High Price Tag for Cologuard Confirmed, but Test Is Welcomed

Zosia Chustecka

November 26, 2014

A final price decision has been announced for Cologuard (Exact Sciences), the first stool DNA colorectal cancer (CRC) screening test, which was approved in the United States earlier this year.

The Centers for Medicare & Medicaid Services (CMS) has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test, the company announced.

The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program, the company said, and noted that Cologuard is the first technology to gain approval through this program.

The price is hugely more than that of traditional stool tests for CRC screening, which home in on hemaglobin in blood in the stool samples. There are various such tests available, with the simpler fecal occult blood test (FOBT) costing around $4 per test and the more sophisticated fecal immunochemical test (FIT) costing around $8 per test, according to a 2012 article. The same article gives an average cost for colonoscopy, which is considered to be the best method for CRC screening, at $ 6345 per procedure.

Improvement on Traditional Tests?

When it was approved, the FDA pointed out that Cologuard detected more cancers than the commonly used FIT.

The clinical data come from a pivotal trial that compared the two tests in nearly 10,000 individuals (N Engl J Med. 2014;370:1287-1297. Abstract). Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; by contrast, FIT screening detected 74% of cancers and 24% of advanced adenomas.

However, Cologuard was less accurate than FIT at identifying patients who tested negative for colorectal cancer or advanced adenomas, giving a negative screening result for 87% of the cohort vs 95% for FIT.

The new test was welcomed by experts when it was approved, even though they warned that it would be more expensive than traditional stool tests.

The new test does more: "We are looking for DNA changes, methylation changes, and fecal blood, all in one test," commented John Marshall, MD, professor of medicine and director of clinical research at the Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, in his Medscape Oncology videoblog.

It performed better than FIT in terms of detection, but it was slightly less accurate, he noted. "This means that we will see a few more false positives with this test, but nonetheless, it is a useful test."

"I believe the role ― the niche ― for this technology will be in that group of patients who refuse colonoscopy or cannot have colonoscopy. There probably will be some crossover with colonoscopy, and this test will be used along with that. Regardless, whatever it takes to get people to undergo screening to keep them out of my office is valuable," he said.

"It is a test that should be offered to patients who refuse colonoscopy," agreed another expert, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, in Norfolk, in a Medscape Gasteroenterology videoblog. He also warned that the test will be expensive, but argued that "it is money well spent if it brings the people who refuse colonoscopy into a screening program." He added, however, that "cost analysis and cost-effectiveness remain to be defined."

But Dr Johnson was adamant that "no screening is not an option. Any screening is better than nothing. We have a screening gap of approximately 20%; we are going to need to increase screening rates from 60% to 80% by 2018."

He was hopeful that the new test "will stimulate discussions between patients and their healthcare providers. Colonoscopy is still the preferred strategy, but for anything that raises the awareness of screening and acceptability of screening, I am all in."

Dr Marshal reports consulting and serving as a speaker for Amgen, Genentech, and Bayer. Dr Johnson reports serving as a consultant to Takeda, CRH Medical, Merck & Co, AstraZeneca, WebMD Health, and Journal Watch Gastroenterology, serving as a speaker for Takeda, and receiving research grants from AstraZeneca and Takeda Pharmaceuticals North America, Inc.

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