AstraZeneca logo

Navigating the Next Frontier of Precision Medicine Oncology – Challenges and Opportunities amid Covid-19 and Beyond

By: The Economist – October 7, 2020

Challenges and Opportunities amid Covid-19 and Beyond

The Covid-19 pandemic has exposed the vulnerabilities and inequities of the global healthcare system, but it could also catalyze overdue transformative change. As the virus began circulating widely in many countries, demand for hospital beds and other resources strained many systems—and the consequences were quickly felt by patient populations struggling with other serious challenges, including cancer. 55 percent of countries experienced partial or severe disruptions to cancer diagnosis and screening services, according to an August survey by the World Health Organization (WHO).[1]

With so many resources diverted to fight the novel coronavirus, cancer care was greatly impacted[2], delaying treatments and even halting many clinical trials. Covid-19’s impact on provision of services for cancer patients raises important questions about the ability of health systems to deliver timely and effective treatments. It also underscores what more we need to do to achieve the full promise of precision medicine, which has proven benefit in cancer care. Critical challenges hindering the development of precision medicine oncology predate Covid-19. But with the pandemic highlighting the urgent need for interdisciplinary cooperation on common health challenges and accelerating the evolution of care delivery vis a vis technology, some obstacles could become easier to overcome in a post-COVID world.

 

Challenges

The key barriers to maximizing precision medicine’s potential lie in the realms of policy and governance, and less in science and technology. That’s the consensus opinion this year from the World Economic Forum’s Global Precision Medicine Council, comprised of experts from across the healthcare landscape.[3] They see five major challenges facing the development of diagnostic, therapeutic and preventive precision tools to fight cancer and other diseases.

Responding to the Covid-19 pandemic requires thought leaders working at the intersection of public health and medicine to collectively increase public awareness and appreciation of precision medicine and delineate the challenges that complicate its broad adoption. Clinicians, researchers, industry executives, patient advocates and payers each have a role in explaining its benefits to both policymakers and the public, especially when it comes to addressing the needs of patients with cancer and other diseases for which precision medicine is transforming the standard of care.

Edward Abrahams, PhDPresident of Personalized Medicine Coalition

The first is data sharing and interoperability. Tools offering treatments geared to a patient’s genetic profile can only emerge on a population-level scale if data sets are standardized and shared on a global scale among all key stakeholders—providers, payers, academic researchers and national health programs, for example. The big data challenge has grown with the ease of sequencing DNA from tumors and the falling cost of sequencing entire genomes.[4] Data sharing is happening among stakeholders, but initiatives often lack interoperability and therefore scalability, delaying valuable innovations.[5]

But a truly global database compiling health, environmental and genomic information is impossible without patients’ trust and engagement. This is the second challenge: ensuring genetic privacy and preventing genetic discrimination to accelerate data gathering. Part of this necessarily involves increasing the general public’s awareness of and comfort with genomics. People want to know who has access to their genetic data and who benefits from its use—and they deserve clear and honest answers. A third, and related challenge involves the appropriate use of oncology-related precision medicine technologies. The potential benefits of biomarker tests for inherited cancer risks, for example, are vast. But if such tests fail to be implemented consistently in clinical practice, the distribution of benefits will be unjust and health disparities could widen. [6]

The Covid-19 pandemic has not only led to alarming reductions in cancer diagnosis, but also to a substantial reduction in biomarker testing, which is often needed to determine the right course of therapy for many common cancers. As such, particularly during times of extraordinary need, ensuring broader and more equitable access to precision medicines and associated biomarker tests – for every patient who stands to benefit – requires greater cooperation and collaboration from organizations working across the full spectrum of oncology care.

Seth Feldman, Head of US Oncology Precision Medicine & Nurse Education at AstraZeneca

Other issues of concern involve informed consent, so that research participants understand the implications and risks of trials they are part of, and inclusiveness of study populations, so the value of treatments is not limited. As of last year, about 80 percent of participants in genomic studies have had European ancestry. [7] In the U.S., the National Institutes of Health (NIH)’s All of Us research program addresses this problem. [8] Launched in 2018, the program aims to gather genetic data and other health information from 1 million people to build a racially and ethnically diverse database. As of last year, more than 80 percent of participants were from groups underrepresented in biomedical research. [9]

Accessibility of treatments, of course, also relates to  perceived value and reimbursements. In the absence of overwhelming evidence of effectiveness, few private insurance companies or government payers currently reimburse broad-based genomic testing and analysis, slowing their entry into clinical practice. [10] Improved global standards for diagnostics pricing models [11] —and more generally, the shift toward value-based pricing and reimbursement models—could enhance the value of precision medicine oncology. The U.S. Department of Health and Human Services’ decision earlier this year to expand coverage of Next Generation Sequencing (NGS) diagnostic tests for Medicare patients with inherited breast or ovarian cancer bodes well. [12]

This segues to the final major challenge facing this area of cancer treatment innovation: the need for more responsive regulatory systems. Some regulatory bodies, such as the U.S. Food and Drug Administration, have evolved over the last decade to meet the unique nature of pharmacogenomics. [13]But overall, the regulatory landscape governing complex precision medicine products and services remains complicated. Tension remains between traditional safety and efficacy frameworks involving large portions of the patient population, and precision medicine drugs targeting relatively small groups of patients with particular biomarkers. [14]

 

Opportunities

Broadly speaking, the Covid-19 pandemic threatens to reverse global health progress achieved over the last decade, as WHO has noted. [15]But in important ways, the global crisis could help overcome longstanding obstacles in the field of precision medicine oncology, accelerating innovation. The coronavirus’ dramatically different impacts on individuals, even in the absence of underlying conditions, is an opportunity to prove the value of precision diagnostic tests that identify those most at risk [16] The NIH’s expansion of data gathering in the All of Us program to better understand covid-19’s spread and impact may do just that. [17] The race against the virus could ultimately prove precision medicine’s power to target infectious diseases and cancers, crystalizing public support for (and regulatory responsiveness to) precision approaches. That would bode well for patient trust and engagement, and R&D.

Two other aspects of the current crisis could also help unlock precision medicine’s potential: the essential need for interdisciplinary cooperation among diverse healthcare stakeholders, and the broad recognition that covid-19 amplifies inequality. [18] This moment could marshal support for a truly global database supporting the development of precision medicine oncology—and more equitable access to and distribution of benefits as the field comes of age.

 

Conclusion

As a disease indiscriminate in its spread, but discriminant in its impact on already-vulnerable populations fighting other diseases like cancer, Covid-19 has served as a wake-up call for the need to embrace collaborative solutions to complex problems. Involving a broad range of stakeholders–from policymakers and healthcare professionals to researchers, payers and patient advocacy groups–is critical to discern mutual values, develop strategies to address shared challenges, promote common goals, and develop desired precision oncology outcomes.

Lastly, it is precisely in moments of crisis, like pandemics, that silver linings can present themselves and new opportunities can be seized. In light of this, what fundamental lessons can be taken from covid-19 to ensure the continuing drive for improvements in cancer care, building health system resilience and developing innovative cancer treatments?

As a continuation of this article, we will detail proposed solutions to these issues following our virtual roundtable on October 13, co-hosted by The Economist Group, Personalized Medicine Coalition and AstraZeneca. During the seminar, a number of oncology leaders will discuss interdisciplinary approaches and innovative strategies to effectively deliver valuable precision medicine oncology outcomes.

[1] WHO, “Pulse survey on continuity of essential health services during the COVID-19 pandemic“. August, 2020.

[2] Nature Cancer, “The impact of the COVID-19 pandemic on cancer care“. May, 2020.

[3] World Economic Forum, “Why precision medicine won’t transform healthcare – but governance could“, May, 2020.

[4] Genetics in Medicine, “The complete costs of genome sequencing: a microcosting study in cancer and rare diseases from a single center in the United Kingdom,” July 2019.

[5] World Economic Forum, “Precision Medicine Vision Statement: Governance Gap 1: Data sharing and interoperability“, May 2020.

[6] PMC, “Implementing Precision Medicine: The Ethical Challenges“, January 2018.

[7] Nature Human Behaviour, “Whose genomics?“, May 2019.

[8] National Institute of Health, “All of Us Research Program”, September 2020.

[9] The New England Journal of Medicine, “The All of Us Research Program”, August 2019.

[10] PMC, “The growing role of precision and personalized medicine for cancer treatment“, January 2019.

[11] World Economic Forum, “Precision Medicine Vision Statement: Governance Gap 1: Data sharing and interoperability“, May 2020.

[12] Centers for Medicare & Medicaid Services, “CMS Expands Coverage of Next Generation Sequencing as a Diagnostic Tool for Patients with Breast and Ovarian Cancer”, January 2020.

[13] PMC, “The growing role of precision and personalized medicine for cancer treatment: Table 6“, January 2019.

[14] Pharmaceutical Technology, “Precision medicine: what barriers remain?“, March 2020.

[15] WHO, “World Health Statistics 2020: Monitoring health for the SDGs“, May 2020.

[16] The Journal of Precision Medicine, “Personalized Medicine in the Aftermath of COVID-19“, March 2020.

[17] National Institutes of Health, “All of Us Research Program launches COVID-19 research initiatives”, June 2020.

[18] Washington State University, “COVID-19 Amplifies Inequality; We Must Do Better“, July 2020.