Medicare will pay $0 toward the $949 Galleri test, a multi-cancer early detection blood test, leaving patients with the entire bill before any coverage decision in 2029. The test, developed by Grail, has a list price of $949 and is not currently covered by Medicare, despite an FDA advisory panel voting in favor of its effectiveness and benefits.
Background And History
Grail, the company behind the Galleri test, is an American biotechnology company based in Menlo Park, California, founded in 2015. The company aims to develop an early cancer screening test for people who do not have symptoms. In June 2021, Grail launched the Galleri test, a liquid biopsy or multi-cancer early detection test. The test works by reading DNA shed by tumors into the blood to find cancer-specific methylation patterns. According to Joshua Ofman, CEO of Grail, the test is designed to be used in addition to guideline-recommended screenings.
How It Works And The Numbers
The Galleri test aims to detect cancers with no recommended screening, including pancreatic, esophageal, ovarian, and liver cancer. The test has a list price of $949, which is equivalent to about 4.7 months of Medicare Part B premiums. However, clinical trial data indicates that the test struggles with early-stage cancer detection and has not yet been shown to lower the risk of death from cancer or prevent advanced cancer. Across all cancer stages, the test missed over two-thirds of cancer cases.
Medicare Coverage And The Future
A new federal law makes Medicare coverage for the test possible starting in 2029, but the age rules may leave some patients out for good. The law requires the FDA to approve or clear the test and the Centers for Medicare and Medicaid Services (CMS) to decide that it is reasonable and necessary for Medicare patients. Grail expects the FDA to make a final decision on the test by early Q1 2027. Investors will note that the FDA advisory panel voted six to four in favor of the test’s effectiveness and seven to two, with one abstention, that its benefits outweigh its risks.
What It Means Now
The bottom line is that patients will have to pay out-of-pocket for the Galleri test until Medicare coverage begins in 2029. By the numbers, this means that patients will have to bear the entire $949 cost of the test. The figure that matters is the $949 price tag, which may be a significant burden for many patients. As the administration continues to support innovative screening technologies, patients facing cancers that are notoriously difficult to detect may have a new option for early detection. Talk to your doctor or oncologist to learn more about the Galleri test and its potential benefits and limitations.
Sources
- Her Doctor Will Order a $949 Blood Test That Screens for Multiple Cancers. Medicare Will Pay $0 Toward the Test, Leaving Her With the Entire Bill Before Any Coverage Decision in 2029
- Grail, Inc.
- New blood test claims to detect 50-plus cancers before symptoms – but there’s no evidence it can reduce your risk of dying from cancer
- Making confident cancer screening decisions in primary care
- Andrew Beggs: University of Birmingham Launches STRIDE-RCT to Advance Early Cancer Detection – OncoDaily
- Fredericks: Trump’s fight against cancer puts patients first
Photo: Hope2018 (CC BY-SA 4.0)
