Introduction

The Individual, Social, and Economic Costs of Cancer

The Importance of Early Cancer Detection

The Promise of Multi-Cancer Early Detection Technologies

The Regulatory and Coverage Environment for MCED

Conclusion

Endnotes

Introduction

Cancer remains one of humanity’s most intractable diseases, and is expected to surpass heart disease as the leading annual cause of American fatalities by 2030. The individual, social, and economic costs cancer inflict are enormous, meaning the need for both effective cancer screening and therapeutic options remains paramount. Fortunately, a new slate of biological and informational technologies—including genome sequencing, big data analytics, artificial intelligence/machine learning (AI/ML), and nanotechnology—are enabling breakthrough innovations in cancer detection and treatment.

In detection, blood-based approaches hold the potential to screen for signals of over 50 cancers simultaneously with a very high rate of accuracy and the ability to trace the detected cancer to its likely tissue of origin with a high degree of confidence. Multi-cancer early detection (MCED) screening holds the promise to radically expand the number of cancers for which there are available screening options and to broaden cancer detection to the asymptomatic population. It heralds a potential paradigm shift from trying to treat cancer in later stages to detecting and treating the disease in its earliest ones. But if the promise of multi-cancer early detection screening approaches is to be realized, policymakers will have to get the regulatory and coverage policies right to support deployment and uptake of this transformative technology.

Multi-cancer early detection (MCED) screening holds the promise to radically expand the number of cancers for which there are available screening options and to broaden cancer detection to the asymptomatic population.

This report begins by examining the social and economic costs cancer inflicts. It discusses the importance of early cancer detection and moves on to an exploration of how MCED technologies work, evidence of their effectiveness to date, the benefits they are capable of providing, and why it’s important the United States remain the global leader in this field. It then analyzes the regulatory and coverage environment before concluding by providing recommendations for how policymakers can enact policies enabling this transformative technology to flourish, including by passing legislation creating a pathway to ensure timely Medicare coverage of MCED screening exams.

The Individual, Social, and Economic Costs of Cancer

Cancer refers to a group of diseases characterized by the uncontrolled growth and spread of abnormal cells.[1] It remains one of America’s, and global societies’, greatest health challenges. Cancer is responsible for almost one in six deaths globally.[2] The global cancer burden is expected to surpass 20 million new yearly cases by 2025.[3] Cancer is the second-most common cause of death in the United States, exceeded only by heart disease, although cancer is expected to become the leading cause of American fatalities by 2030. Likewise, among adults ages 35 to 70, while cardiovascular disease remains the leading cause of mortality globally, “mortality from cancer will probably become the leading cause of death” in the near future.[4] Experts predict the year 2021 will see 1.9 million new cancer cases diagnosed in the United States, with over 600,000 Americans expected to perish from the disease, which translates to about 1,650 deaths per day.[5] Approximately 1 out of every 200 Americans receive a cancer diagnosis each year. For Americans born today, one in two women, and one in three men, are likely to develop cancer at some point in their lifetimes (with one in five perishing from them).[6] One in eight U.S. women will be diagnosed with breast cancer in their lifetimes.[7] One reason cancer rates are increasing is because cancer is primarily a disease of old age, and as Americans live longer in general, the likelihood of their developing a cancer grows. In the United States, 60 percent of all cancer cases diagnosed are in people above age 65, while 80 percent of all cancers in the United States are diagnosed in people 55 years of age or older.[8] Americans ages 65 and older are more than seven times more likely than younger Americans to be diagnosed with cancer.[9] Seventy percent of all American cancer deaths occur with people ages 65 or older.[10] Yet, despite being more prevalent in the older population, cancer is actually the leading cause of death for Americans under age 65.[11] In the United States, health experts predict that breast, prostate, and lung cancers will account for the most new cases diagnosed among American men and women in 2021. (See figure 1.) However, in terms of cancer fatalities, lung cancer is now the leading cause of death for American men and women alike, second is prostate cancer for men and breast cancer for women, followed by colorectal and pancreatic cancer. (See figure 2.)

Figure 1: Estimated new U.S. cancer cases, 2021 (by cancer type, both sexes combined)[12]