An urgent call to raise the bar in oncology.

Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.

[Beating cancer, living with it: success and ethical dilemmas]. / Combattre et vivre avec le cancer : succès et dilemmes éthiques.

Cancers are serious conditions which affect numerous families. The advances made in treatments thanks to research enable a growing number of cancers to be cured. Some cancers which are treated evolve towards a form of chronicity whereby patients have to live with the condition. These varied situations, always sensitive, mobilise and bring together patients, their families, caregivers, researchers and associations. There are many ethical dilemmas facing all those involved in this fight.

Transforming Prior Authorization to Decision Support.

PURPOSE: To evaluate a computer-based prior authorization system that was designed to include and test two new concepts for physician review: (1) the tool would minimize denials by providing real-time decision support with alternative options if the original request was noncompliant, and (2) the tool would collect sufficient information to create a patient registry. METHODS: A new prior authorization tool incorporating real-time decision support was tested with a large national payer. The tool used the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as the content for decision making. Physicians were asked to submit the minimal amount of clinical data necessary to reach a treatment-decision node within the National Comprehensive Cancer Network Guidelines. To minimize denials, all available recommended treatments were displayed for physician consideration and immediate authorization was granted for any compliant selection. RESULTS: During a 1-year pilot in a Florida commercial health plan, 4,272 eligible cases were reviewed with only 42 denials. Chemotherapy drug costs for the prior authorization pilot were compared with a similar time period in the previous year for the state of Florida, as well as for the Southeast region and for the nation, which served as controls. The percentage change between the time periods was -9% in Florida, 10% for the national costs, and 11% for the Southeast region costs. The difference between the regional increase and the Florida decrease represented a savings of $5.3 million dollars for the state of Florida in 1 year. CONCLUSION: There is significant opportunity to reduce the costs of therapy while being compliant with nationally accepted guidelines for cancer chemotherapy.

Prioritization of high-cost new drugs for HCV: making sustainability ethical.

Hepatitis C virus (HCV) infection is a major health problem worldwide. Chronic HCV infection may in the long run cause cirrhosis, hepatic decompensation and hepatocellular carcinoma, with an ultimate disease burden of at least 350,000 deaths per year worldwide. The new generation of highly effective direct acting antivirals (DAA) to treat HCV infection brings major promises to infected patients in terms of exceedingly high rates of sustained virological response (SVR) but also of tolerability, allowing even the sickest patients to be treated. Even in the face of the excellent safety and efficacy and wide theoretical applicability of these regimens, their introduction is currently facing cost and access issues denying their use to many patients in need. Health systems in all countries are facing a huge problem of distributive justice, since while they should guarantee individual rights, among which the right to health in its broader sense, therefore not limited to healing, but extended to quality of life, they must also grant equal access to the healthcare resources and keep the distribution system sustainable. In the face of a disease with a relatively unpredictable course, where many but not of all chronically infected will eventually die of liver disease, selective allocation of this costly resource is debatable. In most countries the favorite solution has been a stratification of patients for prioritization of treatment, which means allowing Interferon-free DAA treatment only in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease. In this report, we will perform an ethical assessment addressing the issues linked to access to new therapies, prioritization and eligibility criteria, analyzing the meaning of the term "distributive justice" and the different approaches that can guide us (individualistic libertarianism, social utilitarianism and egalitarianism) on this specific matter. Even if over time the price of new DAA will be reduced through competition and eventual patent expiration, the phenomenon of high drug costs will go on in the next decades and we need adequate tools to face the problems of distributive justice that come with it.

Asserting the primacy of health over patent rights: a comparative study of the processes that led to the use of compulsory licensing in Thailand and Brazil.

Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government programs. Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006-2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights.

An ethical framework for pharmacy management: balancing autonomy and other principles.

Decisions to control pharmaceutical costs can cause conflicts as to what medications are covered. Such conflicts have ethical implications, however implicit, and given this fact, an ethical framework can help address them. In the following commentary, we discuss the more traditional, individual-level ethical considerations likely familiar to most clinicians. We, then, discuss population-level ethical constructs that clinicians may not as readily embrace. We also present a hypothetical cancer-care case to illustrate how imbalances in ethical foci between individual- and population-level constructs may lead to conflicts among health care actors and promote shifts in pharmaceutical decision making away from providers and toward payers, paradoxically reducing provider autonomy and hence patient autonomy. Finally, we propose a more comprehensive ethical framework to help converge individual, payer, and societal interests when making pharmaceutical use decisions. Pharmacists play a crucial role as pharmacy benefits managers and should be familiar with individual- and population-based ethical constructs.

Coalition Priorité Cancer and the pharmaceutical industry in Quebec: conflicts of interest in the reimbursement of expensive cancer drugs?

In the context of scarce public resources, patient interest groups have increasingly turned to private organizations for financing, including the pharmaceutical industry. This practice puts advocacy groups in a situation of potential conflicts between the interests of patients and those of the drug companies. The interests of patients and industry can converge on issues related to the approval and reimbursement of medications. But even on this issue, interests do not always align perfectly. Using the Quebec example of Coalition Priorité Cancer (CPC) as a case study, we examine the ethical issues raised by such financial relationships in the context of drug reimbursement decision-making. We collected, compiled and analyzed publicly available information on the CPC's organization and activities; this approach allowed us to raise and discuss important questions regarding the possible influence exerted on patient groups by donors. We conclude with some recommendations.

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.