Cost-effectiveness analysis model for sotagliflozin compared with insulin monotherapy for patients with type 1 diabetes and chronic kidney disease

Abstract

BACKGROUND:

Patients with type 1 diabetes (T1D) have a greater than 50% lifetime risk of developing comorbid chronic kidney disease (CKD). Glycemic control can reduce diabetes-related complications and slow CKD progression. Adding sotagliflozin to insulin therapy reduced A1c by 0.46% compared with insulin monotherapy in patients with T1D. However, the long-term economic value for patients with both T1D and CKD remains unknown.

OBJECTIVE:

To evaluate the cost-effectiveness of sotagliflozin as an add-on to insulin in patients with T1D and CKD from a US payer perspective.

METHODS:

A Markov model was generated for individuals diagnosed with both T1D and comorbid CKD stage 3 from a US payer’s perspective. Clinical and economic outcomes were assessed over 30 years and included number of patients prevented from dialysis and transplantation, life-years, quality-adjusted life-year (QALY) gains, incremental costs, incremental cost-effectiveness ratio (ICER), and net monetary benefit. Dynamic pricing, through genericization, was incorporated to account for the economic impacts of market entry by generics.

RESULTS:

Sotagliflozin add-on therapy improved survival, extending life expectancy by 1.27 years (13.08 with sotagliflozin vs 11.81 with insulin monotherapy). During the first 10 years after treatment initiation, dialysis and transplant utilization decreased by 3.06 (99.35 vs 102.41) and 1.73 (30.59 vs 32.32) per 1,000 patients, respectively. QALYs per patient increased by 0.63 (7.70 vs 7.07), largely driven by prolonged time in pre–end-stage renal disease health states (0.59; 6.75 vs 6.16). Total costs rose by $72,914 ($484,674 vs $411,760), primarily because of pharmacy costs increasing by $69,060 ($96,242 vs $27,364). The ICER was $115,677 per QALY and the model was most sensitive to pharmacy costs.

CONCLUSIONS:

Sotagliflozin is a cost-effective adjunct to insulin therapy for T1D and CKD patients, providing clinical benefits and falling below the $150,000/QALY willingness-to-pay threshold in 59% of probabilistic sensitivity analysis simulations.

Plain language summary

Among the 2 million individuals in the United States with type 1 diabetes, many (50%-70%) will develop chronic kidney disease in their lifetime. This study assessed the cost-effectiveness of sotagliflozin, as adjunctive therapy to insulin, for patients with type 1 diabetes and chronic kidney disease. Sotagliflozin slowed rates of dialysis and transplant over a 10-year time frame, decreased mortality, and was found to provide good value for money.

Implications for managed care pharmacy

Sotagliflozin has previously been approved for patients with type 1 diabetes in Europe. Payers and regulators considering use of sotagliflozin in the United States for patients with type 1 diabetes and chronic kidney disease can rely on strong value for money, assuming that the inTandem3 clinical trial results translate to real-world benefits.

Type 1 diabetes (T1D) affects approximately 2 million people in the US. ¹ From 2024, the prevalence of T1D is projected to increase by 10% by 2033. ² The economic burden of T1D is substantial, impacting both patients and health care systems. T1D costs the United States $14.4 billion (2005 US dollars [USD]) annually in medical costs and lost income, with incremental lifetime costs of T1D at $813 billion (2016 USD), compared with patients without T1D. ^{3 , 4}

Patients with T1D are also at increased risk of chronic kidney disease (CKD), with estimates of lifetime CKD incidence among T1D patients ranging from 50% to 70%. ^{5 , 6} Effective management of glycated hemoglobin (hemoglobin A1c [A1c]) levels is crucial for patients with both diabetes and kidney disease to mitigate kidney-related complications and slow the progression of renal function decline. Higher A1c levels have been shown to increase adverse health outcomes (eg, death, progression of kidney disease, new end-stage renal disease (ESRD), cardiovascular events, all-cause hospitalization) among patients with diabetes and CKD. ⁷ The Diabetes Control and Complications Trial (DCCT) and its follow-up study showed a significant reduction in microalbuminuria, albuminuria, and development of stage 3 CKD in patients with T1D who maintained intensive glycemic control. ⁸ Management for CKD can consist of renin-angiotensin systems, such as angiotensin-converting enzyme and angiotensin receptor blockers, to control for albuminuria progression and estimated glomerular filtration rate (eGFR) decline. ⁹

Sotagliflozin, an oral dual inhibitor of sodium-glucose cotransporters 1 and 2, has emerged as a new treatment to control glycemic levels in T1D patients with CKD. ¹⁰ The inTandem3 phase 3 clinical trial demonstrated promising results that patients receiving sotagliflozin as an adjunct to insulin therapy, experienced a 0.46% greater reduction in A1c levels at 24 weeks compared with those receiving insulin therapy alone. ¹¹ Moreover, the treatment has received approval in Europe. Despite the sufficient clinical benefits, the economic benefits of sotagliflozin for T1D and CKD patients are unknown. This study aims to quantify the potential economic value of sotagliflozin for the treatment of US patients with T1D and comorbid CKD stage 3.

Methods

MODEL OVERVIEW

A Markov model was developed with a 1-month cycle length and a 30-year (ie, lifetime) time horizon. The model simulated a hypothetical cohort of 1,000 patients who followed the inTandem3 clinical trial inclusion criteria: individuals aged at least 18 years (average age of 43 years), A1c levels of 7.0% to 11.0%, and body mass index of at least 18.5 (calculated as weight in kilograms divided by height in meters squared). ¹¹ All individuals in the model were assumed to have CKD stage 3, defined as eGFR of 30 to 59. Patients assigned to the intervention group received 400 mg of sotagliflozin once daily prior to their first meal of the day, along with their regular insulin therapy. Patients in the comparator group continued their existing insulin treatment, with no additional interventions. ¹¹

Consistent with previously published CKD studies, this analysis used a 6-state Markov model based on CKD progression, defined by eGFR. Specifically, the health states included CKD stage 3 (eGFR 30-59), CKD stage 4 (eGFR 15-29), ESRD (eGFR<15) without dialysis, ESRD with dialysis, transplant, and death (Figure 1). ^{12 – 14} Transitions between states were determined by disease progression, treatment effects, and mortality risk. The model assumed that patients progressed to further CKD stage and treatment only slowed progression; it was assumed that reversion to earlier disease stages was not possible, ^{13 , 15} with the exception of a failed transplant (ie, patients who experienced a failed transplant transitioned to the ESRD with dialysis state in the subsequent cycle).

FIGURE 1.

Model Structure

CKD = chronic kidney disease; ESRD = end-stage renal disease.

Clinical outcomes were evaluated over a lifetime time horizon and from a US payer perspective, comparing patients receiving sotagliflozin add-on to insulin vs those taking insulin monotherapy. Clinical outcomes included (1) number of patients in each CKD stage by year, (2) number of patients prevented from reaching dialysis, (3) number of patients prevented from having a kidney transplant, (4) patient survival, in terms of life-years (LYs), and (5) quality-adjusted life-years (QALYs) gained. Economic outcomes included (1) changes in medical and pharmacy costs, (2) net monetary benefit (NMB) at a willingness to pay (WTP) of $150,000 per QALY, ¹⁶ and (3) incremental cost-effectiveness ratio (ICER). QALYs and costs were discounted at 3% annually. ¹⁷

The model included dynamic pricing, in the form of genericization, to capture sotagliflozin’s future price declines driven by generic entry and/or the Centers for Medicare & Medicaid Services Medicare Drug Price Negotiation process mandated by the Inflation Reduction Act. At market inception, payers will pay full price to treat patients using sotagliflozin. However, as suggested by the generalized cost-effectiveness analysis (CEA) framework, payers will pay lower prices for sotagliflozin in the future because of expanded competition. ¹⁸ According to the US Department of Health & Human Services, in large markets with more than 15,000 patients per month in which the first generic entered between 2007 and 2019, an average of 9 generics entered within 3 years, leading to an approximate 60% reduction in average price. ¹⁹ Moreover, based on previous evidence, new biological products typically are guaranteed a market exclusivity period between 12 and 16 years after implementation. ²⁰ In this model, we applied a 60% price reduction for sotagliflozin starting in year 14 (ie, the midpoint between 12 and 16). ^{19 , 20}

MODEL INPUTS

Key model inputs included treatment efficacy and safety, health-related quality of life, and cost. Each of these inputs are describe below and summarized in Table 1 (additional details in Supplementary Table 1 ^{(249.2KB, pdf)} , available in online article).

TABLE 1.

Table of Inputs

Category	Parameter	Value		Reference
		Sotagliflozin add-on	Insulin monotherapy	Sotagliflozin add-on	Insulin monotherapy
Efficacy (monthly transition probabilities)	Stage 1 to stage 2	0.43%	0.45%	11 , 21 , 23	23
	Stage 2 to stage 3	0.58%	0.61%	11 , 21 , 23	23
	Stage 3 to stage 4	1.58%	1.66%	11 , 21 , 23	23
	Stage 4 to ESRD without dialysis	0.55%	0.58%	11 , 21 , 23	23
	ESRD without dialysis to ESRD w/dialysis	2.38%	2.50%	11 , 21 , 24	24
	ESRD (with or without dialysis) to transplant	0.45%	0.47%	11 , 21 , 23	23
	Transplant to ESRD w/dialysis	0.71%	0.71%	11 , 21 , 23	23
	Mortality transition probability
	Stage 1	0.28%	0.34%	11 , 22 , 23	23
	Stage 2	0.19%	0.23%	11 , 22 , 23	23
	Stage 3	0.28%	0.35%	11 , 22 , 23	23
	Stage 4	0.56%	0.69%	11 , 22 , 23	23
	ESRD without dialysis	1.06%	1.06%	11 , 13 , 22	13
	ESRD with dialysis	1.61%	1.61%	11 , 22 , 23	23
	Transplant	0.45%	0.45%	11 , 22 , 23	23
Utility (quality of life)	Stages 1, 2, and 3	0.804		26
	Stage 4	0.793		26
	ESRD without dialysis	0.722		26
	ESRD with dialysis	0.436		26
	Transplant	0.722		26
Costs (per month)	Stage 1	$1,875	$2,073	35 – 37	35
	Stage 2	$2,031	$2,245	35 – 37	35
	Stage 3	$2,082	$2,301	35 – 37	35
	Stage 4	$2,978	$3,293	35 – 37	35
	ESRD (stage 5) without dialysis	$3,299	$3,647	35 – 37	36
	ESRD (stage 5) with dialysis	$5,400	$5,970	35 – 37	36
	Transplant	$1,230	$1,360	36 , 37 , 50	35
	Transplant initiation (per event)	$62,167	$68,724	36 – 38	38
	Pharmacy	$634	$246	Assumption	34

ESRD = end-stage renal disease.

EFFICACY

To estimate outcomes, the efficacy of augmented therapy using sotagliflozin was evaluated by incorporating the inTandem3 clinical trial’s estimated hazard ratio (HR) for disease progression relative to insulin monotherapy. The trial reported least-squares mean changes in A1C from baseline to week 24 of −0.79% (95% CI: [−0.85 to −0.73]) for the sotagliflozin group and −0.33% (95% CI: [−0.33 to −0.03]) for the placebo group, a treatment effect of −0.46%. ¹¹ Additionally, the HR for a 1%-point improvement in A1c is 1.107. ²¹ Under the exponential survival assumption, the implied HR for a 1% point improvement in A1c for sotagliflozin add-on, relative to insulin alone, is 0.954 (). Mortality benefits from improved glycemic control for pre-ESRD patients only were derived from the DCCT study, which reported an HR of 1.56 for a 1% improvement in glycemic levels. ²² Therefore, for pre-ESRD sotagliflozin add-on patients, the HR for a 1%-point improvement in A1c is calculated as 0.815 (). Because of a lack of clinical data for ESRD patients, a conservative assumption was made that sotagliflozin had no impact on mortality for ESRD patients (ie, ). ²²

Annual baseline transition probabilities for standard of care (ie, the insulin monotherapy cohort) were obtained from a systematic review of published CEA studies of CKD treatments, as well as additional CEA sources that focus on CKD screening. ^{13 , 23 , 24} The extracted transition probabilities were then converted to monthly probabilities using the exponential survival assumption (Table 1; additional details in Supplementary Table 1 ^{(249.2KB, pdf)} ). Efficacy parameters were then applied to these baseline probabilities to derive the transition probabilities for sotagliflozin add-on to insulin patients using the proportional hazard assumption.

SAFETY

Modeled adverse events (AEs) included those experienced by more than 1% of patients in the InTandem3 clinical trial. These included severe hypoglycemia, adjudicated diabetic ketoacidosis, genital mycotic infection, diarrhea, urinary tract infection, volume depletion, renal event (ie, acute kidney injury), and amputation. ⁹ Retinopathy was also analyzed as an additional AE because of its increased prevalence as CKD progresses. ²⁵ The baseline AE rate of retinopathy for the insulin monotherapy cohort were obtained from publicly available literature, whereas AE rates for sotagliflozin patients were calculated by applying the baseline rates to the HR for A1c improvement. ^{11 , 25}

UTILITY

Utilities used for each health state were derived from a meta-analysis on patients with both diabetes and kidney disease. ²⁶ The disutilities associated with AEs were identified from multiple peer-reviewed sources and applied on a per-month-per-event basis. ^{27 – 32} Because of reductions in quality of life after a kidney transplant, patients who had a transplant initiation received a disutility of 0.011 per month between 1 month prior and 6 months after surgery. ³³

COSTS

Costs were categorized into 4 primary areas: pharmaceutical, stage-specific management, transplant, and AE treatment costs. Pharmaceutical costs for sotagliflozin was assumed to be $634.42 per month and $246.06 per month for insulin. ³⁴ To account for insulin dose reductions observed in the in Tandem3 clinical trial, insulin costs for the sotagliflozin add-on cohort were reduced by 3% relative to the insulin monotherapy arm. ⁹ Baseline stage-specific management costs for the insulin monotherapy cohort was derived from literature, which identified the health care resource utilization and costs among patients with both diabetes and kidney disease. ^{35 , 36} For the sotagliflozin add-on cohort, these costs were adjusted to reflect reduced hospitalization and emergency department visits because of the therapy’s impact on heart failure risk. ^{35 – 37} Transplant initiation costs were accumulated between 1 month prior and 6 months after surgery, ^{36 – 38} whereas AE costs were applied on a per-month-per-event basis. ^{39 – 48} All costs are reported in 2024 USD.

SENSITIVITY AND SCENARIO ANALYSES

A 1-way sensitivity analysis was performed to vary individual parameters across a range of possible values to determine the impact on ICER. All parameters, with the exception of the initial CKD distribution, were included in this analysis. Included parameters, excluding pharmacy costs, were adjusted by ±20%. Pharmacy cost parameters were adjusted by ±$100 per month.

Moreover, a probabilistic sensitivity analysis (PSA) with 1,000 Monte Carlo simulations was conducted to assess economic outcomes under simultaneous parameter variation (Supplementary Material 1 ^{(249.2KB, pdf)} ). The cost-effectiveness plane and ICER acceptability curve illustrated the proportion of simulations yielding cost-effective results.

Finally, series of scenario analyses were also performed. First, cost-effectiveness was evaluated when dynamic pricing was excluded (ie, sotagliflozin cost did not change in perpetuity). Second, mortality benefits from improved A1c, initially applied only to pre-ESRD patients in the base case, was expanded to all patients. Next, as the model base case focused on patients with CKD stage 3 only, ICER was examined when patients entered the model between CKD stage 1 through 3 or CKD stage 1 though ESRD without dialysis (Supplementary Material 2 ^{(249.2KB, pdf)} ). Lastly, economic outcomes were provided under varying WTP thresholds. ¹⁶

Results

BASE CASE

Sotagliflozin combined with insulin improved clinical outcomes, compared with insulin monotherapy, by slowing disease progression to ESRD and keeping patients in pre-ESRD stages longer (Supplementary Figure 1 ^{(249.2KB, pdf)} ). Over the 30-year period, the patients receiving sotagliflozin add-on spent more time in the pre-ESRD stages on average compared with those receiving insulin monotherapy (10.53 vs 9.44 years for sotagliflozin add-on vs insulin monotherapy groups, respectively; difference = 1.09 years) (Supplementary Figure 2 ^{(249.2KB, pdf)} ). Furthermore, as more patients entered the ESRD stage because of the survival benefits in the pre-ESRD stages, patients who progressed to ESRD survived longer with sotagliflozin add-on on average than with insulin monotherapy (2.55 vs 2.37 years; difference = 0.18 years). As a result, sotagliflozin add-on offered longer LYs to the patients diagnosed with T1D and CKD by 1.27 years (13.08 vs 11.81 years) (Table 2).

TABLE 2.

Base Case Model Results

Outcome	Sotagliflozin add-on	Insulin monotherapy	Difference
LYs	13.08	11.81	1.27
10-year utilization
No. of patients with dialysis	99.35	102.41	−3.06
No. of patients with transplant	30.59	32.35	−1.76
30-year utilization
No. of patients with dialysis	241.30	224.97	16.33
No. of patients with transplant	104.50	100.23	4.47
QALYs
Pre-ESRD	6.75	6.16	0.59
ESRD	0.99	0.93	0.06
Adverse events	−0.04	−0.02	−0.02
Transplant	0.00	0.00	0.00
Total	7.70	7.07	0.63
Cost
Pre-ESRD	$259,742	$260,717	−$975
ESRD	$73,693	$76,571	−$2,878
Pharmacy	$96,424	$27,364	$69,060
Adverse events	$25,252	$15,227	$10,025
Transplant	$29,563	$31,881	−$2,318
Total	$484,674	$411,760	$72,914
NMB	+$21,635
ICER	$115,677

ESRD = end-stage renal disease; ICER = incremental cost-effectiveness ratio; LY = life-year; NMB = net monetary benefit; QALY = quality-adjusted life-year.

Sotagliflozin add-on therapy also decreased 10-year dialysis and transplant utilization (Table 2). For the first 10 years, delays in disease progression to ESRD reduced the demand for dialysis and transplants. Total number of dialysis and kidney transplants decreased by 3.06 (99.35 vs 102.41 for sotagliflozin add-on vs insulin monotherapy groups, respectively) and 1.73 (30.59 vs 32.32). However, the utilization of dialysis and kidney transplants for the sotagliflozin add-on group exceeded that of the insulin group over time. Because of improved survival for the sotagliflozin arm, over 30 years, the sotagliflozin add-on group showed an increase in utilization of dialysis compared with the insulin monotherapy group: dialysis utilization increased by 16.33 (241.30 vs 224.97) and transplant utilization increased by 4.27 (104.50 vs 100.23) per 1,000 patients.

QALYs among patients receiving sotagliflozin add-on were higher compared with patients receiving insulin monotherapy by 0.63 (7.70 vs 7.07) (Table 2, Supplementary Figure 3 ^{(249.2KB, pdf)} ) because of patients spending more time in both pre-ESRD and ESRD stages than the insulin group. Most of the QALYs benefits were due to additional time spent pre-ESRD stages (6.75 vs 6.16, difference = 0.59). Additional QALY gains derived from patients in ESRD stages (0.99 vs 0.93, difference = 0.06). QALYs were slightly offset because of increased rates of AEs (−0.04 vs −0.02, difference = −0.02) and transplant initiation (−0.0016 vs −0.0015, difference = −0.0001).

Overall costs increased by $72,914 ($484,674 vs $411,760 for sotagliflozin add-on vs insulin alone, respectively) (Table 2, Supplementary Figure 4 ^{(249.2KB, pdf)} ). Most of the cost increases were due to pharmacy costs, which increased by $69,060 ($96,424 vs $27,364). Additional increases were due to AEs, in which costs rose by $10,025 ($25,252 vs $15,227). However, costs were partially offset through medical costs in the pre-ESRD and ESRD stages and transplant initiation costs by −$975 ($259,742 vs $260,717), −$2,878 ($73,693 vs $76,571), and −$2,318 ($29,563 vs $31,881), respectively. Lower medical costs for the sotagliflozin add-on therapy group can be explained by lower per-unit medical savings costs from reduced heart failure encounters, compared with the insulin monotherapy group. ^{35 – 37}

Sotagliflozin is a cost-effective addition to insulin for patients with T1D and CKD (Table 2). At a 3% discount rate, the ICER was $115,677 per QALY gained, which was lower than the commonly used US payer WTP per QALY of $150,000. ¹⁶ Moreover, this study found a positive NMB of $21,635 at the WTP of $150,000.

SENSITIVITY AND SCENARIO ANALYSES

One-way sensitivity results presented that sotagliflozin add-on therapy continued to be cost-effective compared with insulin monotherapy (Figure 2). The model was shown to be the most sensitive to pharmacy costs (ICER range: [$97,748-$133,606]). Following pharmacy costs, pre-ESRD utility ($112,899-$119,791) and the mortality rate in stage 3 ($113,483-$118,240) were the second and third most sensitive parameter in the model, respectively.

FIGURE 2.

Sensitivity Analysis Results

AE = adverse event; ESRD = end-stage renal disease; ICER = incremental cost-effectiveness ratio.

The simulated ICER values from the PSA clustered around the cost-effectiveness threshold line ($150,000/QALY), with sotagliflozin add-on to insulin dominating insulin alone in 17% of simulations and being dominated by insulin monotherapy in 9% (Supplementary Figure 5, Supplementary Table 2 ^{(249.2KB, pdf)} ). The PSA results also showed that the probability of sotagliflozin add-on therapy being cost-effective at thresholds of $50,000/QALY, $100,000/QALY, $150,000/QALY, and $200,000/QALY was 31%, 45%, 59%, and 66%, respectively (Figure 3).

FIGURE 3.

ICER Acceptability Curve

ICER = incremental cost-effectiveness ratio;

QALY = quality-adjusted life-year;

WTP = willingness to pay.

In all scenario analyses conducted, the model continued to show sotagliflozin add-on to insulin was cost-effective (Supplementary Table 3 ^{(249.2KB, pdf)} ). Compared with including dynamic pricing, excluding dynamic pricing in the model increased the ICER to $130,791. Extending DCCT mortality benefits to all patients, instead of patients with pre-ESRD only, increases ICER to between $119,383 (with dynamic pricing) and $132,980 (without dynamic pricing). This impact was driven by sotagliflozin’s survival benefits, reflected in a 1.7% increase in QALYs, which led to a 3.6% rise in patient treatment costs, primarily because of higher pharmacy expenses. Although sotagliflozin extends survival, the additional LYs come at a significant cost. Next, adjusting the initial stage distribution generally produced lower cost-effectiveness compared with the base case, largely because of higher pharmacy costs from increased survival; however, results are still below the $150,000 per QALY threshold (ICER: $116,791-$143,183). Lastly, changing the WTP threshold from $150,000/QALY to $50,000, $100,000, and $200,000 yielded NMB of −$41,398, −$9,881, and $53,151, respectively (Supplementary Table 4 ^{(249.2KB, pdf)} ).

Discussion

This study found that adding sotagliflozin to insulin therapy resulted in morbidity and mortality gains, with higher QALYs by 0.64 over 30 years and longer LYs by 1.27 compared with insulin monotherapy. These benefits are attributed to sotagliflozin’s ability to improve glycemic control and preserve renal function, thereby delaying CKD progression and reducing mortality associated with complications. Sota-gliflozin also reduced utilization of medically and financially burdensome procedures over the first 10 years, including dialysis by 3.06 among 1,000 patients and transplant needs by 1.73. However, the demand increased by 17.34 and 4.27 for dialysis and transplant, respectively, over 30 years because of the rapid accumulation of survival benefits. Despite its higher overall costs ($72,914), driven primarily by pharmacy expenses ($69,060; 95% of incremental costs), sotagliflozin add-on demonstrated positive economic value with an ICER of $115,677 per QALY and an NMB of $21,635. Sensitivity analysis identified that the model was most sensitive to sotagliflozin’s pharmacy costs. According to the PSA results, sotagliflozin as an add-on therapy had a 59% likelihood of being cost-effective at a threshold of $150,000 per QALY. Scenario analyses indicate that excluding dynamic pricing significantly impacts the ICER. However, this observation is expected because of the model being most sensitive to sotagliflozin’s pharmacy costs. Despite this, all scenarios analyzed produced ICERs below the $150,000 per QALY threshold.

The use of sotagliflozin, as of the time this study was conducted, has not been approved for patients with T1D and comorbid kidney disease in the United States. Given that the health benefits of the sotagliflozin add-on outweigh its additional costs, the lack of approval could result in substantial clinical and economic losses by limiting access to an effective treatment for a chronic disease. ⁴⁹

LIMITATIONS

This study had several limitations. First, because of the absence of selected US-based data, some model parameters were derived from international sources. Because of this limitation, the model may not be fully representative of the US population. Second, data on patients with T1D with comorbid kidney disease was scarce in the literature. To compensate, parameters for patients with T2D were used to substitute for missing data. Third, the efficacy of sotagliflozin derived from a limited period of clinical trial, about 6 months, was extrapolated through 30 years in this study. To address this issue, we incorporated mortality benefits from the DCCT study, which was a study that tracked patients for 7+ years. Lastly, this model did not consider additional clinical benefits from sotagliflozin for cardiac vascular diseases, such as myocardial infarction and stroke, in which the SCORED clinical study report found that the sotagliflozin user group experienced lower rates of these events compared with the non-sotagliflozin user group. ³⁷ Moreover, sotagliflozin use in patients with T1D and CKD delays progression to ESRD and reduces the number of ESRD patients requiring a kidney transplant, thereby increasing kidney availability for other candidates on the transplant waitlist. Although these benefits are not incorporated in this study, they will be explored in future research.

Conclusions

Sotagliflozin as an add-on therapy to insulin was shown to be cost-effective, compared with insulin alone for treating patients with T1D and CKD. The estimated ICER of approximately $115,677 per QALY. ICER estimates continued to be cost-effective at a WTP of $150,000 in 59% of the 1,000 PSA simulations executed. Although pharmacy costs explained more than 90% of the total incremental costs, medical and transplant initiation costs declined.