Glucose Monitoring – Are we in danger of going backwards?
Last week at the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism meeting in Toronto, there was a debate over the need for daily glucose monitoring. This may seem strange given the volumes of evidence that show patients who monitor their glucose levels on a regular basis achieve better control and avoid or delay the onset of the many complications associated with diabetes. Yet there is a growing belief that daily monitoring has little value, in particular for non-insulin using patients.
“The main reason that people are still testing is because of the triumph of emotion and opinion over evidence” this statement came from Dr. Sumit Majumdar, a University of Alberta internist. Dr. Majumdar went onto state, “So 80 percent of all people with diabetes are using pills or just diet, and the population has never shown to have clinically worthwhile benefits testing.”
Dr. Ehud Ur, head of endocrinology at Halifax’s Queen Elizabeth II Health Sciences Centre, who debated Dr. Mujumdar stated, “A simplistic reading of the literature would suggest that blood glucose testing is not helpful. A more sophisticated and nuanced one, one that takes into account the realities of living with diabetes, would suggest it is useful.”
Unfortunately for BGM companies this debate is moving towards Dr. Majumdar way of thinking rather than Dr. Ur position. It appears that a potentially dangerous consensus is building towards making A1C the primary measure for non-insulin using patients. There are several reasons for this, two in particular, cost and education. Unlike daily monitoring, A1C monitoring is recommended on a quarterly basis. A non-insulin using patient that tests twice per day spends approximately $730 per year on test strips, while 4 A1C tests can be done for less than $100 per year.
From an educational viewpoint A1C results are far easier for the patient and physician to understand, a reading of 7 or below is good, above 7 not so good. This compares to daily readings which can vary widely and are affected by a host of factors. The fact of the matter is with nearly 80% of patients being treated by a primary care physician and not a diabetes specialist; patients are not receiving the education they need to understand the value of daily monitoring. Primary care physicians lack the time, infrastructure and are not adequately compensated for patient education. It’s understandable that a non-insulin using patient would fail to test regular as they have no ideas what the numbers mean and there is no action step required based on the result of the monitoring.
Things could get really interesting if the government, which spends over a billion dollars a year on testing supplies, changes how they reimburse for testing supplies for non-insulin using patients. This is not as far fetched as it sounds. At the MCAC meeting this past August panel members also publicly questioned the value of regular monitoring for non-insulin using patients. Since private payors typically follow the governments lead, BGM companies could soon be living in world with less, not more, reimbursement. This is a potential disaster for the BGM market as competition for insulin using patients is already intense and margins are coming under attack.
Conventional BGM companies aren’t the only companies who should be concerned here; anyone in continuous glucose monitoring should be paying close attention. As we pointed out yesterday after Dexcom (NASDAQ:DXCM) reported earnings, reimbursement is critical for the CGM market to be commercially successful. While Diabetic Investor has yet to find anyone who questions the value of monitoring for insulin using patients, the question for CGM companies is does use of such a system justify the added cost. Because none of the CGM products currently on the market or awaiting FDA approval have a replacement claim, patients using a CGM cannot throw away their conventional meter. Besides using conventional meters to calibrate the CGM device, users must use the conventional meter to confirm high and low readings. With sensors costing $35, a CGM patient who uses the device one a weekly basis would spend $1,820 per year just for sensors. This would on top of the $1,460 spent on test strips to calibrate the device and confirm readings.
For CGM companies like Dexcom, Medtronic (NYSE:MDT) and soon Abbott (NYSE:ABT) looking for reimbursement this is not good news. These companies have already acknowledged that studies need to be done that show the value of CGM. Besides taking years to complete and costing millions of dollars, the companies have the added burden of proving that the use of CGM is cost effective. Based on current pricing it costs a patient almost $12 per day for a sensor, even the most expensive test strips cost about $1 each which means the patient can actually test 12 times each day before reaching price parity with a CGM. Granted the information gathered with conventional meters is not as abundant as with a CGM however this cost differential is substantial when you add in the cost to calibrate the device and confirm readings with a conventional meter. The question is can these studies show a direct correlation between use of a CGM and better patient outcomes. Additional will the studies also prove that these better outcomes cannot be achieved using a conventional meter?
Looking at this from the viewpoint of private payors, where cost is paramount, the question they are sure to ask is; Will better outcomes actually lower their costs in the long run? Will spending over $3,000 per year for a CGM system really save them money down the road because patients avoid the many complications associated with diabetes? The realities of the reimbursement world are private payors would rather pay $30,000 for a leg amputation than pay $3,000 per year to prevent the leg amputation. Whereas the leg amputation is a possible cost, paying for a CGM is an actual cost. In the eyes of private payors looking to limit costs and realizing that it takes years for complications to develop, they understand that should complications develop it is likely the patient will no longer be a member of their plan. Simply put, they are passing this possible cost onto another private payor or the government. In the unlikely event this patient actually remains a member of their plan, the $30,000 spent on the amputation is actually a lower cost than what it would have cost to possibly prevent the amputation.
With all the research done related to diabetes and achieving good control, one thing that has never been proved is that solid control guarantees that patients will avoid complications. Diabetes is chronic and unfortunately debilitating disease and while good control does increase the chances of avoiding complications, there are no guarantees. According to a study entitled, “The 30-Year Natural History of Type 1 Diabetes Complications” published in May issue of Diabetes, “In conclusion, while these results show encouraging trends in complication rates, some of the improvements appear to be lost with longer follow-up, suggesting the major change has been delay not prevention. As recently noted, whereas the role of hyperglycemia is the development of complications is critical, other factors play a role. For CAD, which shows the least favorable change over time, these results suggest the need for a focus on its other risk factors, e.g., blood pressure and lipids, which are poorly controlled.”
The bottom line here is that just as there are no guarantees that better control leads to avoiding complications, there no guarantees when it comes to reimbursement rates. This is not good news for anyone, conventional or continuous monitoring.