Navigating Ethical Practices in the Era of High Cost Hematology.

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.

Should Foreigners Get Costly Lifesaving Treatments in the United States?

Many foreign parents bring their children to the United States for medical treatments that are unavailable in their own country. Often, however, parents cannot afford expensive treatments. Doctors and hospitals then face a dilemma. Is it ethically permissible to consider the patient's citizenship and ability to pay? In this Ethics Rounds, we present a case in which a child from another country needs an expensive treatment. His parents cannot afford the treatment. He has come to a public hospital in the United States. We present responses from experts in pediatrics, bioethics, and health policy.

Julio Aristegui Villamil: el médico de los pobres / Julio Aristegui Villamil: the Physician of the Poor

Julio Miguel Aristegui Villamil se gradúa de Doctor en Medicina en la Universidad de La Habana en 1929 y regresa a Cárdenas, su ciudad natal, a ejercer su profesión. Sus ideas progresistas lo afilian a la Izquierda Médica, dentro de la Federación Médica de Cuba. Por el ejercicio desinteresado de su profesión la población le llega a nombrar "el médico de los pobres" (AU).

Julio Miguel Aristegui Villamil graduated as doctor in Medicine in the University of Havana in 1929 and came back to Cardenas, his home city, to practice his profession. His progressive ideas led him to enroll in the Izquierdad Médica (Medical Left translated in English), a group inside the Medical Federation of Cuba. Because of the selfless practice of his profession, the people began to call him "the doctor of the poors" (AU).

Controlling Healthcare Costs: Just Cost Effectiveness or "Just" Cost Effectiveness?

Meeting healthcare needs is a matter of social justice. Healthcare needs are virtually limitless; however, resources, such as money, for meeting those needs, are limited. How then should we (just and caring citizens and policymakers in such a society) decide which needs must be met as a matter of justice with those limited resources? One reasonable response would be that we should use cost effectiveness as our primary criterion for making those choices. This article argues instead that cost-effectiveness considerations must be constrained by considerations of healthcare justice. The goal of this article will be to provide a preliminary account of how we might distinguish just from unjust or insufficiently just applications of cost-effectiveness analysis to some healthcare rationing problems; specifically, problems related to extraordinarily expensive targeted cancer therapies. Unconstrained compassionate appeals for resources for the medically least well-off cancer patients will be neither just nor cost effective.

Ethics of the Physician's Role in Health-Care Cost Control: AOA Critical Issues.

The United States health-care expenditure is rising precipitously. The Congressional Budget Office has estimated that, in 2025, at our current rate of increased spending, 25% of the gross domestic product will be allocated to health care. Our per-capita spending on health care also far exceeds that of any other industrialized country. Health-care costs must be addressed if our country is to remain competitive in the global marketplace and to maintain its financial solvency. If unchecked, the uncontrolled rise in health-care expenditures will not only affect our capacity to provide our patients with high-quality care but also threaten the ability of our nation to compete economically on the global stage. This is not hyperbole but fiscal reality.As physicians, we are becoming increasingly familiar with the economics impacting health-care policy. Thus, we are in a unique position to control the cost of health care. This includes an increased reliance on creating and adhering to evidence-based guidelines. We can do this and still continue to respect the primacy of patient welfare and the right of patients to act in their own self-interest. However, as evidenced by the use of high-volume centers of excellence, each strategy adapted to control costs must be vetted and must be monitored for its unintended ethical consequences.The solution to this complex problem must involve the input of all of the health-care stakeholders, including the patients, payers, and providers. Physicians ought to play a role in designing and executing a remedy. After all, we are the ones who best understand medicine and whose moral obligation is to the welfare of our patients.

The ethics of insurance limiting institutional medical care: It's all about the money.

Dr F. Inest practices surgery at a renowned medical center but is concerned because increasing numbers of medical insurers are excluding his institution from coverage. Many of his former referring physicians are beginning to send their patients elsewhere for this reason. The marketing people have been busy increasing their advertising buys and exploring new business models. There is even talk about reducing expensive clinical trials. However, regardless of his affiliation, he has little control over these and other organizational decisions that directly impact his practice clinically and fiscally. What should he do?

The elephant in the room: ethical issues associated with rare and expensive medical conditions.

The treatment of rare and expensive medical conditions is one of the defining qualities of paediatric cardiology and congenital heart surgery. Increasing concerns over healthcare resource allocation are challenging the merits of treating more expensive forms of congenital heart disease, and this trend will almost certainly continue. In this manuscript, the problems of resource allocation for rare and expensive medical conditions are described from philosophical and economic perspectives. The argument is made that current economic models are limited in the ability to assess the value of treating expensive and rare forms of congenital heart disease. Further, multi-disciplinary approaches are necessary to best determine the merits of treating a patient population such as those with significant congenital heart disease that sometimes requires enormous healthcare resources.

Just caring: assessing the ethical and economic costs of personalized medicine.

Personalized medicine has been touted as a revolutionary form of cancer care. It has been portrayed as precision medicine, targeting with deadly accuracy cancer cells and sparing patients the debilitating broad-spectrum side effects of more traditional forms of cancer therapy. But personalized medicine still has its costs to patients and society, both moral and economic costs. How to recognize and address those issues will be the focus of this essay. We start with these questions: Does everyone faced with cancer have a moral right to the most effective cancer care available, no matter what the cost, no matter whether a particular individual has the personal ability to pay for that care or not? Or are there limits to the cancer care that anyone has a right to at social expense? If so, what are those limits and how are those limits to be determined? Are those limits a matter of both morality and economics? I will answer this last question in the affirmative. This is what I refer to as the "Just Caring" problem in health care.

[The QALY approach - potentials and limits]. / Der QALY-Ansatz - Potentiale und Grenzen.

The concept of quality-adjusted life expectancy ("quality-adjusted life years", QALY) is a type of cost-benefit analysis for health economic evaluation of treatment options. The two parameters quality of life and life expectancy are thereby combined into a single value - the QALY - which can shed light on the cost of therapy per additional quality-adjusted year of life. The concept is, however, widely used in ethical discussions of the adequacy of the generalizations on which this approach is based. Using the simulation of an American research team on treatment forms for prostate cancer, the QALY concept is explained, followed by the presentation of ethical criticisms.

Ethics in oncology: an annotated bibliography of important literature.

The aim of this annotated bibliography about important articles in the field of ethics and oncology is to provide the practicing hematologist/oncologist with a brief overview of some of the important literature in this crucial area.

Pharmacogenomics and personalized medicine: wicked problems, ragged edges and ethical precipices.

In the age of genomic medicine we can often now do the genetic testing that will permit more accurate personal tailoring of medications to obtain the best therapeutic results. This is certainly a medically and morally desirable result. However, in other areas of medicine pharmacogenomics is generating consequences that are much less ethically benign and much less amenable to a satisfactory ethical resolution. More specifically, we will often find ourselves left with 'wicked problems,' 'ragged edges,' and well-disguised ethical precipices. This will be especially true with regard to these extraordinarily expensive cancer drugs that generally yield only extra weeks or extra months of life. Our key ethical question is this: Does every individual faced with cancer have a just claim to receive treatment with one of more of these targeted cancer therapies at social expense? If any of these drugs literally made the difference between an unlimited life expectancy (a cure) and a premature death, that would be a powerful moral consideration in favor of saying that such individuals had a strong just claim to that drug. However, what we are beginning to discover is that different individuals with different genotypes respond more or less positively to these targeted drugs with some in a cohort gaining a couple extra years of life while others gain only extra weeks or months. Should only the strongest responders have a just claim to these drugs at social expense when there is no bright line that separates strong responders from modest responders from marginal responders? This is the key ethical issue we address. We argue that no ethical theory yields a satisfactory answer to this question, that we need instead fair and respectful processes of rational democratic deliberation.

Public health measures to control tuberculosis in low-income countries: ethics and human rights considerations.

In low-income countries, tuberculosis (TB) control measures should be guided by ethical concerns and human rights obligations. Control programs should consider the principles of necessity, reasonableness and effectiveness of means, proportionality, distributive justice, and transparency. Certain measures-detention, infection control, and treatment to prevent transmission-raise particular concerns. While isolation is appropriate under certain circumstances, quarantine is never an acceptable control measure for TB, and any detention must be limited by necessity and conducted humanely. States have a duty to implement hospital infection control to the extent of their available resources and to provide treatment to health care workers (HCWs) infected on the job. HCWs, in turn, have an obligation to provide care unless conditions are unreasonably and unforeseeably unsafe. Finally, states have an obligation to provide adequate access to treatment, as a means of preventing transmission, as broadly as possible and in a non-discriminatory fashion. Along with treatment, states should provide support to increase treatment adherence and retention with respect for patient privacy and autonomy. Compulsory treatment is almost never acceptable. Governments should take care to respect human rights and ethical obligations as they execute TB control programs.

Avaliação econômica das anticitocinas adalimumabe, etanercepte e infliximabe no tratamento da artrite reumatoide no Estado do Paraná / Economic evaluation of anticitokines adalimumab, etanercept and infliximab for treatment of rheumatoid arthritis in Paraná State, Brazil

Este estudo objetivou realizar uma avaliação econômica das anticitocinas adalimumabe (ADA), etanercepte (ETA) e infliximabe (IFX) para o tratamento da artrite reumatoide no Estado do Paraná, sob a perspectiva do SUS. Os dados de eficácia e segurança dos tratamentos foram buscados na literatura, e os custos foram calculados com valores gastos pelo SUS para cada um dos tratamentos. Foi elaborado o modelo de Markov para obter a relação custo-efetividade de cada tratamento. A relação custo-efetividade incremental (ICER) comparado ao tratamento padrão também foi calculada para cada anticitocina. Análises de sensibilidade e taxas de desconto foram aplicadas. Na avaliação custo-efetividade, encontraram-se custos por QALY de R$ 511.633,00, R$ 437.486,00 e R$ 657.593,00 para ADA, ETA e IFX, respectivamente. O ICER por QALY foi R$ 628.124,00, R$ 509.974,00 e R$ 965.927,00 para ADA, ETA e IFX, respectivamente. Nas análises de sensibilidade, o ETA e o ADA apresentaram valores próximos. Cabe aos gestores públicos e aos médicos prescritores a escolha adequada para cada paciente, entre os tratamentos disponibilizados.

This study aimed to perform an economic evaluation of anticytokines adalimumab (ADA), etanercept (ETA) and infliximab (IFX) for the treatment of rheumatoid arthritis in the State of Parana, in Brazil, in the perspective of the Brazilian Unified Health System. Data on efficacy and safety of treatment were collected in literature, and costs were calculated on the amounts spent by the Government for each treatment. A Markov model was performed to get the cost-effectiveness of each treatment. The incremental cost-effectiveness relationship (ICER) compared to a standard treatment was also calculated for each anticytokine. Sensitivity analysis and discount rates were applied. In assessing cost-effectiveness we found the following values (cost at R$ per QALY): 511,633.00, 437,486.00 and 657,593.00 (respectively for ADA, ETA and IFX). The ICER (R$ per QALY) was 628,124.00, 509,974.00 and 965,927.00 (for ADA, ETA and IFX). In the sensitivity analysis, ETA and ADA showed similar values. It is for public managers and physicians the choice for each patient, among the treatments available.

Fraturas do fêmur proximal no idoso: estudo de custo da doença sob a perspectiva de um hospital público no Rio de Janeiro, Brasil / Hip fractures in the elderly: cost of illness study in a public hospital perspective, Rio de Janeiro, Brazil

O artigo visa a estimar o custo direto médico do tratamento hospitalar de pacientes idosos com fraturas de fêmur proximal, no Hospital Municipal Lourenço Jorge, na cidade do Rio de Janeiro. Estudo observacional, prospectivo, para estimar a utilização de recursos e custos diretos médicos associados à hospitalização por fratura de fêmur proximal em idosos, em 2007 e 2008, sob a perspectiva do prestador de serviços. Foi utilizado um instrumento de coleta de dados através do qual foram registrados recursos identificados na revisão prospectiva dos prontuários. Aos recursos utilizados foram atribuídos custos em reais (R$) baseando-se em valores do ano 2010. Foram realizadas análises descritivas dos custos e utilização de recursos, bem como avaliada a associação de variáveis clínicas e demográficas com o custo final observado. Foram incluídos 82 pacientes, 81,7 por cento do sexo feminino, idade média de 76,96 anos, hospitalização média de 12,66 dias. A mediana de custo por paciente foi de R$ 3.064,76 (IC95 por cento: 2.817,63 a 3.463,98). Hospitalização clínica e procedimento cirúrgico foram responsáveis por 65,61 por cento e 24,94 por cento dos custos, respectivamente. Pacientes submetidos ao tratamento cirúrgico até o quarto dia de hospitalização apresentaram mediana de custos menor do que pacientes submetidos após o quarto dia (R$ 2.136,31 e R$ 3.281,45, p<0,00001). Observou-se também diferença significativa nos custos finais por tipo de procedimento cirúrgico realizado. O custo do tratamento das fraturas de fêmur proximal no idoso foi significativamente maior nos pacientes submetidos à cirurgia após o quarto dia de hospitalização. Hospitalização clínica e procedimento cirúrgico foram os principais componentes do custo final observado.

This paper aims to assess direct medical costs associated to hospital treatment of hip fractures in the elderly in the Municipal Hospital Lourenço Jorge (HMLJ), Rio de Janeiro. Observational, prospective study to assess resource utilization and direct medical costs associated to elderly hip fracture hospitalization in 2007 and 2008, under the health care provider perspective. A standard data collection instrument was used to register identified resources during prospective medical charts review. The resource utilization was converted into Brazilian Real (R$), based on 2010 prices. Descriptive analysis of costs and resource utilization and their association with clinical and demographic variables were performed. Eighty two patients were included, 81.7 percent female, mean age of 76.96 years, hospitalization mean time of 12.66 days. Median total costs per patient were R$ 3,064.76 (IC95 percent: 2,817.63 - 3,463.98). Clinical hospitalization and surgical procedure were responsible for 65.61 percent and 24.94 percent of costs, respectively. Median costs for patients submitted to surgical procedure until the fourth day of hospitalization were lower than median costs for patients submitted after the fourth day (R$ 2,136.45 and R$ 3,281.45, respectively, p<0.00001). A significant difference in average costs per type of surgical procedure was also observed. Cost associated to inpatient treatment of hip fractures in the elderly was higher in patients who performed surgery after the fourth day of hospitalization. Clinical hospitalization and surgical procedure were the main cost components observed.

[Demographic change and the need for prioritization in health care: position of the German Medical Association]. / Demografischer Wandel und Notwendigkeit der Priorisierung im Gesundheitswesen: Positionsbestimmung der Arzteschaft.

The German health care system will face major challenges in the near future. Progress in medicine as well as demographic change will combine to drastically exacerbate the scarcity of resources in the health care system. The word scarcity in this case not only refers to the availability of funds. Other resources, e.g., staff, attention, time, and organs for transplantation, are also becoming scarce. It is conceivable that, in the future, it will no longer be possible to provide medical services for all patients to the same extent as in the past. If the necessary resources are not available in the health care system, if the potential for saving resources has been more or less exhausted, and if rationing shall not be an option, the only option to resort to will be prioritization. Prioritization in the health care sector denotes a supply of services according to specific, predetermined criteria. A broad and open public debate, which would have to be accompanied as well as moderated by the Health Council ("Gesundheitsrat"), is essential for determining such criteria.

Ethical and value issues in insurance coverage for cancer treatment.

Many new cancer drugs provide only limited benefits, but at very great cost, for example, $200,000-$300,000 per quality-adjusted life year produced. By most standards of value or cost-effectiveness, this does not represent good value. I first review several of the causes of this value failure, including monopoly patents, prohibitions on Medicare's negotiating on drug prices, health insurance protecting patients from costs, and financial incentives of physicians to use these drugs. Besides value or cost-effectiveness, the other principal aim in health care resource allocation should be equity among the population served. I examine several equity considerations-priority to the worse off, aggregation and special priority to life extension, and the rule of rescue-and argue that none justifies greater priority for cancer treatment on the grounds of equity. Finally, I conclude by noting two recent policy changes that are in the wrong direction for achieving value in cancer care, and suggesting some small steps that could take us in the right direction.