Preparing for a colonoscopy, a procedure in which a doctor slides a flexible tube through the colon to allow a camera eye to view the interior of the organ, remains arguably the biggest barrier to screening. So last year’s approval of a much less nauseating prep option for patients was welcome news.
Pre-cleaning the colon is critical to identifying and removing polyps, often a precursor to cancer, during the procedure. Over the years, several newer-generation prep solutions have become available, each with pros and cons, and others — including those in the form of flavored shakes and food bars — have been tested but not yet approved.
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The solutions most patients drink cleanse the colon, but patients have to ingest large amounts — four liters, or just over a gallon — and the taste is still pretty awful.
Doctors now recommend that patients divide the dose in half, half the day before and the rest several hours before the procedure.
“We tell people to refrigerate it, sip it through a straw, hold their nose, chew gum in between, or suck hard candies,” says Louis Korman, a half-retired gastroenterologist in the DC area. “Everyone hears the stories about how terrible the preparation is. The preparation is what everyone remembers, and it represents a disincentive to getting a colonoscopy.
But last year — in what experts say could end the fear that is keeping many people from this important screening — the Food and Drug Administration approved a regimen of pills, Sutab, that studies show work just as well as the drug. liquid solutions – without the vile taste. It is a 24 tablet regimen: 12 pills the day before and 12 the next day, several hours before the procedure.
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Patients should still drink plenty of water, a total of 48 ounces the first day and another 48 ounces the next day. But at least plain water is tasteless.
“The great thing about Sutab is that it removes the issue of taste,” said Douglas K. Rex, a professor emeritus of medicine at Indiana University School of Medicine. “You’ll still have to sit on the toilet, but not having to drink something that tastes awful is a big advantage.”
Oncologist Arif Kamal, an associate professor of medicine at Duke University, agrees. “This is a good option for those for whom taste is an issue,” says Kamal, who is also chief patient officer at the American Cancer Society. He also points to easier alternatives to full colonoscopies for patients with an average risk of colon cancer, including home screening tests for blood and altered DNA that suggest the presence of cancer.
“The pros: It’s more convenient to do it at home,” Kamal says. “The cons: You still have to taste your own stool. Also, the frequency is more frequent — every two to three years,” compared to a seven to 10 year interval for colonoscopies. Most insurance plans, including Medicare, cover these.
“Virtual” colonoscopies are also available, although patients still have to do the prep, and certain “flat” polyps are easier to see with conventional colonoscopies, experts say. Virtual colonoscopies are not at-home procedures because they involve imaging of the colon and insurance coverage is spotty. They are only covered under special circumstances, such as when a conventional colonoscopy cannot be completed for some reason.
The American Cancer Society now recommends that people age 45 and older with an average risk of colon cancer undergo screening. This is a change from previous guidelines that recommended screening only for those over 50 who are at normal risk.
Excluding skin cancer, colorectal cancer is the third most common cancer in the United States, according to the American Cancer Society, projecting an estimated 106,180 new cases of colon cancer and 44,850 cases of rectal cancer this year. About 7 in 10 American adults ages 50 to 75 are aware of colonoscopy screening, according to the Centers for Disease Control and Prevention. Experts believe that avoiding prep is probably one of the main reasons the rest aren’t.
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The new pills may change that, but they also have a downside.
Many insurance drug plans don’t cover them, and their cash price can be $120 or more. (It cost a friend of mine in Florida $150 after her insurance plan was declined and — after mine declined as well — I paid $60 with a coupon my doctor got from Sebela Pharmaceuticals.)
“For people who don’t get a colonoscopy because of the tedious taste prep, it could be a game changer — if they can afford it,” says gastroenterologist Clement Boland, retired professor of medicine at the University of California at the San Diego School of Medicine. “That’s ridiculous. It shouldn’t be that expensive. It’s just salty [sodium sulfate, magnesium sulfate, potassium chloride]nothing special like monoclonal antibodies.”
Experts say the most likely reason for the insurance denial is that the pills are new and have not yet been proven to be an advantage over cheaper alternatives. “An insurance company will say, ‘Well, if it’s equivalent, we’ll just cover the cheaper one,'” Kamal says.
Many gastroenterologists who deal with restraint in patient preparation consider this retarded thinking. “The insurance companies try very hard to force people to use the generic products, which are not very well tolerated,” says Rex. “When it comes to preparation, efficacy isn’t the issue. From the patient’s perspective, it’s tolerability. That’s very important for patients.”
Several major insurance plans cover the pills, including some in Medicare Part D, said John McGowan, chief of research and development for gastroenterology at Sebela Pharmaceuticals.
However, since others don’t, it’s probably a good idea to check with your own individual plan to see if the pills are covered.
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For those who don’t have insurance or whose plans don’t cover the pills, McGowan suggests checking sutab.com/savings on his company’s website for ways to save. The company also provides free samples and coupons to doctors for patients who can’t afford the pills, he says.
He acknowledges that cost can be a barrier for some patients. Nevertheless, “in the event that a patient is unable to properly complete the liquid preparation, a colonoscopy should be repeated, in which case the additional out-of-pocket expense for Sutab will be worth it,” he says.
The latest pills should not be confused with earlier tablets, made primarily of sodium phosphate, which the FDA found in 2006 caused severe kidney damage in some patients. While still on the market, the old pills are rarely used today, experts say.
“The newer ones have sodium sulfate and are safe,” Rex says, stressing that patients should still drink the recommended amounts of water to avoid dehydration. “You don’t want to drink the bad-tasting stuff, but you have to drink something,” he says.
Di Palma, who conducted the Sutab study, says he has tried all the preparations and used them for his own colonoscopies.
“I’ve had five colonoscopies and Sutab was the easiest yet,” he says.