Diabetes advocates are making progress in their quest to get FDA to look at measures other than glycated hemoglobin (A1C) when approving diabetes treatments. But if payers won’t cover them based on new criteria, it won’t matter, said Aaron Kowalski, PhD, chief mission officer for JDRF, formerly the Juvenile Diabetes Research Foundation.
“We need payers to approve stuff based on hypoglycemia reductions, and based on sleep improvements,” Kowalski said toward the end of his remarks Sunday at the meeting of the American Association of Diabetes Educators in Indianapolis, Indiana. “We need payers to be more encompassing.”
Kowalski is among the diabetes advocates and experts from the clinical, research, and pharmaceutical realms who have worked for more than a year to reach consensus on measures for FDA to consider when approving new devices and drugs. A July 21, 2017, meeting convened by the diaTribe Foundation
marked a huge step forward, he said. He walked the educators through a process fueled by patient input and reviews of evidence, which led to agreement that besides A1C, regulators should consider, in order:
time in range
The movement to look beyond A1C in approving diabetes treatments, especially those for people with type 1 diabetes (T1D), recognizes the enormous effect that hypoglycemia has on health and quality of life, Kowalski said.
“Glycemia comes with tradeoffs,” he said. The more diabetes care can reduce those tradeoffs and bring life closer to what it was before diabetes, the better. To emphasize his point, Kowalski showed the educators slides of predecessors of the continuous glucose monitor (CGM), including a “blue brick” that hung off the waist like a walkie talkie and a “biostator” that confined a person to bed.
More than 20 years ago, the Diabetes Complications and Control Trial showed the relationship between A1C and long-term cardiovascular outcomes, kidney failure, and retinopathy. But “A1C does not capture hypoglycemia,” and it isn’t actionable, Kowalski said.
“High blood sugar is bad, low blood sugar is bad. If you’re swinging between them, it’s bad,” he said. Thus, drugs and devices that help patients avoid highs and lows help reduce the long-term damage of diabetes, let patients sleep, and reduce the fear of an overnight drop in blood sugar that consumes so many patients and families.
As JDRF worked with FDA on standards for the artificial pancreas, Kowalski said, the question came up: what if A1C went up? From the perspective of a person with T1D, the answer is clear: if A1C went up incrementally, say from 6.4% to 6.8%, but the person no longer had repeat episodes of hypoglycemia that landed him in the hospital, that would be a success.
Kowalski reviewed several new devices that offer patients unprecedented levels of control. CGM is becoming more accurate, better than most meters that read glucose levels based on a finger stick blood test. But progress with payers takes time. Kowalski said it took 10 years for JDRF and others to convince CMS to give Medicare patients CGM access, which happened earlier this year.
Despite these developments, “You can’t turn on the news without hearing about healthcare and access issues,” he said. People with diabetes are beset with high deductibles and copayments, as well as the high price of insulin.
“We cannot have people making decisions because they can’t afford insulin,” Kowalski said. “Unacceptable.”