As targeted therapies have grown in importance for treating cancers, the ability to detect genetic mutations that tumors carry has as well. While this often involves performing tissue biopsies, there are many patients for whom that procedure is impractical or impossible, which has led to the rise of liquid biopsy that uses a simple blood draw.
Cambridge, Massachusetts-based diagnostics maker Foundation Medicine made an entry into the market Monday as it launched its FoundationOne Liquid test. In June, Roche spent $2.4 billion to acquire the shares of Foundation Medicine that it didn’t own already.
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The test analyzes 70 genes known to drive cancer growth, including homologous recombination deficiency genes, microsatellite instability (MSI), poly ADP-ribose polymerase (PARP) and others, which can be used to guide therapy options. For example, MSI-high tumors can be treated with Merck & Co.’s Keytruda (pembrolizumab), while drugs such as AstraZeneca’s Lynparza (olaparib) can be used to treat ovarian cancer that expresses PARP.
“We really see it as having great value for patients who have a hard time getting lots of tissue,” Foundation Chief Commercial Officer Tom Civik said in a phone interview. Cancers for which tissue samples have been exhausted from tissue biopsies, patients who are too sick or whose tumors are in hard-to-reach places are the ones who would be candidates, he said, with lung and prostate cancers topping the list. He also mentioned the anecdotal case of a physician whose patient had a cancer of unknown primary, meaning uncertainty where it started, but whose tumor the FoundationOne Liquid test showed to be MSI-high.
However, despite its clinical utility, liquid biopsy has faced challenges from payers. At the MedCity CONVERGE conference in July, Independence Blue Cross senior research analyst Eugean Jiwanmall said in a panel that US payers in particular desire to see more clinical trial evidence to support liquid biopsy and its reimbursement. Indeed, adoption of liquid biopsy has been slow in the US compared with Europe and elsewhere, even in some developing markets like China and Latin America.
“Most payers I’ve interacted with in the 20 years I’ve been in this space always want more information,” Civik said. However, he added that the discussions Foundation has had with government and commercial payers to gain coverage for its FoundationOne CDx next-generation sequencing test open the door for discussions around the liquid biopsy as well. FoundationOne Liquid’s list price is $5,800, roughly in line with the company’s other tests, he added. However, he said it’s too early to nail down specifics of reimbursement for the test given that it was just launched this week. In the meantime, the scientific evidence to support liquid biopsy is still evolving and not yet as robust as it is for tissue biopsy, meaning the company will seek to continue providing updates on clinical utility that it can take to payers, he said.
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