RESUMEN
Financial interactions between healthcare industry and pediatric hematologist/oncologists (PHOs) could be conflicts of interest. Nevertheless, little is known about financial relationships between healthcare industry and PHOs. This cross-sectional analysis of the Open Payments Database examined general and research payments to PHOs from healthcare industry in the United States between 2013 and 2021. Payments to the PHOs were analyzed descriptively. Trends in payments were assessed using generalized estimating equation models. Of 2784 PHOs, 2142 (76.9%) PHOs received payments totaling $187.3 million from the healthcare industry between 2013 and 2021. Approximately, $46.3 million (24.8%) were general payments and $137.7 million (73.5%) were funding for research where PHOs served as principal investigators (associated research funding). Both general payments and associated research funding considerably increased between 2014 and 2019. The number of PHOs receiving general payments and associated research funding annually increased by 2.2% (95% CI: 1.2-3.3%, p < .001) and 5.0% (95% CI: 3.3-6.8%, p < .001) between 2014 and 2019, respectively.
Asunto(s)
Conflicto de Intereses , Hematología , Humanos , Estados Unidos , Conflicto de Intereses/economía , Estudios Transversales , Hematología/economía , Oncólogos/estadística & datos numéricos , Oncólogos/economía , Investigación Biomédica/economía , Apoyo a la Investigación como Asunto/economía , Pediatría/economía , Pediatría/tendencias , Pediatría/estadística & datos numéricos , Sector de Atención de Salud/economía , Historia del Siglo XXIRESUMEN
OBJECTIVE: To assess the characteristics and financial conflicts of interest of presenters, panellists and moderators at haematology and oncology workshops held jointly with or hosted by the US FDA. SETTING: We included information on all publicly available haematology or oncology FDA workshop agendas held between 1 January 2018 and 31 December 2022. EXPOSURE: General and research payments reported on Open Payments, industry funding to patient advocacy organizations reported on their webpages or 990 tax forms and employment in both pharmaceutical and regulatory settings. RESULTS: Among physicians eligible for payments, 78% received at least one payment from the industry between 2017 and 2021. The mean general payment amount was $82,170 for all years ($16,434 per year) and the median was $14,906 for all years ($2981 per year). Sixty-nine per cent of patient advocacy speakers were representing organizations that received financial support from the pharmaceutical industry. Among those representing regulatory agencies or pharmaceutical companies, 16% had worked in both settings during their careers. CONCLUSIONS AND RELEVANCE: Our findings in this cross-sectional study show a majority of US-based physician presenters at haematology and oncology workshops held jointly with members of the US FDA have some financial conflict of interest with the pharmaceutical industry. These findings support the need for clear disclosures and suggest that a more balanced selection of presenters with fewer conflicts may help to limit bias in discussions between multiple stakeholders.
Asunto(s)
Conflicto de Intereses , Industria Farmacéutica , Hematología , Oncología Médica , United States Food and Drug Administration , Estados Unidos , Humanos , Industria Farmacéutica/economía , Hematología/economía , Estudios Transversales , Defensa del Paciente , Médicos/economía , Educación/economía , RevelaciónRESUMEN
PURPOSE OF REVIEW: In this review article, we will highlight ethical issues faced by hematologists due to a growing constellation of expensive diagnostics and therapeutics in hematology. We outline the important issues surrounding this topic including stakeholders, cost considerations, and various ethical challenges surrounding access to care, communication about costs, and individual vs. societal responsibilities. We review available tools to navigate these ethical themes and offer potential solutions. RECENT FINDINGS: We identified several gaps in the literature on the topic of ethical issues in hematology treatment and supplement by non-hematological cancer and general medical literature. We propose proactive solutions to address these problems to include cost transparency, utilization of evidence-based decision making tools, application of the four quadrant approach to ethical care, and advanced systems-based practice curriculum for physician trainees.
Asunto(s)
Toma de Decisiones Clínicas/ética , Conflicto de Intereses , Costos de la Atención en Salud/ética , Hematología/economía , Hematología/ética , Selección de Paciente/ética , Técnicas de Apoyo para la Decisión , Medicina Basada en la Evidencia/economía , Medicina Basada en la Evidencia/ética , Humanos , Participación del Paciente , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Participación de los Interesados , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Despite national-level directives to reduce healthcare waste and promote high-value care (HVC), clinical educators struggle to equip trainees with the knowledge and skills needed to practice value-based care. In this review, we analyze ongoing efforts in graduate medical education (GME) to enhance trainee competence in delivery of high-value and cost-conscious care. RECENT FINDINGS: Surveys of residents and program directors have shown that while many training programs want to offer formal training in high-value care delivery, few succeed. Although several studies suggest that trainees model stewardship behaviors after clinical preceptors, there remains a shortage of faculty role models skilled in providing HVC. Preparing future hematologist-oncologists to provide cost-conscious care will require significant cultural change at the institutional and program levels and will depend heavily on the development of skilled clinical role models.
Asunto(s)
Competencia Clínica , Educación de Postgrado en Medicina , Costos de la Atención en Salud , Hematología/educación , Indicadores de Calidad de la Atención de Salud , Actitud del Personal de Salud , Competencia Clínica/economía , Competencia Clínica/normas , Análisis Costo-Beneficio , Curriculum , Educación de Postgrado en Medicina/economía , Educación de Postgrado en Medicina/normas , Costos de la Atención en Salud/normas , Hematología/economía , Hematología/normas , Humanos , Uso Excesivo de los Servicios de Salud/prevención & control , Indicadores de Calidad de la Atención de Salud/economía , Indicadores de Calidad de la Atención de Salud/normasRESUMEN
PURPOSE OF REVIEW: The Choosing Wisely® initiative, led by the American Board of Internal Medicine Foundation in collaboration with national professional medical societies, aims to help patients choose care that is essential, free from harm, and evidence-based. The American Society of Hematology has advocated practices specific to hematology for physicians and patients to examine carefully. Here, we summarize various barriers to adopting these practices, interventions used to improve adoption, and challenges in measuring the effectiveness of these interventions. RECENT FINDINGS: The Choosing Wisely® campaign has become an international effort with more than 20 countries worldwide having embraced it. Such widespread interest indicates that the campaign initiated an important dialog between patients and physicians about overutilization of resources. Evidence showing the positive impact of interventions on adopting these practices is accumulating, but their effect on improving clinical outcomes is uncertain. Decreasing overuse of resources is a cultural change in perspective for practitioners and patients alike. We believe that healthcare delivery is transitioning from being volume-based to value-based. As we continue to support the Choosing Wisely® campaign, we need to implement strategies to document and measure the influence of our value-based recommendations on physician practices, patient care and attitudes, and healthcare costs.
Asunto(s)
Toma de Decisiones Clínicas , Medicina Basada en la Evidencia/normas , Promoción de la Salud/normas , Hematología/normas , Participación del Paciente , Seguridad del Paciente/normas , Pautas de la Práctica en Medicina/normas , Conducta de Elección , Análisis Costo-Beneficio , Prestación Integrada de Atención de Salud/normas , Medicina Basada en la Evidencia/economía , Costos de la Atención en Salud , Hematología/economía , Humanos , Uso Excesivo de los Servicios de Salud/prevención & control , Seguridad del Paciente/economía , Pautas de la Práctica en Medicina/economía , Medición de Riesgo , Factores de Riesgo , Seguro de Salud Basado en ValorRESUMEN
BACKGROUND: National spending on specialty medications accounted for approximately $193 billion in 2016. The coverage design for Medicare Parts B and D has shifted medication costs to patients, which may prohibit patients from starting or maintaining therapy due to affordability. As a result, patients have enrolled in safety net financial options, such as patient assistance and foundation programs. Safety net options may provide savings not otherwise realized by Medicare; however, they may have a negative financial effect on health systems and pharmaceutical manufacturers. OBJECTIVES: To (a) quantify financial savings to Medicare as a result of patient enrollment in patient assistance programs and (b) quantify the financial effect of safety net options for patients, manufacturers, and the academic medical center that participated in this study. METHODS: A single-center, nonrandomized, retrospective pilot study of Medicare beneficiaries was conducted. Patients who were prescribed hematology/oncology specialty medications and enrolled in safety net options between July 2015 and June 2017 were included. Investigators collected data related to fill history, drug cost, and prescription coverage. The primary outcome was the overall cost savings to Medicare as a result of patient enrollment in patient assistance programs. Secondary outcomes included total patient out-of-pocket savings as a result of foundation copayment support, financial effect on manufacturers as a result of patient assistance programs, and health system revenue impact as a result of safety net options. Descriptive statistics were used. RESULTS: This study included 114 patients. Medicare saved $5,083,816.83 over 2 years as a result of patient assistance programs. Eight foundations provided $240,350.04 in patient insurance copayments. Nine manufacturers provided 2,243 free drug doses, valued at $3,379,032.34. The participating medical center missed the opportunity for $6,481,543.55 in revenue due to patient assistance programs. CONCLUSIONS: The participating medical center's efforts to improve access to oncology care took considerable time and resources. These activities, as well as unreimbursed infusion services, were costs to the medical center that may not be recognized by Medicare. Manufacturers also supported patient access through their sponsored patient assistance programs. The use of these services and safety net options resulted in cost savings to Medicare and their beneficiaries. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Findings from this study were part of a podium research presentation at the Great Lakes Pharmacy Residency Conference; April 25, 2018; West Lafayette, IN.
Asunto(s)
Costos de la Atención en Salud , Hematología/economía , Cobertura del Seguro/economía , Oncología Médica/economía , Medicare/economía , Proveedores de Redes de Seguridad/economía , Anciano , Ahorro de Costo , Análisis Costo-Beneficio , Costos de los Medicamentos , Femenino , Costos de la Atención en Salud/legislación & jurisprudencia , Hematología/legislación & jurisprudencia , Costos de Hospital , Humanos , Cobertura del Seguro/legislación & jurisprudencia , Masculino , Oncología Médica/legislación & jurisprudencia , Medicare/legislación & jurisprudencia , Proyectos Piloto , Formulación de Políticas , Mecanismo de Reembolso/economía , Estudios Retrospectivos , Proveedores de Redes de Seguridad/legislación & jurisprudencia , Estados UnidosRESUMEN
The United States is facing a shortage of physicians dedicated to nonmalignant hematology to meet future needs. The Hemostasis and Thrombosis Research Society (HTRS) developed a medical education program for trainees, "HTRS Trainee Workshops: Building a Career in Hemostasis and Thrombosis" in 2016. The aim of this study is to evaluate the impact of the workshop in recruiting the next generation of nonmalignant hematologists. Two surveys (post-workshop survey and alumni survey) were conducted. The post-workshop survey occurred within 30 days of each workshop and was completed by 81.9% (n = 185) of participants. Majority of respondents reported that the workshop had a positive impact to their practice and/or research (93.0%, n = 174) and career development (87.7%, n = 164). For the alumni survey which was conducted in 2018, 73 participants responded to the survey (38.2% response rate). Of the 38 respondents who had graduated from fellowship at the time of the survey, almost all chose a career in academic medicine. 41.7% (n = 15) reported their specialty as adult nonmalignant hematology and 25.0% (n = 9) as pediatric hematology/oncology with a nonmalignant hematology focus. 41.1% (n = 30) developed collaborative professional relationships, and 78.1% (n = 57) reported that the workshop had a positive influence in their choice to pursue nonmalignant hematology as a career. 67.1% (n = 49) were actively involved in research in nonmalignant hematology, with the most common being clinical research. This survey suggests that the HTRS Trainee Workshop is meeting its goals to recruit, train, and mentor the next generation of nonmalignant hematologists.
Asunto(s)
Educación Médica Continua , Hematología/economía , Hemostasis , Sociedades Científicas , Trombosis , Femenino , Humanos , Masculino , Estados UnidosAsunto(s)
Trastornos de la Coagulación Sanguínea/economía , Tabla de Aranceles/legislación & jurisprudencia , Honorarios Médicos/normas , Reforma de la Atención de Salud/legislación & jurisprudencia , Hematología/economía , Médicos/economía , Trastornos de la Coagulación Sanguínea/epidemiología , Honorarios Médicos/estadística & datos numéricos , Implementación de Plan de Salud/legislación & jurisprudencia , Accesibilidad a los Servicios de Salud/normas , Hematología/legislación & jurisprudencia , Humanos , Médicos/estadística & datos numéricos , Sector Privado , Sector Público , RemuneraciónRESUMEN
BACKGROUND/AIM: Biosimilar agents are biologic products that have no clinically meaningful differences in terms of quality, efficacy, safety and immunogenicity compared to an already approved reference biological product, with the potential to reduce the costs of biologics. Considering the increasing numbers of oncology biosimilars, it is important to calculate the economic impact of biosimilars in oncology and hemathology, considering trastuzumab and rituximab as examples, with their greatest budgetary impact in Oncology and Hematology Units, respectively. The present analysis was conducted to assess the pharmacological costs of trastuzumab and rituximab originator versus the corresponding approved biosimilars. MATERIALS AND METHODS: Pivotal phase III randomized controlled trials (RCTs) were considered for the approved indications in neoadiuvant breast cancer (BC) and in first-line treatment for advanced follicular lymphoma. Pharmacological costs necessary to get the benefit in the cancer outcomes: i) time to treatment failure (TTF) and ii) pathological complete response (pCR) in biosimilars and originators were calculated. The costs of drugs are at the Pharmacy of our Hospital and are expressed in euros (). RESULTS: Our analysis evaluated 5 phase III RCTs, including 2,362 patients. The economic advantage of biosimilars versus (vs.) originator is 274 (rituximab) and from 3,283 to 6,310 (trastuzumab) per month for TTF (about 40% less than the originator). CONCLUSION: Combining pharmacological costs of drugs with the measure of efficacy represented by TTF and pCR, biosimilars of rituximab and trastuzumab are cost-effective treatments for advanced follicular lymphoma and breast cancer.
Asunto(s)
Antineoplásicos Inmunológicos/economía , Biosimilares Farmacéuticos/economía , Rituximab/economía , Trastuzumab/economía , Antineoplásicos Inmunológicos/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Ensayos Clínicos Fase III como Asunto , Hematología/economía , Humanos , Oncología Médica/economía , Ensayos Clínicos Controlados Aleatorios como Asunto , Rituximab/uso terapéutico , Trastuzumab/uso terapéuticoAsunto(s)
Promoción de la Salud/economía , Accesibilidad a los Servicios de Salud/economía , Hematología/economía , Proyectos de Investigación , Apoyo a la Investigación como Asunto , Trombosis/terapia , Costos de la Atención en Salud , Promoción de la Salud/organización & administración , Accesibilidad a los Servicios de Salud/organización & administración , Disparidades en Atención de Salud/economía , Hematología/organización & administración , Humanos , Apoyo a la Investigación como Asunto/organización & administración , Trombosis/diagnóstico , Trombosis/economía , Trombosis/epidemiologíaRESUMEN
The European Hematology Association (EHA) Roadmap for European Hematology Research highlights major achievements in diagnosis and treatment of blood disorders and identifies the greatest unmet clinical and scientific needs in those areas to enable better funded, more focused European hematology research. Initiated by the EHA, around 300 experts contributed to the consensus document, which will help European policy makers, research funders, research organizations, researchers, and patient groups make better informed decisions on hematology research. It also aims to raise public awareness of the burden of blood disorders on European society, which purely in economic terms is estimated at 23 billion per year, a level of cost that is not matched in current European hematology research funding. In recent decades, hematology research has improved our fundamental understanding of the biology of blood disorders, and has improved diagnostics and treatments, sometimes in revolutionary ways. This progress highlights the potential of focused basic research programs such as this EHA Roadmap.The EHA Roadmap identifies nine 'sections' in hematology: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation. These sections span 60 smaller groups of diseases or disorders.The EHA Roadmap identifies priorities and needs across the field of hematology, including those to develop targeted therapies based on genomic profiling and chemical biology, to eradicate minimal residual malignant disease, and to develop cellular immunotherapies, combination treatments, gene therapies, hematopoietic stem cell treatments, and treatments that are better tolerated by elderly patients.
Asunto(s)
Terapia Combinada/métodos , Terapia Genética/métodos , Enfermedades Hematológicas/diagnóstico , Enfermedades Hematológicas/terapia , Hematología/métodos , Terapia Molecular Dirigida/métodos , Antineoplásicos/síntesis química , Antineoplásicos/uso terapéutico , Coagulación Sanguínea/efectos de los fármacos , Terapia Combinada/economía , Consenso , Europa (Continente) , Perfilación de la Expresión Génica , Terapia Genética/economía , Genoma Humano , Servicios de Salud para Ancianos/provisión & distribución , Enfermedades Hematológicas/economía , Enfermedades Hematológicas/patología , Hematología/economía , Hematopoyesis/efectos de los fármacos , Hematopoyesis/genética , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Terapia Molecular Dirigida/economíaRESUMEN
BACKGROUND: Packed red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs. We therefore designed a study to prospectively demonstrate that the transfusion of a single PRBC unit is safe and not inferior to standard care. METHODS: The 1versus2 trial is a randomized trial which will determine if a single-unit transfusion policy is not inferior to a double-unit transfusion policy. The primary endpoint is the incidence of severe complication (grade ≥ 3) defined as stroke, transient ischemic attack, acute coronary syndrome, heart failure, elevated troponin level, intensive care unit transfer, death, new pulmonary infiltrates, and transfusion-related infections during hospital stays. The secondary endpoint is the number of PRBC units transfused per patient per hospital stay. Two hundred and thirty patients will be randomized to receive a single unit or double unit every time the hemoglobin level is less than 8 g/dL. All patients admitted for induction remission chemotherapy, auto-HSCT or allo-HSCT in hematology intensive care units will be eligible for inclusion. Sample size calculation has determined that a patient population of 230 will be required to prove that the 1-unit PRBC strategy is non-inferior to the 2-unit PRBC strategy. Hemoglobin threshold for transfusion is below 8 g/dL. Estimated percentage of complication-free hospital stays is 93 %. In a non-inferiority hypothesis, the number of patients to include is 230 with a power of 90 % and an alpha risk of 5 %. TRIAL REGISTRATION: 14-128; Clinicaltrials.gov NCT02461264 (registered on 3 June 2015).
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Transfusión de Eritrocitos/métodos , Hematología , Trasplante de Células Madre Hematopoyéticas , Unidades de Cuidados Intensivos , Leucemia/tratamiento farmacológico , Aloinjertos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Autoinjertos , Biomarcadores/sangre , Protocolos Clínicos , Análisis Costo-Beneficio , Transfusión de Eritrocitos/efectos adversos , Transfusión de Eritrocitos/economía , Francia , Costos de la Atención en Salud , Hematología/economía , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Trasplante de Células Madre Hematopoyéticas/economía , Hemoglobinas/metabolismo , Humanos , Quimioterapia de Inducción , Unidades de Cuidados Intensivos/economía , Leucemia/sangre , Leucemia/diagnóstico , Selección de Paciente , Valor Predictivo de las Pruebas , Estudios Prospectivos , Factores de Riesgo , Tamaño de la Muestra , Factores de Tiempo , Resultado del TratamientoRESUMEN
The medical research and training enterprise in the United States is complex in both its scope and implementation. Accordingly, adaptations to the associated workforce needs present particular challenges. This is particularly true for maintaining or expanding national needs for physician-scientists where training resource requirements and competitive transitional milestones are substantial. For the individual, these phenomena can produce financial burden, prolong the career trajectory, and significantly influence career pathways. Hence, when national data suggest that future medical research needs in a scientific area may be met in a less than optimal manner, strategies to expand research and training capacity must follow. This article defines such an exigency for research and training in nonneoplastic hematology and presents potential strategies for addressing these critical workforce needs. The considerations presented herein reflect a summary of the discussions presented at 2 workshops cosponsored by the National Heart, Lung, and Blood Institute and the American Society of Hematology.
Asunto(s)
Investigación Biomédica , Fuerza Laboral en Salud/organización & administración , Hematología , Distinciones y Premios , Investigación Biomédica/economía , Investigación Biomédica/organización & administración , Educación/organización & administración , Apoyo Financiero , Hematología/economía , Hematología/organización & administración , Humanos , National Heart, Lung, and Blood Institute (U.S.)/organización & administración , Investigación/organización & administración , Estados UnidosRESUMEN
Major and ongoing changes in health care financing and delivery in the United States have altered opportunities and incentives for new physicians to specialize in nonmalignant hematology. At the same time, effective clinical tools and strategies continue to rapidly emerge. Consequently, there is an imperative to foster workforce innovation to ensure sustainable professional roles for hematologists, reliable patient access to optimal hematology expertise, and optimal patient outcomes. The American Society of Hematology is building a collection of case studies to guide the creation of institutionally supported systems-based clinical hematologist positions that predominantly focus on nonmalignant hematology. These roles offer a mix of guidance regarding patient management and the appropriate use and stewardship of clinical resources, as well as development of new testing procedures and protocols.