NEW YORK – As of Monday, Intermountain Healthcare employees over age 50 are eligible for cancer screening with Grail's blood-based early detection assay as a covered benefit.
The multi-cancer early detection test, dubbed Galleri, is designed to pick up DNA methylation patterns associated with 50 cancer types, including those that may not have effective screening methods. Eligible patients employed by Intermountain and covered by the health system's SelectHealth insurance can now get the early-cancer detection test.
The test requires a blood sample that is sent to Grail for analysis. The increasing market availability of this relatively simple test, however, has broad implications for precision oncology and cancer care. Accordingly, many health system stakeholders are looking to Intermountain to understand the feasibility of implementing universal blood-based cancer screenings, and whether the benefits of early cancer detection outweigh what payors may see as a hefty upfront cost.
In a Grail-sponsored webinar that Precision Oncology News hosted last month, Lincoln Nadauld, Intermountain's VP and chief of precision health and academics, spoke about the considerations for health systems in implementing multi-cancer early detection programs.
Intermountain is one of several employer and health system partners that Grail has targeted for its initial Galleri rollout since commercially launching it last summer.
Galleri is a lab-developed test with New York State Department of Health approval and can be prescribed by doctors to complement existing cancer screening tests. However, it hasn't received US Food and Drug Administration approval and isn't a broadly covered benefit under Medicare or most private health plans. Grail has teamed up with PINC AI, the technology and services platform of healthcare group purchasing organization Premier, to improve access to the test, and Alignment Healthcare recently agreed to offer Galleri as a covered benefit to certain Medicare Advantage members in California and North Carolina. The out-of-pocket cost for Galleri is $949.
In these early days of the test's adoption, programs through health systems, medical practices, and self-insured employers offer fertile ground to introduce Galleri and collect real-world data on its use.
Beyond Intermountain, Grail has partnered with Renton, Washington-based Providence Health System, Point32Health, and the Knight Cancer Institute at Oregon Health and Science University. The company also has deals with Quest Diagnostics and City of Hope subsidiary AccessHope to facilitate sample collection and downstream interpretation of Galleri test results, respectively.
These partners, of note, don't include all of the 31 institutions that participated in the PATHFINDER study, though Intermountain was indeed among them. That study evaluated Galleri's performance in a real-world setting, and, as of an interim analysis presented last summer, more than 6,629 people over age 50 were tested with Galleri, and 92 of these people, or 1.4 percent, received a positive result.
The positivity rate was 1.5 percent among those with additional cancer risk factors like smoking or a genetic predisposition and 1.2 percent for a subgroup of people who did not have such risk factors. At the time Grail presented these data, not all of the positive Galleri diagnoses had been confirmed via other screening tests, but the positive predictive value was about 45 percent for those whose diagnoses had been resolved.
Among the cancer signals confirmed as true positives in the PATHFINDER trial, over half had stage III or earlier disease. For more than 96 percent of confirmed positives, the test identified the cancer's tissue of origin within its top two selections. Grail is still following patients in PATHFINDER to confirm their diagnoses after Galleri testing, and the firm hasn't yet reported a final rate of sensitivity and negative predictive value.
Even though data on Galleri's performance is emerging, it's no surprise that health systems like Intermountain, which have made early investments in precision oncology and have the support systems in place to implement complex genomic tests in routine care, want to test it out.
The Utah-based health system was among the first in the country to offer comprehensive genomic profiling to all late-stage cancer patients. Similar to the Galleri rollout, Intermountain began offering NGS profiling in 2013 to a small pilot cohort, then broadened access to all advanced cancer patients across the hospital system over two years. In 2019, Intermountain began offering germline testing for cancer risk variants to newly diagnosed cancer patients, again through a pilot program.
In 2020, as a precursor to how it is rolling out Galleri now, the health system began offering pharmacogenetic testing to a subset of its employees as a covered benefit through SelectHealth. The insurer is a wholly owned Intermountain subsidiary and provides coverage to most of the health system's 45,000 employees and their families.
At this point, it's not clear how multi-cancer early detection testing will impact health economics and cancer diagnostic workflows within health systems like Intermountain, but the goal of the pilot is to get some insights in this regard. "We don't have all the answers on the economic side," Nadauld said in an interview after the Grail-sponsored webinar. "One hypothesis is that, if we can really find cancers earlier, as is indicated in [Galleri's] trials, then that may be actually less expensive than the unfortunate situation where someone shows up in our ER with an advanced cancer. … That can be very expensive, plus we don't really help people live the healthiest lives possible there."
The lessons learned in this pilot about the costs, benefits, and logistical challenges of early cancer detection will help the system adopt Galleri broadly, in phases, over the next five years to all employees regardless of age, then potentially to all patients treated at Intermountain.
This would expand the scope of Intermountain's early cancer detection program significantly. The system has more than 10,000 employees over age 50, but its full employee population is about five times larger. The health system also serves patients at 24 hospitals and 225 clinics in Utah, Idaho, Nevada, and a handful of other states in the region. SelectHealth boasts close to 1 million members.
Offering multi-cancer early detection testing to all of these members will require significant planning and infrastructure related not only to administering the tests themselves and providing results, but also to managing the tests' downstream effects.
Nadauld laid out the workflow in his webinar presentation. After a comprehensive informed consent process and provider-patient conversations about the fact that Galleri should not preclude regular cancer screening, samples are sent to Grail for analysis. If a cancer signal is detected in the report, the ordering provider must then connect with an oncology nurse navigator, who will advise the patient on the next steps.
Meanwhile, if the provider has questions about the test results, they can contact a Grail customer service representative who, in turn, will connect them to a medical affairs team member at the company. Nadauld noted that a number of Intermountain's primary care providers are familiar with Galleri through their participation in PATHFINDER. Still, Intermountain will train physicians on how to communicate with patients about the Galleri test to underscore that it doesn't replace traditional screening and that a negative signal doesn't clear the patient from cancer risk.
He noted that Intermountain is training providers through grand rounds, leadership communications, team huddles, and disseminating information about Galleri's metrics and performance so they can then relay those to patients. Providers have already had the opportunity to attend question-and-answer sessions about the pilot program, he added.
Intermountain hasn't heavily advertised the pilot to its employees over age 50, all of whom are eligible for Galleri as of Monday if they're covered under SelectHealth. "We don't necessarily want everybody to come in on the first day of practice," Nadauld said, noting that the health system is focusing on a gradual and careful adoption.
A noninvasive test to detect cancers early is an attractive prospect, and interest could be tremendous. But the technology is still new and carries significant caveats when it comes to performance: Galleri performs better for certain cancers than others, and it's better at picking up late-stage cancers than localized ones. At this time, it does not replace traditional screening modalities like mammography or colonoscopies.
All of this could be lost on patients if the rollout is too fast. "We really like the idea of taking this pilot approach and applying it to a small, definable population to get experience applying these tests, ordering these tests, integrating them with our electronic medical records system, educating our primary care providers, and educating our oncologists, who then manage patients diagnosed in this way," Nadauld said. "As we gain experience across all of those fronts, we'll open it up more broadly."
Ultimately, the experience at Intermountain and Grail's other early adopter partners could help create a framework for other health systems to follow once the evidence base for Galleri has matured and its real-world impact is clearer. "We'll learn from our implementations and make adjustments, and where it makes sense, we might even publish some of those learnings," Nadauld said.