hypoglycemia and diabetic ketoacidosis were $271 and $2,159, respectively) and a reduced cumulative incidence of diabetes complications, particularly renal failure (saving $5,292), myocardial infarction (saving $1,996), and congestive heart failure (saving $1,061). Scenario analyses were consistent with the base case results, and the incremental cost-effectiveness ratio for CGM vs SMBG ranged from dominant to cost-effective. In probabilistic analysis, CGM was 100% likely to be cost-effective at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS: CGM is cost-effective compared with SMBG for US patients with type 2 diabetes mellitus receiving basal insulin therapy. This suggests that state Medicaid programs could benefit from broader coverage of CGM.

Colorado Insulin Copay Cap: Lower Out-Of-Pocket Payments, Increased Prescription Volume And Days' Supply.

In 2020, Colorado became the first state to cap out-of-pocket spending for insulin prescriptions, requiring fully insured health plans to cap out-of-pocket spending at $100 for a thirty-day supply. We provide the first evidence on the association of Colorado's Insulin Affordability Program with patient out-of-pocket spending, the amounts paid by plans per insulin prescription, and prescription filling. Using statewide claims data from the period 2018-21, we focused on the first two years that the copay cap law was in effect. We found that Colorado's Insulin Affordability Program was associated with significant reductions in out-of-pocket spending for insulin prescriptions, with the mean out-of-pocket payment per thirty-day supply falling nearly in half (from $62.59 to $35.64). Average plan payments increased slightly more ($31.39) than the decrease in out-of-pocket spending, as the total amount paid per prescription increased by about 1 percent. The average insulin user realized annual savings of $184, while the mean number of fills and the mean days' supply per year increased by 4.2 percent and 11.4 percent, respectively.

State Mandates To Cap Out-Of-Pocket Insulin Costs Are No Longer Necessary.

During the past five years, many states have imposed out-of-pocket spending caps on insulin. In most cases, these reforms have had limited impact, in part because of the limits of state authority. Meanwhile, changes at the federal level and actions by manufacturers and commercial plans have made some of the caps nonbinding. It is not surprising that efforts to measure the impact of these caps yield conflicting results.

State Out-Of-Pocket Caps On Insulin Costs: No Significant Increase In Claims Or Utilization.

Nearly all patients with type 1 diabetes and 20-30 percent of patients with type 2 diabetes use insulin to manage glycemic control. Approximately one-quarter of patients who use insulin report underuse because of cost. In response, more than twenty states have implemented monthly caps on insulin out-of-pocket spending, ranging from $25 to $100. Using a difference-in-differences approach, this study evaluated whether state-level caps on insulin out-of-pocket spending change insulin usage among commercially insured enrollees. The study included 33,134 people ages 18-64 who had type 1 diabetes or who used insulin to manage type 2 diabetes with commercial insurance coverage that was subject to state-level oversight and was included in the 25 percent sample of the IQVIA PharMetrics database during 2018-21. Insulin out-of-pocket caps did not significantly increase quarterly insulin claims for enrollees who had type 1 diabetes or who used insulin to manage type 2 diabetes. State-level caps on insulin out-of-pocket spending for commercial enrollees did not significantly increase insulin use; that may be in part because of out-of-pocket expenses being lower than cap amounts.

Cost-utility analysis of a flash continuous glucose monitoring system in the management of people with type 2 diabetes mellitus on basal insulin therapy-An Italian healthcare system perspective.

AIMS: To assess the cost-utility of the FreeStyle Libre flash continuous glucose monitoring (CGM) system from an Italian healthcare system perspective, when compared with self-monitoring of blood glucose (SMBG) in people living with type 2 diabetes mellitus (T2DM) receiving basal insulin. MATERIALS AND METHODS: A patient-level microsimulation model was run using Microsoft Excel for 10 000 patients over a lifetime horizon, with 3.0% discounting for costs and utilities. Inputs were based on clinical trials and real-world evidence, with patient characteristics reflecting Italian population data. The effect of flash CGM was modelled as a persistent 0.8% reduction in glycated haemoglobin versus SMBG. Costs (€ 2023) and disutilities were applied to glucose monitoring, diabetes complications, severe hypoglycaemia, and diabetic ketoacidosis. The health outcome was measured as quality-adjusted life-years (QALYs). RESULTS: Direct costs were €5338 higher with flash CGM than with SMBG. Flash CGM was associated with 0.51 more QALYs than SMBG, giving an incremental cost-effectiveness ratio (ICER) of €10 556/QALY. Scenario analysis ICERs ranged from €3825/QALY to €26 737/QALY. In probabilistic analysis, flash CGM was 100% likely to be cost effective at willingness-to-pay thresholds > €20 000/QALY. CONCLUSIONS: From an Italian healthcare system perspective, flash CGM is cost effective compared with SMBG for people living with T2DM on basal insulin.

Reduction in Diabetes-Related Hospitalizations and Medical Costs After Dexcom G6 Continuous Glucose Monitor Initiation in People with Type 2 Diabetes Using Intensive Insulin Therapy.

INTRODUCTION: Some people with type 2 diabetes (T2D) require intensive insulin therapy to manage their diabetes. This can increase the risk of diabetes-related hospitalizations. We hypothesize that initiation of real-time continuous glucose monitoring (RT-CGM), which continuously measures a user's glucose values and provides threshold- and trend-based alerts, will reduce diabetes-related emergency department (ED) and inpatient hospitalizations and concomitant costs. METHODS: A retrospective analysis of US healthcare claims data using Optum's de-identified Clinformatics® Data Mart database was performed. The cohort consisted of commercially insured, CGM-naïve individuals with T2D who initiated Dexcom G6 RT-CGM system between August 1, 2018, and March 31, 2021. Twelve months of continuous health plan enrollment before and after RT-CGM initiation was required to capture baseline and follow-up rates of diabetes-related hospitalizations and associated healthcare resource utilization (HCRU) costs. Analyses were performed for claims with a diabetes-related diagnosis code in either (1) any position or (2) first or second position on the claim. RESULTS: A total of 790 individuals met the inclusion criteria. The average age was 52.8 (10.5) [mean (SD)], 53.3% were male, and 76.3% were white. For claims with a diabetes-related diagnosis code in any position, the number of individuals with ≥ 1 ED visit decreased by 30.0% (p = 0.01) and with ≥ 1 inpatient visit decreased by 41.5% (p < 0.0001). The number of diabetes-related visits and average number of visits per person similarly decreased by at least 31.4%. Larger relative decreases were observed for claims with a diabetes-related diagnosis code in the first or second position on the claim. Total diabetes-related costs expressed as per-person-per-month (PPPM) decreased by $341 PPPM for any position and $330 PPPM for first or second position. CONCLUSION: Initiation of Dexcom G6 among people with T2D using intensive insulin therapy was associated with a significant reduction in diabetes-related ED and inpatient visits and related HCRU costs. Expanded use of RT-CGM could augment these benefits and result in further cost reductions.

Cost-effectiveness analysis of metformin versus insulin in the treatment of gestational diabetes mellitus.

OBJECTIVE: Although there have been many studies on gestational diabetes mellitus (GDM) treatment, there is still a knowledge gap regarding the comparative cost-effectiveness of metformin and insulin in the treatment phase. Existing studies have focused on treatment efficacy and drug safety, but relatively little has been explored regarding cost-effectiveness analysis. In particular, no comprehensive study has evaluated the cost-effectiveness of metformin and insulin for GDM treatment. Therefore, this study aimed to fill this knowledge gap by conducting a cost-effectiveness analysis of these two treatments for GDM. METHODS: A decision-analytic model was used to compare the cost-effectiveness of metformin and insulin in China. Probabilities, costs, and utilities were derived from the literature. The cost and quality-adjusted life years (QALYs) were calculated using the roll-back method. The strategy was considered cost-effective if the incremental cost-effectiveness ratio (ICER) was below the willingness-to-pay (WTP) threshold of ¥242,938 per QALY. Sensitivity analyses were also conducted to assess the robustness of the results. RESULTS: The roll-back analysis indicated that insulin was not cost-effective compared to metformin, resulting in increased costs and decreased QALYs, with a negative ICER. These findings suggested that metformin is a cost-effective option than insulin. Furthermore, the sensitivity analysis showed that the model was robust. CONCLUSIONS: Compared with insulin, metformin is a cost-effective treatment option for GDM.

Application of machine learning in affordable and accessible insulin management for type 1 and 2 diabetes: A comprehensive review.

Proper insulin management is vital for maintaining stable blood sugar levels and preventing complications associated with diabetes. However, the soaring costs of insulin present significant challenges to ensuring affordable management. This paper conducts a comprehensive review of current literature on the application of machine learning (ML) in insulin management for diabetes patients, particularly focusing on enhancing affordability and accessibility within the United States. The review encompasses various facets of insulin management, including dosage calculation and response, prediction of blood glucose and insulin sensitivity, initial insulin estimation, resistance prediction, treatment adherence, complications, hypoglycemia prediction, and lifestyle modifications. Additionally, the study identifies key limitations in the utilization of ML within the insulin management literature and suggests future research directions aimed at furthering accessible and affordable insulin treatments. These proposed directions include exploring insurance coverage, optimizing insulin type selection, assessing the impact of biosimilar insulin and market competition, considering mental health factors, evaluating insulin delivery options, addressing cost-related issues affecting insulin usage and adherence, and selecting appropriate patient cost-sharing programs. By examining the potential of ML in addressing insulin management affordability and accessibility, this work aims to envision improved and cost-effective insulin management practices. It not only highlights existing research gaps but also offers insights into future directions, guiding the development of innovative solutions that have the potential to revolutionize insulin management and benefit patients reliant on this life-saving treatment.

Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications.

Escalating insulin prices have prompted public scrutiny of the practices of drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production and distribution of medications. As a result, a series of policies have been proposed or enacted to improve insulin affordability and foster greater equity in access. These policies have implications for other diabetes and obesity therapeutics. Recent legislation, at both the state and federal level, has capped insulin out-of-pocket payments for some patients. Other legislation has targeted drug manufacturers directly in requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain price hikes for existing medications. In addition, government negotiation of drug pricing, a contentious issue, has gained traction, with the Inflation Reduction Act of 2022 permitting limited negotiation for certain high expenditure drugs without generic or biosimilar competition, including some insulin products and other diabetes medications. However, concerns persist that this may inadvertently encourage higher launch prices for new medications. Addressing barriers to competition has also been a priority such as through increased enforcement against anticompetitive practices (e.g., "product hopping") and reduced regulatory requirements for biosimilar development and market entry. A novel approach involves public production, exemplified by California's CalRx program, which aims to provide biosimilar insulins at significantly reduced prices. Achieving affordable and equitable access to insulin and other diabetes and obesity medications requires a multifaceted approach, involving state and federal intervention, ongoing policy evaluation and refinement, and critical examination of corporate influences in health care.

A short-term economic evaluation of early insulin therapy compared to oral anti-diabetic drugs in order to reduce the major adverse events in type 2 diabetes patients in Iran.

OBJECTIVE: While there are some recommendations about early insulin therapy in newly diagnosed Type 2 Diabetes Mellitus (T2DM) patients, there is not sufficient evidence on this strategy's cost-effectiveness. This study compared early insulin therapy versus oral anti-diabetic drugs (OADs) for managing T2DMusing a cost-effectiveness analysis approach in Iran. METHODS: In this economic evaluation, a decision analytic model was designed. The target population was newly diagnosed type 2 diabetic patients, and the study was carried out from the perspective of Iran's healthcare system with a one-year time horizon. Basal insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, and Thiazolidinediones (TZDs) were compared in this evaluation. The main outcome for assessing the effectiveness of each intervention was the reduction in the occurrence of diabetes complications. Strategies were compared using the incremental cost-effectiveness ratio (ICER), and deterministic and probabilistic sensitivity analyses were carried out. RESULTS: The DPP-4 inhibitors strategy was the dominant strategy with the highest effectiveness and the lowest cost. Early insulin therapy was dominated (ICER: $-53,703.18), meaning that it was not cost-effective. The sensitivity analyses consistently affirmed the robustness of the base case findings. The probabilistic sensitivity analysis indicated probabilities of 77%, 22%, and 1% for DPP-4 inhibitors, TZDs strategies, and early insulin therapy, respectively, in terms of being cost-effective. CONCLUSION: In terms of cost-effectiveness, early insulin therapy was not cost-effective compared to OADs for managing newly diagnosed T2DM patients. Future studies in this regard, utilizing more comprehensive evidence, can yield more accurate results.

The impact of a statewide insulin copay cap policy for insured patients with diabetes in Utah.

BACKGROUND: Insulin affordability is a huge concern for patients with diabetes in the United States. On March 30, 2020, Utah signed House Bill 207 into law, aimed at capping copayments for insulin at $30 for a 30-day supply. The bill was enacted on January 1, 2021. OBJECTIVE: To assess patient basal insulin adherence, out-of-pocket costs, health plan costs, total costs on insulin, and hemoglobin A1c (A1c) in prepolicy vs postpolicy periods. METHODS: This study is a retrospective analysis using data from a regional health plan in Utah from October 1, 2019, to September 30, 2021. Inclusion criteria were fully enrolled members of all ages, under commercial insurance, with at least 1 fill for any type of insulin in both the preperiod and the postperiod. Adherence was measured by proportion of days covered (PDC). Paired t-tests and Wilcoxon sign rank tests were conducted to compare the health and economic outcomes. RESULTS: Out of 24,150 commercially insured individuals, a total of 244 patients were included. Across all 244 patients, there was a significant decline in monthly median out-of-pocket costs of insulin by 58.5% (P < 0.001), whereas the monthly median health plan costs of insulin increased by 22.0% (P < 0.001). The total monthly costs of insulin (the sum of out-of-pocket and health plan costs) were unchanged (P = 0.115). Only 74 patients with enough basal insulin fills in both periods were included in the analysis for PDC changes. PDC change was not statistically significant (P = 0.43). Among the 74 patients with PDC calculations, 29 patients had A1c recorded in both periods. The change in A1c was not statistically significant (P = 0.23). CONCLUSIONS: An insulin copayment max of $30 in Utah demonstrated lower patient out-of-pocket costs, subsidized by the health plan. PDC did not change, and HbA1c did not improve. An assessment of a longer period and on a larger population is needed.

The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System Compared to Standard Management of Type 1 Diabetes in a Singapore Setting.

Background: Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). Methods: A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. Results: A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. Conclusion: MM780G is a cost-effective option for people with T1D managed in a Singapore setting.

Insulin Fills by Medicare Enrollees and Out-of-Pocket Caps Under the Inflation Reduction Act.

This study uses data from IQVIA's National Prescription Audit to assess the association of the Inflation Reduction Act's cap on cost sharing with insulin fills by Medicare beneficiaries.

Assessment of Commercial and Mandatory Discounts in the Gross-to-Net Bubble for the Top Insulin Products From 2012 to 2019.

Importance: Insulin list prices have grown substantially since 2010, but net prices have declined since 2015 because of manufacturer discounts, leading to an increasingly large difference between list and net prices of drugs often called the gross-to-net bubble. It remains unclear to what extent the gross-to-net bubble represents voluntary manufacturer discounts negotiated in commercial and Medicare Part D markets (hereafter called commercial discounts) vs mandatory discounts under the Medicare Part D coverage gap, Medicaid, and the 340B program. Objective: To decompose the overall gross-to-net bubble of leading insulin products into discount types. Design, Setting, and Participants: This economic evaluation obtained data from Medicare and Medicaid claims and spending dashboards, Medicare Part D Prescriber Public Use File, and SSR Health for the top 4 commonly used insulin products: Lantus, Levemir, Humalog, and Novolog. The gross-to-net bubble, which represents total discounts, was estimated for each insulin product and year (from 2012 to 2019). Analyses were conducted in June to December 2022. Main Outcomes and Measures: The gross-to-net bubble was decomposed into 4 discount types: (1) Medicare Part D coverage gap discounts, (2) Medicaid discounts, (3) 340B discounts, and (4) commercial discounts. Coverage gap discounts were estimated using Medicare Part D claims data. Medicaid and 340B discounts were estimated using a novel algorithm that accounted for best prices set by commercial discounts. Results: Total discounts for the 4 insulin products increased from $4.9 billion to $22.0 billion. Commercial discounts represented a majority of all discounts, increasing from 71.7% of the gross-to-net bubble in 2012 ($3.5 billion) to 74.3% ($16.4 billion) in 2019. Among mandatory discounts, coverage gap discounts remained relatively consistent as a proportion of discounts (5.4% in 2012 vs 5.3% in 2019). Medicaid rebates decreased as a proportion of total discounts, from 19.7% in 2012 to 10.6% in 2019. The 340B discounts increased as a proportion of total discounts from 3.3% in 2012 to 9.8% in 2019. Results for the contribution of discount types to the gross-to-net bubble were consistent across insulin products. Conclusions and Relevance: Results of a decomposition of the gross-to-net bubble for leading insulin products suggest that commercial discounts play a growing role in lowering net sales compared with mandatory discounts.