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The increasing burden of cancer represents a substantial problem for Latin America and the Caribbean. Two Lancet Oncology Commissions in 2013 and 2015 highlighted potential interventions that could advance cancer care in the region by overcoming existing challenges. Areas requiring improvement included insufficient investment in cancer control, non-universal health coverage, fragmented health systems, inequitable concentration of cancer services, inadequate registries, delays in diagnosis or treatment initiation, and insufficient palliative services. Progress has been made in key areas but remains uneven across the region. An unforeseen challenge, the COVID-19 pandemic, strained all resources, and its negative effect on cancer control is expected to continue for years. In this Series paper, we summarise progress in several aspects of cancer control since 2015, and identify persistent barriers requiring commitment of additional resources to reduce the cancer burden in Latin America and the Caribbean.

Background Adoption of molecular pathology in Brazil is currently very limited. Of note, there are no programs for training new molecular pathologists in the country; thus, documents compiling nationally applicable information on molecular pathology are few. Methods A selected panel of Brazilian experts in fields related to molecular pathology were provided with a series of relevant questions to address prior to the multi-day conference. Within this conference, each narrative was discussed and edited by the entire group, through numerous drafts and rounds of discussion until a consensus was achieved. Results The panel proposes specific and realistic recommendations for implementing molecular pathology in cancer care in Brazil. In creating these recommendations, the authors strived to address all barriers to the widespread use and impediments to access mentioned previously within this manuscript. Conclusion This manuscript provides a review of molecular pathology principles as well as the current state of molecular pathology in Brazil. Additionally, the panel proposes practical and actionable recommendations for the implementation of molecular pathology throughout the country in order to increase awareness of the importance molecular pathology in Brazil.

Purpose: To address the barriers limiting access to combination therapies (CTs) in Latin America (LA), specifically for patients with multiple myeloma (MM), alongside a roadmap to address them. Methods: A panel of LA experts was provided with relevant questions to address in a multi-day conference. Responses were discussed and edited by the panel through numerous drafts and discussions until consensus was achieved. Results: The authors identified challenges in CT access in MM in LA and proposed suggestions to address these, including health technology assessment frameworks that assign value to each constituent, adapted legal structures enabling collaborative pricing negotiations, and innovative pricing and contracting mechanisms. These challenges and suggestions apply to CT for other oncologic diseases. Conclusion: Increasing CT access demands concerted efforts from all stakeholders. As regulatory and pricing barriers persist, a great need exists to increase CT access in LA. These suggestions can serve as a roadmap for CT adoption in other countries. Keywords: Latin America; combination therapy; multiple myeloma; value attribution, HTA, access, pricing; reimbursement.

The congress of the International Society for Pharmacoeconomics and Outcomes Research is one of the main worldwide forums for the dissemination of research and knowledge on healthcare economics. Brazil is the largest country in Latin America, with a per-capita gross domestic product of $15 200 in 2017 and healthcare expenditure of the order of $1 318 per inhabitant. Brazilian specialists participated actively in the society's latest congress, which took place in Boston, Massachusetts, from May 20 to 24, 2017. They met to discuss the main topics dealt with at the congress and their applicability to Brazilian realities. The topics chosen were precision medicine, new challenges for economic modeling within oncology and immuno-oncology, data to aid in managerial decision making (ie, data from real-world studies), and, lastly, strategies for accessing high-cost medications in Brazil. This opinion article sought to report the main conclusions and consensus reached by this group of specialists on the occasion of this discussion.

With the increasing use of genomic profiling for diagnosis and therapy guidance in many tumor types, precision oncology is rapidly reshaping cancer care. However, the current trajectory of drug development in oncology results in a paradox: if patients cannot access advanced diagnostics, we may be developing drugs that will reach few patients. In this Perspective, we outline the major challenges to the implementation of precision oncology and discuss critical steps toward resolving these, including facilitation of equal access to genomics tests, ensuring that clinical studies provide robust evidence for new drugs and technologies, enabling physicians to interpret genomics data, and empowering patients toward shared decision-making. A multi-stakeholder approach to evidence generation, value assessment, and healthcare delivery is necessary to translate advances in precision oncology into benefits for patients with cancer globally.

Background: The global burden of breast cancer (BC) is high, especially in advanced stages. CDK 4/6 inhibitors represent a paradigm shift in the treatment of advanced BC HR+/HER2−, given the clinically and statistically significant gain in overall survival associated with this new class of medications. Nevertheless, as an innovation, the incorporation of these drugs impacts healthcare budgets, requiring cost-effectiveness analyses for decision-making. The aim of this study was to evaluate the cost-effectiveness of ribociclib plus letrozole compared with palbociclib plus letrozole or letrozole as monotherapy for first-line treatment of postmenopausal women with HR+/HER2− locally advanced or metastatic BC (aBC) from a Brazilian private healthcare system perspective. Methods: A model including progression-free survival (PFS), progressed disease, and death health states was used to simulate lifetime costs and outcomes. PFS and overall survival were derived from the MONALEESA-2 trial (lifetime horizon). Healthcare costs included drug acquisition and monitoring, subsequent therapies, adverse events, and end-of-life costs. Effectiveness was measured in quality-adjusted life-years (QALYs). Deterministic and probabilistic sensitivity analyses were performed. Results: The total cost of treatment with ribociclib plus letrozole was USD 72,091.82 versus USD 92,749.64 for palbociclib plus letrozole. Total QALYs were 3.30 and 3.16, respectively. Base-case analysis showed ribociclib as dominant over palbociclib in first-line treatment of women with HR+/HER2− aBC, associated with cost savings and QALY gains. The total cost of treatment with ribociclib plus letrozole was USD 83,058.73 versus USD 29,215.10 for letrozole. Total QALYs were 3.84 and 2.61, respectively. Compared with letrozole, ribociclib plus letrozole was associated with an incremental cost of USD 53,843.64 and an incremental QALY gain of 1.23, with incremental cost-effectiveness ratio of USD 43,826.91 per QALY gained. Conclusions: As demonstrated by the cost-effectiveness dominance over palbociclib, ribociclib results in savings when used as first-line treatment in postmenopausal women with HR+/HER2− aBC, warranting incorporation in the private healthcare system.

203 Background: Anti-EGFR treatment of RAS wild-type metastatic colorectal cancer (mCRC) in Latin America includes cetuximab or panitumumab, added to chemotherapy (cet+CT and pan+CT, respectively). Adverse event (AE) profiles for each regimen may influence the treatment decision. This study aimed to estimate the associated financial impact of AE management in three countries: Argentina (AR), Brazil (BR) and Panama (PA) from a healthcare payer perspective. Methods: We revised a published Microsoft Excel-based economic model to calculate average patient- and population-level costs from a payer perspective of mCRC AE management for first-line cet+CT and pan+CT treatment, using AE frequency and severity data derived from the authorization relevant FDA prescribing information (PI), multiplied by the country-specific unit costs of managing AEs. Costs of AE management were obtained from publicly available sources in each country and converted to US dollars (USD). Country-specific market research data were applied to calculate costs at the eligible mCRC population level. The model structure and input parameters were endorsed by local practising oncologists. Results: A 17.5% (all-grade) and 31.6% (grade 3-4) lower average per patient AE frequency were estimated from the PI, for cet+CT vs pan+CT. Cost results are presented in the table. Projected AE management costs of cet+CT for the eligible mCRC population are $297,643 (AR), $124,981 (BR) and $65,895 (PA), annually, reducing current annual estimated AE costs by $42,181 (AR), $8,548 (BR) and $4,691 (PA). Conclusions: According to the average estimated AE frequencies, patients treated with cet+CT are expected to experience fewer AEs than with pan+CT. According to our analyses, the lower frequency rates could result in lower overall and severe AEs’ management costs, resulting in 12.4% (AR), 6.4% (BR) and 6.6% (PA) lower costs of AE management for cet+CT versus pan+CT.[Table: see text]

Immuno-therapeutics have revolutionized the field of oncology. The Brazilian cancer population would unquestionably benefit from an increase in the availability of cost-effective immuno-oncologic drugs. The challenge is how to incorporate these into the toolbox of health professionals, given the complexity and inequities of the Brazilian healthcare system, limiting financial resources and numerous health needs. We provide a series of recommendations that are likely to improve access and reduce the cost of these important medications. Nonetheless, there are numerous challenges that must be overcome if the entire Brazilian cancer population is to benefit from this remarkable advancement in health care.

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e13610 Background: Cancer is the second leading cause of death worldwide. From 2014 to 2015 Brazil estimated more than 500,000 new cases of cancer, which placed the country among those with the highest cancer incidence. This study evaluates the 10-year evolution of mortality rates due to all causes and cancer and to estimate the potential years of life lost (PYLL) in beneficiaries of health plan, according to sex, age and geographic region. Methods: Retrospective cross-sectional, descriptive study evaluated the causes of death, between 2008 and 2017, by sex and age groups, for all causes (AC) and cancer (CA) data from the health insurance system. The information on the death certificates (DC) was coded according to the ICD-10. Age was stratified into groups: up to 49 years, 50–59 years, 60–69 years, 70–79 years and 80 years or more. Data were analyzed by checking the proportions and mortality rates (MR), grouped into two five-year periods, 2008-2012 (P1) e 2013-2017 (P2). Annual MR per 100,000 population was estimated using the direct method and proportional mortality rates (PMR). To calculate the potential years of life lost (PYLL) the upper limit was 76 years old. The avoidable MR was also analyzed for individuals up to 75 years and cancer. Microsoft Excel v2010 and Qlik Sense v13.21 were used to analyze data and statistics. Results: 5,779 deaths were analyzed, 4,447 in men (77.0%, average 70.1 years) and 1,332 women (33%, 75.9 years). Cancer was the second leading cause of death (n = 953, PMR 16.5%), behind cardiovascular disease (n = 1,662 PMR 28.8%). The major crude death rate per 100,000 was due circulatory system diseases (347), followed by cancer (199) and respiratory system diseases (110). The highest cancer MR were in men, elderly and Brazilian regions with the lowest Human Development Index (HDI). Greatest number of deaths in men at P1 were from cancers of lung (CMP 19.8%), prostate (14.2%) and pancreas (8.0%). At P2, prostate (18.2%), lung (16.8%) and stomach (7.6%). In women, during P1, breast (20.2%), lung (13.1%) and pancreas (83%), and during P2, the same order, 22.5%, 14.6% and 9.3%, respectively. Cancer accounted for a total of 6,335 PYLL and 40.9% of causes of death were classified as avoidable. Conclusions: Cancer was one of the leading causes of mortality during the study. High pancreatic cancer MR differs from national statistics, requiring more analysis that involves possible occupational exposure. Although preventive actions for healthy life habits, early screening and diagnosis, Brazil presents high cancer mortality rates as showed in this analysis.

The development of therapies that restore or activate the host immune response – the socalled “immuno-oncologic” therapy – has improved the survival of some cancer patients harboring specific tumor types. These drugs, however, are very expensive which has greatly limited their use and consequently reduced the number of patients who could likely benefit. Not to mention, the proportion of patients who display a clinical benefit from therapy is limited. Thus, from a clinical and health economics perspective, there is a pressing need to identify and treat those patients for whom a given immuno- oncologic therapy is most likely to be beneficial. At this end, the identification, validation and use of biomarkers emerge as an important therapeutic tool. Here, we briefly review the state of immunologic biomarker development and utilization and make suggestions for interested clinicians, health policy makers and other stakeholders to prepare for the broader use of biomarkers associated with immuno-oncologic therapy in routine practice. The biomarker field is clearly in its earliest stages and there is no doubt that continued research will identify new biomarkers with valuable clinical indications. Of course, the clinical utility of a biomarker must consider patient preferences and perspectives. In addition, health economic analyses are crucial to better define the value of immunotherapy based on precision medicine strategies and promote value-based pricing.

Non-communicable diseases, including cancer, are overtaking infectious disease as the leading health-care threat in middle-income and low-income countries. Latin American and Caribbean countries are struggling to respond to increasing morbidity and death from advanced disease. Health ministries and health-care systems in these countries face many challenges caring for patients with advanced cancer: inadequate funding; inequitable distribution of resources and services; inadequate numbers, training, and distribution of health-care personnel and equipment; lack of adequate care for many populations based on socioeconomic, geographic, ethnic, and other factors; and current systems geared toward the needs of wealthy, urban minorities at a cost to the entire population. This burgeoning cancer problem threatens to cause widespread suffering and economic peril to the countries of Latin America. Prompt and deliberate actions must be taken to avoid this scenario. Increasing efforts towards prevention of cancer and avoidance of advanced, stage IV disease will reduce suffering and mortality and will make overall cancer care more affordable. We hope the findings of our Commission and our recommendations will inspire Latin American stakeholders to redouble their efforts to address this increasing cancer burden and to prevent it from worsening and threatening their societies.

A growing understanding of the molecular pathology of tumours combined with a surge of new drugs and associated diagnostic technologies (ie, precision medicine) has translated into substantial improvements in survival for patients with cancer. However, to achieve the promise that precision medicine has to offer will require overcoming hurdles within a national health-care system in which it is to be implemented. Brazil is one such nation, an emerging middle-income country with a very complex health-care system. To address the challenges associated with implementing precision medicine into a country such as Brazil, a group of experts convened (Nov 16-18, 2015, Miami) to discuss challenges related to precision medicine within an oncology setting. Complex regulatory hurdles, a shortage of human and technical resources, and the complexities of a two-tiered health-care delivery system were all identified as the main shortcomings to effectively implementing this new field of medicine. A path forward was proposed that relies on active collaboration between clinicians, private organisations, and government. It seems entirely possible that, despite many intrinsic economic and political problems, Brazil can readily emerge as a model for other countries in Latin America for the potential benefits of precision medicine and companion diagnostics.

Propofol is a common drug used for anesthetic induction of patients undergoing surgery. This popular drug has been around for many years and has been subjected to changes in formulation from its original patented formula. Once touted as safe, the newer propofol may possess hidden dangers, particularly for individuals suffering with hyperreactive airway disease.