Unification of Efforts to Improve Global Access to Cancer Therapeutics: Report From the 2022/2023 Access to Essential Cancer Medicines Stakeholder Summit.

PURPOSE: There is an urgent need to improve access to cancer therapy globally. Several independent initiatives have been undertaken to improve access to cancer medicines, and additional new initiatives are in development. Improved sharing of experiences and increased collaboration are needed to achieve substantial improvements in global access to essential oncology medicines. METHODS: The inaugural Access to Essential Cancer Medicines Stakeholder Meeting was organized by ASCO and convened at the June 2022 ASCO Annual Meeting in Chicago, IL, with two subsequent meetings, Union for International Cancer Control World Cancer Congress held in Geneva, Switzerland, in October 2022 and at the ASCO Annual Meeting in June of 2023. Invited stakeholders included representatives from cancer institutes, physicians, researchers, professional societies, the pharmaceutical industry, patient advocacy organizations, funders, cancer organizations and foundations, policy makers, and regulatory bodies. The session was moderated by ASCO. Past efforts and current and upcoming initiatives were initially discussed (2022), updates on progress were provided (2023), and broad agreement on resulting action steps was achieved with participants. RESULTS: Summit participants recognized that while much work was ongoing to enhance access to cancer therapeutics globally, communication and synergy across projects and organizations could be enhanced by providing a platform for collaboration and shared expertise. CONCLUSION: The summit resulted in new cross-stakeholder insights and planned collaboration addressing barriers to accessing cancer medications. Specific actions and timelines for implementation and reporting were established.

Benefits, harms and cost-effectiveness of cervical screening, triage and treatment strategies for women in the general population.

In 2020, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer as a public health problem. To support the strategy, the WHO published updated cervical screening guidelines in 2021. To inform this update, we used an established modeling platform, Policy1-Cervix, to evaluate the impact of seven primary screening scenarios across 78 low- and lower-middle-income countries (LMICs) for the general population of women. Assuming 70% coverage, we found that primary human papillomavirus (HPV) screening approaches were the most effective and cost-effective, reducing cervical cancer age-standardized mortality rates by 63-67% when offered every 5 years. Strategies involving triaging women before treatment (with 16/18 genotyping, cytology, visual inspection with acetic acid (VIA) or colposcopy) had close-to-similar effectiveness to HPV screening without triage and fewer pre-cancer treatments. Screening with VIA or cytology every 3 years was less effective and less cost-effective than HPV screening every 5 years. Furthermore, VIA generated more than double the number of pre-cancer treatments compared to HPV. In conclusion, primary HPV screening is the most effective, cost-effective and efficient cervical screening option in LMICs. These findings have directly informed WHO's updated cervical screening guidelines for the general population of women, which recommend primary HPV screening in a screen-and-treat or screen-triage-and-treat approach, starting from age 30 years with screening every 5 years or 10 years.

Developing and sustaining high-quality care for children with cancer: the WHO Global Initiative for Childhood Cancer / Desarrollo y mantenimiento de una atención de alta calidad para pacientes pediátricos con cáncer: la Iniciativa Mundial de la OMS contra el Cáncer Infantil / Desenvolvimento e manutenção de atenção de alta qualidade para crianças com câncer: a Iniciativa Global para o Câncer Infantil da OMS

[ABSTRACT]. Cancer is a major public health concern, impacting nearly 20 million people each year, and it is responsible for 1 in 6 deaths worldwide. The burden of cancer is increasing rapidly, straining health systems that are unable to prevent and manage the disease. Childhood cancer constitutes a significant and relevant public health challenge; it was the ninth leading cause of childhood disease globally, according to findings by the Global Burden of Disease 2017 study. Almost 80% of all children diagnosed with cancer live in low- and middle-income countries where treatment is often unavailable or unaffordable. As a result, only about 15–45% of these children survive compared with more than 80% in high-income countries. This represents a great health inequity. Delivering on the mandate provided by World Health Assembly resolution 70.12, WHO together with St. Jude Children’s Research Hospital and other global partners launched the Global Initiative for Childhood Cancer at the United Nations General Assembly during the third High-level Meeting on the prevention and control of noncommunicable diseases in September 2018. The Initiative aims to increase global survival for children with cancer to at least 60% by 2030, while reducing suffering for all children with cancer. Five years after launching the Initiative, more than 70 countries across the World Health Organization’s 6 regions have advanced to different phases of action through implementation of the Initiative’s CureAll framework for action. Many successful approaches to implementing the CureAll pillars and enablers have demonstrated that improving care for children with cancer in low- and middle-income countries is possible as long as there is strong political will, multisectoral commitments and strategic investment.

[RESUMEN]. El cáncer es un importante problema de salud pública: afecta a cerca de 20 millones de personas cada año y es responsable de 1 de cada 6 muertes a nivel mundial. La carga del cáncer está aumentando rápidamente, lo que somete a una gran presión a los sistemas de salud que no pueden prevenir y manejar la enfermedad. El cáncer infantil constituye un importante problema de salud pública y tiene gran relevancia: fue la novena causa de enfermedad infantil a nivel mundial, según los hallazgos del estudio sobre la carga mundial de enfermedad correspondiente al 2017. Casi el 80% de todos los casos de cáncer infantil se registran en países de ingresos bajos o medianos, donde el tratamiento a menudo resulta inasequible o no está disponible. Por este motivo, solo sobreviven entre el 15% y el 45% de estos pacientes pediátricos, frente a más del 80% en los países de ingresos altos. Esto constituye una gran inequidad en materia de salud. En cumplimiento del mandato establecido en la resolución WHA70.12 de la Asamblea Mundial de la Salud, la Organización Mundial de la Salud (OMS) —junto con el hospital pediátrico de investigación St. Jude y otros asociados mundiales— puso en marcha la Iniciativa Mundial contra el Cáncer Infantil ante la Asamblea General de las Naciones Unidas, en ocasión de la tercera reunión de alto nivel sobre la prevención y el control de las enfermedades no transmisibles, celebrada en septiembre del 2018. Esta iniciativa tiene como objetivo incrementar la tasa de supervivencia mundial de los pacientes pediátricos con cáncer hasta por lo menos el 60% para el 2030 y, simultáneamente, reducir el sufrimiento de toda la población infantil con cáncer. Transcurridos cinco años de la puesta en marcha de la iniciativa, más de 70 países de las seis regiones de la OMS han logrado avanzar a distintas fases de actuación mediante la aplicación del marco de acción de la iniciativa denominado CureAll. Ha habido muchos enfoques que han dado buenos resultados para la consecución de los pilares y los elementos facilitadores de CureAll y que han demostrado que es posible mejorar la atención de la población infantil con cáncer en los países de ingresos bajos y medianos, siempre que haya una férrea voluntad política, compromisos multisectoriales e inversiones estratégicas.

[RESUMO]. O câncer é um importante problema de saúde pública que afeta cerca de 20 milhões de pessoas a cada ano e é responsável por uma em cada seis mortes em todo o mundo. A carga do câncer está aumentando rapidamente, sobrecarregando os sistemas de saúde, que não conseguem prevenir e controlar a doença. O câncer infantil constitui um desafio significativo e relevante para a saúde pública: essa foi a nona principal causa de doenças infantis em todo o mundo, de acordo com os resultados do estudo Global Burden of Disease 2017. Quase 80% de todas as crianças diagnosticadas com câncer vivem em países de baixa e média renda, onde o tratamento geralmente não está disponível ou é inacessível. Como resultado, apenas cerca de 15% a 45% dessas crianças sobrevivem, em comparação com mais de 80% nos países de alta renda. Isso representa uma grande falta de equidade em saúde. Cumprindo o estabelecido pela Resolução 70.12 da Assembleia Mundial da Saúde, a Organização Mundial da Saúde (OMS), juntamente com o Saint Jude Children's Research Hospital e outros parceiros mundiais, lançou a Iniciativa Global para o Câncer Infantil na Assembleia Geral das Nações Unidas, durante a terceira Reunião de Alto Nível sobre prevenção e controle de doenças não transmissíveis, em setembro de 2018. A Iniciativa tem como objetivo aumentar a sobrevida global de crianças com câncer para pelo menos 60% até 2030 e, ao mesmo tempo, reduzir o sofrimento de todas as crianças com câncer. Cinco anos após o lançamento da Iniciativa, mais de 70 países das seis regiões da OMS avançaram para diferentes fases de ação por meio da implementação da estrutura CureAll da Iniciativa. O sucesso de muitas abordagens para implementação dos pilares e facilitadores da CureAll demonstraram que é possível melhorar o atendimento a crianças com câncer em países de baixa e média renda, desde que haja forte vontade política, compromissos multissetoriais e investimento estratégico.

Quality indicators for systemic anticancer therapy services: a systematic review of metrics used to compare quality across healthcare facilities.

PURPOSE: The number of systemic anticancer therapy (SACT) regimens has expanded rapidly over the last decade. There is a need to ensure quality of SACT delivery across cancer services and systems in different resource settings to reduce morbidity, mortality, and detrimental economic impact at individual and systems level. Existing literature on SACT focuses on treatment efficacy with few studies on quality or how SACT is delivered within routine care in comparison to radiation and surgical oncology. METHODS: Systematic review was conducted following PRISMA guidelines. EMBASE and MEDLINE were searched and handsearching was undertaken to identify literature on existing quality indicators (QIs) that detect meaningful variations in the quality of SACT delivery across different healthcare facilities, regions, or countries. Data extraction was undertaken by two independent reviewers. RESULTS: This review identified 63 distinct QIs from 15 papers. The majority were process QIs (n = 55, 87.3%) relating to appropriateness of treatment and guideline adherence (n = 28, 44.4%). There were few outcome QIs (n = 7, 11.1%) and only one structural QI (n = 1, 1.6%). Included studies solely focused on breast, colorectal, lung, and skin cancer. All but one studies were conducted in high-income countries. CONCLUSIONS: The results of this review highlight a significant lack of research on SACT QIs particularly those appropriate for resource-constrained settings in low- and middle-income countries. This review should form the basis for future work in transforming performance measurement of SACT provision, through context-specific QI SACT development, validation, and implementation.

The cost of inaction on physical inactivity to public health-care systems: a population-attributable fraction analysis.

BACKGROUND: Physical inactivity is an important modifiable risk factor for non-communicable diseases (NCDs) and mental health conditions. We aimed to estimate the public health-care costs associated with these diseases because of physical inactivity, which will help policy makers to prioritise investment in policy actions to promote and enable more people to be more active. METHODS: We used a population-attributable fraction formula to estimate the direct public health-care costs of NCDs and mental health conditions for 2020-30. The disease outcomes that we included were incident cases of coronary heart disease, stroke, type 2 diabetes, hypertension, cancer (breast, colon, bladder, endometrial, oesophageal, gastric, and renal), dementia, and depression in adults aged at least 18 years. We used the most recent health and economic data evidence available for 194 countries. FINDINGS: 499·2 million new cases of preventable major NCDs would occur globally by 2030 if the prevalence of physical inactivity does not change, with direct health-care costs of INT$520 billion. The global cost of inaction on physical inactivity would reach approximately $47·6 billion per year. Although 74% of new cases of NCDs would occur in low-income and middle-countries, high-income countries would bear a larger proportion (63%) of the economic costs. The cost of treatment and management of NCDs varied-although dementia accounted for only 3% of new preventable NCDs, the disease corresponded to 22% of all costs; type 2 diabetes accounted for 2% of new preventable cases but 9% of all costs; and cancers accounted for 1% of new preventable cases but 15% of all costs. INTERPRETATION: This health and economic burden of physical inactivity is avoidable. Further investments in and implementation of known and effective policy interventions will support countries to reach the Sustainable Development Goal of reduction of NCD mortality by 2030. FUNDING: None.

The Reality of Inadequate Patient Care and the Need for a Global Action Framework in Organ Donation and Transplantation.

BACKGROUND: Transplant therapy is considered the best and often the only available treatment for thousands of patients with organ failure that results from communicable and noncommunicable diseases. The number of annual organ transplants is insufficient for the worldwide need. METHODS: We elaborate the proceedings of the workshop entitled "The Role of Science in the Development of International Standards of Organ Donation and Transplantation," organized by the Pontifical Academy of Sciences and cosponsored by the World Health Organization in June 2021. RESULTS: We detail the urgency and importance of achieving national self-sufficiency in organ transplantation as a public health priority and an important contributor to reaching relevant targets of the United Nations Agenda for Sustainable Development. It details the elements of a global action framework intended for countries at every level of economic development to facilitate either the establishment or enhancement of transplant activity. It sets forth a proposed plan, by addressing the technical considerations for developing and optimizing organ transplantation from both deceased and living organ donors and the regulatory oversight of practices. CONCLUSIONS: This document can be used in governmental and policy circles as a call to action and as a checklist for actions needed to enable organ transplantation as treatment for organ failure.

Cancer burden and status of cancer control measures in fragile states: a comparative analysis of 31 countries.

BACKGROUND: Information on cancer statistics and cancer control policies is limited in fragile states. This paper describes the cancer burden and status of cancer control measures in these countries. METHODS: In this comparative analysis, fragile states presenting with a Fragile States Index (FSI) score of 90·0 or more (alert for fragility) for at least 10 years during the 2006-20 period were selected. States with fewer than 10 years of data were selected if they were in alert for fragility during all years. Information on cancer burden, prevalence of cancer risk factors, population-attributable fraction, and on political commitment, health financing, and health system capacity was collected. Cancer incidence and mortality was calculated on the basis of data from population-based cancer registries, estimated with modelling that used mortality-to-incidence ratios and incidence-to-mortality ratios derived from cancer registries in neighbouring countries, or average of rates in selected neighbouring countries. For statistical comparison, fragile states were grouped according to the annual percent change (APC) of the FSI, with group 1 showing an increasing fragility trend (APC 0·2% or higher), group 2 a relatively stable fragility trend (APC between 0·2% and -0·2%), and group 3 a decreasing fragility trend (APC of -0·2% or lower). FINDINGS: Overall, the estimated cancer burden in the 31 selected fragile states was lower than worldwide rates, except for cervical and prostate cancer. Cancer cases were attributed to infections (22·40% in group 1, 21·20% in group 2, and 18·80% in group 3) at a higher proportion in fragile states than globally (13·0%). Group 1 and 2 showed a significantly higher exposure to household air pollution (97·70% in group 1 and 94·90% in group 2), whereas current tobacco use in men increased from group 1 to group 3, with lung cancer incidence and mortality being higher in group 3. However, 25 countries had implemented only one or no MPOWER measures for tobacco control. Countries showed an out-of-pocket expenditure of 48·72% in group 1, 42·68% in group 2, and 51·07% in group 3, and only half of the countries had an updated cancer control plan or cancer management guidelines. INTERPRETATION: Fragile states have started the epidemiological transition but are still not implementing enough cancer control measures. There is a need to develop reliable cancer control plans and guidelines, and to create financial mechanisms for implementation. FUNDING: None. TRANSLATIONS: For the Arabic and French translations of the abstract see Supplementary Materials section.

Cancer Medicines: What Is Essential and Affordable in India?

PURPOSE: The WHO essential medicines list (EML) guides selection of drugs for national formularies. Here, we evaluate which medicines are considered highest priority by Indian oncologists and the extent to which they are available in routine practice. METHODS: This is a secondary analysis of an electronic survey developed by the WHO EML Cancer Medicine Working Group. The survey was distributed globally using a hierarchical snowball method to physicians who prescribe systemic anticancer therapy. The survey captured the 10 medicines oncologists considered highest priority for population health and their availability in routine practice. RESULTS: The global study cohort included 948 respondents from 82 countries; 98 were from India and 67 were from other low- and middle-income countries. Compared with other low- and middle-income countries, the Indian cohort was more likely to be medical oncologist (70% v 31%, P < .001) and work exclusively in the private health system (52% v 17%, P < .001). 14/20 most commonly selected medicines were conventional cytotoxic drugs. Universal access to these medicines was reported by a minority of oncologists; risks of significant out-of-pocket expenditures for each medicine were reported by 19%-58% of oncologists. Risk of catastrophic expenditure was reported by 58%-67% of oncologists for rituximab and trastuzumab. Risks of financial toxicity were substantially higher within the private health system compared with the public system. CONCLUSION: Most high-priority cancer medicines identified by Indian oncologists are generic chemotherapy agents that provide substantial improvements in survival and are already included in WHO EML. Access to these treatments remains limited by major financial burdens experienced by patients. This is particularly acute within the private health system. Strategies are urgently needed to ensure that high-quality cancer care is affordable and accessible to all patients in India.

Essential medicines list in national cancer control plans: a secondary analysis from a global study.

With the advent of innovative therapeutics for and the rising costs of cancer management, low-income and middle-income countries face increasing challenges to deliver effective and sustainable health care. Understanding of how countries are selecting and prioritising essential cancer interventions is poor, including in the formulation of policies for essential medicines. We did an in-depth subanalysis from a global dataset of national cancer control plans (NCCPs), aiming to identify possible determinants of inclusion of policies related to essential medicines in the NCCP. The results showed poor global comprehensiveness of NCCPs, and substantial deficits in policies for financial hardships due to cancer care, specifically for access to cancer medicines. Specification of budget allocations, policy of protection from catastrophic health expenditure, and national treatment guidelines in the NCCPs contributed to more consistent policies on essential cancer medicines. The bedrock to deliver effective cancer programmes resides in the assurance of comprehensive, consistent, and coherent policy formulation, to orient resource selection and health investments, ultimately delivering equitable health for all.

National health system characteristics, breast cancer stage at diagnosis, and breast cancer mortality: a population-based analysis.

BACKGROUND: In some countries, breast cancer age-standardised mortality rates have decreased by 2-4% per year since the 1990s, but others have yet to achieve this outcome. In this study, we aimed to characterise the associations between national health system characteristics and breast cancer age-standardised mortality rate, and the degree of breast cancer downstaging correlating with national age-standardised mortality rate reductions. METHODS: In this population-based study, national age-standardised mortality rate estimates for women aged 69 years or younger obtained from GLOBOCAN 2020 were correlated with a broad panel of standardised national health system data as reported in the WHO Cancer Country Profiles 2020. These health system characteristics include health expenditure, the Universal Health Coverage Service Coverage Index (UHC Index), dedicated funding for early detection programmes, breast cancer early detection guidelines, referral systems, cancer plans, number of dedicated public and private cancer centres per 10 000 patients with cancer, and pathology services. We tested for differences between continuous variables using the non-parametric Kruskal-Wallis test, and for categorical variables using the Pearson χ2 test. Simple and multiple linear regression analyses were fitted to identify associations between health system characteristics and age-standardised breast cancer mortality rates. Data on TNM stage at diagnosis were obtained from national or subnational cancer registries, supplemented by a literature review of PubMed from 2010 to 2020. Mortality trends from 1950 to 2016 were assessed using the WHO Cancer Mortality Database. The threshold for significance was set at a p value of 0·05 or less. FINDINGS: 148 countries had complete health system data. The following variables were significantly higher in high-income countries than in low-income countries in unadjusted analyses: health expenditure (p=0·0002), UHC Index (p<0·0001), dedicated funding for early detection programmes (p=0·0020), breast cancer early detection guidelines (p<0·0001), breast cancer referral systems (p=0·0030), national cancer plans (p=0·014), cervical cancer early detection programmes (p=0·0010), number of dedicated public (p<0·0001) and private (p=0·027) cancer centres per 10 000 patients with cancer, and pathology services (p<0·0001). In adjusted multivariable regression analyses in 141 countries, two health system characteristics were significantly associated with lower age-standardised mortality rates: higher UHC Index levels (ß=-0·12, 95% CI -0·16 to -0·08) and increasing numbers of public cancer centres (ß=-0·23, -0·36 to -0·10). These findings indicate that each unit increase in the UHC Index was associated with a 0·12-unit decline in age-standardised mortality rates, and each additional public cancer centre per 10 000 patients with cancer was associated with a 0·23-unit decline in age-standardised mortality rate. Among 35 countries with available breast cancer TNM staging data, all 20 that achieved sustained mean reductions in age-standardised mortality rate of 2% or more per year for at least 3 consecutive years since 1990 had at least 60% of patients with invasive breast cancer presenting as stage I or II disease. Some countries achieved this reduction without most women having access to population-based mammographic screening. INTERPRETATION: Countries with low breast cancer mortality rates are characterised by increased levels of coverage of essential health services and higher numbers of public cancer centres. Among countries achieving sustained mortality reductions, the majority of breast cancers are diagnosed at an early stage, reinforcing the value of clinical early diagnosis programmes for improving breast cancer outcomes. FUNDING: None.

Access to cancer medicines deemed essential by oncologists in 82 countries: an international, cross-sectional survey.

BACKGROUND: The WHO Essential Medicines List (EML) identifies priority medicines that are most important to public health. Over time, the EML has included an increasing number of cancer medicines. We aimed to investigate whether the cancer medicines in the EML are aligned with the priority medicines of frontline oncologists worldwide, and the extent to which these medicines are accessible in routine clinical practice. METHODS: This international, cross-sectional survey was developed by investigators from a range of clinical practice settings across low-income to high-income countries, including members of the WHO Essential Medicines Cancer Working Group. A 28-question electronic survey was developed and disseminated to a global network of oncologists in 89 countries and regions by use of a hierarchical snowball method; each primary contact distributed the survey through their national and regional oncology associations or personal networks. The survey was open from Oct 15 to Dec 7, 2020. Fully qualified physicians who prescribe systemic anticancer therapy to adults were eligible to participate in the survey. The primary question asked respondents to select the ten cancer medicines that would provide the greatest public health benefit to their country; subsequent questions explored availability and cost of cancer medicines. Descriptive statistics were used to compare access to medicines between low-income and lower-middle-income countries, upper-middle-income countries, and high-income countries. FINDINGS: 87 country-level contacts and two regional networks were invited to participate in the survey; 46 (52%) accepted the invitation and distributed the survey. 1697 respondents opened the survey link; 423 were excluded as they did not answer the primary study question and 326 were excluded because of ineligibility. 948 eligible oncologists from 82 countries completed the survey (165 [17%] in low-income and lower-middle-income countries, 165 [17%] in upper-middle-income countries, and 618 [65%] in high-income countries). The most commonly selected medicines were doxorubicin (by 499 [53%] of 948 respondents), cisplatin (by 470 [50%]), paclitaxel (by 423 [45%]), pembrolizumab (by 414 [44%]), trastuzumab (by 402 [42%]), carboplatin (by 390 [41%]), and 5-fluorouracil (by 386 [41%]). Of the 20 most frequently selected high-priority cancer medicines, 19 (95%) are currently on the WHO EML; 12 (60%) were cytotoxic agents and 13 (65%) were granted US Food and Drug Administration regulatory approval before 2000. The proportion of respondents indicating universal availability of each top 20 medication was 9-54% in low-income and lower-middle-income countries, 13-90% in upper-middle-income countries, and 68-94% in high-income countries. The risk of catastrophic expenditure (spending >40% of total consumption net of spending on food) was more common in low-income and lower-middle-income countries, with 13-68% of respondents indicating a substantial risk of catastrophic expenditures for each of the top 20 medications in lower-middle-income countries versus 2-41% of respondents in upper-middle-income countries and 0-9% in high-income countries. INTERPRETATION: These data demonstrate major barriers in access to core cancer medicines worldwide. These findings challenge the feasibility of adding additional expensive cancer medicines to the EML. There is an urgent need for global and country-level policy action to ensure patients with cancer globally have access to high priority medicines. FUNDING: None.

Impact of Strategies for Mitigating Delays and Disruptions in Cancer Care Due to COVID-19: Systematic Review.

PURPOSE: Delays and disruptions in health systems because of the COVID-19 pandemic were identified by a previous systematic review from our group. For improving the knowledge about the pandemic consequences for cancer care, this article aims to identify the effects of mitigation strategies developed to reduce the impact of such delays and disruptions. METHODS: Systematic review with a comprehensive search including formal databases, cancer and COVID-19 data sources, gray literature, and manual search. We considered clinical trials, observational longitudinal studies, cross-sectional studies, before-and-after studies, case series, and case studies. The selection, data extraction, and methodological assessment were performed by two independent reviewers. The methodological quality of the included studies was assessed by specific tools. The mitigation strategies identified were described in detail and their effects were summarized narratively. RESULTS: Of 6,692 references reviewed, 28 were deemed eligible, and 9 studies with low to moderate methodological quality were included. Five multiple strategies and four single strategies were reported, and the possible effects of mitigating delays and disruptions in cancer care because of COVID-19 are inconsistent. The only comparative study reported a 48.7% reduction observed in the number of outpatient visits to the hospital accompanied by a small reduction in imaging and an improvement in radiation treatments after the implementation of a multiple organizational strategy. CONCLUSION: The findings emphasize the infrequency of measuring and reporting mitigation strategies that specifically address patients' outcomes and thus a scarcity of high-quality evidence to inform program development. This review reinforces the need of adopting standardized measurement methods to monitor the impact of the mitigation strategies proposed to reduce the effects of delays and disruptions in cancer health care because of COVID-19.

Delays and Disruptions in Cancer Health Care Due to COVID-19 Pandemic: Systematic Review.

PURPOSE: There has been noteworthy concern about the impact of COVID-19 pandemic on health services including the management of cancer. In addition to being considered at higher risk for worse outcomes from COVID-19, people with cancer may also experience disruptions or delays in health services. This systematic review aimed to identify the delays and disruptions to cancer services globally. METHODS: This is a systematic review with a comprehensive search including specific and general databases. We considered any observational longitudinal and cross-sectional study design. The selection, data extraction, and methodological assessment were performed by two independent reviewers. The methodological quality of the studies was assessed by specific tools. The delays and disruptions identified were categorized, and their frequency was presented. RESULTS: Among the 62 studies identified, none exhibited high methodological quality. The most frequent determinants for disruptions were provider- or system-related, mainly because of the reduction in service availability. The studies identified 38 different categories of delays and disruptions with impact on treatment, diagnosis, or general health service. Delays or disruptions most investigated included reduction in routine activity of cancer services and number of cancer surgeries; delay in radiotherapy; and delay, reschedule, or cancellation of outpatient visits. Interruptions and disruptions largely affected facilities (up to 77.5%), supply chain (up to 79%), and personnel availability (up to 60%). CONCLUSION: The remarkable frequency of delays and disruptions in health care mostly related to the reduction of the COVID-19 burden unintentionally posed a major risk on cancer care worldwide. Strategies can be proposed not only to mitigate the main delays and disruptions but also to standardize their measurement and reporting. As a high number of publications continuously are being published, it is critical to harmonize the upcoming reports and constantly update this review.

Analysis of Mammography Screening Schedules under Varying Resource Constraints for Planning Breast Cancer Control Programs in Low- and Middle-Income Countries: A Mathematical Study.

Background. Low-and-middle-income countries (LMICs) have higher mortality-to-incidence ratio for breast cancer compared to high-income countries (HICs) because of late-stage diagnosis. Mammography screening is recommended for early diagnosis, however, the infrastructure capacity in LMICs are far below that needed for adopting current screening guidelines. Current guidelines are extrapolations from HICs, as limited data had restricted model development specific to LMICs, and thus, economic analysis of screening schedules specific to infrastructure capacities are unavailable. Methods. We applied a new Markov process method for developing cancer progression models and a Markov decision process model to identify optimal screening schedules under a varying number of lifetime screenings per person, a proxy for infrastructure capacity. We modeled Peru, a middle-income country, as a case study and the United States, an HIC, for validation. Results. Implementing 2, 5, 10, and 15 lifetime screens would require about 55, 135, 280, and 405 mammography machines, respectively, and would save 31, 62, 95, and 112 life-years per 1000 women, respectively. Current guidelines recommend 15 lifetime screens, but Peru has only 55 mammography machines nationally. With this capacity, the best strategy is 2 lifetime screenings at age 50 and 56 years. As infrastructure is scaled up to accommodate 5 and 10 lifetime screens, screening between the ages of 44-61 and 41-64 years, respectively, would have the best impact. Our results for the United States are consistent with other models and current guidelines. Limitations. The scope of our model is limited to analysis of national-level guidelines. We did not model heterogeneity across the country. Conclusions. Country-specific optimal screening schedules under varying infrastructure capacities can systematically guide development of cancer control programs and planning of health investments.

Core elements of national cancer control plans: a tool to support plan development and review.

When developed and implemented effectively, national cancer control plans (NCCPs) improve cancer outcomes at the population level. However, many countries do not have a high-quality, operational NCCP, contributing to disparate cancer outcomes globally. Until now, a standard reference of NCCP core elements has not been available to guide development and evaluation across diverse countries and contexts. In this Policy Review, we describe the methods, process, and outcome of an initiative to develop an itemised and evidence-based comprehensive checklist of core elements for NCCP formulation. The final list provides a ready-to-use guide to support NCCP development and to facilitate internal and external critical appraisal of existing NCCPs for countries of all income levels and settings. Governments, policy makers, and stakeholders can utilise this checklist, while considering their own unique contexts and priorities, from the drafting through to the implementation of NCCPs.

Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies.

Importance: High costs and risks of research and development (R&D) have been used to justify the high prices of cancer drugs. However, what the return on R&D investment is, and by extension what a justifiable price might be, is unclear. Objective: To compare incomes from the sales of cancer drugs with the estimated R&D costs. Design, Setting, and Participants: This observational study used global pharmaceutical industry sales data to quantify the cumulative incomes generated from the sales of cancer drugs for companies that have held patents or marketing rights (originator companies). All cancer drugs approved by the US Food and Drug Administration from 1989 to 2017 were identified from the United States Food and Drug Administration's website and literature. Itemized product sales data were extracted from the originator companies' consolidated financial reports. For drugs with data missing in specific years, additional data was sought from other public sources, or where necessary, estimated values from known reported values. Drugs were excluded if there were missing data for half or more of the years since approval. Data analysis was conducted from May 2018 to October 2018. Main Outcomes and Measures: Sales data were expressed in 2017 US dollars with adjustments for inflation. Cumulative incomes from the sales of these drugs were compared against the R&D costs estimated in the literature, which had been adjusted for the costs of capital and trial failure (risk adjusted). Results: Of the 156 US Food and Drug Administration-approved cancer drugs identified, 99 drugs (63.5%) had data for more than half of the years since approval and were included in the analysis. There was a median of 10 years (range, 1-28 years) of sales data with 1040 data points, 79 (7.6%) of which were estimated. Compared with the total risk-adjusted R&D cost of $794 million (range, $2827-$219 million) per medicine estimated in the literature, by the end of 2017, the median cumulative sales income was $14.50 (range, $3.30-$55.10) per dollar invested for R&D. Median time to fully recover the maximum possible risk-adjusted cost of R&D ($2827 million) was 5 years (range, 2-10 years; n = 56). Cancer drugs continued to generate billion-dollar returns for the originator companies after the end-of-market exclusivity, particularly for biologics. Conclusions and Relevance: Cancer drugs, through high prices, have generated returns for the originator companies far in excess of possible R&D costs. Lowering prices of cancer drugs and facilitating greater competition are essential for improving patient access, health system's financial sustainability, and future innovation.

Cancer Control at the District Hospital Level in Sub-Saharan Africa: An Educational and Resource Needs Assessment of General Practitioners.

PURPOSE: The WHO framework for early cancer diagnosis highlights the need to improve health care capacity among primary care providers. In Rwanda, general practitioners (GPs) at district hospitals (DHs) play key roles in diagnosing, initiating management, and referring suspected patients with cancer. We sought to ascertain educational and resource needs of GPs to provide a blueprint that can inform future early cancer diagnosis capacity-building efforts. METHODS: We administered a cross-sectional survey study to GPs practicing in 42 Rwandan DHs to assess gaps in cancer-focused knowledge, skills, and resources, as well as delays in the referral process. Responses were aggregated and descriptive analysis was performed to identify trends. RESULTS: Survey response rate was 76% (73 of 96 GPs). Most responders were 25 to 29 years of age (n = 64 [88%]) and 100% had been practicing between 3 and 12 months. Significant gaps in cancer knowledge and physical exam skills were identified-88% of respondents were comfortable performing breast exams, but less than 10 (15%) GPs reported confidence in performing pelvic exams. The main educational resource requested by responders (n = 59 [81%]) was algorithms to guide clinical decision-making. Gaps in resource availability were identified, with only 39% of responders reporting breast ultrasound availability and 5.8% reporting core needle biopsy availability in DHs. Radiology and pathology resources were limited, with 52 (71%) reporting no availability of pathology services at the DH level. CONCLUSION: The current study reveals significant basic oncologic educational and resource gaps in Rwanda, such as physical examination skills and diagnostic tools. Capacity building for GPs in low- and middle-income countries should be a core component of national cancer control plans to improve accurate and timely diagnosis of cancer. Continuing professional development activities should address and focus on context-specific educational gaps, resource availability, and referral practice guidelines.

Defining priority medical devices for cancer management: a WHO initiative.

Medical devices are indispensable for cancer management across the entire cancer care continuum, yet many existing medical interventions are not equally accessible to the global population, contributing to disparate mortality rates between countries with different income levels. Improved access to priority medical technologies is required to implement universal health coverage and deliver high-quality cancer care. However, the selection of appropriate medical devices at all income and hospital levels has been difficult because of the extremely large number of devices needed for the full spectrum of cancer care; the wide variety of options within the medical device sector, ranging from small inexpensive disposable devices to sophisticated diagnostic imaging and treatment units; and insufficient in-country expertise, in many countries, to prioritise cancer interventions and to determine associated technologies. In this Policy Review, we describe the methods, process, and outcome of a WHO initiative to define a list of priority medical devices for cancer management. The methods, approved by the WHO Guidelines Review Committee, can be used as a model approach for future endeavours to define and select medical devices for disease management. The resulting list provides ready-to-use guidance for the selection of devices to establish, maintain, and operate necessary clinical units within the continuum of care for six cancer types, with the goal of promoting efficient resource allocation and increasing access to priority medical devices, particularly in low-income and middle-income countries.