Ssteph - You are correct there is no screening recommendations for average risk patients. High risk patients can be screened by:
Endoscopic ultrasound (EUS), a minimally invasive imaging test that uses an endoscope (thin, flexible tube) to evaluate the pancreas for lesions or early cancers. If suspicious lesions are present, doctors obtain tissue biopsies during the same procedure.
Magnetic resonance cholangiopancreatography (MRCP), a type of magnetic resonance imaging (MRI) test that focuses on the pancreas and bile duct.
Computed tomography (CT) scans, another imaging test that can show some types of suspicious lesions. Here, our experts can offer high-resolution 3-D pancreatic CT imaging, which produces better, more detailed diagnostic images.
Endoscopic retrograde cholangiopancreatography (ERCP), a test that combines the use of endoscopes and X-rays to visualize the pancreas and biliary tree. Biopsies can also be performed during ERCP.
I would guess you would have to examine stool of patients with various stages of Pan-c and determine the proper markers and cutoffs like they did with Cologuard. (This is already happening). You might get approval to sell this to high risk patients while a prospective randomized control study of high risk patients without known Pan -c is in progress. This type of study would likely take several years since Pan-c is much less common than colon ca. I imagine one or a combination of the above screening tools would be used to try and catch the cancer as early as possible.
Scorekeeper - I think you meant to say there were only 8 African Americans with a diagnosis of Colon Cancer.
There were 1,000 AA's enrolled in the study or 10.7% of the Deep C patients.
pillprep - instead of always mentioning just the GI fee in the colonoscopy, why don't you mention the anesthesia fee and the facility fee and the biopsy/pathology fees. The average mcare colonoscopy COST is $800-1000 and much more for commercial insurers. Why do you ignore that only 16/100 people who get CG will need a colonoscopy?
Jim - The reason you want to replace colonoscopy is because it is very expensive, very uncomfortable, very time consuming and potentially dangerous and 50% of Americans WON'T do it.
The reason we keep comparing it to pap smears is to show that even a less sensitive test if done in short intervals with a very slow growing cancer can virtually ELIMINATE cancer deaths as it has done with cervical cancer. Cologuard is very similar, only better than a pap smear. Done every 3 year CG will likely detect nearly 99% of all cancers in a curable stage. Make sense?
You are correct Sstephan. As long as fobt/fit are in the guidelines they can be used by physicians without concern. BUT, Double Contrast Barium enemas are still on the American Cancer Society list of approved screening tests - and I haven't seen one of them done in 10 years!. It will take some time but CG will eventually get the 3 magic words in non-invasive screening - STANDARD OF CARE.
pillprep- you said " they (Aetna) aren't going to pay $600 for a test that will lead to a colonoscopy if they can just pay $1000 for the colonoscopy and be done with it." You act like every Cologuard leads to a colonoscopy! Under the worst circumstance of 13% false +'s, and 3-4% true positives, that means that 83-84/100 patients who get Cologuard will NOT have to have a colonoscopy. That is a big win for patients and insurers.
As a doc, think of why cervical cancer has been almost eliminated in the US (it is the #1 cause of cancer deaths in women in developing countries). The Pap smear has a sensitivity of of 50-60% but due to interval screening can catch almost all cervical cancers in the early cancer stage or precancer. We could do colposcopy (the colonoscopy equivalent) on every patient and it is much less invasive and expensive than a colonoscopy. However, we have figured out that we could eliminate cervical cancer with testing every 3 years with a simpler screening test.
We can do the same with Cologuard. Wouldn't that be great. Now I agree CG is much more expensive than a Pap. I would be happy with $300/test because it will still be a financial success and I think many more will be done at that price here and in other countries.
I do agree with you that I would not use it on high risk patients unless they refused a colonoscopy until further data comes out.
Of course no insurers are covering the test yet! It just got FDA approve and insurers wait on CMS coverage decisions before moving forward. (see my prior message on CMS and insurer coverage). Coverage will come after CMS decision and will take a little time - but it will get covered.
New article out today: Some excerpts from the article:
"IBD is associated with increased colorectal cancer risk. In fact, 10%-15% of colorectal cancer-related deaths occur in the patients with colitis. Risk factors for colorectal cancer in patients with IBD include longer duration of disease, disease severity, the presence of primary sclerosing cholangitis, and less use of 5-ASA products.
We typically monitor patients with IBD according to duration and extent of their disease. We were taught that they should be monitored with random biopsies and also biopsies of targeted lesions. At a minimum, at least 2 biopsies should be taken 10 cm apart, with a minimum of 33 biopsies per patient. It is very time-consuming, and if you also take targeted biopsies, the cost in terms of processing fees begins to add up.
Frank Farraye, an expert in chromoendoscopy, suggests that we should start training programs for chromoendoscopy and continue to do random biopsies, but use indigo carmine as well to become familiar with it.
What should you be doing? You should be developing a chromoendoscopy program for all of your patients with IBD. There is no question that, when coupled with high-definition endoscopy, this is going to be a standard of care."
Can't wait to see the results of the IBD study by EXACT to see if a simple stool test might be better than 33 biopsies per patient! or chromoendoscopy. This could be very big and I'm sure is not in any projections yet.
JH - glad you're so excited about the container but:
"false positives are less than a colonoscopy" isn't quite accurate!
Colonoscopy was the standard on which the false +'s are based so it's not possible to have a higher false + rates with colonoscopy.
Obviously, it's crucial for coverage of those on Mcare. My question has been will private insurers follow suit and how quickly as I don't think most people will pay $599 out of pocket if their insurer says no coverage.
Found some interesting quotes by healthcare experts when researching this topic:
"The biggest and most intense battle within the U.S. health care system during the past two decades has been over two inter-related questions: (1) who will control the manner in which medical care is paid for and, (2) how much will it cost? � [T]he private sector neither initiated this battle nor provided the critical innovation that transformed health care in the U.S. Instead, it was Medicare�s transition to a prospective payment system (PPS) that both triggered and repeatedly intensified the economic restructuring of the U.S. health care system� Roughly akin to Wal-Mart, in terms of purchasing power, the key to Medicare�s role as the leading catalyst for change in the U.S. health care system is the program�s immense size and influence. As the single largest individual buyer of health care and the �first mover� in the annual payment game between those who provide medical care and those who pay for it, "Medicare invariably drives the behavior of both medical providers and private payers".� [Emphasis added]
Jacob Hacker reiterates that point:
�Over the last two decades, moreover, Medicare has increasingly emphasized improved payment methods and rigorous reviews of technology and treatment, and it has made increasing investments in quality monitoring and improvement. Revealingly, private plans generally use the public Medicare plan�s criteria for covering treatments as their standard of medical necessity, and they have adopted many of Medicare�s innovations in payment methods
Not sure how fast this occurs but it certainly gives me more confidence of complete coverage of Cologuard in the not too distant future.
Dave - Let's say - just for the purpose of discussion- that Mcare reimburses at $400 (1/3 discount to $599).
what would you expect private insurers to reimburse at? Thanks.
You're right Taxlawyer Just got the Email about the NYT ad and a link to asking your Dr. about Cologuard
IT’S A TEST THAT CAN BE USED AT HOME. BRILLIANT.
Cologuard is convenient and easy to use.
Not wasting any time.
Oldguy - good points. I don't think they can advertise this as a colonoscopy replacement or have the sales rep push it as such. I guess in more subtle ways they can show how this truly is comparable to a scope when used at the approved 3 year interval vs. just targeting the FIT user. You guys might be right in that the patient may drive the demand and the docs will follow. Will be fascinating to see the uptake over the next year.
Steph - I hope you are correct, but unfortunately patients can't order the test (and get it paid for by insurance). The docs will have to be on board.
I agree this is the key question. The move from FIT to Cologuard is an easy mental switch and clinically will make sense for most docs. The move from nothing to Cologuard shouldn't be a tough switch for most patients.
The move from colonoscopy to Cologuard will be a bigger sell. Conroy has always stated Exas wants to replace FIT and not colonoscopies. Most of us realize that was BS and a PR tool not to offend the GI community too much. BUT, I think their marketing approach and education of sales staff will have to divert from the company line of Cologuard as a replacement for FIT and really explain to Docs that due to the programmatic sensitivity of the test it really does rival the efficacy of colonoscopy. If KC doesn't take the gloves off a bit on this issue the uptake will be slower.
I was VERY relieved that the FDA statement made no mention of Cologuard as being a replacement for FOBT/FIT and it was a general cancer screen. My big fear was some type of statement that would have recommended that this replace FIT but was not a subsititute for screening colonoscopy.
Yesterdays JAMA also had and article on colonoscopy in the elderly after a dx of Colon cancer. "For Older Colon Cancer Survivors, Colonoscopy Is Risky: Study"
The researchers included a group of nearly 5,000 people over age 75 with a history of colorectal cancer or suspicious polyps who had colonoscopies between 2001 and 2010 in the Kaiser Permanente health system.
Only five cancers were found among the older patients, the authors reported August 11 in JAMA Internal Medicine. Hospitalization within 30 days after the colonoscopy was much more common in the elderly group, 527 of whom were hospitalized.
Post-screening problems included issues directly related to the procedure, such as gastrointestinal bleeding, perforation or arrhythmia, which together accounted for 13% of hospitalizations. Another 33% were for GI problems not directly procedure-related and 30% were for non-GI problems.
"Only catching five cancers in the elderly group seems like a very low number," the researcher said, "and the subsequent hospitalization rate was high."
Sounds like another good use for Cologuard to me.