Cost-Effectiveness Analysis of Trastuzumab Deruxtecan versus Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer in the USA.

INTRODUCTION: Based on data from the DESTINY-Breast03 trial, we performed a cost-effectiveness analysis of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who had been previously treated with trastuzumab and a taxane from the US payer perspective. METHODS: We conducted a Markov model to assess the cost-effectiveness of T-DXd versus trastuzumab emtansine (T-DM1). The simulation time horizon for this model was the lifetime of patients. Transition probabilities were based on data from the DESTINY-Breast03 trial. Health utility data were derived from published studies. Outcome measures were costs (in 2022 US$), quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses assessed the uncertainty of key model parameters and their joint impact on the base-case results. RESULTS: The base-case results found that T-DXd provided an improvement of 3.90 QALYs compared with T-DM1, and the ICER was $220,533 per QALY. The one-way sensitivity analysis demonstrated that the utility value of progression-free survival, hazard ratios of T-Dxd versus T-DM1, and cost of T-Dxd contributed substantial uncertainty to the model. Probabilistic sensitivity analysis predicted T-DXd being cost-effective compared to T-DM1 was 0, 1, 16, and 46% at willingness-to-pay of $50,000, $100,000, $150,000, and 200,000 per QALY, respectively. CONCLUSION: T-DXd was unlikely to offer a reasonable value for the money spent compared to T-DM1 in a US payer setting.

Muscle Energy Technique plus Neurac Method in Stroke Patients with Hemiplegia Complicated by Diabetes Mellitus and Assessment of Quality of Life.

Objective: To analyze the role of muscle energy technique (MET) plus Neurac method in stroke patients with hemiplegia complicated by diabetes mellitus and the impact on quality of life. Methods: From January 2021 to December 2021, 100 stroke patients with hemiplegia complicated by diabetes mellitus treated in our institution and assessed for eligibility were recruited and randomly assigned (1 : 3) via the random sampling method to either the conventional rehabilitation group or the experimental group. The patients in the experimental group were randomized (1 : 1 : 1) into either the MET group (receives MET), the Neurac group (receives Neurac), or the joint group (receives MET plus Neurac). The primary endpoint is the clinical efficacy, and the second endpoint is the quality of life. Results: The eligible patients had similar pretreatment Barthel index scores, Visual Analogue Scale (VAS) scores, Berg balance scale (BBS) scores, Tinetti scores, Fugl-Meyer scores, and quality of life (QoL) scores (P > 0.05). The treatment herein achieved significant improvements in Barthel index scores, VAS scores (2.71 ± 0.28), BBS scores, Tinetti scores, Fugl-Meyer scores, and QoL scores (99.67 ± 10.62), and MET plus Neurac method obtained the best results versus both the conventional rehabilitation and monotherapy of either MET or Neurac (P < 0.05). Conclusion: Neurac method plus MET improves the independent mobility of stroke patients with hemiplegia and diabetes, relieves pain, enhances balance and stability, mitigates limb dysfunction, and boosts patients' quality of life, so it is worthy of clinical application.

Reducing Cardiovascular Risk in the Medicare Million Hearts Risk Reduction Model: Insights From the National Cardiovascular Data Registry PINNACLE Registry.

BACKGROUND: The Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high-risk (ASCVD ≥30%) Medicare patients. To estimate average practice-level ASCVD risk reduction, we applied optimal trial outcomes to a real-world population with high ASCVD risk. METHODS: This study uses observational registry data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence Registry from January 2013 to June 2016. We modeled ASCVD risk reductions using historical clinical trial data (reducing cholesterol by 26.5%, reducing systolic blood pressure by 10.9%, reducing smoking rates by 21.8%) the average reduction in ASCVD risk associated with individual and combined risk factor modifications, and then percentage of practices achieving the various incentive thresholds for the Million Hearts Model. RESULTS: The final study population included 135 166 patients, with 16 248 (12.0%) with 10-year ASCVD risk of ≥30%, but without existing ASCVD. The mean 10-year ASCVD risk was 41.9% (±1 SD of 11.6). Using risk factor reductions from clinical trials, lowering cholesterol, blood pressure, and smoking rates reduced 10-year ASCVD risk by 3.3% (±3.1), 6.3% (±1.1) and 0.5% (±1.3), respectively. Combining all 3 reductions resulted in a 9.7% (±3.6) reduction, with 67 (27.0%) of practices achieving a patient-level average 10-year ASCVD risk reduction of ≥10%, 181 (73.0%) achieving a 2 to 10% reduction, and no practice achieving <2% reduction. CONCLUSIONS: In cardiology practices, about 1 out of 8 patients have a 10-year ASCVD risk ≥30% and qualify as high risk in the Million Hearts Model. If practices target the three main modifiable risk factors and achieve reductions similar to clinical trial results, ASCVD risk could be substantially lowered and all practices could receive incentive payments. These findings support the potential benefit of the Million Hearts Model and provide guidance to participating practices.

Evaluating A Nonemergency Medical Transportation Benefit For Accountable Care Organization Members.

Nonemergency medical transportation benefits, often using smartphone application-based ridesharing services, are increasingly being offered as part of population health management programs. However, the impact of these programs on health care use and costs remains understudied. We conducted a mixed-methods evaluation of a nonemergency medical transportation benefit offered to members of a Medicare accountable care organization (ACO) within a large academic health system, the UNC Health Alliance ACO. Participation in the transportation program was associated with a greater number of per person per year outpatient visits (9.2) and higher outpatient spending ($4,420) than in a comparison group. However, there was no difference in inpatient admissions or emergency department visits, and the program was not cost saving. Qualitative analyses revealed that participants were highly satisfied with the program, reporting that it eased financial burdens and made them feel safer, more empowered, and better able to take control of their health. These findings suggest that although transportation programs are commonly introduced as ways to contain health care spending, it may be better to think of them as programs to improve health care access for people facing difficult circumstances.

Level of disease and association with health status in patients presenting with claudication from the PORTRAIT registry.

OBJECTIVE: Peripheral artery disease (PAD) has been shown to affect health status and quality of life; however, the disability associated by specific anatomic level of disease is unknown. We evaluated patients presenting with claudication by anatomic level and used the Peripheral Artery Questionnaire (PAQ), a PAD-specific validated tool, to quantify patients' symptoms, function, treatment satisfaction, and quality of life. METHODS: The Patient-centered Outcomes Related to Treatment Practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) registry is a multicenter, international, prospective study of patients with PAD. Anatomic level of PAD was stratified as follows: aortoiliac only, femoral-popliteal only, infrapopliteal only, and multilevel disease. Health status information was collected at baseline and at 3, 6, and 12 months using the PAQ. Student t-test, χ2 test, and linear mixed effects models were examined. RESULTS: Anatomic data were present in 623 (48.9%) of 1275 patients: 127 aortoiliac (20.4%), 221 femoral-popliteal (35.5%), 39 infrapopliteal (6.3%), and 236 multilevel disease (37.9%). Groups were similar by sex and race. Baseline PAQ summary scores differed between lesions, with multilevel disease having the lowest (poorest) estimated PAQ summary score (P = .014). Patients with aortoiliac disease were significantly younger, were more likely to be smokers, and presented with higher ankle-brachial index (all P < .05). Almost one-fourth of patients underwent an intervention by 3 months, 83% of which were endovascular. Repeated-measures analyses demonstrated a significant association between anatomic lesion and PAQ scores over time (P = .016), even after adjustment for age, sex, work status, ankle-brachial index, smoking, history of diabetes and chronic kidney disease, and country. Multilevel disease had the lowest adjusted average PAQ summary score over time (63.1; 95% confidence interval [CI], 60.8-65.5) and was significantly lower than aortoiliac (68.1; 95% CI, 64.8-71.4; P = .02) and femoral-popliteal (68.2; 95% CI, 65.8-70.6; P = .002) but not infrapopliteal (66.2; 95% CI, 60.5-72.0; P = .32). CONCLUSIONS: Overall, patients with claudication had similar health status on presentation by level of disease, yet patients with isolated aortoiliac disease fared significantly better over time with regard to quality of life and PAQ scores. Subset analysis demonstrated that patients undergoing interventions for aortoiliac disease and multilevel disease, which were primarily endovascular procedures, appeared to improve health status more over time compared with femoral-popliteal and infrapopliteal interventions. No significant benefits were found with intervention for femoral-popliteal disease or infrapopliteal disease compared with medical management. Treatment of aortoiliac and multilevel disease for claudication should be considered by clinicians as it may represent the greatest potential benefit for improving overall health status in patients with PAD. Further studies evaluating intervention compared with medical management alone are needed to further evaluate this finding.

Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States.

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: -7.0 [-10.7, -3.4]; p < 0.001 and EQ5D: -9.2 [-12.74, -5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: -8.4 [-13.0, -3.8]; p < 0.001 and EQ5D: -9.7 [-13.2, -6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080.

Burden of cardio-renal-metabolic conditions in adults with type 2 diabetes within the Diabetes Collaborative Registry.

We examined the prevalence of cardio-renal-metabolic (CaReMe) conditions and their combinations among 530 747 adults with type 2 diabetes in a USA-based outpatient registry of 271 primary care, cardiology and endocrinology offices. We evaluated the following CaReMe conditions: hypertension, hyperlipidaemia, coronary artery disease (CAD), chronic kidney disease (CKD), cerebrovascular disease, peripheral artery disease, atrial fibrillation, heart failure, and gout or hyperuricaemia; prevalence estimates were adjusted based on the distribution of diabetes by age in the US population in 2015. We found that it was uncommon for patients to have isolated type 2 diabetes without other CaReMe conditions, with only 6.4% having no other CaReMe conditions and 51% having ≥3 other CaReMe conditions. The most prevalent individual conditions were hypertension (83%), hyperlipidemia (81%), CAD (32%) and CKD (20%), and the most common combinations included various groupings of hypertension, hyperlipidaemia, atherosclerotic cardiovascular disease and CKD. Older age, male sex and tobacco use were each associated with increased numbers of CaReMe conditions. These findings highlight the clinical need for novel treatment strategies for diabetes that address both glycaemia and coexisting disease states.

Influence of Direct Oral Anticoagulants on Rates of Oral Anticoagulation for Atrial Fibrillation.

BACKGROUND: Oral anticoagulation (OAC) with warfarin is underused for atrial fibrillation (AF). The availability of direct oral anticoagulants (DOACs) may improve overall OAC rates in AF patients, but a large-scale evaluation of their effects has not been conducted. OBJECTIVES: This study assessed the effect of DOAC availability on overall OAC rates for nonvalvular AF. METHODS: Between April 1, 2008 and September 30, 2014, we identified 655,000 patients with nonvalvular AF and a CHA2DS2-VASc score of >1 in the National Cardiovascular Data Registry PINNACLE registry. Temporal trends in overall OAC and individual warfarin and DOAC use were analyzed. Multivariable hierarchical logistic regression identified patient factors associated with OAC and DOAC use. Practice variation of OAC and DOAC use was also assessed. RESULTS: Overall OAC rates increased from 52.4% to 60.7% among eligible AF patients (p for trend <0.01). Warfarin use decreased from 52.4% to 34.8% (p for trend <0.01), and DOAC use increased from 0% to 25.8% (p for trend <0.01). An increasing CHA2DS2-VASc score was associated with higher OAC use (odds ratio [OR]: 1.06; 95% confidence interval [CI]: 1.05 to 1.07), but with lower DOAC use (OR: 0.97; 95% CI: 0.96 to 0.98). Significant practice variation was present in OAC use (median odds ratio [MOR]: 1.52; 95% CI: 1.45 to 1.57) and in DOAC use (MOR: 3.58; 95% CI: 3.05 to 4.13). CONCLUSIONS: Introduction of DOACs in routine practice was associated with improved rates of overall OAC use for AF, but significant gaps remain. In addition, there is significant practice-level variation in OAC and DOAC use.