Preparing for a colonoscopy, a procedure in which a doctor inserts a flexible tube into the colon to get a camera look inside the organ, remains perhaps the biggest hurdle to screening. So the approval last year of a much less sickening compounding option for patients was welcome news.
Prior colon cleansing is essential to identify and remove polyps, often precursors to cancer, during the procedure. Over the years, several next generation preparation solutions have become available, each with advantages and disadvantages, and others – including those in the form of flavored shakes and food bars — have been tested but not yet approved.
The solutions that most patients drink cleanse the colon, but patients have to ingest large quantities – four liters, or just over a gallon – and the taste is still quite bad.
Doctors now recommend patients split the dose in half, with half taken the day before and the rest several hours before the procedure.
“We tell people to chill it, sip it through a straw, hold their nose, chew gum in between, or suck on hard candy,” says Louis Korman, a semi-retired gastroenterologist from the DC area. “Everyone hears stories about the horror of prep. Prep is what everyone remembers, and that’s a drag on colonoscopy.
But last year – in what experts believe could end the fear that keeps many people from this important screening – the Food and Drug Administration approved a regimen of pills, Sutab, that studies show works just as well as liquid solutions – without the vile flavor. It is a diet of 24 tablets: 12 tablets the day before and 12 the next day, several hours before the procedure.
Patients should still drink plenty of water, a total of 48 ounces the first day and an additional 48 ounces the next day. But at least ordinary water is tasteless.
“The great thing about Sutab is that it eliminates the taste problem,” says Douglas K. Rex, professor emeritus of medicine at Indiana University School of Medicine. “You’re still going to have to sit on the toilet, but not having to drink something that tastes awful is a big plus.”
Oncologist Arif Kamal, an associate professor of medicine at Duke University, agrees. “It’s a good option for those for whom taste is an issue,” says Kamal, who is also a patient manager at the American Cancer Society. It also points to simpler alternatives to full colonoscopies for patients at average risk of colon cancer, including home screening tests for blood and altered DNA that suggest the presence of cancer.
“The advantages: it’s more convenient to do it at home,” says Kamal. “The cons: you still have to taste your own stool. Additionally, the frequency is more frequent—every two to three years,” compared to a seven to ten year interval for colonoscopies. Most insurance plans, including Medicare, cover them.
“Virtual” colonoscopies are also available, although patients still have to do the preparation, and some “flat” polyps are more easily seen in conventional colonoscopies, experts say. Virtual colonoscopies are not home procedures because they involve colon imaging and insurance coverage is spotty. They are only covered in special circumstances, such as when a conventional colonoscopy cannot be performed for some reason.
The American Cancer Society now recommend for people 45 and older at average risk for colon cancer get screened. This is a change from previous guidelines which recommended screening only for people aged 50 and over who are at normal risk.
Excluding skin cancers, colorectal cancer is the third most common cancer in the United States, according to the American Cancer Society, which predicts about 106,180 new cases of colon cancer this year and 44,850 cases of rectal cancer. About 7 in 10 American adults between the ages of 50 and 75 are up to date on colonoscopy screening, according to the Centers for Disease Control and Prevention. Experts believe that avoidance of prep is probably one of the main reasons others don’t.
The new pills might change that, but they have a downside.
Many drug plans don’t cover them, and their out-of-pocket costs can reach $120 or more. (It cost a friend of mine in Florida $150 after her insurance plan declined and – after mine also declined – I paid $60 using a coupon my doctor got from Serve pharmaceuticals.)
“For people who won’t have a colonoscopy because of the poor taste prep, this could be a game-changer — if they can afford it,” says gastroenterologist Clement Boland, a retired professor of medicine at the University. ‘University of California San Diego School of Medicine. “It’s ridiculous. It shouldn’t be so expensive. It’s just salt [sodium sulfate, magnesium sulfate, potassium chloride]not something fancy like monoclonal antibodies.
Experts say the most likely reason for insurance denials is that the pills are new and have not yet proven to be a step up from cheaper alternatives. “An insurance company will say, ‘Well, if it’s the equivalent, we’ll only cover the cheaper one,’” Kamal says.
Many gastroenterologists faced with patient reluctance to prepare see this as retrograde thinking. “Insurance companies try to force people to use generic products, which are not very well tolerated,” says Rex. “When it comes to preparation, efficacy is not the issue. From the patient’s perspective, it’s tolerability. This is very important for patients.”
Several major insurance plans cover the pills, including some in Medicare Part D, says John McGowan, research and development manager for gastroenterology at Sebela Pharmaceuticals.
Because others don’t, however, it’s probably a good idea to check with your own individual plan to see if the pills are covered.
For those who don’t have insurance or whose plans don’t cover pills, McGowan suggests checking out sutab.com/savings on her company’s website to find out how to save. Additionally, the company provides free samples and coupons to doctors for patients who cannot afford the pills, he says.
He acknowledges that cost can be a barrier for some patients. Still, “in the event that a patient cannot properly complete the liquid prep, a colonoscopy must be repeated, in which case the upfront and out-of-pocket additional expense for Sutab is well worth it,” he says.
The newer pills should not be confused with the earlier tablets, composed mainly of sodium phosphate, which the FDA found in 2006 caused severe kidney damage in some patients. Although still on the market, the old pills are rarely used today, experts say.
“The newer ones contain sodium sulfate and are safe,” says Rex, stressing that patients should always drink the recommended amounts of water to avoid dehydration. “You don’t want to drink bad tasting stuff, but you have to drink something,” he says.
Di Palma, who conducted the Sutab study, says he tried all the preparations and used them for his own colonoscopies.
“I’ve had five colonoscopies, and Sutab has been the easiest so far,” he says.