All-cause Emergency Room Visits Research Articles

Treatment Patterns and Outcomes for Patients with Light Chain (AL) Amyloidosis: Analysis of a Large US Claims Database

Background: Light-chain amyloidosis (AL) is a rare, multisystem disease caused by plasma cell dyscrasia (PCD) with a varied presentation, and significant morbidity and mortality. The current standard of care is anti-PCD treatment with a combination of cyclophosphamide-bortezomib-dexamethasone (CyBorD) often supplemented with daratumumab based on National Comprehensive Cancer Network guidelines. These regimens halt amyloid formation but do not treat existing amyloid deposits in organs. Delays in diagnosis and treatment initiation can result in poor survival, particularly in patients with cardiac involvement. Aims: To elucidate the treatment patterns for patients with AL using US-based claims data. Methods: We conducted a retrospective cohort study of adults (age ≥18 years) with AL using IQVIA PharMetrics Plus data (1 January 2016, to 30 September 2022). Patients with ≥2 AL diagnosis codes (index is date of first diagnosis; ICD-10: E85.81), ≥24 months' continuous coverage pre-index, ≥6 months follow-up, and treated within 6 months of index date were included. Results are reported using descriptive statistics. Median time-to-treatment and cumulative probability of treatment were computed using the Kaplan-Meier method. Results: A total of 429 patients (60% male, mean age 62 years) met inclusion criteria. Patients most often received bortezomib (72%). Other common anti-PCD treatments ( Table) included dexamethasone (71%), cyclophosphamide (47%) and daratumumab (38%). The median time to treatment ( Figure) was 27 days (95% CI: 22, 30) post-index. In this cohort, 239 (56%) patients received treatment within 30 days of the index date; treatment was initiated >30 days of index date for the remainder (190; 44%) of patients. Fifty-nine (14%) patients received autologous stem cell transplant (ASCT) within 6 months of index date of which 14 (3%) received no induction therapy prior to transplant. ASCT rates decreased slightly throughout the study period (16% in 2018 to 11% in 2022). Visits to the emergency room (ER) for any cause during the 6-month follow-up period were reported for 138 (32%) patients; 97 (23%) patients visited the ER for cardiovascular-related reasons. The odds of experiencing an all-cause ER visit over the follow-up period was 12% lower (crude, unadjusted odds ratio [OR] of 0.88; p = 0.549) for patients who treatment within 30 days of index date compared with those for whom treatment was initiated >30 days of index. The odds of experiencing a cardiovascular-related ER visit over the follow-up period was 5% higher (crude, unadjusted OR of 1.05; p = 0.823) for patients who treatment within 30 days of index date compared with those for whom treatment was initiated >30 days of index. Conclusions: This study outlines treatment patterns within a US claims-based cohort of patients with AL. Few studies report time-to-treatment initiation in AL, and to our knowledge none have explored whether time-to-treatment initiation may impact likelihood of ER visits. The median time to treatment of 27 days is shorter than historic reports but still requires improvement. 1 We demonstrate that while almost half of patients in this study did not start therapy within 30 days of index date, they did not appear significantly more likely to have ER visits. This may be because those whose treatment was delayed had less severe disease and those treated more promptly had more severe disease. However, these results should be interpreted with caution as the analysis was not adjusted for confounding factors. The majority of patients in this study were treated with bortezomib and dexamethasone, almost half with cyclophosphamide, and 38% with daratumumab. The uptake of ASCT in this cohort was substantially lower than that reported by US amyloidosis specialist centers. 2,3 Uptake of ASCT in this study was more in line with the ~20% of newly diagnosed patients in AL that are generally regarded as transplant eligible. ASCT uptake appeared to fall slightly to 11% of patients in 2021-2022, potentially with the January 2021 approval of daratumumab - although overall numbers were too small to make this conclusion. Further efforts are needed to understand the real-world uptake of ASCT in newly diagnosed AL with the increasing use of CyBorD with daratumumab.

Outcomes of weight-based vs. fixed dose of Pembrolizumab among patients with non-small cell lung cancer.

This study aims to assess outcomes among patients with non-small cell lung cancer (NSCLC) who received treatment with pembrolizumab on a weight-based dose (WBD) or fixed-dose (FD) regimen using a non-inferiority (NI) analysis. This retrospective cohort study included adult patients with NSCLC weighing under 100 kg who received pembrolizumab between 1 January 2015 and 31 December 2020. Patients were grouped into either WBD or FD cohort based on the initial pembrolizumab dose and dosing regimen. The primary effectiveness outcome was overall survival (OS), analyzed using NI analysis with a lower margin of 10% comparing WBD to FD. Safety outcomes were all-cause emergency room visits or hospitalizations and incidence of selected immune-related adverse events (irAEs) and analyzed using NI analysis with an upper margin of 10%. All patients were followed until the end of health plan membership, death, or 30 June 2022, whichever occurred first. A total of 1413 patients were evaluated. OS was observed in 36.6% of the FD group, and 37.7% in the WBD group (rate difference: 1%, 90% CI: -6%-8%, NI p-value < 0.01). NI was met in all three safety outcomes: proportion of all-cause emergency room visits (rate difference: 1.1%, NI p-value < 0.01); proportion of hospitalizations (rate difference: 2%, NI p-value < 0.01); and composite incidence of irAEs (rate difference: -2.2%, NI p-value = 0.03). These findings suggest that WBD of pembrolizumab may be as appropriate as FD for the treatment of lung cancer.

Efficacy of nirmatrelvir and ritonavir for post-acute COVID-19 sequelae beyond 3 months of SARS-CoV-2 infection.

The effect of nirmatrelvir plus ritonavir (NMV-r) on post-acute COVID-19 sequelae beyond 3 months of SARS-CoV-2 infection remains unknown. This retrospective cohort study utilized data from the TriNetX Research Network. We identified nonhospitalized adult patients with COVID-19 receiving a diagnosis between January 1 and July 31, 2022. Propensity score matching (PSM) was used to create two matched cohorts: NMV-r and non-NMV-r groups, respectively. We measured the primary outcomes using a composite of all-cause emergency room (ER) visits or hospitalization and a composite of post-COVID-19 symptoms according to the WHO Delphi consensus, which also stated that post COVID-19 condition occurs usually 3 months from the onset of COVID-19, during the follow-up period between 90 days after the index diagnosis of COVID-19 and the end of follow-up (180 days). Initially, we identified 12 247 patients that received NMV-r within 5 days of diagnosis and 465 135 that did not. After PSM, 12 245 patients remained in each group. During the follow-up period, patients treated with NMV-r had a lower risk of all-cause hospitalization and ER visits compared with untreated patients (659 vs. 955; odds ratio [OR], 0.672; 95% confidence interval [CI], 0.607-0.745; p < 0.0001). However, the overall risk of post-acute COVID-19 symptoms did not significantly differ between the two groups (2265 vs. 2187; OR, 1.043; 95% CI, 0.978-1.114; p = 0.2021). The reduced risk of all-cause ER visits or hospitalization in the NMV-r group and the similarities in the risk of post-acute COVID-19 symptoms between the two groups were consistent in the subgroups stratified by sex, age, and vaccination status. Early NMV-r treatment of nonhospitalized patients with COVID-19 was associated with reduced risk of hospitalization and ER visits during the period of 90-180 days after diagnosis compared with no NMV-r treatment; however, post-acute COVID-19 symptoms and mortality risk did not differ significantly between the groups.

1255. Single-tablet Regimens (STR) Offer Better Persistence and Adherence, with Lower Costs by Adherence Status, than Multiple-tablet Regimens (MTR) for People Living with HIV (PLWH) Enrolled in Medicaid

Abstract Background Pill burden associated with antiretroviral multiple-tablet regimens (MTR) can impact adherence. The shift to single-tablet regimens (STR) has lagged for people living with HIV (PLWH) covered by Medicaid. This study examines persistence, adherence, healthcare resource utilization (HCRU), and costs by STR or MTR use for new initiators and treatment-experienced PLWH over a 1-year study period. Methods A linked patient population was applied using data from IQVIA’s Prescription Claims (Rx), Professional Fee Claims (Dx), and Hospital Charge Data Master (CDM). A 6-month pre-index period was used to assess study eligibility and baseline characteristics. A 12-month post-index period was used to descriptively evaluate treatment patterns and HCRU/costs. Two mutually exclusive cohorts were created based on STR or MTR use during the selection window (01/2018-07/2019). For the STR cohort, date of the first STR claim during the selection window was termed the index date. For the MTR cohort, the date of the first MTR drug during the selection window was termed the index date. Results The final sample comprised 4,603 PLWH in the STR cohort and 2,728 in the MTR cohort (Table 1). The proportion persistent over the 1-year follow-up was higher among treatment experienced compared to new initiators, and higher for STR compared to MTR (Figure 1A). The proportion adherent was higher among treatment experienced compared to new initiators, and higher for STR compared to MTR (Figure 1B). HIV-specific per member per month (PMPM) pharmacy costs were higher among treatment experienced compared to new initiators, and higher for MTR compared to STR (Figure 2). Adherent PLWH had a lower proportion with ≥ 1 all-cause emergency room visit compared to non-adherent PLWH within a cohort/treatment status category; minimal differences in ≥ 1 all-cause hospitalization. Adherent PLWH had higher mean all-cause costs than non-adherent PLWH, driven by pharmacy costs. STR PLWH had lower mean all-cause total costs compared to MTR PLWH with the same adherence/treatment experience status (Figure 3). Conclusion PLWH enrolled in Medicaid are more persistent and adherent to STR than MTR. Among PLWH adherent to antiretroviral therapy, STR offer potential cost savings over MTR for appropriate patients. Disclosures Andrew P. Brogan, PhD, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Cindy Garris, MS, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds Julie Priest, MSPH, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Victoria Divino, BA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Jing He, PhD, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Justin Chen, MHS, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Mitch DeKoven, MHSA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support.

Oral Nirmatrelvir and Ritonavir in Nonhospitalized Vaccinated Patients With Coronavirus Disease 2019.

BackgroundTreatment of coronavirus disease-2019 (Covid-19) with nirmatrelvir plus ritonavir (NMV-r) in high-risk non-hospitalized unvaccinated patients reduced the risk of progression to severe disease. However, the potential benefits of NMV-r among vaccinated patients are unclear.MethodsWe conducted a comparative retrospective cohort study using the TriNetX research network. Patients ≥18 years of age who were vaccinated and subsequently developed Covid-19 between December 1, 2021, and April 18, 2022, were included. Cohorts were developed based on the use of NMV-r within five days of diagnosis. The primary composite outcome was all-cause emergency room (ER) visit, hospitalization, or death at a 30-days follow-up. Secondary outcomes included individual components of primary outcomes, multisystem symptoms, Covid-19 associated complications, and diagnostic test utilization.ResultsAfter propensity score matching, 1,130 patients remained in each cohort. A primary composite outcome of all-cause ER visits, hospitalization, or death in 30 days occurred in 89 (7.87%) patients in the NMV-r cohort as compared to 163 (14.4%) patients in the non-NMV-r cohort (OR 0.5, CI 0.39-0.67; p<0.005) consistent with 45% relative risk reduction. A significant reduction in multisystem symptom burden and subsequent complications such as lower respiratory tract infection, cardiac arrhythmia, and diagnostic radiology testing were noted in NMV-r treated patients. There was no apparent increase serious complications between days 10 to 30.ConclusionTreatment with NMV-r in non-hospitalized vaccinated patients with Covid-19 was associated with a reduced likelihood of emergency room visits, hospitalization, or death. Complications and overall resource utilization were also decreased.

Cannabis use and risks of respiratory and all-cause morbidity and mortality: a population-based, data-linkage, cohort study

IntroductionAlthough cannabis is frequently used worldwide, its impact on respiratory health is characterised by controversy.ObjectiveTo evaluate the association between cannabis use and respiratory-related emergency room (ER) visits and hospitalisations.MethodsA retrospective,...

Impact of Positive Airway Pressure Therapy Adherence on Outcomes in Patients with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease.

Rationale: The co-occurrence of obstructive sleep apnea and chronic obstructive pulmonary disease, termed overlap syndrome, has a poor prognosis. However, data on positive airway pressure (PAP) treatments and their impact on outcomes and costs are lacking. Objectives: This retrospective observational study investigated the effects of PAP on health outcomes, resource usage, and costs in patients with overlap syndrome. Methods: Deidentified adjudicated claims data for patients with overlap syndrome in the United States were linked to objectively measured PAP user data. Patients were considered adherent to PAP therapy if they met Centers for Medicare and Medicaid Services criteria for eight 90-day timeframes from device setup through 2-year follow-up. Propensity score matching was used to create comparable groups of adherent and nonadherent patients. Healthcare resource usage was based on the number of doctor visits, all-cause emergency room visits, all-cause hospitalizations, and PAP equipment and supplies, and proxy costs were obtained. Measurements and Main Results: A total of 6,810 patients were included (mean age, 60.8 yr; 56% female); 2,328 were nonadherent. Compared with the year before therapy, there were significant reductions in the number of emergency room visits, hospitalizations, and severe acute exacerbations during 2 years of PAP therapy in patients who were versus were not adherent (all P < 0.001). This improvement in health status was paralleled by a significant reduction in the associated healthcare costs. Conclusions: PAP usage by patients with overlap syndrome was associated with reduced all-cause hospitalizations and emergency room visits, severe acute exacerbations, and healthcare costs.

Healthcare resource utilization in patients with newly diagnosed atrial fibrillation in the United States

ABSTRACT Objectives To summarize healthcare resource utilization (HCRU) in patients with newly diagnosed (incident) paroxysmal or persistent atrial fibrillation (AF). Methods This retrospective, observational cohort study assessed HCRU among patients with incident paroxysmal or persistent AF using data from 1 January 2015 to 30 September 2019 in the IBM MarketScan® Research Databases. Results A total of 50,796 patients were identified in the overall incident AF cohort. Rates of all-cause inpatient hospital stays, all-cause emergency room visits, and all-cause outpatient visits in the overall incident cohort were 46.8, 114.7, and 2,752.7 events per 100 patient-years (PY), respectively. Rates of cardiovascular-related inpatient stays for the overall population were 11.3 events per 100 PY. During follow-up, 50.4% of the overall cohort filled prescriptions for direct-acting oral anticoagulants and 5.0% had catheter ablation. Conclusions Advances in anticoagulation and ablation have been realized since previously published HCRU analyses of patients with atrial fibrillation. This update suggests that HCRU among patients with incident AF in the US remains high with some subgroups of patients receiving more specialized care.

Comparison of Healthcare Resource Utilization and Costs Related to Infections between Patients Newly Diagnosed with Chronic Myeloid Leukemia Treated with Dasatinib and Nilotinib As First-Line Therapy in the United States

Introduction:In the past decade, targeted inhibition of BCR-ABL1 with tyrosine kinase inhibitor therapies (TKIs) has become the standard-of care for treatment of chronic myeloid leukemia (CML). Second-generation TKIs, including dasatinib and nilotinib, have been shown to be more effective treatment options over imatinib and are approved as first-line therapies for newly diagnosed patients (pts) with Philadelphia chromosome positive CML in chronic phase (CP) and as second-line therapies for pts in CP and accelerated phase resistant to or intolerant to prior therapy. Although TKIs have been demonstrated to prolong overall and progression-free survival, there is evidence that TKIs may be associated with an increased risk of infections. This risk of infections can occur with or without neutropenia and is potentially due to an immunosuppressive effect from off-target activity of the treatment (Reinwald 2016). The real-world healthcare resource utilization (HRU) and costs related to infections have not been well studied, particularly in pts diagnosed with CML treated with second generation TKIs. To address this gap, this study compared HRU and costs of pts receiving dasatinib or nilotinib in first-line therapy for CML, with a focus on infection-related economic outcomes.Methods:Adult pts newly diagnosed with CML who were initiated on dasatinib or nilotinib as first-line therapy on/after October 2010 were identified from 2 large US administrative claims databases (2006-2016). First-line TKI initiation was defined as the index date, the 6-month period before the index date was defined as the baseline period, and pts were observed from index date until the end of first-line TKI therapy (i.e., discontinuation, switch, end of data availability/continuous health plan enrollment). HRU, including inpatient (IP) days, emergency room (ER) visits, and days with outpatient (OP) services, and associated healthcare costs from a payers' perspective (USD 2016) were measured during first-line TKI therapy. All-cause HRU and costs and those related to infections of any type, identified using diagnosis recorded in medical claims, were compared between dasatinib and nilotinib pts using multivariate regression models.Results:A total of 1,156 dasatinib and 677 nilotinib pts met the sample selection criteria. Mean age was 52 years and 54% were male in both cohorts (p>.05). Mean TKI therapy duration was 13.6 months for dasatinib and 15.5 months for nilotinib (p=.014).On average, dasatinib pts had 2.7 all-cause IP days annually, where 1.4 (52%) were related to infections; nilotinib pts had 1.3 all-cause IP days annually, where 0.6 (46%) were related to infections. Dasatinib pts had 90% more all-cause IP days (adjusted IRR=1.9; p=.003) and 2 times more IP days related to infections (adjusted IRR=2.1; p=.020) than nilotinib pts (Figure 1). On average, dasatinib pts had 0.7 all-cause ER visits annually, where 0.2 (29%) were related to infections; nilotinib pts had 0.6 all-cause ER visits annually where 0.1 (16%) were related to infections. Dasatinib pts had 30% more all-cause ER visits (adjusted IRR=1.3; p=.041); 2 times more ER visits related to infections (adjusted IRR=2.1; p<.001) than nilotinib pts (Figure 1). On average, dasatinib pts had 27.5 days with all-cause OP services annually, where 1.6 (6%) were related to infections; nilotinib pts had 26.0 all-cause days with OP services annually where 1.5 (6%) was related to infections (difference not statistically significant).On average, the annual all-cause total cost was $157,767 for dasatinib pts with $37,110 (24%) for medical service costs and $120,657 (76%) for pharmacy costs. Of this total cost, $10,943 (7%) was related to infections. On average, the annual all-cause total cost was $136,290 for nilotinib pts with $24,508 (18%) for medical service costs and $111,782 (82%) for pharmacy costs. Of this total cost, $7,620 (6%) was related to infections. Dasatinib pts incurred higher all-cause total costs by $17,265 per patient per year compared to nilotinib pts (adjusted cost difference; p=.004); where $6,572 (38%) of the difference was related to infections (adjusted cost difference; p=.004; Figure 1). Overall, among pts with infection, the average cost related to infection during first-line TKI therapy was $9,637.Conclusion:Dasatinib was associated with higher HRU and healthcare costs, particularly related to infections, compared to nilotinib. [Display omitted] DisclosuresSeiter:Novartis: Consultancy, Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria, Speakers Bureau; Celgene: Honoraria, Research Funding, Speakers Bureau. Latremouille-Viau:Analysis Group, Inc.: Employment; Novartis: Other: Analysis Group, Inc. has received consulting fees from Novartis. Guerin:Novartis: Other: I am an employee of Analysis Group, which received consulting fees from Novartis; AbbVie Inc.: Other: I am an employee of Analysis Group, which received consulting fees from AbbVie ; Analysis Group, Inc: Employment. Ndife:Novartis Pharmaceuticals Corporation: Employment. Habucky:Novartis: Employment. Joseph:Novartis Pharmaceuticals Corporation: Employment; Pfizer: Other: stock/stock options; Amgen: Other: stock/stock options; Express Scripts: Other: stock/stock options. Pivneva:Analysis Group, Inc: Employment; Novartis: Other: Analysis Group, Inc. has received consulting fees from Novartis. Gagnon-Sanschagrin:Novartis: Other: Analysis Group, Inc. has received consulting fees from Novartis; Analysis Group, Inc.: Employment. Tang:Novartis: Employment, Equity Ownership.

PCV39 Association between Social Determinants of Health, Heathcare Resource Utilization, Medication Adherence, and Medication Persistence Among Patients with Hypertension

The objective of this study was to assess the relationship between social determinants of health (SDoH) characteristics, healthcare resource utilization (HCRU), adherence, and persistence among patients with hypertension. Data from the 2019 National Health and Wellness Survey were linked to medical and prescription claims from Komodo Health. Participants age≥18 who self-reported a physician-diagnoses of hypertension and had continuous medical and prescription eligibility 1/1/2019-12/31/2019 were included. HCRU outcomes include physician-office visits, outpatient visits, emergency room (ER) visits, hospitalizations, and antihypertensive utilization including beta-blockers (BB), calcium channel-blockers (CCB), and renin-angiotensin system antagonists (RASA). Adherence was calculated by class using pharmacy quality alliance proportion of days covered (PDC), with adherent defined as PDC≥80%. Nonpersistence was defined as a gap in therapy ≥30 days or discontinuation ≥30 days prior to observation period end, and was calculated by class among participants with ≥1 prescription claim. Statistical testing was used to assess differences in outcomes when stratified by SDoH (e.g., gender, race/ethnicity, income). 1763 eligible patients with hypertension were analyzed. Statistically-significant differences in HCRU were found for all SDoH characteristics, including: higher proportion of Hispanic patients with a physician-office visit (85.2%;p=0.038) and a higher proportion of non-Hispanic/black patients with an all-cause ER visit (31.8%;p<0.0001) or hospitalization (11.8%;p=0.037). 60.1% (N=1059) of all patients had ≥1 antihypertensive claim, with higher proportions seen in non-Hispanic/Black (65.9%;p=0.032) or patients with an income $25000-$49000 (67.6%;p<0.001). A larger proportion of Hispanic patients were nonpersistent (72.2%p<0.01) or nonadherent (70.6%;p=0.001) to CCBs, and nonadherent to RASAs (60.5%;p<0.05). Among patents with hypertension significant associations exist between SDoH characteristics, HCRU, adherence, and persistence. Further research is needed to understand why Hispanics are less persistent to their antihypertensives while having more frequent contacts with their physicians. A better understanding of the role SDoH plays in the management of hypertension could improve hypertension control and reduce healthcare costs.

Impact of Early Initiation of Eslicarbazepine Acetate on Economic Outcomes Among Patients with Focal Seizure: Results from Retrospective Database Analyses.

IntroductionThis study assessed the association between early initiation of eslicarbazepine acetate (ESL) as first-line therapy (1L cohort) or as first adjunctive regimen to either levetiracetam (LEV) or lamotrigine (LTG) (add-on cohort), and healthcare resource utilization (HCRU) and charges among adults with treated focal seizures (FS).MethodsThis retrospective, longitudinal cohort analysis used Symphony Health’s Integrated Dataverse (IDV®) claims data to identify patients aged ≥ 18 years with a diagnosis of FS who had a new prescription for ESL between April 2015 and June 2018. Baseline was the 90-day period immediately prior to the date of the first-dispensed claim for ESL (index date) with a follow-up of 1–4 consecutive 90-day periods. Linear regression models were estimated to assess changes in HCRU and charge outcomes.ResultsThere were 274 and 153 patients who received ESL in the 1L cohort and add-on cohort, respectively. The 1L cohort experienced significant reductions from baseline during follow-up in all-cause inpatient (IP; P < 0.0001), emergency room (ER; P < 0.0001), and outpatient (OP; P < 0.0001) visits; FS-related IP (P = 0.006) and OP (P < 0.0001) visits; total, medical, all-cause ER and OP, and FS-related medical charges (P < 0.05); and significant increases in total prescription and anti-seizure drug (ASD)-related prescription (P < 0.001) charges. The add-on cohort experienced significant reductions in all-cause IP (P = 0.009) and all-cause and FS-related OP visits (P < 0.0001 for both) and significant increases in total prescription and ASD-related prescription (P < 0.001) charges during the follow-up period. In both cohorts, the increases in prescription charges were smaller than the reduction in total medical charges.ConclusionEarly initiation of ESL as 1L or add-on therapy was associated with statistically significant reductions in all-cause IP and all-cause and FS-related OP visits during follow-up compared to baseline. The 1L cohort also had statistically significant reductions in all-cause ER visits, FS-related IP visits, and total, medical, all-cause ER and OP, and FS-related medical charges.Plain Language SummaryKnowledge of healthcare resource utilization (HCRU) and costs of care in patients taking anti-seizure drugs (ASDs) is required to inform prescribing and formulary decision-making. Levetiracetam (LEV) and lamotrigine (LTG) are the most widely used first-line (1L) ASDs in the USA. Eslicarbazepine acetate (ESL), a third-generation ASD with sodium channel-modulating activity, is typically used in later lines of therapy. Sodium channel-blocking anti-seizure drugs may represent an effective treatment option for patients with epilepsy in the 1L setting. This study assessed the association between early initiation of ESL as 1L therapy (1L cohort) or as first adjunctive therapy to either LEV or LTG (add-on cohort), and HCRU and charges among adults with treated focal seizures (FS). The results showed that following ESL initiation the 1L cohort experienced significant reductions in all-cause inpatient (IP), emergency room (ER), and outpatient (OP) visits; FS-related IP and OP visits; and total, medical, all-cause ER and OP, and FS-related medical charges, and significant increases in total prescription and ASD-related prescription charges. The add-on cohort showed significant reductions in all-cause IP and all-cause and FS-related OP visits and significant increases in total prescription and ASD-related prescription charges. In both cohorts, the increases in prescription charges were smaller than the reduction in total medical charges. These data imply that use of ESL as 1L therapy in adult patients with FS could help conserve scarce healthcare resources and reduce the burden on healthcare budgets. These findings may inform selection of ASD therapy in this patient population.Electronic supplementary materialThe online version of this article (10.1007/s40120-020-00211-6) contains supplementary material, which is available to authorized users.

Hospital utilization rates following antipsychotic dose reduction in mood disorders: implications for treatment of tardive dyskinesia

BackgroundThe relative benefits and risks of long-term maintenance treatment with antipsychotics have not been well studied in patients with bipolar disorder and major depressive disorder. For example, while antipsychotic dose reduction has been recommended in the management of serious side effects associated with antipsychotics, there is limited evidence on the impact of lowering doses on the course of underlying mood disorders.MethodsThis retrospective cohort study analyzed the impact of antipsychotic dose reduction in patients with bipolar disorder or major depressive disorder. Medical claims from six US states over a 6-year period were analyzed for patients with ≥10% or ≥ 30% reductions in antipsychotic dose (cases) and compared using survival analyses with matched controls receiving a stable dosage. Outcomes included hospitalizations for disease-specific mood disorders, other psychiatric disorders and all-cause emergency room visits, and claims for tardive dyskinesia.ResultsA total of 23,992 patients with bipolar disorder and 17,766 with major depressive disorder had a ≥ 10% dose reduction, while 19,308 and 14,728, respectively, had a ≥ 30% dose reduction. In multivariate analyses, cases with a ≥ 10% dose reduction had a significantly increased risk of disease-specific admission (bipolar disorder: hazard ratio [95% confidence interval], 1.22 [1.15–1.31]; major depressive disorder: 1.22 [1.11–1.34]), other psychiatric admission (bipolar disorder: 1.19 [1.13–1.24]; major depressive disorder: 1.17 [1.11–1.23]), all-cause admission (bipolar disorder: 1.17 [1.12–1.23]; major depressive disorder: 1.11 [1.05–1.16]), and all-cause emergency room visits (bipolar disorder: 1.09 [1.05–1.13]; major depressive disorder: 1.07 [1.02–1.11]) (all P < 0.01). Similar results were observed following an ≥30% dose reduction. Dose reduction was not associated with decreased claims for tardive dyskinesia.ConclusionsPatients with mood disorders who had antipsychotic dose reductions showed small but statistically significant increases in all-cause and mental health-related hospitalizations, which may lead to increased healthcare costs. These results highlight the need for additional long-term studies of the necessity and safety of maintenance antipsychotic treatment in mood disorders.

Single Pill Regimen Leads to Better Adherence and Clinical Outcome in Daily Practice in Patients Suffering from Hypertension and/or Dyslipidemia: Results of a Meta-Analysis.

IntroductionCardiovascular diseases (CVD) represent the first cause of mortality in western countries. Hypertension and dyslipidemia are strong risk factors for CVD, and are prevalent either alone or in combination. Although effective substances for the treatment of both factors are available, there is space for optimization of treatment regimens due to poor patient’s adherence to medication, which is usually a combination of several substances. Adherence decreases with the number of pills a patient needs to take. A combination of substances in one single-pill (single pill combination, SPC), might increase adherence, and lead to a better clinical outcome.AimWe conducted a meta-analysis to compare the effect of SPC with that of free-combination treatment (FCT) in patients with either hypertension, dyslipidemia or the combination of both diseases under conditions of daily practice.MethodsStudies were identified by searching in PubMed from November 2014 until February 2015. Search criteria focused on trials in identical hypertension and/or dyslipidemia treatment as FCT therapy or as SPC. Adherence and persistence outcome included proportion-of-days-covered (PDC), medication possession ratio (MPR), time-to treatment gap of 30 and 60 days and no treatment gap of 30 days (y/n). Clinical outcomes were all cause hospitalisation, hypertension-related hospitalisation, all cause emergency room visits, hypertension-related emergency room visits, outpatient visits, hypertension-related outpatient visits, and number of patients reaching blood pressure goal. Randomized clinical studies were excluded because they usually do not reflect daily practice.Results11 out of 1.465 studies met the predefined inclusion criteria. PDC ≥ 80% showed an odds ratio (OR) of 1.78 (95% CI: 1.30–2.45; p = 0.004) after 6 months and an OR of 1.85 (95% CI: 1.71; 2.37; p < 0.001) after ≥ 12 months in favour to the SPC. MPR ≥ 80% after 12 months also was in favour to SPC (OR 2.13; 95% CI: 1.30; 3.47; p = 0.003). Persistence was positively affected by SPC after 6, 12, and 18 months. Time to treatment gap of 60 days resulted in a hazard ratio (HR) of 2.03 (95% CI: 1.77; 2.33, p < 0.001). The use of SPC was associated with a significant improvement in systolic blood pressure reduction, leading to a higher number of patients reaching individual blood pressure goals (FCT vs SPC results in OR = 0.77; 95% CI: 0.69; 0.85, p < 0.001). Outpatient visits, emergency room visits and hospitalisations, both overall and hypertension-related were reduced by SPC: all-cause hospitalisation (SPC vs FCT: 15.0% vs 18.2%, OR 0.79, 95% CI 0.67; 0.94, p = 0.009), all-cause emergency room visits (SPC vs FCT: 25.7% vs 31.4%, OR 0.75, 95% CI 0.65; 0.87, p = 0.001) and hypertension related emergency room visits (SPC vs FCT: 9.7% vs 14.1%, OR 0.65, 95% CI 0.54; 0.80, p < 0.001).ConclusionsSPC improved medication adherence and clinical outcome parameter in patients suffering from hypertension and/or dyslipidemia and led to a better clinical outcome compared to FCT under conditions of daily practice.

Real-World Analysis of Switching Patients with Schizophrenia from Oral Risperidone or Oral Paliperidone to Once-Monthly Paliperidone Palmitate.

PurposeReducing the dosing frequency of antipsychotics (APs) with long-acting injectables (LAIs) such as once-monthly paliperidone palmitate (PP1M) can improve adherence and clinical outcomes for schizophrenia patients. This US study compared physical and psychiatric comorbidity-related outcomes, AP adherence, healthcare resource utilization (HRU), and costs pre- and post-transition to PP1M among schizophrenia patients treated with oral risperidone/paliperidone pre-PP1M transition.MethodsHealth insurance claims from the IQVIA™ PharMetrics Plus database (01/01/2012–07/31/2018) were used to identify adults with ≥ 2 schizophrenia diagnoses, ≥ 1 claim for PP1M, and ≥ 30 days of treatment with oral risperidone/paliperidone in the 60 days before the first PP1M claim (i.e., the index date). Comorbidity-related outcomes, adherence to APs (measured via the proportion of days covered [PDC]), all-cause per-patient-per-month (PPPM) HRU, and all-cause PPPM medical, pharmacy, and total costs (i.e., sum of medical and pharmacy costs) during the 6-month periods pre- and post-transition to PP1M were compared using generalized estimating equation models adjusted for repeated measurements. Analyses were replicated in the subset of patients with ≥ 1 all-cause inpatient stay pre-PP1M transition.FindingsAmong 427 schizophrenia patients transitioning from oral risperidone/paliperidone to PP1M, the mean age was 41.1 years and 37.9% were female. Following the PP1M transition, patients were less likely to have claims with a diagnosis for psychoses (odds ratio [OR] 0.41; P < 0.001), hypertension (OR 0.80; P = 0.011), depression (OR 0.70; P < 0.001), drug abuse (OR 0.60; P < 0.001), substance-related and addictive disorders (OR 0.73; P = 0.003), bipolar and related disorders (OR 0.59; P < 0.001), sleep-wake disorders (OR 0.68; P = 0.017), anxiety disorders (OR 0.78; P = 0.034), and other conditions that may require a focus of clinical attention (OR 0.58; P < 0.001). Mean PDC by APs was higher post-PP1M (mean = 0.81) versus pre-PP1M (mean = 0.68) transition. Post-PP1M, patients were less likely to have an all-cause emergency room visit (OR 0.51; P < 0.001) or inpatient stay (OR 0.39; P < 0.001) compared to pre-PP1M. All-cause total healthcare costs remained similar post- versus pre-transition to PP1M (mean monthly cost difference [MMCD] = $228; P = 0.260). Pharmacy costs increased post-PP1M (MMCD = $960; P < 0.001), but were offset by decreasing medical costs (MMCD = − $732; P < 0.001), largely driven by lower costs related to inpatient stays (MMCD = − $695; P < 0.001) and emergency room visits (MMCD = − $63; P < 0.001). For patients with ≥ 1 all-cause inpatient stay pre-PP1M transition (N = 177), a more pronounced improvement in comorbidity-related outcomes, a more pronounced reduction in HRU, and a reduction in total healthcare costs (MMCD = − $1308; P < 0.001) were observed post-transition to PP1M.ImplicationsAmong schizophrenia patients in the US, transitioning to PP1M following oral risperidone/paliperidone treatment was associated with improved comorbidity-related outcomes, higher adherence, and a reduction in HRU, while remaining cost neutral. Furthermore, patients with ≥ 1 all-cause inpatient stay pre-PP1M transition had significantly lower total healthcare costs post-PP1M transition.

Association of antipsychotic treatment switching in patients with schizophrenia, bipolar, and major depressive disorders

Aims: To evaluate the association of relapse and healthcare resource utilization in patients with schizophrenia (SZ), bipolar disorder (BD), or major depressive disorder (MDD) who switched antipsychotic medication versus those who did not.Materials and methods: Medicaid claims from six US states spanning six years were retrospectively analyzed for antipsychotic switching versus non-switching. For all patients with SZ, BD, or MDD, and for the subset of patients who also had ≥1 extrapyramidal symptoms (EPS) diagnosis at baseline, times to the following outcomes were analyzed: underlying disease relapse, other psychiatric relapse, all-cause emergency room (ER) visit, all-cause inpatient (IP) admission, and EPS diagnosis.Results: Switchers (N = 10,548) had a shorter time to disease relapse, other psychiatric relapse, IP admissions, ER visits, and EPS diagnosis (all, log-rank p < .001) than non-switchers (N = 31,644). Switchers reached the median for IP admission (21.50 months) vs non-switchers (not reached) and for ER visits (switchers, 9.07 months; non-switchers, 13.35 months). For disease relapse, other psychiatric relapse, and EPS diagnosis, <50% of patients had an event during the two-year study period. Subgroup analysis of those with ≥1 EPS diagnosis revealed similar associations.Limitations: Only association, not causation, may be inferred, and there may be differences between the patient groups in parameters not evaluated.Conclusions: These results show that disease and other psychiatric relapse, all-cause ER visits, IP admissions, and EPS diagnosis occurred earlier for patients who switched antipsychotics than for those who did not, suggesting that switching is associated with an increased risk of relapse in patients with SZ, BD, and MDD. This may be attributed to more-severely ill patients being less responsive than those with less-severe illness, which, in turn, may require more episodes of switching.

A Meta-analysis on the relations between short-term exposure to PM(2.5) and both mortality and related emergency visits in China

Objective: To carry out a quantitative estimate that related to the effects of short-term exposure to PM(2.5) on all-cause mortality and emergency visits in China by using the systematic review and Meta-analysis. Methods: We selected all the studies published before March 2018 from China National Knowledge Infrastructure, Wanfang database, PubMed and EMBASE and data on relative risk (RR), excess risk (ER) and their 95%CIs: appeared in these papers were extracted. According to the differences in the size or direction (heterogeneity) of the results, we computed summary estimates of the effect values using a random-effect or fixed effect model. We also conducted the subgroup analysis and Meta-analysis to have assessed the selected studies for the evidence of study bias. Results: A total of 33 original studies, indexed in databases, were identified. Among those studies, 39 sets of data on mortality and 4 sets of data on emergency were valid to show that within the daily concentration range from 47.7 to 176.7 μg/m(3), for 10 μg/m(3) increases in PM(2.5) concentrations, it would increase the daily numbers of deaths by 0.49% (95%CI: 0.39%-0.59%) and 0.30% (95%CI: 0.10%-0.51%) for all-cause deaths and all-cause emergency-room visits, respectively. For subgroup analysis, the combined effect of PM(2.5) in causing short-term all-cause deaths in the northern areas (ER=0.42%, 95%CI: 0.30%-0.54%) seemed lower than that in the southern areas (ER=0.63%, 95%CI: 0.44%-0.82%). The combined effect of PM(2.5) concentration below 75 μg/m(3) (ER=0.50%, 95%CI: 0.37%-0.62%) was higher than that of PM(2.5) concentration ≥75 μg/m(3) (ER=0.39%, 95%CI: 0.26%-0.52%). Conclusion: Within the concentration range from 47.7 to 176.7 μg/m(3), short-term exposure to current level of PM(2.5) might increase both the all-cause daily mortality and daily emergency visits in China.

Hospital utilization rates following antipsychotic dose reductions: implications for tardive dyskinesia

BackgroundData are limited on the benefits and risks of dose reduction in managing side effects associated with antipsychotic treatment. As an example, antipsychotic dose reduction has been recommended in the management of tardive dyskinesia (TD), yet the benefits of lowering doses are not well studied. However, stable maintenance treatment is essential to prevent deterioration and relapse in schizophrenia.MethodsA retrospective cohort study was conducted to analyze the healthcare burden of antipsychotic dose reduction in patients with schizophrenia. Medical claims from six US states spanning a six-year period were analyzed for ≥10% or ≥ 30% antipsychotic dose reductions compared with those from patients receiving a stable dose. Outcomes measured were inpatient admissions and emergency room (ER) visits for schizophrenia, all psychiatric disorders, and all causes, and TD claims.ResultsA total of 19,556 patients were identified with ≥10% dose reduction and 15,239 patients with ≥30% dose reduction. Following a ≥ 10% dose reduction, the risk of an all-cause inpatient admission increased (hazard ratio [HR] 1.17; 95% confidence interval [CI] 1.11, 1.23; P < 0.001), and the risk of an all-cause ER visit increased (HR 1.09; 95% CI 1.05, 1.14; P < 0.001) compared with controls. Patients with a ≥ 10% dose reduction had an increased risk of admission or ER visit for schizophrenia (HR 1.27; 95% CI 1.19, 1.36; P < 0.001) and for all psychiatric disorders (HR 1.16; 95% CI 1.10, 1.23; P < 0.001) compared with controls. A dose reduction of ≥30% also led to an increased risk of admission for all causes (HR 1.23; 95% CI 1.17, 1.31; P < 0.001), and for admission or ER visit for schizophrenia (HR 1.31; 95% CI 1.21, 1.41; P < 0.001) or for all psychiatric disorders (HR 1.21; 95% CI 1.14, 1.29; P < 0.001) compared with controls. Dose reductions had no significant effect on claims for TD.ConclusionPatients with antipsychotic dose reductions showed significant increases in both all-cause and mental health–related hospitalizations, suggesting that antipsychotic dose reductions may lead to increased overall healthcare burden in some schizophrenia patients. This highlights the need for alternative strategies for the management of side effects, including TD, in schizophrenia patients that allow for maintaining effective antipsychotic treatment.

Pharmacogenetic testing among patients with mood and anxiety disorders is associated with decreased utilization and cost: A propensity-score matched study.

Naturalistic and small randomized trials have suggested that pharmacogenetic testing may improve treatment outcomes in depression, but its cost-effectiveness is not known. There is growing enthusiasm for personalized medicine, relying on genetic variation as a contributor to heterogeneity of treatment effects. We sought to examine the relationship between a commercial pharmacogenetic test for psychotropic medications and 6-month cost of care and utilization in a large commercial health plan. We performed a propensity-score matched case-control analysis of longitudinal health claims data from a large US insurer. Individuals with a mood or anxiety disorder diagnosis (N=817) who received genetic testing for pharmacokinetic and pharmacodynamic variation were matched to 2,745 individuals who did not receive such testing. Outcomes included number of outpatient visits, inpatient hospitalizations, emergency room visits, and prescriptions, as well as associated costs over 6 months. On average, individuals who underwent testing experienced 40% fewer all-cause emergency room visits (mean difference 0.13 visits; P<0.0001) and 58% fewer inpatient all-cause hospitalizations (mean difference 0.10 visits; P<0.0001) than individuals in the control group. The two groups did not differ significantly in number of psychotropic medications prescribed or mood-disorder related hospitalizations. Overall 6-month costs were estimated to be $1,948 (SE 611) lower in the tested group. Pharmacogenetic testing represents a promising strategy to reduce costs and utilization among patients with mood and anxiety disorders.

Metformin use and health care utilization in patients with coexisting chronic obstructive pulmonary disease and diabetes mellitus.

BackgroundChronic obstructive pulmonary disease (COPD) is associated with persistent systemic inflammation. Anti-inflammatory therapies have been shown to decrease acute exacerbations of COPD. The antidiabetic medication metformin decreases oxidative stress and inflammation and may benefit patients with COPD. We aimed at investigating the effect of metformin on health care utilizations in patients with coexisting COPD and diabetes mellitus (DM).MethodsWe studied 5% Medicare beneficiaries with coexisting COPD and DM prescribed metformin or other antidiabetics during the period 2007–2010. The primary outcome was COPD-specific emergency room (ER) visits and hospitalizations; the secondary outcome was all-cause ER visits and hospitalizations over the 2-year follow-up after the index antidiabetic prescription. The effects of metformin were examined by COPD complexity and compared with the effects of other antidiabetic medications.ResultsAmong 11,260 patients, 3,193 were metformin users and 8,067 were nonusers. Metformin users were younger, were less sick, were less likely to be on oxygen, and had fewer hospitalizations in the prior year compared with the nonusers. Over a 2-year period, metformin users had lower COPD-specific and all-cause ER visits and hospitalizations (7.11% vs 9.61%, p<0.0001; and 61.63% vs 71.27%, p<0.0001, respectively). In a stratified multivariable analysis, the odds of COPD-specific ER visits and hospitalizations were lower in patients with low-complexity COPD (adjusted odds ratio =0.66, 95% confidence interval =0.52–0.85). However, patients with all COPD complexities get benefits of metformin on all-cause ER visits and hospitalizations.ConclusionThe use of metformin in patients with coexisting COPD and DM was associated with fewer COPD-specific ER visits and hospitalizations, especially in low-complexity COPD.

Healthcare utilization and costs for patients initiating Dabigatran or Warfarin

BackgroundNovel oral anticoagulants (NOAC) such as dabigatran, when compared to warfarin, have been shown to potentially reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) together with lower healthcare resource utilization (HCRU) and similar total costs. This study expands on previous work by comparing HCRU and costs for patients newly diagnosed with NVAF and newly initiated on dabigatran or warfarin, and is the first study specifically in a Medicare population.MethodsA retrospective matched-cohort study was conducted using data from administrative health care claims during the study period 01/01/2010–12/31/2012. Cox regression analyses were used to compare all-cause risk of first hospitalizations and emergency room (ER) visits. Medical, pharmacy, and total costs per-patient-per-month (PPPM) were compared between dabigatran and warfarin users.ResultsA total of 1110 patients initiated on dabigatran were propensity score-matched with corresponding patients initiated on warfarin. The mean number of hospitalizations (0.92 vs. 1.13, P = 0.012), ER visits (1.32 vs. 1.56, P < 0.01), office visits (21.43 vs. 29.41; P < 0.01), and outpatient visits (10.86 vs. 22.02; P < 0.01) were lower among dabigatran compared to warfarin users. Patients initiated on dabigatran had significantly lower risk of first all-cause ER visits [hazard ratio (HR): 0.84, 95% confidence interval (CI): 0.73–0.98] compared to those initiated on warfarin. Adjusted mean pharmacy costs PPPM were significantly greater for dabigatran users ($510 vs. $250, P < 0.001); however, mean medical costs PPPM ($1912 vs. $1956, P = 0.55) and mean total costs PPPM ($2381 vs. $2183, P = 0.10) were not significantly different compared to warfarin users.ConclusionsDabigatran users had significantly lower HCRU compared to warfarin users. In addition, dabigatran users had lower risk of all-cause ER visits. Despite higher pharmacy costs, the two cohorts did not differ significantly in medical or total all-cause costs.