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OBJECTIVE: To quantify the economic burden of all-cause health care resource utilization (HCRU) among adults with and without chronic vestibular impairment (CVI) after a mild traumatic brain injury (mTBI). DESIGN: Retrospective matched cohort study. SETTING: IQVIA Integrated Data Warehouse. PARTICIPANTS: People with mTBI+CVI (n=20,441) matched on baseline age, sex, year of mTBI event, and Charlson Comorbidity Index (CCI) score to people with mTBI only (n=20,441) (N=40,882). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: All-cause health HCRU and costs at 12 and 24 months post mTBI diagnosis. RESULTS: People with mTBI+CVI had significantly higher all-cause HCRU and costs at both time points than those with mTBI only. Multivariable regression analysis showed that, when controlling for baseline variables, costs of care were 1.5 times higher for mTBI+CVI than mTBI only. CONCLUSIONS: People who developed CVI after mTBI had greater overall HCRU and costs for up to 2 years after the injury event compared with people who did not develop CVI after controlling for age, sex, region, and CCI score. Further research on access to follow-up services and effectiveness of interventions to address CVI is warranted.
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Lesões Encefálicas Traumáticas/economia , Lesões Encefálicas Traumáticas/reabilitação , Custos de Cuidados de Saúde/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde , Sistema Vestibular/lesões , Adolescente , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto JovemRESUMO
INTRODUCTION: Real-world evidence on later line treatment of relapsed/refractory multiple myeloma (RRMM) is sparse. We evaluated clinical outcomes among RRMM patients in the 1-year following treatment with pomalidomide or daratumumab and compared economic outcomes between RRMM patients and non-MM patients. PATIENT AND METHODS: Adult patients with ≥1 claim of pomalidomide or daratumumab were identified between January 2012 and February 2018 using IQVIA PharMetrics® Plus US claims database. Patients were required to have a diagnosis or treatment for MM and a claim of any immunomodulatory drugs and proteasome inhibitors before the index date. Mean time to new therapy, overall survival (OS) using Kaplan-Meier curve and adverse events (AEs) were reported over the 1-year post-index period. RRMM patients were also matched to a non-MM comparator cohort and economic outcomes were compared between the two cohorts. RESULTS: 289 RRMM patients were matched to 1,445 patients without MM. Most prevalent hematological AE was anemia (72.0%) and non-hematological AE was infections (75.4%). Mean (SD) time to a new treatment was 4.7 (5.3) months and median OS was 14.6 months. RRMM patients had significantly higher hospitalizations and physician office visits (Both P < .0001) compared to non-MM patients. Adjusting for baseline characteristics, patients with RRMM had 4.9 times (95% CI 3.8-6.4, P < .0001) the total healthcare costs compared with patients without MM. The major driver of total costs among RRMM patients was pharmacy costs (67.3%). CONCLUSION: RRMM patients showed a high frequency of AEs, low OS, and a substantial economic burden suggesting need for effective treatment options.
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Mieloma Múltiplo , Adulto , Anticorpos Monoclonais , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Dexametasona/uso terapêutico , Humanos , Mieloma Múltiplo/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Talidomida/análogos & derivadosRESUMO
The current study assessed the impact of urinary incontinence (UI) on residents, staff, care processes, and quality measures in long-term care (LTC) settings. A 70-question quantitative online survey was sent to directors of nursing (DONs) who had worked for ≥1 year in a ≥100-bed facility (≥80% LTC beds). Of the 62% of residents with UI, 40% were always incontinent, and 81% used incontinence products for UI. Overall, 59% of DONs reported that UI management contributes to certified nursing assistant turnover. Approximately 36% of resident falls occurred while trying to get to the bathroom. LTC quality measures reported as significantly impacted by UI included urinary tract infection and falls with major injury. Only 14% of residents with UI were treated with medication. Most (75%) DONs were unaware of any link between anticholinergic medications and risk of cognitive side effects. These results highlight the need for improved UI treatment, awareness, and management in this population. [Journal of Gerontological Nursing, 48(7), 38-46.].
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Enfermagem Geriátrica , Bexiga Urinária Hiperativa , Incontinência Urinária , Idoso , Enfermagem Geriátrica/métodos , Humanos , Assistência de Longa Duração/métodos , Inquéritos e Questionários , Bexiga Urinária Hiperativa/epidemiologia , Bexiga Urinária Hiperativa/terapiaRESUMO
Aim: Compare healthcare resource utilization and costs among patients with HER2+ metastatic breast cancer (MBC) with and without central nervous system (CNS) metastases. Methods: Retrospective matched cohort study using IQVIA's PharMetrics® Plus claims database. Results: Patients with CNS metastases (n = 753) experienced more outpatient, emergency room and inpatient visits versus controls (n = 753; all p < 0.05). In the post-index year, median total all-cause healthcare costs were significantly higher among patients with CNS metastases versus controls ($112,402 vs $50,835; p < 0.0001); outpatient costs primarily drove the cost differential. Conclusion: More effective therapies are needed that improve clinical outcomes and reduce economic burden associated with CNS metastases in patients with HER2+ MBC.
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Neoplasias da Mama/economia , Neoplasias do Sistema Nervoso Central/economia , Bases de Dados Factuais , Estresse Financeiro/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Receptor ErbB-2/metabolismo , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Neoplasias da Mama/terapia , Estudos de Casos e Controles , Neoplasias do Sistema Nervoso Central/metabolismo , Neoplasias do Sistema Nervoso Central/secundário , Neoplasias do Sistema Nervoso Central/terapia , Terapia Combinada , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Prognóstico , Estudos RetrospectivosRESUMO
BACKGROUND: Disparities in prescription abandonment may exacerbate health inequities. Whether copay assistance is associated with changes in prescription abandonment across different patient groups is unknown. OBJECTIVE: To assess disparities in copay assistance use; prescription abandonment across race, ethnicity, or income; and association of copay use with prescription abandonment and whether it differs across race, ethnicity, or household income. METHODS: This pooled, cross-sectional study assessed claims-level prescription data linked to a consumer database containing information on race, ethnicity, and household income for commercially insured patients. The first prescription for rheumatoid arthritis (RA) or oral oncolytic medicines from 2016 to 2020 was included. Logistic regression models measured odds of copay assistance use (copay/discount cards or free-trial voucher) and prescription abandonment (prescription not filled within 30 days of health plan approval). Interaction terms for copay assistance use by race, ethnicity, and income were tested. RESULTS: The sample included 67,674 patients prescribed RA medications and 9,560 prescribed oral oncolytic medications. Copay assistance use across race, ethnicity, and income ranged from 28.2% to 31.1% (RA medicines) and 27.2% to 36.7% (oral oncolytic medicines). Among those prescribed RA medicines and not using copay assistance, Black/African American, Hispanic patients, and those with household incomes less than $50,000 were more likely to abandon prescriptions than White patients and patients with household incomes more than $200,000 (odds ratio [OR] [95% CI], P value: Black/African American: 1.17 [1.06-1.29], P < 0.01; Hispanic: 1.11 [1.01-1.22], P = 0.03; income <$50,000: 1.24 [1.11-1.37], P < 0.01). Among patients using oral oncolytic medicines and not using copay assistance, there was no racial or ethnic difference in prescription abandonment. Patients using oral oncolytics with household incomes less than $50,000 were more likely to use copay assistance (1.34 [1.12-1.61], P < 0.01), but also more likely to abandon their prescriptions if not using copay assistance (1.44 [1.12-1.85], P < 0.01). Copay assistance was associated with a 79% (RA) and 71% (oral oncolytics) lower odds of prescription abandonment (0.21 [0.19-0.24], P < 0.01; 0.29 [0.24-0.36], P < 0.01), which did not differ across race, ethnicity, or income levels (P > 0.05). CONCLUSIONS: Copay assistance has potential to narrow disparities in prescription abandonment for commercially insured Black/African American or Hispanic patients taking RA medicines and patients with household incomes less than $50,000; however, efforts to improve access to copay assistance are needed. Copay assistance, as a factor facilitating equal access to medicines, is an important consideration when evaluating policies that impact access to copay assistance programs. DISCLOSURES: Genentech, Inc., provided funding and support for this study. Dr Wong is an employee of Genentech, Inc., and shareholder of Roche, Inc. Ms Donahue, Mr Thiesen, and Mr Yeaw are employees of IQVIA.
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Artrite Reumatoide , Adesão à Medicação , Honorários por Prescrição de Medicamentos , Humanos , Artrite Reumatoide/tratamento farmacológico , Estudos Transversais , Etnicidade , Hispânico ou Latino , Estados Unidos , Negro ou Afro-Americano , Brancos , Renda , Gastos em Saúde , Assistência Pública/economiaRESUMO
Objective: To evaluate real-world treatment patterns for patients initiating benztropine and to understand treatment approaches in patients with drug-induced movement disorders from a health care provider perspective.Methods: A retrospective claims analysis was conducted among patients with evidence of benztropine initiation from January 2017 through March 2020 to assess treatment patterns and patient health care resource utilization. Subsequently, a 30-minute, United States-based online survey fielded from December 2021 to January 2022 was sent to physicians, nurse practitioners, and physician assistants who reported a primary care or psychiatry specialty currently treating drug-induced movement disorders and prescribed benztropine.Results: The health care claims analysis included 112,542 patients. Polypharmacy and multiple comorbidities were frequent characteristics in this population; 54.1% of patients had ≥ 2 comorbidities at baseline, and 59.1% had claims for > 10 medications. Benztropine was used for > 3 months in > 50% of the population. Health care costs and resource utilization were high, with mean all-cause pharmacy and outpatient costs totaling $11,755. Survey results from 349 primary care or psychiatry health care providers indicated that benztropine is often used in non-tardive dyskinesia drug-induced movement disorders but frequently continued for > 3 months or used in tardive dyskinesia. In this study, psychiatry providers prescribed benztropine in line with guideline recommendations more often than primary care providers; however, < 40% indicated familiarity with 2020 American Psychiatric Association Practice Guideline for the Treatment of Patients with Schizophrenia.Conclusions: These complementary analyses suggest that benztropine is used long-term in non-tardive dyskinesia drug-induced movement disorders and in tardive dyskinesia despite risks of worsening tardive dyskinesia or adverse effects.Prim Care Companion CNS Disord 2023;25(4):22m03472. Author affiliations are listed at the end of this article.
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Transtornos dos Movimentos , Discinesia Tardia , Humanos , Benzotropina , Revisão da Utilização de Seguros , Estudos Retrospectivos , Pessoal de SaúdeRESUMO
BACKGROUND: Arginase 1 Deficiency (ARG1-D) is an inherited metabolic disease that leads to significant morbidity. AIMS: Despite the recognized burden of disease, information on health care resource utilization (HCRU) among patients with ARG1-D is lacking. We, therefore, sought to evaluate HCRU in ARG1-D relative to non-ARG1-D cohort. MATERIALS AND METHODS: Patients with ≥2 ICD-10-CM diagnosis codes for ARG1-D were identified (first diagnosis code = index date) using professional fee claims linked with prescription claims. Patients with ARG1-D were matched 1:1 to a comparator cohort of patients with other medical conditions. Matching variables included age, sex, index year, payer type (Medicare, Medicaid, third party) and geographic region. RESULTS: A total of 77 patients met the inclusion criteria for the ARG1-D cohort, with a median age of 15 years, 52% <18 years, and 52% male. Several concurrent diagnoses were recorded at a higher frequency in the ARG1-D cohort versus the matched comparator (spasticity 7 times higher; developmental delay â¼2 times higher; intellectual disability 5 times higher; and seizures 8 times higher). Emergency room visits occurred twice as often, laboratory tests were performed 1.5 times more often, hospitalization was required 3 times more often, and mean length of stay was longer for patients with ARG1-D than the comparator cohort (2.4 days vs. 0.3 days). LIMITATIONS: A relatively short study period while the burden of ARG1-D increases over a lifetime due to disease progression. CONCLUSIONS: Patients with ARG1-D had significantly greater HCRU compared with those without the disease; they presented with a more extensive comorbidity profile, accessed the health care system more frequently, required more intense monitoring and management, and had more frequent and longer hospitalizations relative to the comparator group. These findings demonstrate a high health burden in ARG1-D that is not mitigated by standard-of-care measures and emphasize the need for improved treatment options.
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Arginase , Medicare , Adolescente , Idoso , Atenção à Saúde , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Aceitação pelo Paciente de Cuidados de Saúde , Estudos Retrospectivos , Estados UnidosRESUMO
BACKGROUND: Myotonic dystrophy (DM) is a rare, inherited disorder with multi-systemic effects that impact the skeletal muscles, eyes, heart, skin and gastrointestinal, endocrine, respiratory, and central nervous systems. DM is divided into two subtypes: DM1 can present from early childhood through adulthood and also has a congenital form (cDM) while DM2 typically manifests during mid-adulthood. Both forms are progressive with no approved treatments, and unmet need for disease-modifying therapies remains high. This study interrogated health insurance claims data to explore the clinical experience, healthcare resource utilization (HCRU), and all-cause costs for DM. RESULTS: A total of 8541 patients with DM and 242 patients with cDM and their matched controls were selected from a database of over 200 million claimants. HCRU and all-cause costs, including pharmacy, outpatient, and inpatient services, were analyzed across four years in 12-month follow-up periods. Mean all-cause costs per DM patient were high in each of the four periods (range $14,640-$16,704) and showed a steady increase from 13 to 23 months on, while the control group mean costs declined from $9671 in the first 12 months after the index event, to approach the US population average ($5193) over time. For cDM, the highest mean costs were in the first 12-months ($66,496 vs. $2818 for controls), and remained high (above $17,944) across all subsequent periods, while control mean costs approached $0. For DM and cDM, HCRU was higher compared to controls across all study periods and all-cause healthcare costs were mostly driven by inpatient and outpatient encounters. Analysis of all diagnosis codes over the study period (comorbidities) demonstrated an elevated comorbidity profile consistent with the clinical profile of DM. CONCLUSIONS: This study is among the first to utilize claims data to increase understanding of the clinical experience and health economic outcomes associated with DM. The markedly elevated HCRU patterns and comorbidity profile presented here add to the broad body of scientific and clinical knowledge on DM. These insights can inform clinical care and support the development of disease modifying and/or symptom-targeting therapies that address the multi-systemic, progressive nature of DM.
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Distrofia Miotônica , Adulto , Pré-Escolar , Comorbidade , Atenção à Saúde , Custos de Cuidados de Saúde , Humanos , Seguro Saúde , Estudos RetrospectivosRESUMO
BACKGROUND: Prior studies have found that patients taking single-pill amlodipine/atorvastatin (SPAA) have greater likelihood of adherence at 6 months than those taking 2-pill calcium-channel blocker and statin combinations (CCB/statin). This study examines whether this adherence benefit results in fewer cardiovascular (CV) events. METHODS: A retrospective cohort study was conducted using administrative claims data from the IMS LifeLink: US Health Plan Claims database, identifying adults already taking CCB or statin (but not both) who had an index event of either initiating treatment with SPAA or adding CCB to statin (or vice versa) between April 1, 2004 to August 31, 2005. Inclusion criteria included age 18+ years, continuously enrolled for minimum of 6 months prior and 18 months following treatment initiation, >1 diagnosis of hypertension, and no prescription claims for SPAA or added CCB or statin for 6 months prior. Exclusion criteria included >1 claim with missing or invalid days supplied, age 65+ years and not enrolled in Medicare Advantage, or history of prior CV events, cancer diagnosis, or chronic renal failure. The primary outcome measure was the rate of CV events (myocardial infarction, heart failure, angina, other ischemic heart disease, stroke, peripheral vascular disease, or revascularization procedure) from 6 to 18 months following index date, analyzed at three levels: 1) all adherent vs. non-adherent patients, 2) SPAA vs. dual-pill patients (regardless of adherence level), and 3) adherent SPAA, adherent dual-pill, and non-adherent SPAA patients vs. non-adherent dual-pill patients. RESULTS: Of 1,537 SPAA patients, 56.5% were adherent at 6 months, compared with 21.4% of the 17,910 CCB/statin patients (p < 0.001). Logistic regression found SPAA patients more likely to be adherent (OR = 4.7, p < 0.001) than CCB/statin patients. In Cox proportional hazards models, being adherent to either regimen was associated with significantly lower risk of CV event (HR = 0.77, p = 0.003). A similar effect was seen for SPAA vs. CCB/statin patients (HR = 0.68, p = 0.02). In a combined model, the risk of CV events was significantly lower for adherent CCB/statin patients (HR = 0.79, p = 0.01) and adherent SPAA patients (HR = 0.61, p = 0.03) compared to non-adherent CCB/statin patients. CONCLUSIONS: Patients receiving SPAA rather than a 2-pill CCB/statin regimen are more likely to be adherent. In turn, adherence to CCB and statin medications is associated with lower risk of CV events in primary prevention patients.
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Anlodipino/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/fisiopatologia , Ácidos Heptanoicos/uso terapêutico , Pirróis/uso terapêutico , Angina Pectoris , Atorvastatina , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Quimioterapia Combinada , Feminino , Seguimentos , Insuficiência Cardíaca , Humanos , Masculino , Programas de Assistência Gerenciada , Pessoa de Meia-Idade , Infarto do Miocárdio , Cooperação do Paciente , Estudos Retrospectivos , Estados UnidosRESUMO
BACKGROUND: The National Quality Forum recently endorsed the proportion of days covered (PDC)-a measure of medication adherence-as an indicator of quality in drug therapy management. OBJECTIVE: To inform initial efforts to improve the quality of drug therapy management, we compared PDC and persistence among new users of 6 commonly used chronic medication categories. METHODS: A retrospective analysis of pharmacy claims in a database of more than 64 million members enrolled in 100 health plans assessed persistence and adherence to drug therapy in 6 chronic conditions. Patients were included in the analysis if they initiated a prescription drug of interest in any of 6 drug classes-prostaglandin analogs, statins, bisphosphonates, oral antidiabetics, angiotensin II receptor blockers (ARBs), and overactive bladder (OAB) medications-between January 1 and December 31, 2005. The first claim for a drug of interest during this period was considered a patient's index date. Patients were required to have a minimum of 12 months of continuous enrollment both preceding and following their index date. New users of a treatment were identified by excluding patients who filled a prescription for any drug in the same class during the previous 12 months and were followed for a minimum of 12 months. Nonpersistence was defined as discontinuation of the therapy class following an allowed gap between refills-30-, 60-, and 90-day refill gaps were used. Adherence was defined as a continuous measure of the proportion of days covered (PDC) during the 12-month post-index period. Logistic regression analyses predicted (a) nonpersistence during the 12-month post-index period and (b) adherence (PDC) of at least 80%, with drug class as the predictor variable of interest, controlling for demographic variables, insurance and plan type, history of hospitalization, Charlson comorbidity score, copayment for index medication, and number of medications at index. RESULTS: A total of 167,907 patients were identified across 6 cohorts. Using the 60-day gap, 6-month persistence rates were prostaglandin analogs 47%, statins 56%, bisphosphonates 56%, oral antidiabetics 66%, ARBs 63%, and OAB medications 28%. After the first 90 days of therapy, relative persistence was stable across cohorts, and rates declined consistently from 6 months post-index to study end. Logistic regression models showed that oral antidiabetic users had a 59%, 36%, 37%, and 79% decreased risk of nonpersistence in a 12-month follow-up period compared with patients taking prostaglandin analogs, statins, bisphosphonates, or OAB medications, respectively. Risk of nonpersistence decreased with increasing age. Mean (SD) 12-month adherence rates were: prostaglandin analogs 37% (26%), statins 61% (33%), bisphosphonates 60% (34%), oral antidiabetics 72% (32%), ARBs 66% (32%), and OAB medications 35% (32%). Logistic regression indicated that oral antidiabetic use was a significant predictor of adherence (PDC) of at least 80% compared with other therapy classes. Adjusted odds ratios for oral antidiabetics were 17.60 (95% confidence interval [CI] = 15.38-20.14) versus prostaglandin analogs, 2.06 (95% CI = 1.99-2.12) versus statins, 1.92 (95% CI = 1.83-2.02) versus bisphosphonates, 1.29 (95% CI = 1.24-1.34) versus ARBs, and 5.77 (95% CI = 5.38-6.19) versus OAB medications. CONCLUSION: This analysis of adherence (PDC) and persistence across a sample of 6 chronic therapies found variable but uniformly suboptimal medication use. Adherence to prostaglandin eye drops and OAB medications was lower than to cardiovascular, oral antidiabetic, and oral osteoporosis therapies. These findings provide useful baseline information for the development of initiatives to improve the quality of drug therapy management.
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Programas de Assistência Gerenciada/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/normas , Preparações Farmacêuticas/administração & dosagem , Adulto , Idoso , Bases de Dados Factuais , Feminino , Seguimentos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Garantia da Qualidade dos Cuidados de Saúde/métodos , Estudos Retrospectivos , Fatores de TempoRESUMO
Aim: Objective was to compare adherence and persistence, as well as direct healthcare costs and utilization, of ospemifene to available local estrogen therapies (LETs). Patients & methods: This retrospective database study used integrated medical and pharmacy claims data from the IQVIA Real-World Data Adjudicated Claims - US Database. Results: Ospemifene patients had significantly greater adherence and persistence compared with the other nonring LETs. Ospemifene had the lowest mean outpatient costs of any of the LET cohorts, including the estradiol vaginal ring. Total all-cause healthcare costs were also significantly less for ospemifene patients compared with all other LETs.
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Dispareunia/tratamento farmacológico , Estrogênios/economia , Estrogênios/uso terapêutico , Tamoxifeno/análogos & derivados , Administração Intravaginal , Fatores Etários , Idoso , Gerenciamento de Dados , Estrogênios/administração & dosagem , Feminino , Custos de Cuidados de Saúde , Gastos em Saúde , Humanos , Adesão à Medicação , Pessoa de Meia-Idade , Pós-Menopausa , Estudos Retrospectivos , Moduladores Seletivos de Receptor Estrogênico , Tamoxifeno/administração & dosagem , Tamoxifeno/economia , Tamoxifeno/uso terapêuticoRESUMO
OBJECTIVE: Treatment adherence and persistence are essential to achieving therapeutic goals in diabetes and may be improved by patient support programs (PSPs). The COACH Program was launched in 2015 with the goal of supporting patients with diabetes who are prescribed insulin glargine 300 U/mL (Gla-300). The study objective was to assess the program's impact on persistence and adherence with therapy among patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A retrospective 12-month analysis was conducted to compare treatment adherence and persistence in patients treated with Gla-300 who actively participated in the COACH PSP versus those who did not enroll using COACH engagement and claims data for the identification period from February 1, 2016 to July 31, 2016. COACH (n=544) and non-COACH (n=544) participants were matched on selected baseline characteristics. RESULTS: COACH participants were more likely to be adherent to (68.0% vs 61.4%, p= 0.0201; OR: 1.81, p=0.0002) and persistent (48.5% vs 42.1%, p= 0.0309; discontinuation HR: 0.60, p<0.0001) with Gla-300 than non-COACH patients during the 12-month follow-up after controlling for clinical confounders. Additionally, both insulin-naive and basal insulin switcher COACH participants, respectively, were more likely to be adherent (OR: 2.25, p=0.0082 and OR: 1.662, p=0.0364) and persistent (discontinuation HR: 0.53, p=0.0054 and HR: 0.67, p=0.0492) than non-COACH patients. Finally, COACH participants with greater level of engagement showed better persistence. CONCLUSION: These data demonstrate that participation and engagement with COACH PSPs are associated with improved persistence and adherence to Gla-300 among patients with type 2 diabetes.
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Background: Pulmonary arterial hypertension (PAH) is described by proliferation of small pulmonary arteries leading to increased pulmonary vascular resistance, right ventricular failure, and death. Research confirms long-term improvement in composite morbidity and mortality endpoints on some endothelin receptor antagonists alone and in combination with phosphodiesterase type 5 inhibitors (PDE-5is) but not with PDE-5i monotherapy. While current treatment guidelines incorporate these findings, a substantial number of patients are started or maintained on PDE-5i monotherapy. Objectives: This study describes real-world clinical practice and treatment patterns with PDE-5i monotherapy including events indicative of clinical worsening, treatment modifications, adherence, allcause healthcare resource utilization, and costs. Methods: This retrospective study analyzed PharMetrics Plus claims data including 150 million lives; study period was January 1, 2009 through December 31, 2013. Eligible patients were ≥18 years with ≥1 inpatient or ≥2 outpatient claims ≥30 days apart, a diagnosis of pulmonary hypertension or other chronic pulmonary heart disease, and an initial PDE-5i prescription. To include only World Health Organization group 1 PAH patients, ≥1 encounter for right-heart catheterization or Doppler echocardiogram was required during the pre-index period. Results: PDE-5i monotherapy for PAH treatment was associated with high treatment modification rates, low adherence, increased healthcare resource utilization, and high costs. At 12 months post index, 41.5% of patients experienced treatment modification. For the index therapy, 47% of patients had ≥80% adherence to therapy. Almost 50% of patients had ≥1 hospitalization, with costs increased three fold to $197 111 compared to $59 164 for non-hospitalized patients. Conclusions: Initial treatment with PDE-5i monotherapy was associated with substantial direct medical costs, including hospitalizations and emergency department visits, low therapy adherence and a high rate of treatment modifications.
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BACKGROUND: Clinical inertia in type 2 diabetes mellitus (T2DM) refers to the failure of clinicians to intensify therapy when indicated. Many T2DM patients remain suboptimally controlled after initiating basal insulin. OBJECTIVE: To examine the prevalence of patients treated with basal insulin but in poor glycemic control (hemoglobin A1c [A1c] ≥ 7%) after initiation and subsequent treatment intensification patterns and glycemic outcomes in a real-world setting. METHODS: Adults diagnosed with T2DM newly initiating a basal insulin analog (insulin glargine or detemir) from January 2010 to September 2014 were identified in the QuintilesIMS Real-World Data Adjudicated Claims linked to the QuintilesIMS Real-World Data Electronic Medical Records. Patients were previously naive to insulin and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), were persistent on therapy for ≥ 6 months, and had ≥ 12 months of continuous health plan enrollment after initiation. First treatment intensification (increase in basal insulin dose [of ≥ 10%], addition of bolus insulin, GLP-1 RA, or a new oral antidiabetic drug [OAD]) was assessed among patients in poor glycemic control at 6 months after initiation over the available (minimum ≥ 12-month) follow-up. Subsequent glycemic outcomes and treatment intensification were assessed. Kaplan-Meier (KM) analysis evaluated time-to-treatment intensification and time to A1c goal. RESULTS: Of 427 eligible patients with A1c available at 6 months, 59.3% were male; mean age was 53.9 years; mean follow-up was 29.4 months; and mean dose of the initiated prescription was 29.6 insulin units (U) (median 24U). Six months after initiating basal insulin, 81.0% of patients (n = 346) remained in poor glycemic control, and mean basal insulin dose was 31.0U (median 25U). Most (88.4%; n = 306) of these uncontrolled patients subsequently intensified treatment over the available follow-up. Using KM analysis, these patients intensified treatment in a median of 58 days (range: 17.5 days [GLP-1 RA addition] to 52 days [increase in basal insulin dose]) from the first elevated A1c measurement taken after 6 months, and 72.5% (GLP-1 RA addition) to 91.1% (OAD addition) of patients continued to remain in poor glycemic control at 12 months after intensification. Most patients (66.8%; n = 231/346) first intensified treatment by increasing their basal insulin dose, and mean dose increased to 61.7U (median 38U) at intensification. Six months following basal insulin increase, almost all patients remained on basal insulin therapy and among those with available A1c, 92.1% (140 of 152) were in poor glycemic control. In the subsequent 12 months, only a third (34%) of uncontrolled patients added another antihyperglycemic agent. CONCLUSIONS: The vast majority of patients remained uncontrolled in the 6 months following basal insulin initiation. Basal insulin up-titration was slow and insufficient in the 6 months after initiation, indicating treatment inertia. Subsequently, most patients failed to achieve glycemic targets despite intensification with basal insulin. This finding suggests a substantial unmet need for effective treatment intensification among T2DM patients treated with basal insulin who remain uncontrolled. Improved provider education and guidelines on appropriate intensification are warranted. DISCLOSURES: This study was funded by Novo Nordisk. Mocarski, Guerrero, Langer, and Thorsted are employees and shareholders of Novo Nordisk. Yeaw, Divino, and DeKoven are employed by QuintilesIMS, which received remuneration from Novo Nordisk for work on this study. Study concept and design were contributed by Mocarski, DeKoven, Langer, and Thorsted. Yeaw took the lead in data collection, along with Divino and DeKoven. Data interpretation was performed by Yeaw, Divino, DeKoven, and Guerrero. The manuscript was written by Mocarski and Divino and revised by Guerrero, Langer, and Thorsted, along with Yeaw and DeKoven. Some of the data from this study were presented via poster at the AMCP Annual Meeting in March 2017 and at the 53rd EASD Annual Meeting in September 2017.
Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Conduta do Tratamento Medicamentoso/normas , Administração Oral , Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Feminino , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Hemoglobinas Glicadas/análise , Humanos , Masculino , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: To evaluate adherence to newly initiated biologic disease-modifying antirheumatic drugs (bDMARDs) in effectively treated patients with rheumatoid arthritis (RA). STUDY DESIGN: Retrospective cohort study of administrative claims data (IMS PharMetrics Plus) for services incurred from July 1, 2008, to December 31, 2014. METHODS: Data from patients with RA aged 18 to 64 years with continuous enrollment for at least 30 months and initiating abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab were analyzed. Treatment effectiveness was determined using a validated algorithm. Outcomes included adherence rates (proportion of days covered ≥80%) for 1 year and 2 years, year 2 adherence among patients effectively and noneffectively treated in year 1, year 2 adherence predictors, and year 2 costs and cost predictors. RESULTS: Across 10,374 patients, adherence rates were 46% for year 1 and 34% for 2 years; rates were lowest for golimumab and highest for infliximab. In year 1, 3076 (29.7%) patients were considered effectively treated. Year 2 adherence was 59% in effectively treated patients, 32% in patients who failed any effectiveness criteria, and 12% in patients who failed only the adherence criterion. Intravenous bDMARDs, older age, male sex, Northeast region, commercial payer, prior DMARD use, index year 2010 or later, and lower preindex all-cause costs each predicted better adherence. Adjusted year 2 all-cause and RA-related costs were $39,425 and $22,123, respectively, for effectively treated patients and $25,313 and $9250 for noneffectively treated patients. Cost predictors included effective treatment, region, payer, and index year. CONCLUSIONS: Adherence to the first bDMARD was suboptimal even in effectively treated patients, suggesting opportunities to improve adherence in patients with RA initiating biologics.
Assuntos
Antirreumáticos/administração & dosagem , Antirreumáticos/economia , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/administração & dosagem , Produtos Biológicos/economia , Adesão à Medicação/estatística & dados numéricos , Adolescente , Adulto , Algoritmos , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/economia , Estudos de Coortes , Relação Dose-Resposta a Droga , Esquema de Medicação , Custos de Medicamentos , Feminino , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND: A non-interventional study suggested that use of angiotensin-converting enzyme inhibitors (ACEIs) or aliskiren was associated with an angioedema risk three times that of beta-blockers (BBs). OBJECTIVE: The aim was to assess angioedema incidence rates (IRs) and the relative angioedema risk of aliskiren compared to other antihypertensive drugs (AHDs). METHODS: A cohort study in hypertensive patients with an AHD prescription between 2007 and 2012 was conducted using data from the US PharMetrics Plus™ claims database. Angioedema was identified using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9CM) code 995.1. Additionally, a nested case-control analysis was conducted to assess the relative angioedema risk of aliskiren or other AHDs versus BBs. RESULTS: A total of 3,090,114 patients were included (aliskiren n = 30,720). There were 15,744 angioedema events (IR 2.28/1000 person-years; 95% confidence interval (CI) 2.24-2.32). Aliskiren IRs were: any aliskiren 2.58 (2.08-3.17), aliskiren monotherapy 1.71 (0.74-3.37), aliskiren fixed-dose combination (FDC) 1.27 (0.41-2.96), and aliskiren free-standing combination (FSC) 2.93 (2.31-3.66). The case-control analysis included 15,100 angioedema cases and 60,400 controls; the angioedema risk for both aliskiren monotherapy and FDC was not significantly different from BBs [adjusted odds ratio (adjOR) 0.99 (95% CI 0.45-2.20) and 1.06 (0.40-2.76)]; aliskiren FSC was associated with an increased angioedema risk [adjOR 3.29 (2.42-4.48)], mainly driven by concomitant ACEI use [adjOR 7.03 (4.10-12.05)]. CONCLUSIONS: The IR and risk of angioedema in patients with aliskiren monotherapy or FDC are comparable to BBs. The higher IR and risk of angioedema identified in the aliskiren FSC group may largely be driven by the concomitant use of ACEIs.
Assuntos
Amidas/efeitos adversos , Angioedema/induzido quimicamente , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Anti-Hipertensivos/efeitos adversos , Fumaratos/efeitos adversos , Adolescente , Antagonistas Adrenérgicos beta/efeitos adversos , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Idoso , Amidas/administração & dosagem , Amidas/uso terapêutico , Angioedema/epidemiologia , Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/uso terapêutico , Estudos de Casos e Controles , Estudos de Coortes , Bases de Dados Factuais , Quimioterapia Combinada , Feminino , Fumaratos/administração & dosagem , Fumaratos/uso terapêutico , Humanos , Hipertensão/tratamento farmacológico , Incidência , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto JovemRESUMO
OBJECTIVE: Estrogen therapy is considered to be the most effective treatment of vaginal atrophy (VA) symptoms. This retrospective study compares rates of pharmacy refill-based treatment persistence in women treated for VA with local estrogen therapy (LET) creams versus low-dose vaginally administered tablets. METHODS: Study cohort included treatment-naive women aged 45 years or older within the IMS PharMetrics Plus claims database who filled one or more prescriptions for a LET cream or tablet between January 1, 2010 and September 30, 2012. Index LET was the first observed LET claim in pharmacy records. Persistence was defined as the number of consecutive days of treatment available of the index LET during the 12-month follow-up period. In adjusted analyses, we compared the risks of discontinuation of index therapy. RESULTS: Of 30,197 women eligible for analysis, 12,187 (40.4%) initiated treatment with conjugated estrogens vaginal cream, 11,574 (38.3%) initiated treatment with estradiol vaginal cream, and 6,436 (21.3%) initiated treatment with 10-µg vaginal estradiol tablets (formulation introduced in 2010). Cohorts were comparable on age, geography, and baseline comorbidities. During the 12-month follow-up period, 86.2% to 89.4% of cream users discontinued LET after the first prescription compared with 57.8% of tablet users (Pâ<â0.0001). A greater proportion of tablet initiators than cream users were fully (100%) persistent during the 12-month follow-up period. Mean treatment duration was 103.4 days for tablets versus 44.6 to 48.1 days for creams (Pâ<â0.0001). After adjustment for baseline characteristics, tablet initiators had a lower risk of discontinuation compared with cream users (Pâ<â0.0001). CONCLUSIONS: Low-dose LET tablets, compared with cream formulations, are associated with greater persistence in the treatment of VA.
Assuntos
Atrofia/tratamento farmacológico , Estrogênios Conjugados (USP)/uso terapêutico , Doenças Urogenitais Femininas/tratamento farmacológico , Pós-Menopausa , Vagina/patologia , Administração Intravaginal , Atrofia/patologia , Estudos de Coortes , Feminino , Doenças Urogenitais Femininas/patologia , Humanos , Concentração de Íons de Hidrogênio , Pessoa de Meia-Idade , Estudos Retrospectivos , Cremes, Espumas e Géis VaginaisRESUMO
OBJECTIVES: Because clinical guidelines do not offer clear recommendations for treatment options after discontinuing a tumor necrosis factor (TNF) blocker, this study evaluated treatment patterns within 360 days after discontinuation of TNF-blocker treatment. METHODS: The IMS LifeLink Health Plan Claims database was used to identify patients diagnosed with rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis who received etanercept, adalimumab, or infliximab between January 1, 2005 and March 31, 2009. Discontinuation from index (first) TNF blocker was defined as switching to a different TNF blocker or a >45-day gap in therapy. Patients were categorized into mutually exclusive groups in descending order: (a) restart of index TNF blocker; (b) switch to another TNF blocker; (c) switch to a different biologic; (d) switch to nonbiologic therapy; or (e) no new treatment. RESULTS: Among 27,704 patients who initiated TNF-blocker therapy, 14,707 (53%) patients discontinued treatment over 1-3 years of follow-up. Within 360 days of discontinuing index TNF blocker, 53.4% of patients restarted index therapy: etanercept 59.9%, adalimumab 46.5%, and infliximab 43.1% (P < 0.001 for etanercept vs. adalimumab and infliximab). The majority of therapy restarts occurred within the first 3 months after discontinuation. Other patients switched to another TNF blocker: etanercept 17.1%, adalimumab 19.1% (P = 0.010 vs. etanercept), and infliximab 15.0% (P = 0.009 vs. etanercept). Switches from index TNF blocker to non-TNF-blocker biologic therapy were low: etanercept 1.9%, adalimumab 4.1%, and infliximab 10.7% (P < 0.001 for etanercept vs. adalimumab and infliximab). Switches from index TNF blocker to nonbiologic treatments were 5.4% for etanercept, 6.5% for adalimumab, and 6.9% for infliximab. CONCLUSIONS: Restarting of index TNF-blocker therapy occurs frequently after discontinuation, suggesting that long gaps in TNF-blocker therapy may be common. A significantly higher proportion of etanercept patients restarted their index TNF blocker within 3 months of discontinuation, compared with adalimumab and infliximab patients.
Assuntos
Adalimumab/administração & dosagem , Antirreumáticos/administração & dosagem , Etanercepte/administração & dosagem , Infliximab/administração & dosagem , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Suspensão de Tratamento/estatística & dados numéricos , Adulto , Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Bases de Dados Factuais , Substituição de Medicamentos/métodos , Feminino , Humanos , Masculino , Programas de Assistência Gerenciada/estatística & dados numéricos , Conduta do Tratamento Medicamentoso , Pessoa de Meia-Idade , Estudos Retrospectivos , Espondilite Anquilosante/tratamento farmacológico , Estados UnidosRESUMO
OBJECTIVES: To estimate biologic cost per effectively treated patient with rheumatoid arthritis (RA) using a claims-based algorithm for effectiveness. METHODS: Patients with RA aged 18-63 years in the IMS PharMetrics Plus database were categorized as effectively treated if they met all six criteria: (1) a medication possession ratio ≥80% (subcutaneous) or at least as many infusions as specified in US labeling (intravenous); (2) no biologic dose increase; (3) no biologic switch; (4) no new non-biologic disease-modifying anti-rheumatic drug; (5) no new or increased oral glucocorticoid; and (6) ≤1 glucocorticoid injection. Biologic cost per effectively treated patient was defined as total cost of the index biologic (drug plus intravenous administration) divided by the number of patients categorized by the algorithm as effectively treated. Similar methods were used for the index biologic in the second year and for a second biologic after a switch. RESULTS: Rates that the index biologic was categorized as effective in the first year were 31.0% etanercept (2243/7247), 28.6% adalimumab (1426/4991), 28.6% abatacept (332/1160), 27.2% golimumab (71/261), and 20.2% infliximab (474/2352). Mean biologic cost per effectively treated patient, per the algorithm, was $50,141 etanercept, $53,386 golimumab, $56,942 adalimumab, $73,516 abatacept, and $114,089 infliximab. Biologic cost per effectively treated patient, using this algorithm, was lower for patients who continued the index biologic in the second year and higher after switching. CONCLUSIONS: When a claims-based algorithm was applied to a large commercial claims database, etanercept was categorized as the most effective and had the lowest estimated 1-year biologic cost per effectively treated patient. This proxy for effectiveness from claims databases was validated against a clinical effectiveness scale, but analyses of the second year or the year after a biologic switch were not included in the validation. Costs of other medications were not included in cost calculations.