Objectives
To assess treatment patterns and outcomes of patients with metastatic castration‐resistant prostate cancer (mCRPC) receiving first‐line chemotherapy or antiandrogen therapy.
Patients and ...Methods
Patients initiating first‐line antiandrogen therapy (abiraterone, enzalutamide) or chemotherapy (taxane) between October 2012 and September 2014 were retrospectively identified in the US Veterans Health Administration database. The impact of antiandrogen therapy vs chemotherapy on overall survival (OS) and time to discontinuation was assessed using Cox proportional hazard models, adjusting for prior androgen deprivation therapy (ADT) duration and available prognostic factors.
Results
Overall, 1445 patients were evaluable, of whom 1108 received antiandrogen therapy and 337 received chemotherapy (docetaxel). On multivariable analysis and propensity score analysis, the OS times for antiandrogen therapy vs chemotherapy were not significantly different (hazard ratio HR 1.041, 95% confidence interval (CI) 0.853–1.270, P = 0.694, and HR 1.047, 95% CI 0.861–1.273, P = 0.644, respectively). Time to discontinuation was shorter for chemotherapy vs antiandrogen therapy (HR 2.339, 95% CI 1.969–2.779; P < 0.001). Prior ADT duration above the median was associated with longer OS (HR 0.566, 95% CI 0.464–0.690; P < 0.001) and time to discontinuation (HR 0.831, 95% CI 0.699–0.988; P = 0.036) in the antiandrogen therapy cohort and not the chemotherapy cohort, while prior ADT duration below the median was associated with higher prostate specific antigen (PSA) response rate in the chemotherapy vs antiandrogen therapy cohort (61.5% vs 51.1%; P = 0.024). The treatment‐free interval after discontinuation was longer after first‐line chemotherapy vs antiandrogen therapy (mean 53 vs 39 days; P = 0.030).
Conclusion
After adjusting for key prognostic factors in this large mCRPC dataset, the OS was similar for first‐line chemotherapy vs antiandrogen therapy despite shorter time to discontinuation with chemotherapy and longer treatment‐free interval after first‐line chemotherapy. These hypothesis‐generating data also suggest that duration of prior ADT may assist in the selection of patients for chemotherapy vs antiandrogen therapy.
Once-daily, single-tablet regimens (STRs) have been associated with improved patient outcomes compared to multi-tablet regimens (MTRs). This study evaluated real world adherence and persistence of ...HIV antiretroviral therapy (ART), comparing STRs and MTRs.
Adult Medicaid beneficiaries (aged ≥ 18 years) initiating ART with ≥ 2 ART claims during the identification period (January 1, 2015-December 31, 2016) and continuous health plan enrollment for a 12-month baseline period were included. For STRs, the first ART claim date was defined as the index date; for MTRs, the prescription fill claim date for the last drug in the regimen was defined as the index date, and prescription fills were required to occur within a 5-day window. Adherence was assessed in 30-day intervals over a 6-month period, with adherence defined as having less than a 5-day gap between fills. Persistence was evaluated as median number of days on therapy and percent persistence at 12 months. Cox Proportional Hazard models were used to evaluate risk of discontinuation, controlling for baseline and clinical characteristics.
A total of 1,744 (STR = 1290; MTR = 454) and 2409 (STR = 1782; MTR = 627) patients newly prescribed ART had available data concerning adherence and persistence, respectively. Average age ranged 40-42 years. The patient population was predominantly male. Adherence assessments showed 22.7% of STR initiators were adherent to their index regimens over a 6-month period compared to 11.7% of MTR initiators. Unadjusted persistence analysis showed 36.3% of STR initiators discontinued first-line therapy compared to 48.8% for MTR initiators over the 2-year study period. Controlling for baseline demographic and clinical characteristics, MTR initiators had a higher risk of treatment discontinuation (hazard ratio HR = 1.6, p < 0.0001). Among STRs, compared to the referent elvitegravir(EVG)/cobicistat(COBI)/emtricitabine(FTC)/tenofovir alafenamide(TAF), risk of discontinuation was higher for efavirenz(EFV)/FTC/tenofovir disoproxil fumarate(TDF) (HR = 3.6, p < 0.0001), EVG/COBI/FTC/TDF (HR = 2.8, p < 0.0001), and abacavir (ABC)/lamivudine (3TC)/dolutegravir (DTG) (HR = 1.8, p = 0.004). Among backbones, FTC/TAF was associated with lower risk of discontinuation than FTC/TDF (HR = 4.4, p < 0.0001) and ABC/3TC (HR = 2.2, p < 0.0001).
Among patients newly prescribed ART, STR initiators were significantly less likely to discontinue therapy and had greater adherence and persistence compared to MTR initiators. Regimens containing FTC/TAF as a backbone had higher persistence than those consisting of other backbones.
At the time of this study, prior to the introduction of biologics in the US, systemic therapies used for the treatment of moderate-to-severe atopic dermatitis included off-label immunosuppressants ...and corticosteroids. Immunosuppressant therapy is associated with a substantial risk of side-effects, therefore needing clinical monitoring, and is likely to incur a significant healthcare burden for patients and payers. This retrospective cohort study based on claims data measured immunosuppressant use and its associated burden among US adult patients with atopic dermatitis covered under commercial or Medicare Supplemental insurance from January 01, 2010, to September 30, 2015. Overall, based on age, gender, region, and index year, 4201 control patients with atopic dermatitis without immunosuppressant use were matched with 4204 patients treated with immunosuppressants. The majority (68.5%) of patients using immunosuppressants were non-persistent with immunosuppressant treatment during the 12-month follow-up period after a mean (standard deviation) of 88.1 (70.7) days of immunosuppressant use; 72.3% required systemic steroid rescue treatment. Immunosuppressant users had higher incidence of immunosuppressant-related clinical events than controls; in addition, a larger proportion of immunosuppressant users versus controls developed cancer (0.28% vs 0.14%, respectively; P < 0.0001). Healthcare utilization and costs associated with clinical events and monitoring were also higher for immunosuppressant users compared with controls (total costs, $9516 vs $1630, respectively; P < 0.0001; monitoring costs, $363 vs $54, respectively; P < 0.0001). This study revealed that patients treated with systemic immunosuppressants often require systemic steroids or changes to treatment. The increase in immunosuppressant-related clinical events, including the need for increased monitoring with immunosuppressant treatment, compared with controls demonstrates a substantial treatment burden and highlights the unmet need for more effective long-term therapies for atopic dermatitis with improved safety profiles and reduced monitoring requirements.
To compare real-world dose escalation of risankizumab with other US Food and Drug Administration (FDA)-approved biologic treatments for management of moderate-to-severe psoriasis (PsO) in the United ...States.
The Merative® MarketScan® Research Database was used to identify adults with ≥2 medical claims for PsO, ≥3 claims of the index biologic medication in the maintenance period, and ≥6 months continuous enrollment pre-induction and ≥6 months after initiation of the maintenance period. Dose escalation was defined as ≥2 dosing intervals where the average daily dose was ≥30% higher than the expected daily dose (per FDA-approved dosing). Comparisons between risankizumab and other cohorts were made using chi-square tests and logistic regression models.
At the 30% threshold, the percentage of patients with dose escalation in the full maintenance period was significantly lower with risankizumab (2.0%) compared with other drug classes (tumor necrosis factor, interleukin (IL)-12/23, IL-17, or other IL-23 inhibitors: 17.6%, 10.0%, 18.3%, or 7.1%, respectively; p < 0.0001 for each) and individual biologics (adalimumab, ustekinumab, secukinumab, ixekizumab, and guselkumab; 17.9%, 10.0%, 15.7%, 18.0%, and 7.2%, respectively; p < 0.0001).
A significantly lower proportion of risankizumab-treated patients with PsO had dose escalations compared with patients treated with other biologics.
Schizophrenia is associated with high health care resource utilization and treatment costs.
This study compared treatment patterns, health care resource utilization, and medical costs before and ...after a switch from oral antipsychotic drug (risperidone or paliperidone RIS/PALI) therapy to the long-acting injectable once-monthly paliperidone palmitate (PP1M) in patients with schizophrenia.
Data for adult patients (aged ≥18 years) with at least 1 diagnosis of schizophrenia who initiated treatment with oral RIS/PALI ≥6 months before switching and had continuous health plan enrollment during the study period before and after the switch were extracted from the Veterans Health Administration database. Treatment patterns, health care resource utilization, and costs were compared between the period 6 or 12 months before and after switching directly from oral RIS/PALI to PP1M.
The analysis included 676 and 493 patients in the 6-month and 12-month cohorts, respectively. Adherence to oral RIS/PALI during the 12 months preswitch was 11.0% and 22.1% as measured by proportion of days covered and medication possession ratio ≥80%, respectively. During the 12 months postswitch, adherence to PP1M was 27.0% and 35.9%, respectively. Among patients treated with oral RIS/PALI, from 12 months pre- to 12 months post-PP1M switch, fewer all-cause inpatient stays (2.2 vs 1.1, respectively; P < 0.05) and a shorter mean length of inpatient stay (28.1 and 14.0 days, respectively; P < 0.05) were observed. This pattern was similar for both the number of mental health– and schizophrenia-related inpatient stays and length of stay. Compared with 12 months pre-PP1M switch, significantly higher mean numbers of all-cause outpatient visits and pharmacy visits were observed at 12 months postswitch. In line with health care resource utilization findings, at 12 months pre- versus 12 months post-PP1M switch we observed decreases in all-cause inpatient stay costs ($41,886 vs $20,489; P < 0.05) and increases in outpatient visit costs ($22,005 vs $29,069; P < 0.05). Findings for the 6-month cohort followed a similar pattern.
Post-PP1M switch, a decrease in total medical costs fully offset an increase in pharmacy costs, resulting in similar total costs. The findings suggest potential economic benefits of switching patients with schizophrenia from oral RIS/PALI to PP1M in the Veterans Health Administration.
A retrospective, observational analysis of administrative claims data from the IBM MarketScan Databases assessed adherence and persistence among GLP-1 RA naive adult patients with T2D newly ...initiating dulaglutide (DU) or oral semaglutide (OS) between Sept 2019 and Nov 2020.
Patients had continuous enrollment in the 6-mo pre-index period and 6-mo follow-up periods. The DU patients were propensity-score matched 1:1 to OS patients (6,166 pairs) . The median age was 54 years at index date, and 48% were female. At pre-index, mean aDCSI was 0.6 and 10% of patients had ASCVD. Most patients used oral anti-hyperglycemic medication (87%) ; a smaller proportion used insulin (15%) . The most common prescribing provider was primary care (62%) .
More DU patients were adherent (proportion days covered PDC ≥80%) (65% vs. 50%, p<0.001) and had higher mean PDC vs. OS (0.78 vs. 0.68, p<0.001) . More DU patients were persistent on therapy compared to OS patients (72% vs. 57% p<0.001) and had longer mean duration of persistence (148 vs. 128, p<0.001) . Among patients with ≥2 fills of their index drug, 73% of DU and 62% of OS patients were adherent.
During the 6-mo follow-up period, DU patients had significantly higher adherence and persistence compared to OS patients.
Disclosure
R. Paczkowski: Employee; Eli Lilly and Company. M. Hoog: Employee; Eli Lilly and Company, Stock/Shareholder; Abbott, Eli Lilly and Company. J. Peleshok: Employee; Eli Lilly and Company, Eli Lilly and Company. M. Yu: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A. Huang: None. B. Limone: None. J. Manjelievskaia: Employee; IBM Watson Health, Other Relationship; Eli Lilly and Company.
Funding
Eli Lilly and Company
Background: In the past 5 years, type 2 diabetes practice guidelines have shifted to prioritize agents with cardiovascular (CV) and renal benefit. This study assessed whether real-world medication ...use has changed in line with these evolving guidelines.
Methods: We retrospectively examined the treatment patterns (12 months pre and post) of people with T2D (PwT2D) who initiated basal insulin (BI) in either 2015 (cohort 1) , 2017 (cohort 2) , or 2019 (cohort 3) using IBM® MarketScan® Databases. Between-group differences were analyzed via t-test or chi-square as appropriate.
Results: In the study period, 6,396,441 PwT2D were identified. The number of PwT2D initiating BI was 17,801/948,805 (1.88%) in 2015 vs. 10,870/622,455 (1.75%) in 2019 and a progressively larger share of BI initiators had prior GLP-1RA use (14.8% in cohort 1 vs. 25.2% in cohort 3; p < 0.001) or SGLT-2i use (11.4% in cohort 1 vs. 20.5% in cohort 3; p < 0.001) . Furthermore, in patients without prior GLP-1RA, SGLT-2i, or bolus use who initiated GLP-1RA or SGLT-2i in the first year of BI, time to first GLP-1RA (132.4 days in cohort 1 vs. 120.5 days in cohort 3; p = 0.02) or SGLT-2i (131.5 days in cohort 1 vs. 113.3 days in cohort 3; p = 0.002) decreased.
Conclusions: Real-world data suggests growing and earlier use of GLP-1RA and SGLT-2i among BI users, and a growing proportion of PwT2D on BI-GLP-1RA combination treatment, in line with changing practice guidelines.
Disclosure
D. Schapiro: Employee; Eli Lilly and Company. A. Meeks: Employee; Eli Lilly and Company. D. Liu: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. F. Gelsey: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. R. Juneja: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M. Perez-nieves: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A. Huang: None.
Funding
Eli Lilly and Company
Introduction
Little is known about the burden of schizophrenia among United States veterans early after diagnosis. This retrospective study describes treatment patterns, healthcare resource ...utilization (HRU) and healthcare costs among veterans with a recent schizophrenia diagnosis.
Methods
Adults with a schizophrenia diagnosis recorded between 1 April 2014 and 31 December 2017 and no history of schizophrenia over the preceding 12 months were identified from a Veterans Health Administration (VHA) database. Continuous enrollment in the VHA was required for ≥ 12 months before and after the index date when the first schizophrenia diagnosis code was identified. Baseline characteristics and follow-up treatment patterns, HRU and costs were examined descriptively.
Results
The study population (20,389 patients) had a high baseline mental health comorbidity burden. Despite a schizophrenia diagnosis, 32.1% of patients received no antipsychotic medication during the follow-up period. Among those with ≥ 1 antipsychotic prescription fill, 64.0% received ≥ 1 oral antipsychotic (OAP) therapy and 11.6% received ≥ 1 long-acting injectable (LAI). A delay was observed between diagnosis and treatment for both OAPs (39.0 ± 67.2 days) and LAIs (69.4 ± 96.2 days). Adherence to therapy (defined as proportion of days covered ≥ 80%) was greater with LAIs (34.5%) vs OAPs (27.3%). Inpatient stays were reported for 33.8% of patients during the 12-month follow-up period, and 5.5% of patients had readmissions. All-cause inpatient stay costs with 12-month follow-up equaled $7999 per patient per year.
Conclusions
These data indicate that pharmacotherapy after a recent diagnosis of schizophrenia in the VHA system is suboptimal, and that these patients face a considerable burden in terms of hospitalization, other HRU, and healthcare costs.
Objective: To address gaps in the literature on healthcare resource utilization (HRU) and costs among patients with schizophrenia and prior hospitalization who transition from oral risperidone or ...paliperidone (oral ris/pali) to once-monthly paliperidone palmitate (PP1M) in a real-world setting by comparing treatment patterns, HRU, and costs 12-months pre- and post-transition to PP1M among Veterans Health Administration (VHA) patients affected by schizophrenia who have had ≥1 hospitalization.
Methods: VHA patients with schizophrenia (aged ≥18 years) who initiated oral ris/pali, had ≥1 all-cause inpatient stay, and transitioned to PP1M from January 2015-March 2017 were included from the VHA database. The first transition date to PP1M was identified as the index date. Patients were required to have continuous health plan eligibility for 12 months pre- and post-PP1M. Outcomes were compared using the Wilcoxon signed-rank and McNemar's test, as appropriate.
Results: The study included 319 patients (mean SD age = 51.6 4.2 years) during 12 months of baseline and follow-up. During pre-PP1M transition, 7.2% of the patients were adherent (proportion of days covered PDC ≥ 80%) to oral ris/pali. Post-PP1M transition, 27.6% of the patients were adherent to PP1M. Comparison of HRU outcomes from the pre- to post-PP1M transition revealed significantly lower all-cause inpatient stays (3.5 vs 1.4, p < .0001) and shorter inpatient length of stay (43.4 vs 18.3 days, p < .0001). Similar trends were seen for mental health and schizophrenia-related HRU. Cost outcome comparison indicated significantly lower all-cause inpatient costs ($64,702 vs $24,147, p < .0001), total medical costs ($87,917 vs $56,947, p < .0001), and total costs ($91,181 vs $69,106, p < .0001). A similar trend was observed for mental health and schizophrenia-related costs.
Conclusions: Transitioning from oral ris/pali to PP1M may significantly improve HRU and provide potential cost savings in VHA patients with schizophrenia and ≥1 prior hospitalization.
Evidence is limited on the economic burden associated with treatment-resistant depression (TRD) among US veterans. We evaluated the economic burden among patients with major depressive disorder (MDD) ...with and without TRD, and those without MDD in the Veterans Health Administration (VHA).
Three cohorts were identified using VHA claims data (01APR2014-31MAR2018). Patients with MDD (aged ≥18) who failed ≥2 antidepressant treatments of adequate dose and duration were defined as having TRD; patients with MDD not meeting this criterion constituted the non-TRD MDD cohort (index: first antidepressant claim). The non-MDD cohort included those without MDD diagnosis (index: randomly assigned). Patients with psychosis, schizophrenia, manic/bipolar disorder, or dementia in the 6-month pre-index period were excluded. Patients with non-TRD MDD and non-MDD were matched 1:1 to patients with TRD based on demographic characteristics (age, gender, race, index year). Health care resource utilization (HRU) and costs were analyzed during the post-index period using a negative binomial model and ordinary least squares regression model, respectively.
After 1:1 exact matching, 10,449 patients were included in each cohort (mean age: 48.9 years). Patients with TRD had higher per patient per year (PPPY) HRU than non-TRD MDD (all-cause inpatient visits: incidence rate ratio IRR: 1.70 95% confidence interval: 1.57-1.83) and non-MDD (IRR: 5.04 95% confidence interval: 4.51-5.63), and incurred higher total all-cause health care costs PPPY than non-TRD MDD (mean difference: $5,906) and non-MDD (mean difference: $11,873; all p<.0001).
Among US veterans, TRD poses a significant incremental economic burden relative to non-TRD MDD and non-MDD.
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