US Healthcare Claims Research Articles

Risk of hypoglycaemia among people with type 2 diabetes not treated with insulin: A retrospective analysis of Medicare Advantage beneficiaries.

In 2022, the Centers for Medicare & Medicaid Services released proposed changes to Medicare's continuous glucose monitoring (CGM) coverage policy, making individuals with a history of problematic hypoglycaemia eligible for CGM coverage, irrespective of insulin use. This study estimated the burden of hypoglycaemia in Medicare Advantage beneficiaries with noninsulin-treated type 2 diabetes (T2D). We retrospectively analysed US healthcare claims data using Optum's deidentified Clinformatics® database. Noninsulin-treated beneficiaries were identified in the 16 years from January 2007 to March 2023. Hypoglycaemia-related encounters (HREs) were those accompanied by a hypoglycaemia-specific ICD-9/10 diagnosis code in any position on the claim or the first or second position. HREs following the first claim related to T2D were reported by setting (ambulatory or inpatient/emergency department [ED]). HREs were identified in 689,853 (21.4%) of 3,229,695 noninsulin-treated Medicare Advantage beneficiaries, of whom 82.9% (n = 571,581) had ≥1 HRE in an ambulatory location and 26.8% (n = 184,833) in an ED/inpatient location. Use of sulfonylurea (odds ratio [OR]: 4.33 confidence interval [CI: 4.27-4.38]), evidence of end-stage kidney disease (OR: 2.87 [CI: 2.79-2.94]), hypertension (OR: 3.09 [CI: 3.04-3.15]) and retinopathy (OR: 2.94 [CI: 2.82-3.07]) were the strongest predictors of an HRE (p < 0.001). These findings show that HREs are prevalent in noninsulin-treated diabetes and identify a large number of patients who may benefit from CGM. Because >80% of HREs occur in the ambulatory setting and >70% occur in patients not taking sulfonylureas, primary care providers should be aware of the latest eligibility criteria for Medicare's coverage of CGM and not restrict this technology to their sulfonylurea-treated patients.

Maternal and Infant Morbidity and Mortality in relation to Delivery Mode in a large US Healthcare Claims Database in 2019 and 2020.

Provide contemporary data on maternal and infant outcomes after delivery to better understand risks of Cesarean section (CS). Data for deliveries in 2019 and 2020 were obtained from a large US commercial healthcare claims database. Maternal morbidity measures included twenty Severe Maternal Morbidity (SMM) outcomes and seven additional obstetric and mental health outcomes. Infant morbidity measures included eight outcomes related to respiratory health, digestive health, atopic dermatitis, and birth trauma. Outcome prevalence was ascertained at 42 days (maternal only) and 360 days after delivery. Logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI) for prevalence adjusted for risk factors for delivery mode and each outcome. Analyses were conducted for 2019 and 2020 to assess the influence of the COVID-19 pandemic. A total of 436,991 deliveries were identified (145,061 CS; 291,930 vaginal). The prevalence of SMM was 3.3% at 42 days and 4.1% at 360 days. The covariate-adjusted odds of SMM were higher among CS than vaginal deliveries at 42 days (OR: 2.0, 95% CI: 1.9, 2.1) and 360 days (OR: 1.7, 95% CI: 1.7, 1.8). There were 226,983 infants available for analysis of outcomes at 360 days. Most adverse infant outcomes were more prevalent at 360 days among CS than vaginal deliveries, and the covariate-adjusted odds of any adverse infant outcome at 360 days were higher among CS than vaginal deliveries (OR: 1.2; 95% CI: 1.1, 1.3). Respiratory morbidity was most affected by delivery mode. Maternal and infant mortality up to 360 days was rare. Similar trends were observed in the 2019 and 2020 cohorts. This observational study, performed using recent data obtained from a large US commercial claims database, provides contemporary evidence of risks to mothers and infants of CS relative to vaginal delivery.

Emulating Randomized Trials by Observational Database Studies: The RCT-DUPLICATE Initiative in COPD and Asthma.

Observational studies are increasingly used to provide real-world evidence in regulatory decision-making. The RCT-DUPLICATE initiative conducted observational studies emulating two trials in patients with asthma and three in COPD. For each trial, new-user cohorts were constructed from two US healthcare claims databases, comparing initiators of the study and comparator drugs, matched on propensity scores. Proportional hazards models were used to compare the treatments on study outcomes. The observational studies involved more subjects than the corresponding trials, with treatment arms well-matched on baseline characteristics. An asthma example involved emulation of the 26-week FDA-mandated D5896 trial. With 6,494 asthma patients per arm, the hazard ratio (HR) of a serious asthma-related event with budesonide-formoterol versus budesonide was 1.29 (95% CI: 0.63-2.65), compared with 1.07 (95% CI: 0.70-1.65) in the trial. A COPD example is the emulation of the one-year IMPACT trial. With 4,365 COPD patients per arm, the HR of a COPD exacerbation with triple therapy versus dual bronchodilators was 1.08 (95% CI: 1.00-1.17), compared with 0.84 (95% CI: 0.78-0.91) in the trial. We found mainly discordant results between observational analyses and randomized trials, likely from the forced discontinuation of treatments prior to randomization in the trials, not mimicable in the observational analyses.

COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.

Obeticholic acid (OCA) treatment for primary biliary cholangitis (PBC) was conditionally approved in the phase 3 POISE trial. The COBALT confirmatory trial assessed whether clinical outcomes in PBC patients improve with OCA therapy. Patients randomized to OCA (5-10 mg) were compared with placebo (randomized controlled trial [RCT]) or external control (EC). The primary composite endpoint was time to death, liver transplant, model for end-stage liver disease score ≥15, uncontrolled ascites, or hospitalization for hepatic decompensation. A prespecified propensity score-weighted EC group was derived from a US healthcare claims database. In the RCT, the primary endpoint occurred in 28.6% of OCA (n=168) and 28.9% of placebo patients (n=166; intent-to-treat [ITT] analysis hazard ratio [HR]=1.01, 95% CI=0.68-1.51), but functional unblinding and crossover to commercial therapy occurred, especially in the placebo arm. Correcting for these using inverse probability of censoring weighting (IPCW) and as-treated analyses shifted the HR to favor OCA. In the EC (n=1051), the weighted primary endpoint occurred in 10.1% of OCA and 21.5% of non-OCA patients (HR=0.39; 95% CI=0.22-0.69; P=0.001). No new safety signals were identified in the RCT. Functional unblinding and treatment crossover, particularly in the placebo arm, confounded the ITT estimate of outcomes associated with OCA in the RCT. Comparison with the real-world EC showed that OCA treatment significantly reduced the risk of negative clinical outcomes. These analyses demonstrate the value of EC data in confirmatory trials and suggest that treatment with OCA improves clinical outcomes in patients with PBC.

Abstract PO2-12-07: Risk of anaphylaxis associated with the use of pertuzumab or other biologics with potential for use outside the hospital

Abstract BACKGROUND Intravenous (IV) pertuzumab (P) and trastuzumab (H) are approved in the US for the treatment of HER2-positive breast cancer. P and H are also approved as a fixed-dose combination for SC injection (pertuzumab, trastuzumab, and hyaluronidase-zzxf; PH FDC SC). PH FDC SC may offer the possibility of treatment outside a hospital setting by a healthcare professional. Anaphylactic reactions can be a concern with the use of biologics. PH is also frequently initiated with six to eight cycles of taxanes, which can also be associated with anaphylaxis. We used administrative claims data to evaluate the risk of anaphylaxis associated with the real-world administration of PH or other biologic drugs in the real world. Our objective was to evaluate the risk of anaphylaxis associated with the administration of P and to contextualize the risk estimate by using other biologics that can be used outside the hospital as a benchmark. METHODS Cohorts of incident users were selected using retrospective records from a US healthcare claims database (IQVIA). Patients included were privately insured in the US, aged 16 to 65 years, and initiated a treatment of interest between 2012 and 2021. Possible and severe anaphylactic events (PAEs) were identified using the algorithm developed by the US Food and Drug Administration (FDA) Sentinel Initiative and updated with ICD10 codes (PMID: 34181291). PAEs were attributed to a drug if it occurred on the day of administration or the day after. The prevalence proportion (PP) of PAE was used to approximate the risk of anaphylaxis at each cycle. A sensitivity analysis using the proportion of prior P use amongst the cases of PAE beyond cycle 1 in the H cohort was conducted to approximate how many cases of PAE could have been missed at cycle 1 of P due to a depletion of susceptibles (as P IV and H may be administered sequentially in any order, patients with a PAE from H would not receive scheduled P and thus be excluded from the P cohort). RESULTS A total of 1,919,748 patients constituted 27 cohorts. Of them, 184,414 patients initiated monoclonal antibodies (mAbs) in 12 cohorts of which 12,264 and 184 initiated P IV and PH FDC SC, respectively. In the P IV cohort, seven PAE events were observed up to cycle 6 and none after. The PP at cycle 1 of P was 1.63 per 10,000 patients (95% confidence interval [CI] = 0.45, 5.94). The risk was comparable to that of other mAbs where anaphylaxis risk is described as uncommon/rare (Table). Accounting for a potential depletion of susceptibles increased the PP at cycle 1 of P to 2.45/10,000 (95% CI = 0.83, 7.19). No PAEs were reported in patients treated with PH FDC SC. CONCLUSIONS Using one of the largest datasets available, results suggest the risk of PAE with P administration could be within the range of what is observed with other mAbs that can be administered outside of the hospital. All events were observed when patients are expected to receive treatment at the hospital due to taxane administration. No PAE events were identified for PH FDC SC, but there were few patients in this cohort. Efforts are ongoing to identify a larger cohort treated with PH FDC SC. Risk of anaphylaxis by mAb * According to summary of product characteristics. † ≥1/1,000 to &amp;lt;1/100. ‡ ≥1/10,000 to &amp;lt;1/1,000. CI = confidence interval; H = trastuzumab; IV = intravenous; P = pertuzumab; PH FDC SC = pertuzumab, trastuzumab, and hyaluronidase-zzxf. Citation Format: Thibaut Sanglier, Tom Chambers, Joanna Harton, Laurentia Wahyudi, Magali Genevray, Eleonora Restuccia, Cécile Droz-Perroteau, Chau Dang. Risk of anaphylaxis associated with the use of pertuzumab or other biologics with potential for use outside the hospital [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-07.

Effectiveness and safety in non-valvular atrial fibrillation patients switching from warfarin to direct oral anticoagulants in US healthcare claims

IntroductionThere is a paucity of real-world studies examining the risks of stroke/systemic embolism (SE) and major bleeding (MB) among non-valvular atrial fibrillation (NVAF) patients switching from warfarin to a direct oral anticoagulant (DOAC). This retrospective study was conducted to compare the stroke/SE and MB risks between patients switched from warfarin to apixaban, dabigatran, or rivaroxaban in real-world clinical practice.Materials and methodsThis study used data from four United States commercial claims databases from January 1, 2012 to June 30, 2019. The study population included NVAF patients initially treated with warfarin and switched to apixaban, dabigatran, or rivaroxaban within 90 days of their warfarin prescription ending. Patients were matched 1:1 between the DOACs in each database using propensity scores and then pooled for the final analysis. Cox proportional hazards models were used to calculate the risk of stroke/SE and MB.Results and conclusionsThe final population consisted of 2,611 apixaban-dabigatran, 12,165 apixaban-rivaroxaban, and 2,672 dabigatran-rivaroxaban pairs. Apixaban vs. dabigatran was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.39–0.96) and MB (HR: 0.67; 95% CI: 0.50–0.91). Apixaban vs. rivaroxaban was associated with a similar risk of stroke/SE (HR: 0.88; 95% CI: 0.73–1.07) and a lower risk of MB (HR: 0.60; 95% CI: 0.52–0.68). There was no significant difference in either risk between dabigatran and rivaroxaban. These results provide important insights into how the risks of stroke/SE and MB for NVAF patients vary when switching from warfarin to different DOACs.

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.

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. 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. 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. 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.

Attributable Cost of Adult Respiratory Syncytial Virus Illness Beyond the Acute Phase.

Estimates of the cost of medically attended lower respiratory tract illness (LRTI) due to respiratory syncytial virus (RSV) in adults, especially beyond the acute phase, is limited. This study was undertaken to estimate the attributable costs of RSV-LRTI among US adults during, and up to 1 year after, the acute phase of illness. A retrospective observational matched-cohort design and a US healthcare claims repository (2016-2019) were employed. The study population comprised adults aged ≥18 years with RSV-LRTI requiring hospitalization (RSV-H), an emergency department visit (RSV-ED), or physician office/hospital outpatient visit (RSV-PO/HO), as well as matched comparison patients. All-cause healthcare expenditures were tallied during the acute phase of illness (RSV-H: from admission through 30 days postdischarge; ambulatory RSV: during the episode) and long-term phase (end of acute phase to end of following 1-year period). The study population included 4526 matched pairs of RSV-LRTI and comparison patients (RSV-H: n = 970; RSV-ED: n = 590; RSV-PO/HO: n = 2966). Mean acute-phase expenditures were $42 179 for RSV-H (vs $5154 for comparison patients), $4409 for RSV-ED (vs $377), and $922 for RSV-PO/HO (vs $201). By the end of the 1-year follow-up period, mean expenditures-including acute and long-term phases-were $101 532 for RSV-H (vs $36 302), $48 701 for RSV-ED (vs $27 131), and $28 851 for RSV-PO/HO (vs $20 523); overall RSV-LRTI attributable expenditures thus totaled $65 230, $21 570, and $8327, respectively. The cost of RSV-LRTI requiring hospitalization or ambulatory care among US adults is substantial, and the economic impact of RSV-LTRI may extend well beyond the acute phase of illness.

Retreatment rates and postprocedural complications are higher than expected after BPH surgeries: a US healthcare claims and utilization study

BackgroundUp to 50% of men over 50 and 80% over 80 are affected by BPH. Shared decision-making regarding BPH treatment options can benefit from an improved understanding of relative risks and benefits for various treatments.MethodsData for this longitudinal retrospective population-based cohort study were obtained from a random sample of US Medicare and commercial claims (IBM Watson MarketScan) and restricted to men undergoing BPH surgery (TURP, PVP, PUL, WVTT) from 2015 to 2021 across all sites of service. Retreatments included Holmium laser enucleation and index procedures. Main outcomes were rates of retreatment and procedural complications over 1 year, identified via CPT and ICD-9/10CM codes. Procedural complications that occurred at least 1 day post-index treatment were assessed, as were surgical retreatments with patients who had at least 1 and 5 year’s-worth of data. Baseline phenotype characterization did not control for symptomatology and was limited to age, comorbidities, and BMI. Univariate cumulative incidence estimates, cumulative proportion and log-rank tests justified inclusion for covariate (e.g., age, comorbidities) adjustment in Cox proportional hazard models.Results43,147 men diagnosed with BPH underwent 22,629 TURP, 11,392 PVP, 7,529 PUL, and 1,597 WVTT. At 1-year post-index: PUL was associated with the lowest rate of complication (PUL 15%, TURP 17%; PVP 19%, ; WVTT 26%); retreatment rates were not different (TURP 5.3%, PVP 5.3%, PUL 5.9%, WVTT 6.2%). At 5 years post-index: retreatment was lowest for TURP (7.0%) and was not significantly different between PVP and PUL (8.9% and 11.6%, respectively).ConclusionsReal-world patients diagnosed with BPH may be selected to undergo one of the various available therapies based on patient preference or baseline phenotype. These therapies, however, are associated with different risks for complications. The results of this study suggest that within one year of BPH surgery, one-in-twenty patients may require retreatment regardless of treatment choice, and for some technologies as many as one-in-four may require treatment for a complication.

Comparative safety of conjugated estrogens/bazedoxifene versus estrogen/progestin combination hormone therapy among women in the United States: a multidatabase cohort study.

To assess the risk of select safety outcomes including endometrial cancer, endometrial hyperplasia, and breast cancer among women using conjugated estrogens/bazedoxifene (CE/BZA) as compared with estrogen/progestin combination hormone therapy (EP). We conducted a new-user cohort study in five US healthcare claims databases representing more than 92 million women. We included CE/BZA or EP new users from May 1, 2014, to August 30, 2019. EP users were propensity score (PS) matched to users of CE/BZA. Incidence of endometrial cancer, endometrial hyperplasia, breast cancer, and eight additional cancer and cardiovascular outcomes were ascertained using claims-based algorithms. Rate ratios (RR) and differences pooled across databases were estimated using random-effects models. The study population included 10,596 CE/BZA and 33,818 PS-matched EP new users. Rates of endometrial cancer and endometrial hyperplasia were slightly higher among CE/BZA users (1.6 and 0.4 additional cases per 10,000 person-years), although precision was limited because of small numbers of cases (endometrial cancer: RR, 1.50 [95% confidence interval {CI}, 0.79-2.88]; endometrial hyperplasia: RR, 1.69 [95% CI, 0.51-5.61]). Breast cancer incidence was lower in CE/BZA users (9.1 fewer cases per 10,000 person-years; RR, 0.79; 95% CI, 0.58-1.05). Rates of other outcomes were slightly higher among CE/BZA users, but with confidence intervals compatible with a wider range of possible associations. CE/BZA users might experience slightly higher rates of endometrial cancer and endometrial hyperplasia, and a lower rate of breast cancer, than EP users in the first years of use.

Healthcare resource utilization and cost among individuals with late-onset versus adult-onset Huntington’s disease: a claims‑based retrospective cohort study

AimsQuantify healthcare resource utilization (HRU) and costs for individuals with late-onset Huntington’s disease (LoHD) and compare these with adult-onset HD (AoHD) and non-HD controls.MethodsThis retrospective cohort study used US healthcare claims data from the IBM MarketScan Commercial and Medicare Supplemental Databases. Individuals newly diagnosed with HD between 1/1/2009 and 12/31/2017 were selected (index date was first HD claim). Individuals ≥60 years of age at the index date were categorized as having LoHD while individuals 21–59 years of age were categorized as having AoHD. Non‑HD controls were exact matched 2:1 to LoHD and AoHD cohorts. Individuals were required to have continuous enrollment for ≥12 months pre- and post-index. Twelve-month all-cause HRU and healthcare costs were assessed for each cohort.ResultsIn total, 763 individuals with LoHD and 1,073 individuals with AoHD were matched with 3,762 non-HD controls. Unadjusted all-cause HRU in the 12 months post-index was higher for individuals with LoHD and AoHD compared with non-HD controls across most service categories. Adjusted all-cause HRU for the LoHD cohort was significantly higher compared with non-HD controls across all service categories. In the 12 months post-index, mean total costs for the LoHD cohort ($29,055) were significantly higher than for non-HD controls (≥60 years old: $17,286; 21–59 years old: $12,688; p <.001) and similar to total costs in the AoHD cohort ($31,701; p =.47).LimitationsIt was not possible to control for differences in HD stage but regression models were adjusted for baseline HRU. Evaluations of costs did not include indirect costs, which are known to be significant components of the wider HD burden.ConclusionsThis study provides the first analysis of HRU and costs in LoHD, demonstrating that individuals with LoHD experience a significantly higher healthcare burden compared with non-HD controls and a similarly high burden compared with individuals with AoHD.

358-OR: Better Adherence to Real-Time Continuous Glucose Monitoring (rtCGM) than to Intermittently Scanned CGM (isCGM) among People with Type 2 Diabetes (PWT2D) on Intensive Insulin Therapy (IIT)

Background: For PWT2D, medication regimen adherence is associated with improved glycemic control and reduced health care utilization. However, little is known about CGM adherence for managing T2D, and how it varies by type of CGM. Materials and Methods: A retrospective analysis of Merative’s MarketScan® US healthcare claims data was conducted. The cohort included CGM-naïve PWT2D on IIT who initiated rtCGM or isCGM between 1/1/2017 through 12/31/2020 (index date=earliest observed pharmacy claim). Adherence was defined as having ≥80% proportion of days covered (PDC) by pharmacy claims. Inclusion criteria were adults ≥30 years of age with T2D, using bolus insulin, with continuous health plan enrollment coverage 12 months before (baseline) and 12 months after the index date (follow-up), and no evidence of prior CGM use. The association between CGM adherence and change in A1C was examined in a subset of 663 patients with 6-month baseline and 6-month follow-up laboratory values. Results: The rtCGM group (n=2,349) was [mean (SD)] 49.2 (8.0) years of age and 48% female, while the isCGM group (n=8,881) was 50.4 (8.0) years of age and 48% female. Average PDC was 85% (26%) for the rtCGM group and 68% (32%) for the isCGM group. A total of 76.2% of the rtCGM group and 50.6% of the isCGM group met the ≥80% PDC level of adherence. A multivariate logistic regression model showed the odds of adherence were three times greater for rtCGM compared to isCGM (OR=3.2, 95% CI 2.8-3.5, p&amp;lt;0.001). Those adherent to CGM, regardless of device type, had a greater decrease in A1C (-0.94%) compared to those who did not meet the adherence criterion (-0.54%) (p&amp;lt;0.001). Conclusions: These findings indicate that for PWT2D on IIT, adherence to rtCGM is higher than to isCGM. The association between adherence and reduced A1C suggests patients can improve glycemic control with consistent use of CGM. Disclosure P.Nemlekar: Employee; Dexcom, Inc. K.Hannah: Employee; Dexcom, Inc. G.J.Norman: Employee; Dexcom, Inc. Funding Dexcom, Inc.

991-P: Reduction in Diabetes-Related Hospitalizations and Medical Costs after Real-Time Continuous Glucose Monitor (rtCGM) Initiation in Patients with Type 2 Diabetes (PWT2D) on Intensive Insulin Therapy (IIT)

This study evaluated changes in diabetes-related hospitalizations and healthcare resource utilization (HCRU) costs after rtCGM initiation in PWT2D on IIT. Retrospective analysis of US healthcare claims data using Optum’s Clinformatics® database was conducted. The cohort included CGM naïve PWT2D on IIT who initiated rtCGM (Dexcom G6) between 8/1/2018 through 3/31/2021 (index date=earliest observed pharmacy claim). Diabetes-related (e.g., diabetic ketoacidosis, hyperglycemia and hypoglycemia) hospitalizations (ER and inpatient visits) and associated HCRU costs were assessed 12-months pre- and post-index. Hospitalizations were expressed as changes in the number of visits. Changes in diabetes-related HCRU costs were reported as per-person-per-month (PPPM) costs. Hospitalizations and HCRU costs were defined as claims with a diabetes-related diagnosis code in the 1st or 2nd position on the claim. A total of 790 PWT2D (average age=52.8 (sd=10.5) years, 46.7% female) rtCGM users on IIT with commercial health insurance met inclusion criteria. A 50% reduction (p&amp;lt;0.0001) in the number of diabetes-related inpatient visits after rtCGM initiation was observed (baseline n=132, follow-up n=66). Similarly, after rtCGM initiation, a 47% reduction (p&amp;lt;0.05) in the number of diabetes-related ER visits occurred (baseline n=85, follow up n=45). Average PPPM diabetes-related hospitalization medical costs decreased by $329.53 (p&amp;lt;0.05). HCRU cost reductions were driven by reduced diabetes-related inpatient medical costs (-$308.46 PPPM). Payer claims showed that hyperglycemia and ketoacidosis were the most common reasons for hospitalizations 12-months pre- and post-device initiation. Findings suggest that rtCGM initiation may contribute to reduced HCRU for PWT2D on IIT by way of improving glycemic control. Disclosure K.Hannah: Employee; Dexcom, Inc. P.Nemlekar: Employee; Dexcom, Inc. G.J.Norman: Employee; Dexcom, Inc. Funding Dexcom, Inc.

1-OR: Burden of Hypoglycemia in Medicare Advantage Beneficiaries with Type 2 Diabetes Not on Insulin Therapy

In 2022, the Centers for Medicare &amp; Medicaid Services released proposed changes to Medicare’s continuous glucose monitoring (CGM) coverage policy, making individuals with a history of problematic hypoglycemia eligible for CGM coverage, irrespective of insulin use. This study estimated the burden of hypoglycemia in Medicare Advantage (MA) beneficiaries with type 2 diabetes not on insulin therapy (T2D-NIT). We retrospectively analyzed US healthcare claims data using Optum’s Clinformatics® database. MA beneficiaries with T2D-NIT were identified in the 15 years from 2007 to 2021. Hypoglycemia-related encounters (HREs) were those accompanied by a hypoglycemia-specific ICD9/10 diagnosis code in any position on the claim. HREs following the first claim related to T2D were enumerated and classified by setting (ambulatory or inpatient/emergency department [ED]). MA beneficiaries with T2D-NIT included a study population of 2,708,762 individuals (53% female, 65.2% White) followed for an average of 5 years. HREs were identified in 19.4% (n=525,741) of individuals, of whom 15.8% (n=428,734) had ambulatory encounter(s) and 5.41% (n=146,454) had inpatient/ED encounter(s). Prior to the first HRE, 26.5% (n=142,918) were using a sulfonylurea (SU), 35.9% (n=193,677) had evidence of chronic kidney disease, and 11.5% (n=62,404) had chronic kidney disease and were using a SU. These findings show that HREs are prevalent in the T2D-NIT population and identify a large number of patients who may benefit from CGM. Since &amp;gt;80% of HREs occur in the ambulatory setting and &amp;gt;70% occur in patients not taking SUs, primary care providers should be aware of the latest eligibility criteria for Medicare’s coverage of CGM and not restrict CGM to SU users. The generalizability of these findings is limited to the data source and may not be representative of the overall MA T2D-NIT or Medicare fee-for-service populations. Disclosure K.Hannah: Employee; Dexcom, Inc. P.Nemlekar: Employee; Dexcom, Inc. J.S.Bushman: Employee; Dexcom, Inc. G.J.Norman: Employee; Dexcom, Inc. Funding Dexcom, Inc.

Diagnosed and Drug-Treated Prevalence of Essential Tremor in Pediatric Patients: Retrospective Analyses of Two US Healthcare Claims Databases (S51.003)

Diagnosed and Drug-Treated Prevalence of Essential Tremor in Pediatric Patients: Retrospective Analyses of Two US Healthcare Claims Databases (S51.003)

Diagnosed and Drug-Treated Prevalence of Essential Tremor in Adult Patients: Retrospective Analyses of Two US Healthcare Claims Databases (S51.004)

Diagnosed and Drug-Treated Prevalence of Essential Tremor in Adult Patients: Retrospective Analyses of Two US Healthcare Claims Databases (S51.004)

Under recognition and treatment of lymphedema in head and neck cancer survivors – a database study

PurposeHead and neck cancer (HNC) will be diagnosed in approximately 54,000 Americans in 2022 with more than 11,000 dying as a result. The treatment of HNC often involves aggressive multimodal therapy including surgery, radiotherapy, and systemic therapy. HNC and its treatments are associated with multiple painful and function-limiting neuromusculoskeletal and visceral long-term and late effects. Among these is head and neck lymphedema (HNL), the abnormal accumulation of protein rich fluid, in as many as 90% of survivors. Though HNL is common and potentially contributory to other function-limiting issues in this population, it is notoriously understudied, underrecognized, underdiagnosed, and undertreated. This study seeks to determine the incidence of HNC-related lymphedema diagnosis and treatment in a large US healthcare claims repository database.MethodsA retrospective observational cohort design and data from an integrated US healthcare claims repository—the IBM MarketScan Commercial Claims and Encounters (CCAE) and Medicare Supplemental and Coordination of Benefits (MDCR) Databases spanning the period April 1, 2012 through March 31, 2020.ResultsOf the 16,654 HNC patients eligible for evaluation, 1,082 (6.5%) with a diagnosis of lymphedema were identified based on eligibility criteria. Of the 521 HNC patients evaluated for lymphedema treatment, 417 (80.0%) patients received 1.5 courses of MLD, 71 (13.6%) patients were prescribed compression garments, and 45 (8.6%) patients received an advanced pneumatic compression device.ConclusionHNL in this population of HNC survivors was underdiagnosed and treated compared with contemporary assessments HNL incidence.

Impact of Vagus Nerve Stimulation for the Treatment of Drug-resistant Epilepsy on Patterns of Use and Cost of Health Care Services and Pharmacotherapy: Comparisons of the 24-Month Periods Before and After Implantation

PurposeThis study examines the impact of vagus nerve stimulation (VNS) as treatment for drug-resistant epilepsy (DRE) on the use and cost of health care services and pharmacotherapy. MethodsUsing a large US health care claims database, we identified all patients with DRE who underwent VNS between January 1, 2012 and December 31, 2019. VNS implantation date was designated as the index date, and patients had to be continuously enrolled for the 24-month period before this date (preindex period). Outcomes included all-cause and epilepsy-related hospitalization, emergency department (ED) visits, and health care costs; health care claims resulting in an epilepsy diagnosis and all claims for antiseizure medications were deemed epilepsy related. Preindex data, except care related to preoperative medical clearance for VNS, were used to estimate multivariate regression models predicting outcomes during the 24-month postindex period (follow-up period). Predicted outcomes during follow-up were then compared with observed values. As a sensitivity analysis, we also replicated all analyses among subgroups defined by comorbid depression. FindingsA total of 659 patients underwent VNS for DRE and met the selection criteria. For the composite outcome of all-cause hospitalizations and ED visits, observed values were 42% lower than expected during the 24-month follow-up period; for the composite outcome of epilepsy-related hospitalizations and ED visits, observed values were 49% lower (P < 0.001 for both). Observed mean total all-cause costs, inclusive of costs of the procedure, were not significantly different than expected costs by month 19 of follow-up; mean total epilepsy-related costs were comparable by month 18. Findings were similar in subgroups with and without depression, although nominally greater differences (observed – expected) were seen in those with comorbid depression. ImplicationsOur findings suggest that VNS is associated with decreased risk of hospitalization or ED visits (all cause and epilepsy related) during the 2-year period subsequent to implantation and may become cost-neutral within 2 years of implantation (vs continued medical management of DRE without VNS). Although expected outcomes were estimated based on the 24-month period before implantation, the degree to which they approximated what would have happened in the absence of VNS is unknowable. Further research is needed to better understand the extend and duration of the impact of VNS on seizure frequency and severity and health-related quality of life, including its performance among those with and without comorbid depression.

Comparison of utilization and cost of healthcare services and pharmacotherapy following implantation of vagus nerve stimulation vs. responsive neurostimulation or deep brain stimulation for the treatment of drug-resistant epilepsy: analyses of a large United States healthcare claims database

Aim Vagus nerve stimulation (VNS), responsive neurostimulation (RNS), and deep brain stimulation (DBS) all are options for drug-resistant epilepsy (DRE). However, little is known about how the choice of neurostimulation impacts subsequent healthcare costs. Materials and methods We used a large US healthcare claims database to identify all patients with epilepsy who underwent neurostimulation between 2012 and 2019. Eligible patients were identified and stratified based on procedure received (VNS vs. RNS/DBS). VNS patients were matched by propensity scoring to RNS/DBS patients. Use and cost of healthcare resources and pharmacotherapy were ascertained over the 24-month period following neurostimulation, incorporating all-cause and epilepsy-related measures. Disease-related care was defined based on diagnoses of claims for medical care and relevant pharmacotherapies. Results Seven hundred and ninety-two patients met all selection criteria. VNS patients were younger, were prescribed a higher pre-index mean number of anti-seizure medications (ASMs), and had higher pre-index levels of use and cost of epilepsy-related healthcare services. We propensity matched 148 VNS patients to an equal number of RNS/DBS patients. One year following index date (inclusive), mean total all-cause healthcare costs were 50% lower among VNS patients than RNS/DBS patients, and mean epilepsy-related costs were 55% lower; corresponding decreases at the two-year mark were 41% and 48%, respectively. Limitations Some clinical variables, such as seizure frequency and severity, quality of life, and functional status were unavailable in the database, precluding our ability to comprehensively assess differences between devices. Administrative claims data are subject to billing code errors, inaccuracies, and missing data, resulting in possible misclassification and/or unmeasured confounding. Conclusions After matching, VNS was associated with significantly lower all-cause and epilepsy-related costs for the two-year period following implantation. All-cause and epilepsy-related costs remained statistically significantly lower for VNS even after costs of implantation were excluded.

HSD97 Use Machine Learning (ML) Techniques to Identify the Likelihood of Hospitalization for High-Risk Patients Diagnosed with COVID 19

HSD97 Use Machine Learning (ML) Techniques to Identify the Likelihood of Hospitalization for High-Risk Patients Diagnosed with COVID 19