POPULATION NEEDS

Facts: Colorectal Cancer and Population Screening

The colorectal cancer (CRC) is the third leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that there would be about 141,210 new cases of colorectal cancer in 2011 in the United States, from which 49,380 deaths would result. Colonoscopy is recognized as the Gold Standard of colorectal cancer screening for its accuracy.

The CRC can be prevented through detection and removal of polyps at an early stage of development, a precursor of colorectal cancer, during colonoscopy. Despite ever increasing awareness among eligible population of the need for the Screening Colonoscopy, the level of compliance still lags those of more widely adopted cancer screening modalities such as the Mammography and Pap Smear.

Barriers to Compliance

There are a number of identified factors, not related to the screening procedure itself, influencing population compliance with the Screening Colonoscopy including lack of awareness, high cost and limited accessibility of service.

An overwhelming majority of those who have had the screening procedure points to the difficulty of self-administered, oral colon preparation, followed by pain during the procedure, as the worst aspect of the Screening Colonoscopy experience. Those who are eligible and aware of the need for the Screening Colonoscopy but have not had the screening procedure often cite fear of the colon preparation and procedure pain as a primary reason for their reluctance to take the screening procedure.

High Costs of Incomplete Colonoscopies

Several studies have found that a substantial number of colonoscopy procedures are suboptimal because of inadequate colon preparation. This figure ranges from 17 to 30% in randomized trials and is probably higher in clinical practice. Up to 10% of all colonoscopy procedures are aborted prematurely due to inadequate colon preparation.

Suboptimal colon preparation leads to prolonged procedure times, lower rates of completed procedure, reduced screening intervals, higher screening costs and possibly an increased risk for procedure-related complications. It also has been reported that the quality of colon preparation can strongly influence the quality of colonoscopy procedure measured by the polyp and adenoma detection rates.

The cost associated with preparing a patient’s colon for colonoscopy is much larger than the average retail price of colon cleansing prescription dispensed to any one patient. In US, the cost of repeat examination alone, for aborted colonoscopy due to poor colon preparation, is estimated to be in the billions of dollars and could easily surpass the total market size of colon preparation prescriptions, possibly by more than an order of magnitude.

It has been reported that depending on the level of experience of physician performing colonoscopy, about 5 to 10% of all procedures are prematurely terminated before the tip of endoscope reaches the cecum due to technical difficulties in inserting the endoscope. Many of these incomplete procedures are due to patient’s unusual colon anatomy or intolerable level of pain during insertion of endoscope making deep insertion of the endoscope impossible.

By the time the operating physician decides to abort the procedure, a fair amount of time and effort has already been spent. This loss of productivity, when combined with the costs of follow-up procedures to complete the examination of the colon through repeat colonoscopies or alternate examination modalities, has a truly significant economic impact on the healthcare system, possibly in the billions of dollars.

It has been shown that an insertion assist device improves probability of reaching the cecum when repeat examinations are preformed.

Economic Impacts of Patient Sedation

Presently, most, if not all, of colonoscopy procedures in the US and other countries are performed with patients under varying degrees of sedation of a type chosen by the physician. This is to help patients to cope with and not remember the inevitable pain and discomfort during instrument insertion (colon intubation) phase of colonoscopy. It is estimated that close to half of total colonoscopy cost is attributable to the cost of sedation, which is assessed as part of the “Facility Charges” in the US. Given the large volume of procedures, this cost component could amount to or even surpass 15 billion dollars a year.

The routine uses of patient sedation negatively influence the productivity of colonoscopy providers by introducing uncertainties in planning and managing available time and resources allotted to each patient. The lengths of time of response to sedation and recovery from the effect of sedation are specific to each patient and there are no indicators that help reliably predict these parameters. Nor is there predictor of the pain threshold of a given patient against which the amount of sedative to be used for a specific patient can be judged.

A substantial improvement in the patient throughput could result if all or some part of provider’s time and resources required in administering and managing patient sedations could be freed and reallocated to delivering additional colonoscopy procedures to prospective patients. Benefits of reduced sedation can be obtained through the reductions of percentage of colonoscopy cases performed without sedation and/or collective amount of sedative used in all of the colonoscopy cases.

Clear and Pressing Needs

Born over a half a century ago, the field of colonoscopy is yet to see the kind of technological advances that have helped transform the standards of care in many other healthcare specialties. The primary instrument, colonoscope, and pain-inducing techniques used in the insertion of the instrument remained virtually unchanged over the years.

From day one, there has been and still is only one way, ingestion of a large quantity of medicated liquid in a short span of time, to clean the colon in preparation of the colonoscopy procedure, which most people find hardly tolerable.

An effective colon preparation should consistently produce a high-quality colon cleansing. It also must be safe, work quickly with no serious side effects and, importantly, well tolerated by patients. None of currently available colon preparation regimens meet all of these criteria. The screening population’s dire needs for an alternate, tolerable colon preparation method and improved screening services have been building up for decades.

The large and ever expanding colonoscopy market is characterized by:

· Approximately 30M procedures per year worldwide (15M in US, < 1.5M in Korea)

· Aging population

· Increasing awareness of the need for the CRC screening

· Rapid rise in the CRC cases in developing countries due to diet change

· Primary driver of the Screening Colonoscopy market - Eligible population

· Projected consumer adoption pattern of new technology/service - Similar to Convenient Care Clinic case

Population Needs

Prevention through Screening