To compare SGLT2 inhibitors and GLP-1 agonists on cardiovascular (CV) outcomes, treatment persistence/discontinuation, healthcare utilization and costs.
This retrospective cohort study utilized ...medical and pharmacy claims to identify new SGLT2 inhibitor or GLP-1 agonist users from January 2015 to June 2017. A total of 5,507 patients were included in each treatment group after 1:1 propensity score matching. Cox proportional hazards models were used to compare CV outcomes and treatment discontinuation. Healthcare utilization and costs were compared using Wilcoxon signed rank test.
No differences in the primary composite CV outcome or secondary CV outcome were observed. Patients using GLP-1 agonists were more likely to discontinue treatment (hazard ratio 1.15, 95% confidence interval 1.10–1.21) and more likely to have an inpatient hospitalization (14.4% vs. 11.9%, P < 0.001) or emergency department visit (27.4% vs. 23.5%, P < 0.001) compared to patients on SGLT2 inhibitors. The average per-person per-month cost difference was +$179 for total cost (P < 0.001), +$70 for medical cost (P < 0.001) and +$108 for pharmacy cost (P < 0.001) for GLP-1 agonists compared to SGLT2 inhibitors.
Differences in composite CV outcomes were not established. However, other findings that favored SGLT2 inhibitors should be weighed against the known risks associated with this therapeutic class.
This retrospective cohort study compared sodium-glucose co-transporter-2 (SGLT2) inhibitor and glucagon-like peptide-1 (GLP-1) agonist therapeutic drug classes on cardiovascular (CV) outcomes, ...treatment persistence/discontinuation, healthcare utilization and costs. Using medical and pharmacy claims data from the Humana Research Database, new users of SGLT2 inhibitors or GLP-1 agonists from January 2015 to June 2017 were identified. Eligible patients were 19-89 years, enrolled in a Medicare Advantage Prescription Drug or fully-insured commercial health plan, with at least 12 months of continuous enrollment pre- and post-index date (i.e., date of first new prescription). Propensity score matching (1:1) was used to balance baseline characteristics. Cox proportional hazards models were used to compare CV outcomes and treatment discontinuation. Healthcare resource utilization and costs were compared using Wilcoxon signed rank test. A total of 5,507 patients were included in each treatment group. Patients indexed to use GLP-1 agonists were more likely to discontinue treatment (hazard ratio 1.15, 95% confidence interval 1.10-1.21) and more likely to encounter an inpatient hospitalization (14.4% vs. 11.9%, P<0.001) or emergency department visit (27.4% vs. 23.5%, P <0.001) compared to patients indexed on SGLT2 inhibitors. The risk of primary composite CV outcome (myocardial infarction or stroke or mortality) and secondary CV outcome (heart failure or death) was similar across cohorts. The average per-person per-month total cost ($1,796 vs. $1,617, P<0.001), medical ($904 vs. $834, P<0.001) and pharmacy costs ($891 vs. $783, P<0.001) were higher for the GLP-1 agonist cohort compared to the SGLT2 inhibitor cohort. Although differences in extra-glycemic CV benefits were not established, these findings may be useful to providers and payers, as this real-world data showed SGLT2 inhibitors were associated with longer treatment persistence and reduced healthcare utilization and costs relative to GLP-1 agonists.
Disclosure
I. Poonawalla: None. A. Bowe: Employee; Self; Humana. M. Tindal: None. Y.A. Meah: None. P. Schwab: Employee; Self; Humana. Employee; Spouse/Partner; Humana.
While emerging evidence shows cardiovascular (CV) benefits associated with use of specific glucagon-like peptide-1 (GLP-1) agonists, there is limited data on how outcomes compare between agents in ...the same drug class. This retrospective cohort study compared once-weekly dulaglutide and once-daily liraglutide on CV outcomes, treatment persistence/discontinuation, healthcare utilization and costs. Using administrative claims data from a large commercial and Medicare Advantage Prescription Drug health plan, new users of liraglutide or dulaglutide from January 2015 to June 2017 were identified. Eligible patients were 19-89 years, with at least 12 months of continuous enrollment pre- and post-index date (i.e., date of first new prescription). Patients who had prescription claims for other GLP-1 agonists were excluded. Propensity score matching (1:1) resulted in 2,245 patients in each treatment arm. The risk of primary composite CV outcome (myocardial infarction MI or stroke or mortality) and secondary CV outcome (heart failure HF or mortality) was similar across treatment groups, but patients indexed to dulaglutide were less likely to encounter a MI (relative risk RR 0.80, P=0.028) or HF (RR 0.81, P=0.001) event. Treatment discontinuation was lower in patients who used dulaglutide vs. liraglutide (57.8% vs. 63.2%, P<0.0001; hazard ratio 0.85, 95% confidence interval 0.79-0.92). The average per-person per-month pharmacy cost was higher for dulaglutide compared to the liraglutide cohort ($1,027 vs. 954, P=0.047). Total and medical costs, inpatient hospitalization stays, emergency department visits and outpatient service visits were similar across cohorts. Despite a lack of significant effect on the study’s composite CV outcomes, this real-world study showed longer treatment persistence with the use of dulaglutide that may be associated with lower MI and HF events. Findings may be useful to providers, especially in the treatment of patients who prefer once-weekly versus once-daily subcutaneous injection.
Disclosure
A. Bowe: Employee; Self; Humana. I. Poonawalla: None. M. Tindal: None. Y.A. Meah: None. P. Schwab: Employee; Self; Humana. Employee; Spouse/Partner; Humana.
Since 2016, empagliflozin (EFZ) has been known to reduce cardiovascular (CV) events in patients with type 2 diabetes; however, similar label expansions for dapagliflozin (DFZ) and canagliflozin (CFZ) ...are quite recent. To date, limited evidence has been published comparing these drugs in real-world practice. This retrospective cohort study address that gap, and used administrative claims data from a nationwide Medicare Advantage Prescription Drug and commercial health plan to compare CFZ, EFZ and DFZ on CV outcomes, treatment persistence, healthcare utilization and costs. Eligible patients naïve to the SGLT2 inhibitor drug class for 6 months from January 2015 to June 2017 were identified. Patients had at least 12 months of continuous enrollment pre- and post-index date (i.e., date of first new prescription). Propensity score method using inverse probability of treatment weighting was used to adjust outcomes. A total of 5,503, 2,052 and 587 patients used CFZ, EFZ and DFZ, respectively. Weighted comparisons showed no difference in the risk of primary composite CV outcome (myocardial infarction, stroke, or mortality) between treatments, but a lower risk of secondary CV outcome (heart failure or death) in the DFZ cohort (hazard ratio 0.82, 95% CI 0.75-0.88) compared to CFZ. Patients indexed to use EFZ were more likely to remain persistent to treatment (odds ratio OR 1.09, 95% CI 1.03-1.16), and patients who used DFZ had lower odds of an emergency department visit encounter (OR 0.85, 95% CI 0.79-0.92), relative to the use of CFZ. There were no differences in inpatient hospitalization stays and outpatient services between treatment groups. This population-based study showed minor differences in clinical and cost outcomes between CFZ, EFZ and DFZ, including a post-hoc analysis showing slight variations in use of adjuvant glucose lowering therapies across the SGLT2 inhibitor cohorts. With the ever-evolving landscape of treatment in the care of patients with diabetes, these findings may be helpful to providers.
Disclosure
P. Schwab: Employee; Self; Humana. Employee; Spouse/Partner; Humana. A. Bowe: Employee; Self; Humana. M. Tindal: None. Y.A. Meah: None. I. Poonawalla: None.
Concerns about the opportunity costs of social screening initiatives have led some healthcare organizations to consider using social deprivation indices (area-level social risks) as proxies for ...self-reported needs (individual-level social risks). Yet, little is known about the effectiveness of such substitutions across different populations.
This analysis explores how well the highest quartile (cold spot) of three different area-level social risk measures-the Social Deprivation Index, Area Deprivation Index, and Neighborhood Stress Score-corresponds with six individual-level social risks and three risk combinations among a national sample of Medicare Advantage members (N=77,503). Data were derived from area-level measures and cross-sectional survey data collected between October 2019 and February 2020. Agreement between individual and individual-level social risks, sensitivity values, specificity values, positive predictive values, and negative predictive values was calculated for all measures in summer/fall 2022.
Agreement between area and individual-level social risks ranged from 53% to 77%. Sensitivity for each risk and risk category never exceeded 42%; specificity values ranged from 62% to 87%. Positive predictive values ranged from 8% to 70%, and negative predictive values ranged from 48% to 93%. There were modest performance discrepancies across area-level measures.
These findings provide additional evidence that area-level deprivation indices may be inconsistent indicators of individual-level social risks, supporting policy efforts to promote individual-level social screening programs in healthcare settings.
Objective
To describe the epidemiology of nontraumatic headache in adults presenting to emergency departments (EDs).
Background
Headache is a common reason for presentation to EDs. Little is known ...about the epidemiology, investigation, and treatment of nontraumatic headache in patients attending EDs internationally.
Methods
An international, multicenter, observational, cross‐sectional study was conducted over one calendar month in 2019. Participants were adults (≥18 years) with nontraumatic headache as the main presenting complaint. Exclusion criteria were recent head trauma, missing records, interhospital transfers, re‐presentation with same headache as a recent visit, and headache as an associated symptom. Data collected included demographics, clinical assessment, investigation, treatment, and outcome.
Results
We enrolled 4536 patients (67 hospitals, 10 countries). “Thunderclap” onset was noted in 14.2% of cases (644/4536). Headache was rated as severe in 27.2% (1235/4536). New neurological examination findings were uncommon (3.2%; 147/4536). Head computed tomography (CT) was performed in 36.6% of patients (1661/4536), of which 9.9% showed clinically important pathology (165/1661). There was substantial variation in CT scan utilization between countries (15.9%–75.0%). More than 30 different diagnoses were made. Presumed nonmigraine benign headache accounted for 45.4% of cases (2058/4536) with another 24.3% classified as migraine (1101/4536). A small subgroup of patients have a serious secondary cause for their headache (7.1%; 323/4536) with subarachnoid hemorrhage (SAH), stroke, neoplasm, non‐SAH intracranial hemorrhage/hematoma, and meningitis accounting for about 1% each. Most patients were treated with simple analgesics (paracetamol, aspirin, or nonsteroidal anti‐inflammatory agents). Most patients were discharged home (83.8%; 3792/4526). In‐hospital mortality was 0.3% (11/4526).
Conclusion
Diagnosis and management of headache in the ED is challenging. A small group of patients have a serious secondary cause for their symptoms. There is wide variation in the use of neuroimaging and treatments. Further work is needed to understand the variation in practice and to better inform international guidelines regarding emergent neuroimaging and treatment.
Importance There is increased focus on identifying and addressing health-related social needs (HRSNs). Understanding how different HRSNs relate to different health outcomes can inform targeted, ...evidence-based policies, investments, and innovations to address HRSNs. Objective To examine the association between self-reported HRSNs and acute care utilization among older adults enrolled in Medicare Advantage. Design, Setting, and Participants This cross-sectional study used data from a large, national survey of Medicare Advantage beneficiaries to identify the presence of HRSNs. Survey data were linked to medical claims, and regression models were used to estimate the association between HRSNs and rates of acute care utilization from January 1, 2019, through December 31, 2019. Exposures Self-reported HRSNs, including food insecurity, financial strain, loneliness, unreliable transportation, utility insecurity, housing insecurity, and poor housing quality. Main Outcomes and Measures All-cause hospital stays (inpatient admissions and observation stays), avoidable hospital stays, all-cause emergency department (ED) visits, avoidable ED visits, and 30-day readmissions. Results Among a final study population of 56 155 Medicare Advantage beneficiaries (mean SD age, 74.0 5.8 years; 32 779 58.4% women; 44 278 78.8% White; and 7634 13.6% dual eligible for Medicaid), 27 676 (49.3%) reported 1 or more HRSNs. Health-related social needs were associated with statistically significantly higher rates of all utilization measures, with the largest association observed for avoidable hospital stays (incident rate ratio for any HRSN, 1.53; 95% CI, 1.35-1.74;P < .001). Compared with beneficiaries without HRSNs, beneficiaries with an HRSN had a 53.3% higher rate of avoidable hospitalization (incident rate ratio, 1.53; 95% CI, 1.35-1.74;P < .001). Financial strain and unreliable transportation were each independently associated with increased rates of hospital stays (marginal effects of 26.5 95% CI, 14.2-38.9 and 51.2 95% CI, 30.7-71.8 hospital stays per 1000 beneficiaries, respectively). All HRSNs, except for utility insecurity, were independently associated with increased rates of ED visits. Unreliable transportation had the largest association with increased hospital stays and ED visits, with marginal effects of 51.2 (95% CI, 30.7-71.8) and 95.5 (95% CI, 65.3-125.8) ED visits per 1000 beneficiaries, respectively. Only unreliable transportation and financial strain were associated with increased rates of 30-day readmissions, with marginal effects of 3.3% (95% CI, 2.0%-4.0%) and 0.4% (95% CI, 0.2%-0.6%), respectively. Conclusions and Relevance In this cross-sectional study of older adults enrolled in Medicare Advantage, self-reported HRSNs were common and associated with statistically significantly increased rates of acute care utilization, with variation in which HRSNs were associated with different utilization measures. These findings provide evidence of the unique association between certain HRSNs and different types of acute care utilization, which could help refine the development and targeting of efforts to address HRSNs.
Filgrastim-sndz, a granulocyte-colony stimulating factor (G-CSF), was introduced as a biosimilar to filgrastim in 2015, but real-world comparative effectiveness for filgrastim versus filgrastim-sndz ...has not been reported to date.
To (a) compare the incidence of febrile neutropenia for patients taking filgrastim versus those taking filgrastim-sndz and (b) compare the incidence of a potential serious adverse event for filgrastim versus filgrastim-sndz.
This retrospective cohort study identified patients receiving a G-CSF following chemotherapy, using administrative claims from the Humana Research Database. Patients enrolled in a Medicare Advantage Prescription Drug plan with a claim for a G-CSF from October 1, 2015, through September 30, 2016, were identified. G-CSF use had to occur within 6 days of exposure to chemotherapy and without any subsequent chemotherapy within 14 days after G-CSF use. Febrile neutropenia requiring hospitalization was defined as hospitalization within 14 days after G-CSF use with (a) diagnosis of infection and/or neutropenia (broad definition) or (b) infection and neutropenia diagnoses (narrow definition). Serious adverse drug events (spleen rupture, acute respiratory syndrome, serious allergic reactions, capillary leak syndrome, thrombocytopenia, leukocytosis, cutaneous vasculitis, or bones and muscle ache) were also identified within 14 days after G-CSF use. An incidence difference of < 1% with 90% CI crossing zero qualified as support for noninferiority. Two-tailed chi-square tests were also used to investigate differences.
A total of 88 filgrastim and 101 filgrastim-sndz patients were identified. Filgrastim and filgrastim-sndz met the criteria for noninferiority based on an incidence difference of -0.6% (90% CI = -5.1%-4.0%; P = 0.84) for the broad definition of febrile neutropenia and a difference of -0.8% (90% CI = -3.8%-2.1%; P = 0.64) for the narrow definition. For the analysis of serious adverse events, an incidence difference of -2.5% (90% CI = -7.5%-2.5%; P = 0.42) for filgrastim compared with filgrastim-sndz was not sufficient to establish noninferiority.
This study is one of the first analyses of real-world evidence regarding the noninferiority of filgrastim and filgrastim-sndz. The study results support noninferiority of filgrastim and filgrastim-sndz for prevention of febrile neutropenia requiring hospitalization. While noninferiority for serious adverse events was not supported, there was also no statistically significant difference between filgrastim and filgrastim-sndz. The study's small sample size could have limited the analysis of the relatively rare outcomes of febrile neutropenia requiring hospitalization and serious adverse events. A study including a larger numbers of patients taking filgrastim or filgrastim-sndz could provide additional insights.
This study received no outside funding. Douglas, Kennedy, and Slabaugh were employees of Humana Pharmacy Solutions at the time the study was conducted. Bowe, Schwab, and Lane were employees of Comprehensive Health Insights, a wholly owned subsidiary of Humana, at the time the study was conducted. Study concept and design were contributed by Douglas, Kennedy, Schwab, and Lane, along with Slabaugh and Bowe. Bowe took the lead in data collection, assisted by Schwab, and data interpretation was performed by Schwab, along with the other authors. The manuscript was written by Schwab, Lane, and Douglas and revised by Kennedy, Slabaugh, and Bowe, along with Schwab, Lane, and Douglas.
Recent research highlights the association of social determinants of health with health outcomes of patients with type 2 diabetes (T2D).
To examine associations between health-related social needs ...(HRSNs) and health care quality and utilization outcomes in a Medicare Advantage population with T2D.
This cross-sectional study used medical and pharmacy claims data from 2019. An HRSN survey was given between October 16, 2019, and February 29, 2020, to Medicare Advantage beneficiaries. Inclusion criteria were diagnosis of T2D, age of 20 to 89 years, continuous Medicare Advantage enrollment in 2019, and response to the HRSN survey. Data were analyzed between June 2021 and January 2022.
Enrollment in Medicare Advantage, diagnosis of T2D, and completion of a survey on HRSNs.
Quality outcomes included diabetes medication adherence, statin adherence, completion of a glycated hemoglobin (HbA1c) laboratory test in the past 12 months, and controlled HbA1c. Utilization outcomes included all-cause hospitalization, potentially avoidable hospitalization, emergency department discharge, and readmission.
Of the 21 528 Medicare Advantage beneficiaries with T2D included in the study (mean SD age, 71.0 8.3 years; 55.4% women), most (56.9%) had at least 1 HRSN. Among the population with T2D reporting HRSNs, the most prevalent were financial strain (73.6%), food insecurity (47.5%), and poor housing quality (39.1%). In adjusted models, loneliness (odds ratio OR, 0.85; 95% CI, 0.73-0.99), lack of transportation (OR, 0.80; 95% CI, 0.69-0.92), utility insecurity (OR, 0.86; 95% CI, 0.76-0.98), and housing insecurity (OR, 0.78; 95% CI, 0.67-0.91) were each associated with lower diabetes medication adherence. Loneliness and lack of transportation were associated with increased emergency visits (marginal effects of 173.0 95% CI, 74.2-271.9 and 244.6 95% CI, 150.4-338.9 emergency visits per 1000 beneficiaries for loneliness and transportation, respectively). Food insecurity was the HRSN most consistently associated with higher acute care utilization (marginal effects of 84.6 95% CI, 19.8-149.4 emergency visits, 30.4 95% CI, 9.5-51.3 inpatient encounters, and 17.1 95% CI, 4.7-29.5 avoidable hospitalizations per 1000 beneficiaries).
In this cross-sectional study of Medicare Advantage beneficiaries with T2D, some HRSNs were associated with care quality and utilization. The results of the study may be used to direct interventions to the social needs most associated with T2D health outcomes and inform policy decisions at the insurance plan and community level.
Much of the evidence for bundled payments has been drawn from models in the traditional Medicare program. Although private insurers are increasingly offering bundled payment programs, it is not known ...whether they are associated with changes in episode spending and quality.
To evaluate whether a voluntary bundled payment program offered by a national Medicare Advantage insurer was associated with changes in episode spending or quality of care for beneficiaries receiving lower extremity joint replacement (LEJR) surgery.
Cross-sectional study of 23 034 LEJR surgical episodes that emulated a stepped-wedge design by using the time-varying, geographically staggered rollout of the bundled payment program from January 1, 2012, to September 30, 2019. Episode-level multivariable regression models were estimated within practice to compare changes before and after program participation, using episodes at physician practices that had not yet begun participating in the program during a given time period (but would go on to do so) as the control. Data analyses were performed from July 1, 2021, to June 30, 2022.
Physician practice participation in the bundled payment program.
The primary outcome was episode spending (plan and beneficiary). Secondary outcomes included postacute care use (skilled nursing facility and home health care), surgical setting (inpatient vs outpatient), and quality (90-day complications including deep vein thrombosis, wound infection, fracture, or dislocation and readmissions).
The final analytic sample included 23 034 LEJR episodes (6355 bundled episodes and 16 679 control episodes) from 109 physician practices participating in the program. Of the beneficiaries, 7730 were male and 15 304 were female, 3057 were Black, 19 351 were White, 447 were of other race or ethnicity (assessed according to the Centers for Medicare & Medicaid Services beneficiary race and ethnicity code, which reflects data reported to the Social Security Administration), and 179 were of unknown race and ethnicity. The mean (SD) age was 70.9 (7.2) years. Participation in the bundled payment program was associated with a 2.7% (95% CI, 1.3%-4.1%) decrease in spending per episode (mean episodic spending, $21 964 95% CI, $21 636-$22 296 vs $22 562 95% CI, $22 346-$22 779), as well as reductions in skilled nursing facility use after discharge (21.3% for bundled episodes vs 25.0% for control episodes; odds ratio OR, 0.81 95% CI, 0.67-0.98) and increased use of the outpatient surgical setting (14.1% for bundled episodes vs 8.4% for control episodes; OR, 1.79 95% CI, 1.53-2.09). The program was not associated with changes in quality outcomes, including 90-day complications (8.8% for bundled episodes vs 8.6% for control episodes; OR, 1.02 95% CI, 0.86-1.20) and readmissions (4.3% for bundled episodes vs 4.6% for control episodes; OR, 0.92 95% CI, 0.75-1.13).
In this study of an LEJR bundled payment program offered by a national Medicare Advantage insurer, findings suggest that physician practice participation in the program was associated with a decrease in episode spending without changes in quality. Bundled payments offered by private insurers, including Medicare Advantage plans, are an alternate payment option to fee for service that may reduce spending for LEJR episodes while maintaining quality of care.
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