Exact Sciences

Situation:

Exact Sciences (ES) was close to launching a stool test to detect blood in stool which could be a sign of having polyps in the colon or colorectal cancer. ES was aware of low patient colonoscopy compliance rates but were not sure how to best position a noninvasive stool test. They wanted to determine how best to understand patient’s (consumers) reasons for not getting colonoscopies and determine their willingness to use a noninvasive at-home test instead.  ES tried to interview health care providers but were mostly rebuffed. They then contacted BTS due to our background in healthcare marketing.

Task:

Interview about 20 clinicians in the area and determine if they thought there was a need for another colon screening test, how open-minded would they be about adoption, what data would they want to see, and how should this new test be positioned. More importantly, since this was a consumer product, ES wanted to know what doctors heard from patients about existing screening tests, why the compliance rate was so low, and what steps can the company in terms of product attributes or messaging take to enhance the likelihood that patients would get screened. This is important because colorectal cancer is mostly preventable and treatable disease and many lives are lost needlessly because too many patients refuse to follow doctors’ advice or federal guidelines. The following goals guided physician interviews:

• Determine physician perspectives on the strengths and weaknesses of existing modalities for colorectal screening
• Determine how patient factors influence the adoption of new screening tests
• Why are major causes of hesitancy in patients to get screened? What can be done to overcome these objections?
• Do they expect that handling stool by consumers be as big a deterrent to compliance as bowel preparation and invasiveness is for a colonoscopy?
• Characterize optimal parameters and refine perspectives for future development of Exact Science’s new test, i.e., sensitivity, specificity, detection of adenomas, etc.
• Physician views regarding gaining information and getting educated about product attributes

Action:

BTS was able to secure face-to-face interviews with 20 health care professionals which included primary care physicians, GI specialists, nurse practitioners, and physician assistants. These interviews lasted from 15-45 minutes. The interviews were insightful and at times produced unexpected business intelligence which was not only enlightening but helped craft messages and the positioning strategy.

Here is a sample of findings:

• Doctors generally follow guidelines in terms of intervals between procedures, i.e., 10 years between colonoscopies unless there are abnormalities detected during the previous procedure. Fecal occult blood tests (FOBTs) are performed in intervening years annually and in cases when patients refuse to get a colonoscopy done which is not unusual.
• Very few offices have an actual system where they would be prompted that a patient is due for colorectal screening. This is not a great source of revenue for PCPs which may be a reason why vigilance is low.
• GIs, on the other hand, are much more vigilant about follow-ups on colonoscopies. It is a big source of revenue for them and they stay on top of required colorectal check-ups.
• Colonoscopy is the gold standard and is being performed increasingly. While not perfect, doctors really like the sensitivity through visualization and removal of even small polyps and the quality and quantity of information retrieved, e.g., if a growth is a tubular adenoma, hyperplastic or adenocarcinoma.
• A major problem with enemas and FOBTs is that if abnormal results are obtained, patients have to undergo colonoscopy anyways. So why not get it done in the first place.
• Colonoscopies have their own disadvantages. High cost, prep work, sedation, small chance of colon rupture (19 patients out of 10,000), need to take time off work and someone has to drive you home were all cited repeatedly. A few physicians also mentioned that many times GIs are not able to complete the procedure (not able to intubate cecum about 10% of the time). Importantly, barium enemas and FOBT may detect a problem in the upper GI (esophagus, stomach and duodenum) through detection of occult blood which is not possible with colonoscopy. Virtual colonoscopy has seen very modest adoption rates. Even though it has the benefit of being non-invasive, it is not part of ACS guidelines for colorectal screening and not reimbursed well. It is too expensive for most patients to pay out-of-pocket. It also may also be too sensitive, providing many false positives.
• The biggest problem with colonoscopies is patient resistance and low compliance rates. Some doctors told me that fewer than 50% of their patients get the procedure done, many times canceling appointments with GIs at the last moment. It is a great source of frustration for GIs as well.
• There also seems to be a turf war taking place between GIs and surgeon on which specialty should be performing colonoscopies. A physician told me that he refers his patients to surgeons who are more adept at fixing ruptures if they occur. There is evidence that, when looking at quality scores, PCPs are just as capable in performing colonoscopies as GIs.
• Most physicians are unhappy with the sensitivity and specificity of FOBTs and hope that repetition would allow them to detect abnormalities if present. They would clearly prefer a more sensitive and specific assay that gives them fewer false positives and negatives.
• To adopt a test, it needs to be FDA approved. Most thought an experimental test would fail to achieve commercial success. The test should be sensitive and specific. They said that the test does not have to be as sensitive as colonoscopy (using 95% sensitivity as a benchmark) but has to approach that figure. Many physicians talked about making an economic argument for the test in comparison to existing modalities. Insurances would also be pleased to save money and be happy to reimburse it.

Economic rationale may be as following:

If a hundred 50+ males are asked to have a colonoscopy done and there is 50% compliance, then 50 would undergo the procedure. According to U.S. Multi-Society Task Force, 25% should have adenomas detected. So adenomas should be detected in 12.5 patients at a cost of $100,000 (50 * $2,000 per procedure). That means $8,000 per patient for detection of adenomas.

On the other hand, if Cologuard’s compliance rate is 75%, then 75 patients agree to get tested. If detection rate is 64% compared to colonoscopies, then 8 people’s adenomas get detected at a cost of $225,000 ($300 * 75). This means $2,813 per patient for detection of adenomas. Decreased detection rate can be compensated by doing tests more frequently.

• Patient/consumer factors, such as convenience and compliance, are very important. From a clinical standpoint, colonoscopy is almost unassailable but a great test is not a great test if patients refuse to partake in it. This provides the opening for ES in terms of establishing a lucrative niche in the marketplace and should be the basis for differentiation, messaging, and positioning strategy. ES should also make economic justification for adoption of the DNA-based stool test.
• It is not necessary to go after colonoscopies from a positioning point of view. First of all, GIs would be quite resistant to abandon a lucrative procedure. Secondly, colonoscopy needs to be performed every ten years in most patients. Cologuard can be positioned as the best alternative in the intervening years since sensitivity and specificity of current FOBTs is quite poor.
• Cologuard can also be positioned as the general go-to test to reduce the number of colonoscopies that are expensive. A colonoscopy could be the second test to be performed if the stool test produced results that needed further analysis.

Results:

Cologuard had an extremely successful launch and continue to grow at a high rate. According to Kevin Conroy, CEO of ExactSciences, “Cologuard is changing how Americans get screened for colorectal cancer.” For the three-month period ended March 31, 2019, as compared to the same period of 2018, revenue was $162.0 million, an increase of 79%, and test volume was 334,000, an increase of 79%. The company anticipates revenue of $725-$740 million during 2019 with a goal of screening at least 40% of the eligible U.S. population.