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STARK INEQUALITIES IN THE ACCESS TO THERAPY FOR WOMEN WITH BREAST CANCER. NEW FINDINGS FROM THE ONCOLLEGE-001 STUDY ILLUSTRATE THE GLOBAL BURDEN OF THE PROBLEM.

• ONCOLLEGE-001 is the first global survey on the availability, accessibility, and affordability of comprehensive treatments for women with breast cancer. 
• HER2-positive breast cancer is selected as a case study: essential HER2 diagnostics and anti-HER2 essential medicines are used as tracer interventions. The HER2 blocking antibody trastuzumab is listed on the WHO List of Essential Medicines. 
• Most respondents belong to low and middle-income countries (LMICs), so the recently published article provides unprecedented insights into access to therapies worldwide. 
• Immunohistochemistry of the HER2 receptor (HER2 IHC) is a broadly available molecular assay, though more commonly accessible in the private sector in LMICs, resulting in significant financial constraints for patients. 
• Targeted therapies directed to the receptor (trastuzumab and its biosimilars) are commonly available (>90%) but only accessible with significant financial distress for >20% of the patients.
• The study demonstrated an impact of the health insurance scheme reimbursement coverage on the chance of affordable access to treatments.

Breast cancer is the leading cause of morbidity, mortality, and disability for women worldwide. Based on the last global estimates, > 2 million new cases and half million deaths occurred in 2020 related to breast cancer. The global sharing of the breast cancer burden weighs mainly on low- and middle-income countries (LMICs), where 60% of the diagnosis and three-quarters of the deaths are reported.  In LMICs, life expectancy for breast cancer is dismal and poorer than in high-income settings due to several barriers to timely and affordable access to diagnostic and therapeutic interventions. ONCOLLEGE-001 is the first survey to investigate the access to breast cancer treatments on the global scale, exploring key elements of the cancer continuum: pathology services and treatments. HER2-positive breast cancer was used as a case study for the consolidated therapeutic algorithms for diagnostics and treatment. 

"The survey was possible only with the support of the oncologists from all the world, affiliated to the ONCOLLEGE network of cancer providers. These Colleagues deserve our sincerest appreciation because they drove this research. By their help, this project could deliver global voices on a public health issue incredibly impacting women's lives, their families, and other collateral persons." - summarized by the senior author Dr. Shah, a practicing clinical oncologist from Pakistan and serves the BINOR Hospital in Bannu. 

ONCOLLEGE-001 captured data from providers of all the income-areas, and across several countries in the world. While no misalignment from the evidence-based clinical practice was reported, the responders addressed major issues in the affordable access to pathology services, including molecular diagnostics. Unaffordability of HER2 immunohistochemistry – a basic pathology procedure for breast cancer and more sophisticated molecular assays- was a common barrier to cancer care, reported in a third of oncologists from low to lower-middle income countries. 

"The idea that breast cancer patients face financial difficulties (even bankruptcy) in order to obtain basic information about breast cancer patterns is simply not acceptable. While patient's journey to access to cancer care is tortuous in low- and middle- income countries, and commonly sorrowful for low-income patients in all the world, we must advocate as one voice to get access to the essential interventions to all", echoed Dr. Sara Altuna. She is a medical oncologist from Caracas, and ESMO-2019 recipient of a merit award, that permitted her to join the ESMO annual meeting in Barcelona, and present the preliminary findings of the research in an oral discussion session. Nearly 10% of the responders had no access to trastuzumab, mainly in Latin America and African Sub-Saharan countries. However, the availability of trastuzumab was not an assurance of accessibility. More than a third of the responders reported partial or total co-payments from patients, with significant catastrophic health expenditure. 

"We live in a world that favors innovation and top technology achievements, and praises the advent of major scientific discoveries. Nevertheless, we are very far from achieving equitable access to therapies. We should focus more on achieving uniform access to basic treatments, when essential medicines and sophisticated diagnostics are not available to the majority of patients in need, there is much to do…" - stated Dr. Lengyel and Dr. Trapani, both oncologists, who co-led this global effort. "If we think that widespread, sustainable and affordable access to therapies and diagnostics simply occurs because some regulatory body, we are very far from the truth." The investigators also addressed specific healthcare settings outside the primary scope of the research but inevitably captured and reported by multiple responders. The humanitarian crisis and other war settings were addressed as priority areas of cancer care, chronically neglected and for which minor consideration is commonly provided. 

"Humanitarian crises have impacted on the settings of our clinical practice: this is just obvious. The consequences of conflicts are carved for decades in health systems, and expose patients to more vulnerability; sometimes, quality public services and reference hospitals are targets of armed attacks. But it is more than this: when the procurement chain disrupted, it leads to the proliferation of non-quality pathways for drug procurement and the emergence of substandard medical goods. Desperation in humanitarian crisis settings is the fertile ground of medical crimes, for example, counterfed and falsified medicines. Building back better for us is a priority and deserves the greatest attention from the decision-makers," specified Dr. Habeeb and Dr. Hussain, both oncologists belonging to the Middle-Eastern Mediterranean area of the world. Dr. Habeeb is chair of an oncology department in Erbil and reported personal experience in the setting of war. Dr Hussain is a global oncologist who has worked in multiple countries, now established in the UK, who has a policy and research interest for cancer care in war settings. 

But solutions have been portrayed. Cooperation with cancer-pertinent non-governmental organizations and other civil society stakeholders, including patient advocacy, has been highlighted as a key mechanism to change the status quo. 

"I don't have many doubts on this, as a medical oncologist: working for patients' rights and access to therapy can only work with patients' involvement. There is a motto I love to report: 'not for us, without us'. In my clinical practice, I learned that a shared decision is a bedrock for solid patient care. I don't understand why we should not consolidate such a paradigm in public health?" suggested Dr. Petrillo, a medical oncologist with expertise in GI tumors from Naples, and Dr. Mazher, a hospitalist oncologist from the USA, who is originally from Pakistan. 

"Assuring the access to the best diagnostics and therapeutics must be a priority for decisions makers: we want the best health interventions for our patients, it is time for universal healthcare – no more poverty must impact on clinical decisions, we advocate for global standards and health to all" reported Dr. El Bairi, a physician-researcher from Morocco, and Dr. Elfaham, a practicing oncologist from Alexandria-Egypt, now working also in Kuwait. 

"In the race for innovation, we must value the best medicines and help to consolidate access for all. The COVID19 pandemic taught us that accelerated scientific progress can positively impact health and dramatically change the disease trajectories of lethal health conditions of major public health interest. Well, breast cancer is clearly one of those diseases, and we must work to consolidate affordable access to all women, including the best innovative treatments" closed prof Curigliano, from Milan. 

As the World Health Organization has launched a Global Initiative for Breast cancer in March 2021, it is clear that there is much work to do and help to offer.

"Raising global voices, underlining neglected areas of cancer care, inform policy with global studies and advocate for patients with cancer is our commitment. The ONCOLLEGE network of cancer providers is the key, to us. We hope that our survey will help policy-makers better understand the status quo and provide actions to serve health for all", asserted Dr. Shah from Pakistan, in a powerful call to action. 

See the full research at: https://www.sciencedirect.com/science/article/pii/S2213538321000163.  

Milan – Budapest – Erbil – Caracas – Naples – Oujda – Londonderry– Dallas – Alexandria - Bannu, 29 April 2021.

Media contact information: global.oncollege@gmail.com