MARKET LANDSCAPE - The Future of Cancer Care Post-Pandemic: What Doctors, Patients, and the Healthcare Industry at Large Should Expect

INTRODUCTION

The future of the healthcare ecosystem for cancer patients from a post-pandemic perspective is complex. The COVID-19 pandemic saw failures in the healthcare delivery system not only in general medicine, but also specifically in oncology. At the same time, several opportunities came to light during such a difficult, frightening moment, bringing a number of large- and small-scale innovations forth.

While some areas of medicine will remain unaltered post-COVID, the unique nature of cancer research and cancer care delivery has ultimately been changed forever. As a result, here’s what doctors, patients, and the entire healthcare industry as a whole can and should expect for cancer care in the very near fu­ture:

THE REGULATORY ENVIRONMENT FOR APPROVING & AUTHORIZING NOVEL MEDICINES FOR THE MARKET WILL BE AFFECTED

From a regulatory perspective, it is becoming more apparent that a dichotomy is evolving between the liberalism of health au­thorities, such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), to provide emergency use authorizations for a number of anti-infective agents (specifically those having to do with COVID-19, including vaccines) and the reticence over the past year by the FDA to approve oncology agents.

This may be a temporary effect due to the recent change in the US administration, but there are already signs the regulatory environment for oncology agents may be stricter in the near fu­ture, with several recent agents under review at the FDA receiving seemingly unexpected Complete Response Letters (CRLs) that in­dicate the FDA has conducted a complete review but cannot ap­prove the application. We need to be vigilant as to whether this trend will continue.

Additionally, although the FDA is not able to regulate prices for drugs in the US, the overall pressure in the federal budget by various relief plans during the COVID-19 pandemic may be re­flected in some regulatory hesitancy in providing a torrent of new approvals. There may be a tendency for requesting more analysis of data and/or real-world evidence for not only the efficacy but also the real-world “effectiveness” of new anti-cancer therapies, especially in niche indications that are typically managed with very pricey novel therapies.

CANCER PATIENT “FLOW” & IMPLEMENTING CANCER SCREENINGS, DIAGNOSES & MANAGEMENT PLANS ARE STILL BEING IMPACTED BY COVID

The COVID-19 pandemic has slowed, or even temporarily stopped, access to standard, routine cancer screenings (eg, skin exams for melanoma, mammography for breast cancer, Pap smears for cervical cancer, etc) and raised barriers for patients who need to make initial visits for suspected cancer diagnostic work-ups, follow-ups, and monitoring for those who have a known cancer diagno­sis. This has led to delays in applying stan­dard therapies, especially when it comes to surgical oncology.

Therefore, there is a broad belief among the medical community that signif­icant underdiagnoses, misdiagnoses, or delayed diagnoses of cancer cases have occurred since March 2020. Conse­quently, post-COVID-19 – after most of society has been vaccinated and a satis­factory level of herd immunity has been reached – there is the possibility of seeing a marked increase in the volume of pa­tients who are seen in cancer practices, es­pecially in the community setting.

This will have a significant impact on hospital budgets, as well as general care expenses that will be submitted for reim­bursement at insurance carriers (Centers for Medicare and Medicaid Services and private insurers). It is possible we may see a period sometime in mid-2022, whereby there have been “unspent funds” in major insurance carriers’ budgets, which were specifically allocated for cancer care ex­penditures for several millions of “cov­ered” lives in the US. Thus, the reimbursement environment may be par­adoxically positive or elastic during this particular period.

However, once large volumes of pa­tients return and, furthermore, the percent­age of patients presenting for care ends up coming in with more advanced stages of malignancies (which are much more ex­pensive to manage), we may see intense efforts for cost containment and retrench­ment from the insurers’ standpoint, with increases in demands for prior authoriza­tions, more restricted drug formularies, and more stringent pathways of clinical care in oncology. Hence, access to novel agents and “expensive” cancer care (ex­tensive and complex cancer surgeries, stem cell transplants, etc) may lessen after mid-2022.

THERE IS INCREASED AWARENESS & RECEPTIVITY OF MRNA-BASED NOVEL TECHNOLOGIES/DRUGS

There is no doubt that both the public and other stakeholders in the healthcare ecosystem have been exposed to the po­tential of novel technologies that are RNA-based, considering the rapid and successful clinical development of mRNA-based anti-SARS-CoV-2 vaccines (eg, Pfizer/BioNTech, Moderna). This enthusi­asm is certainly shared by the investor community and, therefore, access to healthcare public and private investment capital for RNA-based technologies will in­crease.

The potential for growth in genomic and proteomic platforms for individualized patient care in cancer is clear. There may be a very specific halo effect regarding the development of RNA-based cancer vac­cines.

TRUE INNOVATION & ENTREPRENEURSHIP IN THE PHARMACEUTICAL & BIOTECH SECTORS ARE HERE TO STAY

From an innovation perspective, there has been an unprecedented speed of pro­gression in the anti-infective drug/vaccines arena with the Operation Warp Speed ini­tiative and the mobilization of huge re­sources at a global level, both from the government and private sectors.

However, the general environment of innovation support, both by governmental funding sources and the broader capital markets, remains uncertain for therapeutic areas other than anti-infectives/vaccines and antivirals. This uncertainty cuts across the board for smaller pharmaceutical and biotech companies, as well as the oncol­ogy portfolios of Big Pharma.

To some degree, the capital markets have been stronger than anyone would have anticipated, with the exception of the 2020 spring dip in the indices globally, but there is currently an overall cautious opti­mism in the general market. Whether this will continue unabated specifically in the healthcare sector remains to be seen.

TELEHEALTH IS AN ESTABLISHED TOOL FOR CANCER CARE & ADVANCED PRACTICE PROVIDERS ARE EVEN MORE CRITICAL

While telemedicine was introduced at least a decade ago, until the advent of the pandemic, its uptake had been slow and incremental. The pandemic turned that notion around rapidly, and now telemedi­cine is here to stay.

There is a broad belief that perhaps 40% to 50% of all office visits, even after the COVID-19 pandemic, will be done vir­tually through telemedicine. This brings into the foray the enhanced and crucial role of mid-level providers, or Advanced Practice Providers (APPs) in oncology, in­cluding Advanced Practice Registered Nurses (APRNs), Nurse Practitioners (NPs), Clinical Nurse Specialists (CNSs), Physi­cian Assistants (PAs), and Nurse Naviga­tors (NNs). The role of these professionals as “extenders” of surgical, radiation, and medical oncologists will become even more valuable and visible in the post-COVID-19 era across the entire cancer care ecosystem.

Along these lines, COVID-19 brought forth the need for patients to think about more self-care options. The pandemic forced patients to take more individual re­sponsibility for their care by being more in­ventive and solution-seeking (along with their caregivers) regarding how to best manage their disease.

PUBLIC DEMAND FOR TRANSPARENCY IN CANCER RESEARCH HAS INCREASED

During the pandemic, there has been a clarion call by the public – at a global scale – demanding more transparency and accountability among major organi­zations, such as the World Health Organi­zation’s (WHO) research in infectious diseases in general and clinical virology. This will create a halo effect in the cancer healthcare ecosystem as well, especially for organizations with increased global remit and influence – eg, the International Agency for Research on Cancer (IARC), an agency that is part of the WHO, as its proclamations and guidelines affect can­cer care at a global level.

There will also be a need for trans­parency at the regional and national level organizations with guidelines or policy-making authorities, along with govern­mental agencies, regulatory bodies, and state-level Medicaid.

This need for more transparency in many ways will affect perception of credi­bility and level of reputation and public trust of all the various innovation incuba­tors, both in academia and Big Pharma. On a global scale, there will be height­ened sensitivity in the way that certain av­enues of research, as well as key clinical and translational data, will be communi­cated to the public through all available channels, including FDA guidance docu­ments, presentations, and FDA advisory committee meetings.

This may also affect the way that in­dustry (both at the level of individual man­ufacturers and Pharmaceutical Research and Manufacturers of America as an or­ganization) and academic centers issue press releases in the media in their effort to communicate key findings and corpo­rate leadership decisions to investors, an­alysts, payers, patients, caregivers, and the public at large.

Post-COVID-19, the public will expect some degree of audacity from this long and diverse list of organizations to “tell the truth.” This may be a welcome change, as there are already indications that the ac­ceptability, popularity, and credibility of the pharmaceutical/biotech industry have al­ready modestly increased.

Further enhancement of transparency, especially by the drug manufacturers that are involved in developing novel medi­cines for cancer and publicly traded healthcare companies (eg, manufacturers of medical devices, various lab diagnostics and imaging agents, including radionuclides, manufactur­ers of generics and biosimilars, as well as hospital systems and healthcare insurance carriers) will help to translate innovation into long-term trust by the public, which can only be a positive outcome for the shareholders of these companies.

THE INDUSTRY IS BOTH ACCEPTING & EMBRACING NEW TECHNOLOGIES IN CANCER MEDICINE POST-COVID

There is no doubt the pandemic exposed decision-makers within the entire healthcare ecosystem to unprecedented levels of uncertainty, anxiety, false hope (eg, early data with hydroxy­chloroquine) or even desperation and decision-paralysis. On the other hand, one of the attitudes of these key decision-mak­ers that was profoundly affected by COVID is the level of readi­ness to use novel tools and solutions – from telehealth to the rapid deployment of special equipment, to novel patterns of healthcare delivery, to the development and successful market entry of vaccines based on the highly innovative mRNA technol­ogy.

Along these lines, 2020 was not only the year of COVID-19, but it was also the year of the Nobel Prize in Chemistry given to the discoverers of the CRISPR/Cas9 gene editing technologies and the spawning of several companies and academic groups that are currently working on the use of CRISPR/Cas9-based therapeutics for several diseases, including cancer.

This past year, we also witnessed a true explosion in mo­lecular novel biomarkers of tumors and progressively broader applicability of next-generation sequencing (NGS) technologies. Several of these innovations will pass regulatory barriers and translate into commercially available companion diagnostics. This trend will continue; however, how it will evolve exactly in the post-COVID-19 era remains unknown. We must wait and see how the entire cancer care ecosystem will transform itself in the near future.

In summary, in the post-COVID era, key aspects of health­care far beyond infectious disease will change – in many cases significantly and permanently. Subtle or not so subtle changes in attitudes, degree of knowledge, and understanding of the pandemic across all stakeholders (physicians, patients, payers, guideline- and policy-issuing bodies, pharmaceutical manufac­turers, regulatory authorities, various governmental organiza­tions and NGOs, as well as the sentiment of the healthcare in­vestor community) will continue to evolve.

Perhaps what looked familiar and ordinary in the pre-COVID-19 era will become only a memory, while some com­pletely novel and emerging patterns of societal and healthcare ecosystem stakeholder behaviors change across the board. We are already living during an era of transformation, which will lead to an altered environment. All of us involved in cancer re­search and oncology care will be witnessing and feeling these shifts.

This is a time of meta-stable milieu – an environment in transition – and we all have to be sensitive and vigilant during these shifts to ensure we avoid undesirable or unpredictable ef­fects from these changes. In other words, we don’t want to go down the wrong path. We need to have the courage and apti­tude, especially in the pharmaceutical and biotech industry, to steer the ship back to the right direction. This can only be done by continuous optimization, identification, and immediate cor­rection of errors of judgment, omission, and commission during these years of change.

Dr. Angelos Stergiou is the Founder, President, and Chief Executive Officer of SELLAS Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications. Prior to founding SELLAS in 2012, he co-founded Genesis Life Sciences, Ltd., a boutique health economics and pricing-reimbursement and health access company, where he served as President and Chief Operating Officer from 2009 to 2011. Dr. Stergiou has also previously held various leadership roles at a number of pharmaceutical and biotechnology companies, including PAION AG, Accentia Biopharmaceuticals, BioVest International, Analytica International, and Anavex Life Sciences, ranging from Head of Clinical Research and Vice President of Product Development to Chief Medical Officer and Chief Operations Officer.