就老年人获得突破性医疗技术向众议院能源和商业健康小组委员会作证（英）

Stephen Ezell Vice President, Global Innovation PolicyDirector, Center for Life Sciences InnovationInformation Technology and Innovation Foundation Before the: U.S. House of RepresentativesCommittee on Energy and CommerceSubcommittee on Health Hearing on: “Examining Policies to Enhance Seniors’ Accessto Breakthrough Medical Technologies” September 18, 20252123 Rayburn House Office BuildingWashington, DC INTRODUCTION AND SUMMARY The Information Technology and Innovation Foundation (ITIF) is pleased to submit thesecomments in response to the House of Representatives Committee on Energy and CommerceSubcommittee on Health hearing on “Examining Policies to Enhance Seniors’ Access toBreakthrough Medical Technologies.” Founded in 2006, ITIF is an independent 501(c)(3)nonprofit, nonpartisan research and educational institute that has been recognized repeatedly as theworld’s leading think tank for science and technology policy. Cancer remains a global scourge, the second-leading cause of death among Americans, killing over600,000 annually. About 40 percent of Americans will develop cancer in their lifetimes. Age is theleading risk factor for cancer; therefore, it’s not surprising the disease hits America’s older citizensparticularly hard. Americans over 65 account for 60 percent of newly diagnosed malignancies and 70percent of all cancer deaths. 1,200 Medicare beneficiaries are diagnosed every day with late-stagecancer. That’s 50 Medicare beneficiaries an hour. Unfortunately, despite some progress,too many cancers are still found late—when outcomes areworse and costs are highest.That’s in part because it’s remained extremely difficult to effectivelypreventively screen for cancer at the population scale. In fact, only five types of cancer—breast,cervical, colorectal, prostate, and “high-risk” lung—currently have guideline-recommendedscreening options available. The vast majority of cancers—including blood, head and neck,pancreatic, ovarian, and liver cancers, among others—have no guideline-recommended screeningtests available. In fact,70 percent of all U.S. cancer fatalities come from cancers for which there arecurrently no proven screening tests.This explains why so many cancers are unfortunately detectedonly when patients arrive at doctors’ offices manifesting physical symptoms; as only 20 percent ofU.S. cancer cases are screen-detected. It’s thus time for the United States (and the world) to embrace a revolutionary new approach tocancer detection, akin to major technological advancements that have resulted in vast improvementsfor Americans’ health and economic well being. Enter multi-cancer early detection (MCED)screening tests, which, from a simple blood draw, can detect as many as 50 different kinds of cancerwith a low false positive rate and connect the cancer to the tissue of origin in the body. MCED testsuse modern technologies including artificial intelligence (AI), machine learning, and genomicsequencing to identify circulating tumor DNA (ctDNA) shed by cancer cells in the body. MCEDtests herald the ability to test for many cancers simultaneously and also to detect cancers at earlystages of progression in the body. Detecting cancers earlier could produce tremendous individual health, public health, and economicbenefits. Catching cancers earlier can give patients a four times greater chance of survival. Indeed,when cancer is diagnosed after it has spread, the five-year cancer-specific survival rate is 21 percent,compared with 89 percent when the cancer is diagnosed early and still localized. Likewise, cancers are far more economical to treat at earlier than later stages of disease progression. In the Medicarepopulation, average total annual costs of care are up to seven times higher for Medicare beneficiarieswho are diagnosed at later stages rather than earlier stages. In short, MCED technologies can detectmore cancer earlier, saving lives and saving costs. The United States has led in the development of MCED screening tests, but competitors areemerging worldwide. In particular, Chinais prioritizing the development of MCEDs as part of itsnational priority to dramatically expand its global biotech leadership.IfAmerica is going to continueto lead in this field amidst growing global competition, enabling both its innovative companies tothrive and its citizens to enjoy the benefits of these technologies, policymakers will need to craft asupportive regulatory and coverage environment. If we don’t, other countries will, and they mayeventually come to dominate the largest longitudinal public health application of genomicsequencing. Congress has a long history of acting to create Medicare coverage for cancer screening, most recentlywhen the Balanced Budget Act of 1997 added prostate and colorectal cancer screening benefits toMedicare coverage. To help make it possible for older Americans to take advantage of the enormouspotential of MCED technologies, it’s time for Congress to act again. Congress shou