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1.
Artigo em Inglês | MEDLINE | ID: mdl-33517548

RESUMO

BACKGROUND: Data on short-acting recombinant granulocyte colony-stimulating factor (G-CSF) biosimilar utilization from claims data in the USA are limited. OBJECTIVE: To evaluate patient baseline characteristics and utilization patterns for short-acting G-CSF products with particular focus on the assessment of filgrastim biosimilar usage relative to the originator product. PATIENTS AND METHODS: We examined filgrastim, filgrastim-sndz, and tbo-filgrastim use among adult patients between January 2012 and March 2019 across the five health-plan research partners in the BBCIC Distributed Research Network. The publicly available Sentinel System analytic toolkit was used to perform the distributed analyses. RESULTS: We evaluated over 38 million eligible health-plan members representing more than 88 million person-years of data. We identified 45,204 incident treatment episodes, including 33,118 episodes with filgrastim, 6525 episodes with filgrastim-sndz, and 5,561 episodes with tbo-filgrastim. We observed that the demographic and clinical characteristics of users were comparable across products. While total use of all filgrastim products remained consistent, the proportion of incident episodes of the originator filgrastim steadily decreased since 2014, with filgrastim-sndz and tbo-filgrastim making up the difference. Utilization for the G-CSF biosimilar, filgrastim-sndz, increased from 40 (1%) of 6823 total filgrastim product episodes in 2015, to 2486 (44%) of a total 5668 episodes of filgrastim products in 2018 (partial data for 2018). CONCLUSION: New episodes of short-acting biosimilar filgrastim products have increased over time while the overall number of new users remained flat. Although barriers to biosimilar use in oncology have been noted, uptake has begun and continues to grow.

2.
JMIR Res Protoc ; 9(11): e21811, 2020 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-33136063

RESUMO

BACKGROUND: Certain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration's (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information. OBJECTIVE: This study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention's National Death Index Plus (NDI+) data. METHODS: We will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications. RESULTS: We will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals. CONCLUSIONS: This study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA's ability to assess mortality-related safety questions in the postmarket, real-world setting. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21811.

3.
Pharmacoepidemiol Drug Saf ; 29(11): 1489-1493, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32929845

RESUMO

PURPOSE: The use of validated criteria to identify birth defects in electronic healthcare databases can avoid the cost and time-intensive efforts required to conduct chart reviews to confirm outcomes. This study evaluated the validity of various case-finding methodologies to identify neural tube defects (NTDs) in infants using an electronic healthcare database. METHODS: This analysis used data generated from a study whose primary aim was to evaluate the association between first-trimester maternal prescription opioid use and NTDs. The study was conducted within the Medication Exposure in Pregnancy Risk Evaluation Program. A broad approach was used to identify potential NTDs including diagnosis and procedure codes from inpatient and outpatient settings, death certificates and birth defect flags in birth certificates. Potential NTD cases were chart abstracted and confirmed by clinical experts. Positive predictive values (PPVs) and 95% confidence intervals (95% CI) are reported. RESULTS: The cohort included 113 168 singleton live-born infants: 55 960 infants with opioid exposure in pregnancy and 57 208 infants unexposed in pregnancy. Seventy-three potential NTD cases were available for the validation analysis. The overall PPV was 41% using all diagnosis and procedure codes plus birth certificates. Restricting approaches to codes recorded in the infants' medical record or to birth certificate flags increased the PPVs (72% and 80%, respectively) but missed a substantial proportion of confirmed NTDs. CONCLUSIONS: Codes in electronic healthcare data did not accurately identify confirmed NTDs. These results indicate that chart review with adjudication of outcomes is important when conducting observational studies of NTDs using electronic healthcare data.

4.
Hypertension ; 76(4): 1097-1103, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32862713

RESUMO

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P=0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], P=0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.

5.
JAMA Netw Open ; 3(8): e2013595, 2020 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-32804216

RESUMO

Importance: Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy. Objectives: To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases. Design, Setting, and Participants: In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank. Main Outcomes and Measures: The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured. Results: Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013. Conclusions and Relevance: Price increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.

6.
BMC Cancer ; 20(1): 373, 2020 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-32362277

RESUMO

BACKGROUND: As more states legalize cannabis for medical and recreational use, people increasingly use cannabis to treat medical conditions and associated symptoms. The prevalence and utility of cannabis for cancer-related symptoms may be clarified by examining cannabis use among patients with a common cancer diagnosis. We aimed to determine the prevalence of cannabis use among colorectal cancer (CRC) survivors and its associations with quality of life (QoL) and cancer-related symptomatology. METHODS: A cross-sectional survey of patient-reported QoL outcomes and behaviors, including cannabis use, was conducted within the Patient Outcomes To Advance Learning network's (PORTAL) CRC Cohort. The cohort included a population-based sample of healthcare system members ≥18 years old diagnosed with adenocarcinoma of the colon or rectum from 2010 through 2016. We assessed the association between cannabis use and QoL using the European Organization for Research and Treatment of Cancer QLQ-C30 summary score. RESULTS: Of the 1784 respondents, 293 (16.4%) reported cannabis use following CRC diagnosis. Current tobacco smokers were more likely to use cannabis compared to former or never tobacco smokers (adjusted odds ratio [aOR] 2.71, 95% confidence interval [CI] 1.56 to 4.70). Greater alcohol use (> 4 drinks per month versus ≤4 drinks per month) was associated with cannabis use (aOR 2.17, 95% CI 1.65 to 2.85). There was an association between cannabis use and cancer stage at diagnosis, with stage 3 or 4 CRC patients more likely to use cannabis than stage 1 or 2 CRC patients (aOR 1.68, 95% CI 1.25 to 2.25). After adjusting for demographics, medical comorbidities, stage and site of CRC diagnosis, and prescription opioid use, people who used cannabis had significantly lower QoL than people who did not use cannabis (difference of - 6.14, 95% CI - 8.07 to - 4.20). CONCLUSION: Among CRC survivors, cannabis use was relatively common, associated with more advanced stages of disease, associated with tobacco and alcohol use, and not associated with better QoL. Clinicians should inquire about cannabis use among their patients and provide evidence-based recommendations for cancer-related symptoms.

7.
Breast Cancer Res Treat ; 180(1): 219-226, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31975315

RESUMO

PURPOSE: Reports suggest that up to 50% of women with hormone receptor-positive (HR+) breast cancer (BC) do not complete the recommended 5 years of adjuvant endocrine therapy (AET). We examined the impact of an outreach program at Kaiser Permanente Northern California (KPNC) on adherence and discontinuation of AET among patients who initiated AET. METHODS: We assembled a retrospective cohort of all KPNC patients diagnosed with HR+, stage I-III BC initiating AET before (n = 4287) and after (n = 3580) implementation of the outreach program. We compared adherence proportions and discontinuation rates before and after program implementation, both crude and adjusted for age, race/ethnicity, education, income, and stage. We conducted a pooled analysis of data from six Cancer Research Network (CRN) sites that had not implemented programs for improving AET adherence, using identical methods and time periods, to assess possible secular trends. RESULTS: In the pre-outreach period, estimated adherence in years 1, 2, and 3 following AET initiation was 75.2%, 71.0%, and 67.3%; following the outreach program, the estimates were 79.4%, 75.6%, and 72.2% (p-values < .0001 for pairwise comparisons). Results were comparable after adjusting for clinical and demographic factors. The estimated cumulative incidence of discontinuation was 0.22 (0.21-0.24) and 0.18 (0.17-0.19) at 3 years for pre- and post-outreach groups (p-value < .0001). We found no evidence of an increase in adherence between the study periods at the CRN sites with no AET adherence program. CONCLUSION: Adherence and discontinuation after AET initiation improved modestly following implementation of the outreach program.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Hormonais/administração & dosagem , Antineoplásicos Hormonais/efeitos adversos , Neoplasias da Mama/etiologia , Neoplasias da Mama/patologia , California/epidemiologia , Quimioterapia Adjuvante , Terapia Combinada , Feminino , Implementação de Plano de Saúde , Humanos , Adesão à Medicação , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Melhoria de Qualidade , Programas Médicos Regionais , Sistema de Registros , Estudos Retrospectivos , Fatores Socioeconômicos
8.
Contemp Clin Trials ; 92: 105939, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31981712

RESUMO

BACKGROUND: Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S. POPULATION: Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care. AIMS/OBJECTIVES: To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research. METHODS: The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects. CONCLUSION: This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.

9.
PLoS One ; 14(12): e0223515, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31805056

RESUMO

BACKGROUND: Data from randomized controlled trials and observational studies on older adults who take statins for primary prevention of atherosclerotic cardiovascular disease are limited. To determine the incidence of statin use in older adults with and without cardiovascular disease (CVD) and/or diabetes (DM), we conducted a descriptive observational study. METHODS: The cohort consisted of health plan members in the NIH Collaboratory Distributed Research Network aged >75 years who had continuous drug and medical benefits for ≥183 days during the study period, January 1, 2008- March 31, 2018. We defined DM and CVD using diagnosis codes, and identified statins using dispensing data. Statin use was considered incident if a member had no evidence of statin exposure in the claims during the previous 183 days, and the use was considered long-term if statins were supplied for ≥180 days. Incidence rates were reported among members with and without CVD and/or diabetes, and stratified by year, sex, and age group. RESULTS: Among 757,569 eligible members, 109,306 older adults initiated statins and 54,624 became long-term users. Health plan members with CVD had the highest incidence of statin use (143.9 initiators per 1,000 member-years for CVD & DM; 114.5 initiators per 1,000 member-years for CVD & No DM). Among health plan members without CVD, those with DM had rates of statin use that were over two times higher than members without DM (76.1 versus 34.5 initiators per 1,000 member-years, respectively). Statin initiation remained steady throughout 2008-2016, was slightly higher in males, and declined with increasing age. CONCLUSION: Incidence of statin use varied by CVD and DM comorbidity, and was lowest among those without CVD. These results highlight the potential clinical equipoise to conduct large pragmatic clinical trials to generate evidence that could be used to inform future blood cholesterol guidelines.


Assuntos
Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/tratamento farmacológico , Estudos de Coortes , Diabetes Mellitus Tipo 2/tratamento farmacológico , Uso de Medicamentos , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino
10.
Case Rep Oncol Med ; 2019: 7950782, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31885975

RESUMO

Radiation-induced sarcomas in the brain are extremely rare, usually occur with an average latency of 9 years, and are associated with poor outcomes. Latency periods shorter than 1 year may indicate a genetic predisposition such as Li-Fraumeni syndrome. A 34-year-old man underwent initial tumor resection and radiation therapy for a World Health Organization (WHO) Grade II Astrocytoma. Within 6 months, the tumor recurred as WHO Grade III and was treated with temozolomide and then bevacizumab. Despite the patient's apparent improving condition, MRI revealed new dural-based lesions 10 months after radiation therapy and identified as high-grade sarcoma. The patient resumed bevacizumab, began NovoTTF treatment for progressing glioma, and ifosfamide/doxorubicin for the sarcoma. Genetic testing revealed no pathogenic mutation in the TP53 gene. Ultimately, treatment was unsuccessful and the patient succumbed to glioma and sarcoma within 2 years of initial diagnosis. This case was unique due to the rapidly progressing glioma and sudden appearance of a high-grade sarcoma. It is unusual to have two separate intracranial primary cancers with each requiring a different chemotherapy regimen. We discuss the difficulty of simultaneously treating with separate chemotherapy regimens. It remains unclear whether the sarcoma was induced by the radiation treatment or a genetic predisposition.

11.
J Natl Compr Canc Netw ; 17(10): 1166-1172, 2019 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31590146

RESUMO

BACKGROUND: Oral tyrosine kinase inhibitors (TKIs) have been the standard of care for chronic myeloid leukemia (CML) since 2001. However, few studies have evaluated changes in the treatment landscape of CML over time. This study assessed the long-term treatment patterns of oral anticancer therapies among patients with CML. METHODS: This retrospective cohort study included patients newly diagnosed with CML between January 1, 2000, and December 31, 2016, from 10 integrated healthcare systems. The proportion of patients treated with 5 FDA-approved oral TKI agents-bosutinib, dasatinib, imatinib, nilotinib, and ponatinib-in the 12 months after diagnosis were measured, overall and by year, between 2000 and 2017. We assessed the use of each oral agent through the fourth-line setting. Multivariable logistic regression estimated the odds of receiving any oral agent, adjusting for sociodemographic and clinical characteristics. RESULTS: Among 853 patients with CML, 81% received an oral agent between 2000 and 2017. Use of non-oral therapies decreased from 100% in 2000 to 5% in 2005, coinciding with imatinib uptake from 65% in 2001 to 98% in 2005. Approximately 28% of patients switched to a second-line agent, 9% switched to a third-line agent, and 2% switched to a fourth-line agent. Adjusted analysis showed that age at diagnosis, year of diagnosis, and comorbidity burden were statistically significantly associated with odds of receiving an oral agent. CONCLUSIONS: A dramatic shift was seen in CML treatments away from traditional, nonoral chemotherapy toward use of novel oral TKIs between 2000 and 2017. As the costs of oral anticancer agents reach new highs, studies assessing the long-term health and financial outcomes among patients with CML are warranted.


Assuntos
Antineoplásicos/uso terapêutico , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
12.
JCO Clin Cancer Inform ; 3: 1-10, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31487201

RESUMO

PURPOSE: To evaluate health care systems for the availability of population-level data on the frequency of use and results of clinical molecular marker tests to inform precision cancer care. METHODS: We assessed cancer-related molecular marker test data availability across 12 US health care systems in the Cancer Research Network. Overall, these systems provide care to a diverse population of more than 12 million people in the United States. We performed qualitative analyses of test data availability for five blood-based protein, nine germline, and 14 tissue-based tumor marker tests in each health care system's electronic health record and tumor registry using key informants, test code lists, and manual review of data types and output. We then performed quantitative analyses to estimate the proportion of patients with cancer with test utilization data and results for specific molecular marker tests. RESULTS: Health systems were able to systematically capture population-level data on all five blood protein markers, six of 14 tissue-based tumor markers, and none of the nine germline markers. Successful, systematic data capture was achievable for tests with electronic data feeds for test results (blood protein markers) or through prior manual abstraction by tumor registrars (select tumor-based markers). For test results stored in scanned image files (particularly germline and tumor marker tests), information on which test was performed and test results was not readily accessible in an electronic format. CONCLUSION: Even in health care systems with sophisticated electronic health records, there were few codified data elements available for evaluating precision cancer medicine test use and results at the population level. Health care organizations should establish standards for electronic reporting of precision medicine tests to expedite cancer research and facilitate the implementation of precision medicine approaches.


Assuntos
Registros Eletrônicos de Saúde , Neoplasias/epidemiologia , Biomarcadores Tumorais , Coleta de Dados , Assistência à Saúde , Gerenciamento Clínico , Humanos , Biópsia Líquida , Técnicas de Diagnóstico Molecular , Neoplasias/diagnóstico , Neoplasias/etiologia , Neoplasias/terapia , Medicina de Precisão , Vigilância em Saúde Pública , Pesquisa , Estados Unidos/epidemiologia
13.
J Manag Care Spec Pharm ; 25(11): 1156-1161, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31397619

RESUMO

INTRODUCTION: As clinical trials test efficacy rather than effectiveness of medications, real-world effectiveness data often vary from clinical trial data. Given the recent market entry of multiple biologics and biosimilars, a dedicated assessment of these diverse agents is needed to build the evidence base regarding efficacy and safety of innovator biologics and biosimilars. PROGRAM DESCRIPTION: The Academy of Managed Care Pharmacy's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was convened to address the lack of real-world, postmarket outcome evidence generation for innovator biologics and corresponding biosimilars. The BBCIC is a multistakeholder scientific research consortium whose participants prioritize topics and collaboratively conduct research studies. The BBCIC conducts a wide range of analyses, including population characterization, epidemiologic studies, and active observational studies, and develops best practices for conducting large-scale studies to provide real-world evidence. OBSERVATIONS: Over the past 3 years, we undertook multiple descriptive analyses with the goal of characterizing data availability and demonstrating the feasibility and efficacy of using the BBCIC distributed research network (DRN), which includes commercial claims data from 2008-2018 covering approximately 100 million lives, with approximately 20 million active members in 2017 from 2 major U.S. health plans and 3 regional integrated delivery networks. We analyzed 4 medication classes of particular interest to biologics and biosimilars development: insulins, granulocyte colony-stimulating factors, erythropoietic-stimulating agents, and anti-inflammatories. We were able to identify exposures and user characteristics in all 4 categories. Herein we describe the successes and challenges of conducting some of our analyses, specifically among insulin users with type 1 diabetes mellitus. IMPLICATIONS: Our results demonstrate the BBCIC DRN's ability to identify and characterize exposures, cohorts, and outcomes that can contribute to more sophisticated comparative surveillance of biosimilars and innovator biologics in the future. Additional linkages to laboratory data and a wider range of insurance carriers will further strengthen the BBCIC DRN. DISCLOSURES: This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC; Eichelberger was employed by the BBCIC at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. This work was presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Adolescente , Adulto , Idoso , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/efeitos adversos , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Hipoglicemia/sangue , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemia/prevenção & controle , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Masculino , Conduta do Tratamento Medicamentoso/organização & administração , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Estados Unidos/epidemiologia , Adulto Jovem
14.
J Manag Care Spec Pharm ; 25(11): 1162-1171, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31405345

RESUMO

BACKGROUND: As new biosimilar and follow-on insulins enter the market, more data are needed on safety, effectiveness, and patterns of use for these products to inform prescriber and patient decision-making regarding treatment. Additionally, data are needed regarding real-world patterns of use to inform future studies comparing the safety and effectiveness of bio-similars to already approved agents for diabetes treatment. OBJECTIVE: To analyze the medication use patterns, adverse events, and availability of glycated hemoglobin (A1c) values for adult patients with type 2 diabetes mellitus (T2DM) who use long-acting insulin (LAI) or neutral protamine Hagedorn (NPH), an intermediate-acting insulin. METHODS: We used the Biologics and Biosimilars Collective Intelligence Consortium's (BBCIC) distributed research network (DRN) for this descriptive analysis. The analysis time frame was January 1, 2011, to September 30, 2015, and included patients continuously insured for at least 183 days before the first date of a filled prescription for LAI or NPH insulin alone or with rapid- or short-acting insulin or sulfonylureas, whether newly starting insulin or switching to a different product. Insulin exposure episodes were the unit of analysis, and patients were classified in cohorts according to treatment. We followed patients until end of health plan enrollment or the end of the study period. We used occurrence of a study outcome, switch to another medication regimen, discontinuation of the current medication, or study end date to mark the end of an insulin episode. We describe demographics and availability of A1c values for analysis. Study outcomes included severe hypoglycemic events and major adverse cardiac events (MACE). RESULTS: We identified 103,951 patients with T2DM from a database of 39.1 million patients with commercial or Medicare Advantage pharmacy and medical benefits, who contributed 279,533 unique insulin exposure episodes. Most episodes (89%) included patients using LAI, and 52% of patients contributed data to 2 or more exposure cohorts. Insulin episodes lasted an average of 3.5 months, and patients had an average follow-up of 8.6 months. The unadjusted rate of severe hypoglycemic events requiring medical attention was 96.9 per 10,000 patient-years at risk (10kPYR). The unadjusted incident MACE rate was 676.9 events per 10kPYR. 38,330 T2DM patients in the BBCIC DRN had a baseline A1c available, and of those, less than 50% had a follow-up A1c result. CONCLUSIONS: Among patients with T2DM, our observed insulin patterns of use and rates of severe hypoglycemic outcomes and MACE are consistent with other studies. We noted a paucity of A1c results available, which implies that additional data sources may be needed to augment the BBCIC DRN. DISCLOSURES: This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC and the Academy of Managed Care Pharmacy (AMCP). Eichelberger was employed by the BBCIC and AMCP at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. This work was previously presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Cardiopatias/epidemiologia , Hipoglicemia/epidemiologia , Hipoglicemiantes/efeitos adversos , Insulina de Ação Prolongada/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/efeitos adversos , Glicemia/análise , Glicemia/efeitos dos fármacos , Estudos de Coortes , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Feminino , Hemoglobina A Glicada/análise , Cardiopatias/sangue , Cardiopatias/etiologia , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/prevenção & controle , Hipoglicemiantes/administração & dosagem , Insulina de Ação Prolongada/administração & dosagem , Insulina de Ação Curta/administração & dosagem , Insulina de Ação Curta/efeitos adversos , Masculino , Pessoa de Meia-Idade , Compostos de Sulfonilureia/administração & dosagem , Compostos de Sulfonilureia/efeitos adversos , Adulto Jovem
15.
Cancer Causes Control ; 30(7): 747-755, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31102084

RESUMO

PURPOSE: Our objective was to describe differences in treatment patterns and survival between early-onset (< 50 years old) and late-onset colorectal cancer (CRC) patients in community-based health systems. METHODS: We used tumor registry and electronic health record data to identify and characterize patients diagnosed with adenocarcinoma of the colon or rectum from 2010 to 2014 at six US health systems in the patient outcomes to advance learning (PORTAL) network. We used logistic regression to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) comparing the distribution of tumor characteristics and treatment patterns in early-onset versus late-onset CRC. Cox regression models were used to estimate adjusted hazard ratios (HRs) and CIs comparing survival between early- and late-onset CRC patients. RESULTS: There were 1,424 early-onset and 10,810 late-onset CRC cases in our analyses. Compared to late-onset CRC, early-onset CRC was significantly associated with advanced-stage disease, high-grade histology, signet ring histology, and rectal or left colon location. After adjusting for differences in tumor and patient characteristics, early-onset patients were more likely than late-onset patients to have > 12 lymph nodes examined (OR 1.60, CI 1.37-1.87), to receive systemic therapy (chemotherapy or immunotherapy) within 6 months of diagnosis (OR 2.84, CI 2.40-3.37), and to have a reduced risk of CRC-specific death (HR 0.66, CI 0.56-0.79). CONCLUSIONS: Early-onset CRC is associated with aggressive tumor characteristics, distal location, and systemic therapy use. Despite some adverse risk factors, these patients tend to have better survival than older onset patients.


Assuntos
Adenocarcinoma , Neoplasias Colorretais , Adenocarcinoma/diagnóstico , Adenocarcinoma/epidemiologia , Adenocarcinoma/terapia , Adolescente , Adulto , Idade de Início , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Sistema de Registros , Adulto Jovem
16.
J Natl Compr Canc Netw ; 17(4): 331-338, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30959468

RESUMO

BACKGROUND: Electronic health records are central to cancer care delivery. Electronic clinical decision support (CDS) systems can potentially improve cancer care quality and safety. However, little is known regarding the use of CDS systems in clinical oncology and their impact on patient outcomes. METHODS: A systematic review of peer-reviewed studies was performed to evaluate clinically relevant outcomes related to the use of CDS tools for the diagnosis, treatment, and supportive care of patients with cancer. Peer-reviewed studies published from 1995 through 2016 were included if they assessed clinical outcomes, patient-reported outcomes (PROs), costs, or care delivery process measures. RESULTS: Electronic database searches yielded 2,439 potentially eligible papers, with 24 studies included after final review. Most studies used an uncontrolled, pre-post intervention design. A total of 23 studies reported improvement in key study outcomes with use of oncology CDS systems, and 12 studies assessing the systems for computerized chemotherapy order entry demonstrated reductions in prescribing error rates, medication-related safety events, and workflow interruptions. The remaining studies examined oncology clinical pathways, guideline adherence, systems for collection and communication of PROs, and prescriber alerts. CONCLUSIONS: There is a paucity of data evaluating clinically relevant outcomes of CDS system implementation in oncology care. Currently available data suggest that these systems can have a positive impact on the quality of cancer care delivery. However, there is a critical need to rigorously evaluate CDS systems in oncology to better understand how they can be implemented to improve patient outcomes.


Assuntos
Sistemas de Apoio a Decisões Clínicas/normas , Oncologia/normas , Humanos
17.
Cancer Epidemiol Biomarkers Prev ; 28(5): 996-999, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30967418

RESUMO

BACKGROUND: Relatively little is known about factors associated with long-term survival (LTS) following a diagnosis of ovarian cancer. METHODS: We conducted a retrospective study of high-grade serous ovarian cancer (HGSOC) to explore predictors of LTS (defined as ≥7 years of survival) using electronic medical record data from a network of integrated health care systems. Multivariable logistic regression with forward selection was used to compare characteristics of women who survived ≥7 years after diagnosis (n = 148) to those who died within 7 years of diagnosis (n = 494). RESULTS: Our final model included study site, age, stage at diagnosis, CA-125, comorbidity score, receipt of chemotherapy, BMI, and four separate comorbid conditions: weight loss, depression, hypothyroidism, and liver disease. Of these, only younger age, lower stage, and depression were statistically significantly associated with LTS. CONCLUSIONS: We did not identify any new characteristics associated with HGSOC survival. IMPACT: Prognosis of ovarian cancer generally remains poor. Large, pooled studies of ovarian cancer are needed to identify characteristics that may improve survival.


Assuntos
Sobreviventes de Câncer/estatística & dados numéricos , Cistadenocarcinoma Seroso/mortalidade , Neoplasias Ovarianas/mortalidade , Adolescente , Adulto , Fatores Etários , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , California/epidemiologia , Colorado/epidemiologia , Comorbidade , Cistadenocarcinoma Seroso/tratamento farmacológico , Cistadenocarcinoma Seroso/patologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/patologia , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida , Washington/epidemiologia , Adulto Jovem
18.
EGEMS (Wash DC) ; 7(1): 16, 2019 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-30984796

RESUMO

Context: In existence for nearly 25 years, the Healthcare Systems Research Network (HCSRN) is an established and sustainable network of health care systems that serves as a "real world" laboratory to enable the integration of research findings into practice. The objective of this paper is to demonstrate how the HCSRN serves as an ideal environment for studying dissemination and implementation of evidence-based practices into health care systems through the example of developing a multi-site study on the implementation of evidence-based precision medicine practices. Case description: The "Implementing Universal Lynch Syndrome Screening (IMPULSS)" study (NIH R01CA211723) involves seven HCSRN health care systems and two external health care systems. The IMPULSS study will describe and explain organizational variability around Lynch syndrome (LS) screening to identify which factors in different organizational contexts are important for successful implementation of LS screening programs and will create a toolkit to facilitate organizational decision making around implementation and improvement of precision medicine programs in health care systems. Major Themes: The strengths of the HCSRN that facilitate D&I research include: 1) a culture of collaboration, 2) standardization of data and processes across systems, and 3) researchers embedded in diverse health care systems. We describe how these strengths contributed to developing the IMPULSS study. Conclusion: Given the importance of conducting research in real world settings to improve patient outcomes, the unique strengths of the HCSRN are of vital importance. The IMPULSS study is one case example of how the strengths of the HCSRN make it an excellent environment for research on implementing evidence-based precision medicine practices in health care systems.

19.
J Am Heart Assoc ; 8(9): e011246, 2019 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-31020929

RESUMO

Background PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors effectively lower LDL (low-density lipoprotein) cholesterol and have been shown to reduce cardiovascular outcomes in high-risk patients. We used real-world electronic health record data to characterize use of PCSK9 inhibitors, in addition to standard therapies, according to cardiovascular risk status. Methods and Results Data were obtained from 18 health systems with data marts within the National Patient-Centered Clinical Research Network (PCORnet) using a common data model. Participating sites identified >17.5 million adults, of whom 3.6 million met study criteria. Patients were categorized into 3 groups: (1) dyslipidemia, (2) untreated LDL ≥130 mg/dL, and (3) coronary artery disease or coronary heart disease. Demographics, comorbidities, estimated 10-year atherosclerotic cardiovascular disease risk, and lipid-lowering pharmacotherapies were summarized for each group. Participants' average age was 62 years, 50% were female, and 11% were black. LDL cholesterol ranged from 85 to 151 mg/dL. Among patients in groups 1 and 3, 54% received standard lipid-lowering therapies and a PCSK9 inhibitor was prescribed in <1%. PCSK9 inhibitor prescribing was greatest for patients with coronary artery disease or coronary heart disease and, although prescribing increased during the study period, overall PCSK9 inhibitor prescribing was low. Conclusions We successfully used electronic health record data from 18 PCORnet data marts to identify >3.6 million patients meeting criteria for 3 patient groups. Approximately half of patients had been prescribed lipid-lowering medication, but <1% were prescribed PCSK9 inhibitors. PCSK9 inhibitor prescribing increased over time for patients with coronary artery disease or coronary heart disease but not for those with dyslipidemia.


Assuntos
Anticolesterolemiantes/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Dislipidemias/tratamento farmacológico , Lipídeos/sangue , Padrões de Prática Médica/tendências , Pró-Proteína Convertase 9/antagonistas & inibidores , Inibidores de Serino Proteinase/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/efeitos adversos , Biomarcadores/sangue , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Prescrições de Medicamentos , Uso de Medicamentos/tendências , Dislipidemias/sangue , Dislipidemias/diagnóstico , Dislipidemias/epidemiologia , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pró-Proteína Convertase 9/metabolismo , Medição de Risco , Fatores de Risco , Inibidores de Serino Proteinase/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
20.
Psychooncology ; 28(4): 896-902, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30803097

RESUMO

OBJECTIVES: We estimated prevalence of complementary and alternative medicine (CAM) use by reason for use (treatment, wellness, or both) among non-institutionalized adults with cancer in the United States. We also examined health-related quality of life (HRQOL) outcomes among adults with cancer who used CAM. METHODS: We used data from the 2012 National Health Interview Survey (NHIS), which represents non-institutionalized adults with cancer (n = 2967 unweighted). Using a cross-sectional design with survey sampling techniques, we estimated past year prevalence of CAM use. We ran multivariable logistic regression analyses to investigate the odds of perceived benefits of CAM. RESULTS: In the past 12 months, 35.1% of adults with cancer reported using some form of CAM. Among CAM users, 56.0% used CAM for both treatment and wellness, and 32.4% used CAM for wellness only. Only 11.6% used CAM for treatment only. Regardless of reason for use, the most commonly used CAM types in the past year were herbal therapies (56.8%), chiropractic (27.1%), and massage (24.9%). Among CAM users, those using CAM for wellness only and for a combination of treatment and wellness reported significantly higher odds of "a better sense of controlling health" and "improved overall health and feeling better" compared with treatment only users. Similar patterns were found in other HRQOL outcomes, but they were not statistically different. CONCLUSIONS: CAM is widely used among adults with cancer for wellness only or a combination of treatment and wellness. Given improved HRQOL outcomes, CAM may be a promising approach for enhancing health promotion and well-being among adults with cancer.


Assuntos
Terapias Complementares/psicologia , Promoção da Saúde/métodos , Neoplasias/psicologia , Neoplasias/terapia , Satisfação do Paciente/estatística & dados numéricos , Qualidade de Vida/psicologia , Adulto , Idoso , Terapias Complementares/estatística & dados numéricos , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Estados Unidos
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