The global landscape of availability, accessibility and affordability of essential diagnostics and therapeutics for the management of HER2-positive breast cancer: The ONCOLLEGE-001 survey
Introduction
The sustained rise of the global burden of cancer represents a major public health challenge for many low- and middle-income countries: according to the epidemiology projections, up to 24 million people are expected to have a diagnosis of cancer by 2050 [[1], [2], [3]]. Among them, 70 % of patients belong to low- and middle-income settings, where cancer- related outcomes are commonly poorer [1,2].
Disparities in breast cancer outcomes are largely related to unequal access to care [2]. Global discrepancies can be identified across the entire cancer continuum, embedded in the weaker resilience and preparedness of health systems to respond to the rising burden of cancer, that is more rapid in low- middle income than in high income countries (HIC) [2]. Inconsistent governance for national cancer planning along with insufficiencies of resources, inadequate investments in cancer and deficits of skilled workforce are some of the key determinants of the poorer outcome of patients, resulting in increasing inequalities when resources are constrained. 2
Breast cancer is the leading cause of mortality, disability, and morbidity among women, with more than 2 million of new cases and half million of deaths in 2020 [3]. According to the International Agency for Research on Cancer, 60 % of the new cases and 70 % of breast cancer- related deaths occur in low- and middle-income countries [3]. Life expectancy for patients diagnosed with breast cancer is variable, with poorer prognosis in some settings. In US, the average 5-year survival rate for women with invasive breast cancer is around 90 %; this rate increases at 99 %, when the disease is localized to the breast at diagnosis [4]. International differences still remain very wide, with survival rates as low as 40–70 % in lower- income settings [5].
Of all the diagnosed breast malignancies, up to one- quarter overexpresses the epidermal growth factor receptor 2 (HER2); no wide variability is described across populations [6]. The over- expression of HER2 is associated with a poorer prognosis and predicts benefit derived from the monoclonal antibody trastuzumab and its biosimilars, and other anti-HER2 agents [6].
The use of trastuzumab in patients with breast cancer has demonstrated to improve meaningfully the survival, both in early and advanced disease, as confirmed in multiple controlled studies and real-world evidence [7]. For the relevant benefit gained, trastuzumab is acknowledged by the European Society for Medical Oncology as a priority medicine, and scored as “A” (high priority) with the Magnitude of Clinical Benefit Scale (MCBS v1·1) for the use in the adjuvant setting [8]. For the valuable role in the management of breast cancer across different settings, trastuzumab, trastuzumab biosimilars and the HER2 pathology assays for breast cancer have been included in the essential lists of medicines (EML) and in-vitro diagnostics (EDL) of the World Health Organization (WHO) [9].
Although the access to the essential diagnostics and treatments for cancer patients is a priority worldwide, major challenges to provide affordable, quality cancer care still exist [10].
The aim of this work was to paint the global landscape of accessibility and affordability of essential HER2 testing and anti-HER2 treatments for breast cancer patients, with an emphasis on low- middle income countries.
Section snippets
Methodology of the survey
The authors developed a questionnaire to investigate accessibility, affordability, and reimbursement patterns of HER2 testing and anti-HER2 medicines for breast cancer. The authors excluded other indications of trastuzumab, for the narrower clinical benefit added, for example in gastric cancer – currently not considered an essential indication from WHO [11,12]. The questions were developed as multiple-choices or open responses. Possibility to provide comments and specifications was generally
Demography and distribution of the responders
Two-hundred twenty-seven emails were sent to clinicians working in an oncology setting, registered within the ONCOLLEGE network of healthcare providers and/or reached through snowballing [14]. The survey was compiled with all the information requested by 210 cancer providers. We only included responders who specified the country and the setting of care (n = 191/210), identified as cancer health providers; oncologists in training, residents and fellows were eligible. The responders were
Discussion
ONCOLLEGE-001 is the first study developed by cancer providers to cancer providers, to assess the global landscape of availability, accessibility, and affordability of both essential HER2 testing and anti- HER2 medicines. The survey painted a picture of wide variability, with gaps and insufficiencies more prominent in low- middle income countries. The results showed that the challenging journey of cancer patients may present obstacles since the diagnostic phase, potentially exposing the most
Contributors
The survey was originally developed by SZK, CGL and DT and refined with the inputs of all the authors. DT and CGL provided the data analyses; the interpretation and the presentation of the data was discussed by emails and tele- conferences and agreed as consensus by all the authors. KE added methodological support and guidance for data collection and their quality check. All the authors were actively involved in the diffusion of the survey to a selected audience of cancer health providers, led
Statement of DOI
GC has received honoraria from Pfizer, Novartis, Lilly, Roche and fees for expert testimony and medical education from Pfizer and has participated in advisory boards for Pfizer, Roche, Lilly, Novartis, Seattle Genetics, Celltrion. AP reported personal fees from Eli Lilly outside of the present work; CGL reported employment by Bristol-Myers Squibb (started after the data collection period and outside this work); all the other authors declare no potential conflicts of interest to disclose.
Funding statement
No finance resources were received for the present work.
Disclaimer
The contents of the present paper have been presented at ESMO Breast 2019 in Berlin (poster display) and ESMO meeting 2019 in Barcelona (poster display and oral discussion) – however this is the first time the data are presented comprehensively, including the survey on biosimilars of trastuzumab, never shared elsewhere. The authors belong to different institutions; however, the present paper does not mirror the position, value or perspectives of their institutions and must be regarded as
Acknowledgment
We thank all the colleagues in the world who gave consent to share their data and provided the responses – investing their time to support research in global oncology and global cancer policy. This contribution is of the highest value and deserves sincerest gratitude and recognition. Although not all the reviewers provided the consent to be acknowledged publicly, the ONCOLLEGE-001 project is made up of the multiple voices of global oncology and would never happen without all of them. As
References (36)
- et al.
Cancer burden in the year 2000. The global picture
Eur. J. Cancer
(2001) - et al.
Global surveillance of trends in cancer survival 2000–14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries
Lancet
(2018) - et al.
Access to pathology and laboratory medicine services: a crucial gap
Lancet
(2018) - et al.
Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
Lancet
(2010) - et al.
Pathology and laboratory medicine: the Cinderella of health systems
Lancet
(2018) - et al.
Cost-Effectiveness of Adjuvant Trastuzumab Therapy for Early Breast Cancer in Asia: A Systematic Review
Value Health Reg. Issues
(2019) - et al.
The Economic Impact of Switching to Trastuzumab Biosimilar for the Treatment of Metastatic Breast Cancer from a Chinese Payer Perspective
Value Health
(2018) - et al.
Knowledge and use of biosimilars in oncology: a survey by the European Society for Medical Oncology
ESMO Open
(2019) - et al.
ESMO International Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in countries outside of Europe
Ann. Oncol.
(2017) - et al.
ESMO European Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe
Ann. Oncol.
(2016)
The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer
Clin. Breast Cancer
Performance of Systems of Cancer Care in OECD Countries: Exploration of the Relation between Resources, Process Quality, Governance and Survival in Patients with Breast, Cervical, Colorectal and Lung Cancers
Global Cancer Observatory
Cancer statistics, 2019
CA Cancer J. Clin.
HER2 expression in breast cancer primary tumours and corresponding metastases. Original data and literature review
Br. J. Cancer
Trastuzumab containing regimens for early breast cancer
Cochrane Database Syst. Rev.
World Health Organization Model List of Essential Medicines, 21st List, 2019.
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2023, The Lancet Global HealthCitation Excerpt :This disparity particularly affects newer products, as these are sometimes not registered in LMICs, and non-communicable diseases (NCDs) for which the majority of essential biotherapeutics are indicated.2,3 This inequity earlier resulted, according to some studies, in some patients from LMICs being left behind as treatments that markedly improve survival in some high-burden conditions (such as HER2 [also known as ERBB2]-positive breast cancer) took a long time to be integrated into public health systems and be scaled up.4–6 This unequal availability of essential medicines might be one of the contributing factors to the lower reduction of premature deaths from cancer observed between 2010 and 2015 in low-income countries (5%) compared with high-income countries (20%), reflecting the global inequality in access to care observed across non-communicable diseases and biotherapeutics.7
Global challenges and policy solutions in breast cancer control
2022, Cancer Treatment ReviewsCitation Excerpt :Essential elements for breast cancer pathology includes the accurate determination of hormone receptor status, to inform the prognosis and tailor treatment options. Disparities deepen when considering molecular pathology, that is increasingly important in prognostication and treatment decision-making [34]. The landscape of access to cancer treatments is similarly heterogeneous [37,38].
The Global Landscape on the Access to Cancer Medicines for Breast Cancer: The ONCOLLEGE Experience
2023, Cancer Treatment and Research
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Contributed equally.