Obstacles to Covering Precision Medicine Multicancer Screenings

While precision medicine multicancer screening tests could blaze a path to lower cancer-related costs and earlier cancer detection, these precision medicine tools face many hurdles to acquiring payer coverage, according to the authors of a Health Affairs article.

Breast cancer, colorectal cancer, cervical cancer, and lung cancer screening tests have all been assigned an A or B rating from the US Preventive Services Task Force (USPSTF), and prostate cancer screening is recommended for men. Successful preventive care services depend on early detection of aggressive cancers like these.

If an individual could receive a single screening for multiple cancers, it could improve screening and early detection rates. Such tests are called multicancer early detection screenings or liquid biopsies. These tests leverage precision medicine to identify the presence of protein biomarkers and tumor DNA for as many as 50 types of tumors.

Researchers are still gathering data on the efficacy of multicancer screening tests. But the authors of the Health Affairs report pointed out that, if these precision medicine tools prove useful, new coverage methods will be required. They examined the payer considerations for multicancer early detection screening coverage in preparation for that potentiality.

In order for payers to responsibly decide whether or not to provide coverage for multicancer early detection screening tests, the authors highlighted five key considerations.

First, gathering enough evidence to substantiate that the screening produces benefits—financial, clinical, or otherwise—would be difficult with a precision medicine tool such as the multicancer early detection screening test. 

Collecting sufficient evidence would require massive studies with thousands of patients—most of whom will have no asymptomatic cancer for the test to detect—over a prolonged period to determine whether the screening is an effective tool for chronic disease prevention efforts.

“A balance will need to be struck between conducting clinical trials and developing robust models and real-world data studies of the benefits and harms of implementing MCED screening tests alongside standard screening,” the authors explained.

Second, Medicare likely would not cover these screening tests because screenings covered as a medically-necessary preventive care service can only qualify if they fall under a particular legislative exemption or if USPSTF supports them. Ultimately, obtaining Medicare coverage would demand a national coverage determination, which is a complex process.

Clinical integration is the third obstacle, specifically for follow-up procedures. Even if the precision medicine test's cost is fully covered, the authors pointed out that the uncertainty around follow-up procedures could generate more low-value healthcare spending. 

These tests are meant to be performed in conjunction with standard-of-care cancer tests. But standard-of-care screenings may falter with the introduction of multicancer early detection screening tests, which could have unknown downstream impacts.

Fourth, lack of insurance coverage for multicancer early detection screening tests could exacerbate existing care disparities among cancer patients. But coverage of this tool could reduce care disparities by making screenings and preventive care more accessible.

Finally, the short-term and long-term economic outcomes could help or hinder the case for multicancer early detection screening test coverage. 

Multicancer screenings could lead to lower costs through earlier detection—which could result in more effective preventive care—and the ability to retest more frequently. But the cost for individual tests and the greater number of cancers detected could have long-term negative economic impacts.

“Private payers may be less influenced by cost-effectiveness data, given member turnover and the need to account for not only the substantial increase in per member per month costs of covering MCED screening tests but also the downstream costs associated with confirmatory diagnostic testing and false positives,” the authors noted.

In order to move forward, payers will need to outline how they intend to verify the screening test’s clinical validity and utility. They will also need to establish a structure through which to assess the value of these tests.

Payer claims and EHR data can help provide evidence for these precision medicine tools. And payers can engage in performance-based risk-sharing arrangements with laboratories and test developers in order to gather evidence.

Additionally, stakeholders should gather information from patients about the impacts of multicancer early detection screening tests on their behavioral health and wellness.