Commentary by A. Jay Cohen, MD
EndocrineWeb: What are the challenges of transitioning from adolescent to adult care among patients with endocrine disorders?
Dr. Cohen: These patients are changing in many ways, including physically, intellectually and emotionally. In many patients, the disease state changes as well. For example, by the time teenagers with type 1 diabetes are 25 years old, they have gained 15 to 20 pounds and have developed insulin-resistance on top of their insulin deficiency.
We see a big drop off in medical follow-up for patients during the transition from adolescent care to adult care. As an adult endocrinologist, I see 22- and 23-year-old patients in renal failure who have severe retinopathy with photocoagulation and panphotocoagulation as a result of this drop off in care.
Part of the problem is that there is often a big gap between a young adult’s knowledge of what to do and actually doing it. And this gap can be cavernous. In addition, a high percentage of these teenagers have one parent, not two, at home and may have limited supervision to make sure that they are controlling their disease.
Two good things about the Affordable Care Act is that an insurance company cannot exclude a patient with a preexisting condition, and young adults can still be on their parents’ health plan until they are 26 years old. This should help remove the barrier to health insurance for young adults who do not have their own health insurance yet.
Clearly, we know from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Control and Complications trials that the teens and young adults who have tight glycemic control in the 10-year period around adolescence have greater control during the transition to adulthood, even if their control loosens up.1 There is some type of memory that stays with them that is protective. We have no idea why that happens, but it is spectacular that it does. One of the things that may be helpful is to develop national initiatives to help create messaging for parents, adolescent patients, and adult and pediatric endocrinologists on why tight control in the young teenager is important for their future.
EndocrineWeb: What challenges in treating adolescent patients are related to the drug approval process?
Dr. Cohen: Other challenges include lack of access to newly approved medications among adolescents. For example, while 18 new drugs for type 2 diabetes were approved by the U.S. Food and Drug Administration (FDA) in the past year—and another 7 are expected to be approved shortly—none of these are approved for use in adolescents. This presents a dilemma.
More than 30 phase III trials are currently ongoing investigating use of diabetes medications in adolescents and children. Nearly every GLP-1, SGLT2, DPPIV, and medication combinations with metformin are attempting to gain approval for younger patients. To my knowledge, none of these trials are enrolling to a point where we can actually derive P values, because there are more than 30 trials competing with each other.
What I would love to have is American Association of Clinical Endocrinologists (AACE), American Diabetes Association (ADA), Endocrine Society, and our pharmaceutical colleagues get together and meet with the FDA and discuss a possible compromise to allow adolescents access to these medications sooner. Perhaps we can get an approval starting at age 15 instead of 18 years. We need the approval in order for insurance companies to be able to cover some of these phenomenal breakthrough therapies that we have all seen work in our adults with type 2 diabetes.
In addition, we should express that we don’t want just efficacy data from phase III trials involving adolescents, but we want to make sure there are no side effects in different populations.
EndocrineWeb: What challenges in treating adolescent patients are related to insurance coverage?
Dr. Cohen: We know that the drugs that patients receiving Medicare Part D or Medicaid are different than those covered by commercial insurance companies. This is another reason I think that our leadership at AACE, ADA, and Endocrine Society should meet with Centers for Medicare & Medicaid Services (CMS) and the FDA. Endocrinologists and their sister organizations should be part of the formulary committees of all insurance companies, including government plans; it is unfortunate that patients are deprived of safer medications when it appears that cost is the only criteria for access.
It would be helpful to know what the formulary is for covering a drug under Medicare Part D. We have developed groups of medications that result in dramatic improvement in hemoglobin A1c levels with weight loss as a secondary benefit that have an incredible safety profile. The safety of our diabetes drugs is unparalleled compared to where we were during our fellowship years ago. I would urge CMS to tell us what is the formulary is, so that we can provide the necessary data to get approval for use of these agents in our adolescent patients. This access would enable prescribers to pick the right drug that fits into the puzzle to provide long-term good health and prevent complications.
EndocrineWeb: What tools can health care providers use to help during this transition from adolescence to adulthood in patients with endocrine disorders?
Dr. Cohen: The National Diabetes Educational Program offers wonderful transitional tools (http://ndep.nih.gov/transitions/). JDRF also has developed transitional material for families (http://jdrf.org/life-with-t1d/teenagers/). Medical groups and families both can access these fine resources.
September 24, 2015
Cohen AJ. Challenges in Management of the Endocrine Patient: Transition of Care from Pediatric to Adult Endocrinology. Presented at: AACE 24th Annual Scientific & Clinical Congress; May 13-17, 2015; Nashville, Tenn: T32
1. Writing Group for the DCCT/EDIC Research Group, Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015;313(1):45-53