JDRF’s mission is to seek new treatments for type 1 diabetes (T1D), but the skyrocketing costs of existing insulin formulations have hurt so many patients that the new CEO of the 50-year-old organization has asked legislators to reduce the cost of currently available medications. The JDRF officially backs a new bill that would ban rebates on insulin formations that sell above their 2006 prices.

Aaron Kowalski, PhD, said in an interview with 

 that action is needed not only by Congress, but also by insulin makers, health plans, and the executive branch. The most important goal: ending a crosspayment scheme that many blame for potentially deadly price increases.

“We see the issues related to the rebate system as being the biggest challenge for us right now,” Kowalski said. “In a normal capital market where you have at least 3 similar products, as we do for most types of insulin, you’d see competition driving retail prices down. The rebate system lets the 3 insulin makers chase the prices up rather than chase them down. It hurts everyone, but it is extremely painful to people who are uninsured, who are underinsured, and who have high deductibles or copays.”

Pharmaceutical companies and payers keep nearly everything related to drug costs as confidential as the law allows, so many market specifics remain unknown, but the basics seem clear:

Drug makers typically revise each product’s list price about once a year and then negotiate rebates with each of the health insurers and pharmacy benefits managers (PBMs) that buy those products.

Insurers and PBMs negotiate rebate size aggressively, but they have no reason to ask drug makers to lower the list prices they never pay. No other organization has power to get drug companies to lower list prices, so those prices rise. A lot.

Researchers estimate that the price of a 40-day supply of insulin rose from $344 in 2012 to $666 by 2016.

 Out-of-pocket insulin costs for Medicare patients have more than quadrupled since 2007.2

It’s unclear what effect the rise in list prices has had on major payers. They may be negotiating such good rebates that their net insulin costs have risen very little, if they have risen at all. But skyrocketing list prices have hammered people who pay list prices or make copayments that are based on list prices—even very affluent people. Kowalski, the first CEO of the JDRF who has T1D, has seen it up close.

“My brother is a successful architect who runs his own business, but it’s a small business, 15 people or so, and his deductible was $12,000 or $14,000 a year,” Kowalski said. “His wife switched jobs for insurance because he was paying out of pocket for this insulin, at full list price, until he hit his deductible every year. He is a successful business person, but paying $300 a vial, multiple times a month, is a life-altering cost. For anybody who is living on a more normal income, which is the bulk of our population, that is an incredibly painful price for a drug that sustains your life.”

The legislation, whose primary sponsor is US Senator Jeanne Shaheen, D-New Hampshire,  is also supported by the American Diabetes Association. It would restrict the use of rebates, both in Medicare Part D and the private insurance market, for insulins whose list prices were initially rolled back to 2006 levels and then increased at no more than the general rate of medical inflation. The legislation would also require private insurance plans to waive deductibles for medications whose list prices fell to the required levels.3

“If that passes and all goes as expected, that would drive list prices down about 70%, but prices would still be considerably higher than they are in Canada, where people are paying about $40 a vial,” Kowalski said. “During recent Congressional hearings, the manufacturers admitted they were making money at the Canadian price. They’re not giving away insulin or selling it at a loss. And that tells us that there is plenty of room for profitability at 30% of current prices.”

Even if this particular bill does not pass, Kowalski believes there’s a very good chance that patients will get some relief.

“We have been encouraged that there is bipartisan anger at the situation that we’re in,” he said. “I’ve talked about this in both the House and Senate, and both sides of the aisle are very frustrated, as are both President Trump and the Democratic candidates [for president]. The reason for this support is that diabetes doesn’t affect only [Republicans or Democrats]. It affects both, and that should drive a bipartisan effort to help fix this problem.”

The US patent and market exclusivity systems attempt to balance the need for innovation and affordability in the drug market. Patents award a 20-year period of patent protection at any time during the development of a new drug before (theoretically) allowing generics or biosimilars to the market. Exclusive marketing rights are granted by the FDA upon approval of new drugs, the length of which depends on the type of product. Patents and exclusivity are separate and may or may not run concurrently. Analysis from JDRF’s health policy team, among others, has convinced Kowalski that pharmaceutical companies have undermined this balance with tactics that range from gaming the patent system for longer protection to bribing would-be competitors not to compete.

“We at the JDRF believe that the key to getting pricing down further is to get more biosimilars to market, increase competition, and provide more options to patients, but, frankly, we’re fairly disappointed at the pace that the biosimilar market has played out in the United States,” Kowalski said. “The same seems to be true for the senior leadership at the FDA. They seem very committed to doing everything possible to get biosimilars to market as quickly as they can without compromising the quality of the product, so the real problem here seems to be the aggressive use of the patent system and everything else that companies do to keep competition off the market. It’s definitely a problem, but we haven’t taken a stance on how to fix it because we are focusing on the rebate issue first.”

The price of patent-protected drugs in the United States tends to be 20% to 40% higher than in other rich nations, and there are many economists who believe that reducing American prices would greatly reduce development spending by pharmaceutical companies, which currently make about half of all their profits here.

 The insulin market may be different, however, as the price premium on insulin formulations is much greater. Insulin prices here can be more than 10 times what they are in Canada, and prices remain way above production costs for medications that have been off patent for years. As a result, there is much more room for cutting prices while maintaining incentives for innovations that Kowalski says are still very badly needed.

“Insulins have improved greatly over the past few decades, but there is still a lot of room for improvement,” he said. “Today’s insulins are easier to use, but they’re still too difficult, and we know that from data. The bulk of people don’t get to target A1C [glycated hemoglobin] levels because dosing insulin is like walking on a tightrope. If you use just a little too much, you have hypoglycemia, which is immediately dangerous. If you use just a little too little, you have hyperglycemia, which brings about long-term complications. Insulins also work faster than they used to, but they’re not even close to what the body can do. We’d certainly like a faster-acting insulin. We’d also like what some people call a smart insulin, a product that only reacted when your blood sugar was high. We need innovation, so we do need enough profit to be made for innovation. But we also need fair pricing once things get to market.”

Although the JDRF hopes that dramatic price cuts will soon allow anyone to go to their local pharmacy and load up on the most sophisticated insulins, Kowalski says there are workarounds for people who cannot buy such products at current prices.

“No one should be using so little insulin that they put their lives in jeopardy. There are options,” Kowalski said. “For people who live near Canada, that is an option. I have a friend who is a doctor in Seattle, and he says that nearly half of his patients who need insulin get it in Canada, where the price of analogue insulins is about $40 a vial.”

Community health centers can provide help, too, as can company drug assistance programs (the JDRF has listed information at jdrf.org/insurance). Another option is using older insulin formulations.

“I went out for my daughter’s graduation this May, and I realized I didn’t have insulin with me. I have good coverage, but I had just filled my prescription, so my options were to pay cash for the insulin I normally use or to go back to the nonanalogue human insulin that I used back in the 80s or 90s. I chose the old insulin because it was much cheaper. You can buy it at Walmart for about $25 a vial, and it’s a genuine alternative. If your options are full doses of cheap, nonanalogue insulin or way too little of the newer formulations, the older insulin is clearly the better option. It will keep you alive.”

But it’s nothing like a perfect solution.

“It simply isn’t as good,” Kowalski said. “I’m a PhD scientist, I work in the business, and I had more than a decade of experience using these formulations before analogue insulins came around, but my blood sugar was still an absolute mess when I was using that older formulation.”

Importing medicines from Canada also has obvious difficulties for individuals. As for reimportation at the national level, which President Trump recently proposed, Kowalski believes there has to be a better way to drive prices down.

“It shouldn’t come to that,” he said. “It is silly to devise this Rube Goldberg system for sending drugs from here to Canada and bringing them back to here. We need systemic change.”

JDRF’s very public advocacy for price-reducing measures from Washington has been well received by other advocates for patients with T1D. Some of those advocates have accused the JDRF of shying away from stances that would upset the pharmaceutical companies and device makers that are developing the next generation of treatments and that donate some money to JDRF coffers—a criticism that Kowalski says is utterly unfounded.

“I strongly object to that characterization. The dollars we receive from pharmaceutical companies or other companies in the medical field make up a tiny fraction of our budget; I believe it’s less than 3%. And those are unrestricted grants or targeted to educational programs that we run,” Kowalski said. “That amount of money wouldn’t affect decisions anywhere, let alone at an organization that is governed by people who have type 1 diabetes and people whose children have type 1 diabetes. Parents whose children have type 1 diabetes are not going to compromise patient care for pharma dollars. That money has no effect on any of our decisions. This organization is driven by a passion for helping people with this disease, not for seeking corporate support.”

Hargraves J, Frost A. Price of insulin prescription doubled between 2012 and 2016. Health Care Cost Institute website. healthcostinstitute.org/blog/entry/price-of-insulin-prescription-doubled-between-2012-and-2016. Published November 29, 2017. Accessed August 19, 2019.

Cubanski J, Neuman T, True S, Damico A. How much does Medicare spend on insulin? Kaiser Family Foundation website. 

kff.org/medicare/issue-brief/how-much-does-medicare-spend-on-insulin/

. Published April 1, 2019. Accessed August 19, 2019.

Summary of the Insulin Price Reduction Act. Senator Jeanne Shaheen, D-New Hampshire, website. 

shaheen.senate.gov/imo/media/doc/Insulin%20Price%20Reduction%20Act%20Summary.pdf

. Published July 22, 2019. Accessed August 19, 2019.

Goldman D, Lakdawalla D. The global burden of medical innovation. The Brookings Institute website. 

brookings.edu/research/the-global-burden-of-medical-innovation/

. Published January 30, 2018. Accessed August 19, 2019.

Articles

Evidence-Based Diabetes Management

Aaron Kowalski, PhD, the new CEO of the JDRF, says in a discussion about insulin pricing that action is needed not only by Congress, but also by insulin makers, health plans, and the executive branch. The most important goal: ending a crosspayment scheme that many blame for potentially deadly price increases.

JDRF's Kowalski Sees Hope in Bipartisan Support for Insulin Pricing Reform

As insulin prices have climbed since 2012, stories have emerged of patients with diabetes rationing their insulin. They either take smaller doses or they skip doses. Sometimes, the results are deadly: Deaths have been reported of young adults who were rationing insulin, including those who had aged off their parents’ insurance plans.

Are these isolated incidents? What we can expect from an insulin pricing system that is out of control? The results of a study published last year in 

suggest that rationing is more common than the healthcare system wants to admit.

 Between June and August 2017, a team of researchers at Yale Diabetes Center, led by Kasia J. Lipska, MD, MHS, senior author and assistant professor of medicine, surveyed patients who had type 1 diabetes (T1D) and type 2 diabetes (T2D). All of the patients had been prescribed insulin within the past 6 months, and the findings were stunning:

Lipska’s team found that 1 in 4 patients (25.5%) at the urban clinic at Yale reported some type of cost-related insulin underuse in the previous 12 months, which included using less insulin than prescribed, not filling a prescription, or stopping it.

Insulin rationing is tied to poor glycemic control. 

This result was not surprising, Lipska said. The research team found that patients who reported rationing for cost reasons were 3 times more likely to have poor glycemic control than those who did not (odd ratio [OR], 2.96; 95% CI, 1.14-8.16; 

Since the results were published, Lipska has met with executives from pharmaceutical manufacturers and appeared before Congress. Her April testimony before the House Committee on Energy and Commerce Oversight and Investigations Subcommittee featured the story of a clinic patient, a woman in her mid-20s with T1D, who “deliberately let her sugars run high so she could be admitted to the hospital and get free samples of insulin upon discharge.”

“It was a risky plan—she could have died,” Lipska testified. “But that’s how desperate she was.”

Deaths from insulin rationing are the outer edge of a continuum that includes patients who are risking blindness, amputations, and hospital stays. For these patients, rationing could erode their health, and the costs will fall to Medicare or possibly Medicaid. Thus far, no one has tallied what avoidable costs the health system will absorb because too many patients with T1D or T2D cannot afford to use insulin in the amounts prescribed.

In a commentary that accompanied Lipska’s results, Elisabeth Rosenthal, MD, editor-in-chief of Kaiser Health News, discussed the health consequences of insulin rationing:

“It can hasten disability (eg, blindness and kidney failure) and early death. Thanks to tight glucose control and more precise insulin dosing, researchers estimated in 2012 that children with diabetes born between 1965 and 1980 were living 15 years longer than those born between 1950 and 1965. Will that 15-year gain now be erased because of the price?”

), Lipska said questions about the long-term effects of insulin rationing are among the topics she hopes to explore over the next few years, as it becomes clear how widespread the problem is. The degree of rationing seen in the Yale clinic was surprising, but it made sense that not using enough insulin was closely linked with poor control (glycated hemoglobin ≥9% at the survey visit or within 3 months).

“The prevalence of insulin rationing should be shocking to all of us. It’s shocking that we live in a prosperous country, where we spend more on healthcare [per person] than any other country,

 that 1 in 4 patients should be rationing insulin, which has been around for a century,” Lipska said. “But it’s not shocking to clinicians who see this in practice. Clinicians should be asking patients about rationing. We know we see this. We don’t think these findings are wrong. They’ve been confirmed in other surveys.”

Lipska referred specifically to the 2018 survey by T1International, which found 1 in 4 people with T1D are rationing insulin.

The Short- and Long-term Costs of Rationing

The physical outcomes of not using the right insulin dose are well known, Lipska said: Patients will have more severe hyperglycemia emergencies, more heart disease, more blindness, and more disability. 

asked if there are other, less easily documented effects on patients who ration supplies. Does skipping or stretching doses increase stress?

 In turn, this can further elevate blood glucose levels in people with diabetes.

Lipska said she is seeking funding to study this issue. “What is it like to live with that uncertainty? Clearly, it’s extremely distressing. As a physician, it’s distressing for me. I see people who are struggling to obtain a medicine that we tell them is a necessity to live and they can’t afford it. It breaks my heart.”

“I have patients in impossible situations,” she said. Patient assistance programs, insulin samples, or coupons can sometimes bridge the gap, but in other cases it’s very difficult to find a solution. “It’s cruel,” Lipska said.

Lipska sees equal numbers of patients with T1D and T2D, and she said the rationing problem first came to her attention through her treatment of this second group; these patients tend to be older and enrolled in Medicare Part D.

Those with T2D also tend to come from lower socioeconomic backgrounds and suffer greater stigma; in turn, they are less visible in the advocacy community. Mick Mulvaney, the acting White House Chief of Staff, once derided “the person who sits at home, eats poorly, and gets diabetes.”

“You don’t hear about them,” Lipska said. Patients would hit the Part D “donut hole” and paying for insulin would become a huge challenge. “A lot of older patients are still working, and some have adult children move in with them.… but they don’t have [insurance] plans that cover insulin adequately.”

The patients with greatest challenges are those in the “middle space” who make too much money to qualify for Medicaid, but who have health plans with high deductibles or very high cost sharing, perhaps because the plan is for a small employer.

“It’s not the most destitute. The patients in the middle have an income, but they are struggling,” Lipska said. “When they have a chronic illness, it absolutely adds to their stress.”

Separately from her proposed research on the stress associated with insulin costs, Lipska is seeking funding to understand the long-term costs that will result from patients rationing insulin. If a broken system among payers and pharmacy benefit managers forces patients to ration insulin today, what will be the cost years from now, in higher healthcare utilization?

“Is it going to come back to haunt us that this is going to cost us a lot more down the line? It’s very shortsighted,” Lipska said. “The system right now makes no sense to a clinician. It makes no economic sense, really.”

In recent years, the nurses at the Yale Diabetes Clinic have become experts at navigating patient assistance programs and figuring out which pharmacies can handle complex cases. The increased knowledge doesn’t make the situation any less frustrating, Lipska said.

After the survey results appeared, Lipska met with insulin manufacturers and discussed the flaws of the current rebate system, which critics say drives up prices and harms those who must pay the list price or cost sharing that is tied to the list price. Discount programs and coupons won’t completely solve the problem, nor will offering older “human” insulins at very low prices, as some companies have done.

Capping out-of-pocket costs for those below a certain income level will squeeze those at incomes just above the cutoff. “There’s always somebody who is left out. I feel I’m only seeing the people who are left out,” she said. “What would solve the problem is if the list price went substantially down. That would solve the problem for many different groups of people.”

The crisis has propelled Lipska to act. “It’s hard because there’s only so much as a clinician that I can do,” she said. “I had to step out of my clinic to address this problem.”

Jones S. Another person has died from rationing insulin. 

nymag.com/intelligencer/2019/07/another-person-has-died-from-rationing-insulin.html

Herkert D, Vijayakumar P, Luo J, et al. Cost-related insulin underuse among patients with diabetes. 

2019;179(1):112-114. doi: 10.1001/jamainternmed.2018.5008.

Lipska K. Testimony submitted for hearing, “Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs.” House Energy and Committee website. 

docs.house.gov/meetings/IF/IF02/20190402/109502/HHRG-116-IF02-Wstate-LipskaMDK-20190402.pdf

. Published April 2, 2019. Accessed August 20, 2019.

Rosenthal E. When high prices mean needless death. 

How does health spending in the US compare to other countries? Peterson-Kaiser Health System Tracker website. healthsystemtracker.org/chart-collection/health-spending-u-s-compare-countries/#item-relative-size-wealth-u-s-spends-disproportionate-amount-health

. Published December 7, 2018. Accessed August 20, 2019.

Cost and rationing of insulin and diabetes supplies: findings from the 2018 T1International patient survey. T1International website. 

t1international.com/media/assets/file/T1International_Report_-_Costs_and_Rationing_of_Insulin__Diabetes_Supplies_2.pdf

. Published June 18, 2019. Accessed August 20, 2019.

Marcovecchio ML, Chiarelli F. The effects of acute and chronic stress in diabetes control. 

. 2012;5(247):pt10. doi: 10.1126/scisignal.2003508.

Diabetes discrimination and Mick Mulvaney. 

diabetesselfmanagement.com/blog/diabetes-discrimination-mick-mulvaney/

Drugmakers discount insulin, and lawmakers ask what took so long. Bloomberg website. 

bloomberg.com/news/articles/2019-04-10/sanofi-widens-insulin-discounts-ahead-of-congressional-hearing

. Published April 10, 2019. Accessed August 19, 2019.

Belluz J. Walmart’s $25 insulin can’t fix the diabetes drug crisis. 

Vox website. vox.com/science-and-health/2019/4/10/18302238/insulin-walmart-relion

. Published April 11, 2019. Accessed August 20, 2019.

The results of a study published last year from authors at Yale Diabetes Center suggest that rationing is more common than the healthcare system wants to admit. Senior author Kasia Lipska, MD, MHS, says the findings raise a whole new set of questions.

Gathering Evidence on Insulin Rationing: Answers and Future Questions

Three months from now, Allie Marotta will have her birthday. The Brooklyn, New York, resident has spent her summer applying for doctoral programs in theater. But pursuit of a PhD will not just represent a step forward in her career, it could throw her a lifeline.

When Marotta turns 26 on December 10, she will age off her parents’ health insurance and become responsible not only for the typical expenses of someone her age, such as undergraduate student loans or rent, but also for the cost of a drug she needs to survive: insulin.

It’s a cliff that Marotta and others with type 1 diabetes (T1D) see coming for months or even years before it arrives. In decades past, the quest to finance insulin—and stay alive&mdash;would come earlier in a young person’s life; the Affordable Care Act (ACA) only means the search comes later. For those who live with T1D, the ACA means insurers can no longer turn them away for having a preexisting condition. But for too many, turning 26 makes this protection a chimera. Soaring insulin costs and the rise of high-deductible health plans (HDHPs) can put the best products beyond the reach of young adults living on lean budgets.

For Marotta and the other young adults who spoke with 

), the reality of insulin’s out-of-pocket costs can mean that life decisions and career choices are based not on following dreams, but on finding health benefits.

“Having a chronic illness is already a huge burden to carry around,” Marotta said in an interview with 

. “To add to that, this whole layer of uncertainty and having to stretch and make things work and get creative is really frustrating.”

Marotta has been managing her T1D since it was diagnosed in August 2006 during a back-to-school physical. The diagnosis explained her extreme thirst, frequent urination, and weight loss—things she had been experiencing for some time&mdash;all classic symptoms of T1D.

If a doctoral program accepts her, Marotta can join a health plan offered by the school. However, that won’t happen until July 2020, which is when the academic year begins and she can finally enroll in the school’s plan, leaving a nearly 7-month gap in coverage. This means scavenging for extra insulin and supplies now or shoveling out the full cost of insulin and supplies starting in December. And there is the possibility that Marotta will not be accepted into a program, which would send her searching for a job that offers benefits.

For the time being, Marotta has had to get creative. She’s identified tools like Catch,

 which offers a financial safety net to those without an employer benefit plan. She also recently began using a Dexcom G6 continuing glucose monitoring system, the first time she’s used this technology. Marotta is already thinking ahead about how she will pay for sensors if she is temporarily uninsured; a 3-month supply of sensors will cost nearly $3000. She knows that some people with T1D end up “hacking” their systems to extend the life of sensors beyond the approved 10-day wear.

Marotta is among the 1.25 million people with T1D in the United States

 who are absorbing the costs of 2 decades’ worth of steep price hikes on insulin. In 2016, a research letter appearing in 

 revealed that insulin prices nearly tripled between 2002 and 2013, jumping from $4.34/mL to $12.92/mL. During the same period, estimated spending for insulin per patient increased from $231 to $736.

 And the increases didn’t stop there. In January 2019, the Health Care Cost Institute released a report showing that between 2012 and 2016, insulin spending per patient almost doubled, from $2864 to $5705, during the 5-year period.

These price hikes have resulted in people making the trek to Canada, where insulin can be up to 90% cheaper.

 The issue has also struck the attention of Capitol Hill,

 with patients, family members, and T1D advocates testifying before Congress about the dire consequences of the skyrocketing costs of insulin, which has forced some to choose between paying the steep price for the life-preserving medication or compromising their lives by skipping or rationing doses. Hearings in Congress examined how health plans, pharmacy benefit managers, and a system of rebates have pushed patients to this point; a Senate bill seeks to squeeze rebates out of the system and drive prices back down to 2006 levels.

The fallout from the cost of insulin has made headlines over the past year, with news outlets detailing stories of young adults rationing supplies or switching to older insulin formulations sold over the counter after aging off their parents’ insurance. In the most serious cases, patients have died. In July, 27-year-old Josh Wilkerson suffered a series of strokes that killed him.

 He had aged off of his stepfather’s insurance and found himself unable to afford his prescription insulin. As a result, he turned to an OTC human insulin, Novolin ReliOn, that at $25 sells for one-tenth of the price of more effective versions.

Compared with the newer insulins, human insulin has a delayed onset of action and is less predictable than the rapid-acting analogue versions.

 Analogue insulins have been shown to improve treatment adherence and satisfaction because of fewer injections, flexibility in timing of basal analogues, and less fear of dose adjustments.

 said they fear being forced to switch back to older formulations after having success with analogue insulins.

For Those With T1D, Planning Begins Early

Of the many parts of the ACA, 2 stand out in popularity among voters: the ban on insurers rejecting people with preexisting conditions and the provision that allows young adults to stay on family health plans until they turn 26.

 This second provision took effect in May 2010, years ahead of the rest of the law; at that time, young adults had the highest uninsured rate in the country at 30%.

For those with T1D, the change gives young adults and their families more time to plan, but that does not always prevent tragedy. Wilkerson’s story represents the worst-case scenario. Knowing the dangers associated with not having coverage, many young adults with T1D take preemptive measures to avoid being left in this position. For Marotta, conversations with her family to plan for her future began 2 years ago. For Sarah Tackett, a 26-year-old living in New York City, her planning started when T1D was diagnosed in 2013 when she was 20.

After being misdiagnosed for 6 months, Tackett received her T1D diagnosis in 2013 while she was attending college as a voice major. Back then, her most difficult decision was whether to major in music education or vocal performance. In the months before her diagnosis, Tackett was sleeping for up to 18 hours a day; although she passed all her classes, she was falling behind.

Once she learned she had T1D, Tackett knew she had to find a job with benefits to prepare for the day she turned 26. She switched her major to communications, knowing it would increase her employment options.

“I thought, ‘What am I going to do?’ Try and be a successful musician for 4 years, and then when I get cut off from my parents’ insurance, get a ‘real’ job? It’s not just switching your lifestyle, it’s also sometimes giving up what you love and doing something more practical,” she explained.

“Diabetes fully ripped my life and potential away. I always grew up thinking I would be a professional musician,” Tackett said. “I feel like I’m still mourning the loss of what my life would have been.”

When the ACA was introduced, its goal was to make health coverage more accessible and affordable so that Americans could see physicians and get prescription drugs when they needed them. However, the ACA coincided with a trend that was already in motion among employers and, some argue, hastened it: the rise of the HDHP.

Intended to encourage the use of high-value services, HDHPs have lower premiums and higher deductibles relative to other plans. The percentage of people under the age of 65 enrolled in a HDHP increased from 25.3% in 2010 to 47% in 2018.

The results of studies on HDHPs indicate that the high cost-sharing associated with the plans creates barriers that delay or reduce care for people with diabetes. A study published last year in 

 found that after patients switched to a HDHP, emergency department (ED) visits dropped by 4% and direct hospital admissions dropped by 11%, which resulted in 3.8% lower total expenditures.

 However, patients with lower incomes had significant increases in high-severity ED visit expenditures and hospitalization days, suggesting that these patients are attempting to minimize health spending by avoiding care, causing missed opportunities for prevention and treatment and resulting in more severe hospitalizations.

Much-needed relief is coming to those with diabetes and other chronic conditions with HDHPs who’ve paid high costs for their medications. In July, the Internal Revenue Service (IRS) and the US Department of the Treasury released guidance allowing HDHPs with health-savings accounts to cover chronic care treatment, such as insulin, before a patient meets their deductible.

“With this new IRS guidance, no insured American with diabetes should ever have to pay the full price for their insulin again,” said A. Mark Fendrick, MD, director of the Center for Value-Based Insurance Design at the University of Michigan, in an email to 

The feature of the ACA that has helped people with T1D the most, the protection for people with preexisting conditions, faces uncertainty as the law is again challenged in court.

 This has those affected by T1D questioning what will happen if the entire law is overturned.

Lala Jackson has T1D diagnosed at age 10 in 1997, more than a decade before the ACA arrived. In those days, young adults aged off of their parents’ insurance at 19 or when they were no longer in school full time. The month before she finished college, Jackson’s mother warned that she would be kicked off the family’s insurance shortly after graduation and that despite her best efforts, she could not help. Back then, insurers in the individual market could turn down someone with T1D, so Jackson was unable to purchase insurance on her own.

She graduated in 2009 in the midst of the financial crisis and found herself without insurance and unable to get a job with benefits. She considered joining the Peace Corps, but her application was turned down due to her T1D status. (In an email to 

, a Peace Corps spokesperson said applicants with T1D are evaluated on a “case by case basis,” and may serve if their diabetes “is well managed and the country the volunteer serves in can support their management” of the condition.)

Living in Savannah, Georgia, at the time, Jackson took an internship working 30 hours a week at $10/hour and tried to pay for things herself; her rent cost $500 and her insulin, $100 per bottle. Jackson uses 3 to 4 bottles of insulin a month. She went to the local Medicaid office for help, only to be told they could not help her unless she was pregnant.

When her internship ended in August 2010, Jackson moved in with her mom in Richmond Hill, Georgia. That October, she moved to Atlanta, Georgia, where she accepted a job without benefits with the hope that if she worked hard, she would be offered health coverage. Between October 2009 and May 2010, her pay increased from $800 to $1500 per month, her rent was $650 per month, and insulin cost $125 per bottle. After 9 months at the job, she was taken on full time and offered benefits.

During the year and a half that Jackson lived without insurance, she would ration her insulin. She also landed in the hospital 3 times, which added ED bills to her plate.

“Most people who knew me during the time would say I was just existing, that I was kind of a shell at that point,” said Jackson in an interview with 

. “I only survived because of all the people who understood what was happening,” she explained, reflecting on the time when her friends would pool their resources to try and help her, including her rent.

Fast forward to 2019, and the current mix of high prices, rebates, cost-sharing, and benefit design can mean that despite the ACA, today’s young adults with T1D face similar challenges.

 her days of seeking care when she needs it are coming to an end. “Now I have the freedom to go to urgent care whenever I think something is wrong and be proactive about it or go see my primary care,” she said. “When I’m uninsured, seeing a doctor is not an option, because it will be so expensive.”

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“Diabetes fully ripped my life and potential away. I always grew up thinking I would be a professional musician. I feel like I’m still mourning the loss of what my life would have been.”

--Sarah Tackett, age 26 

For Young Adults With Type 1 Diabetes, Insulin Costs Can Mean Chasing Benefits, Not Dreams

Shortly before Lloynisha White turned 26 a year ago, she received a letter in the mail. With her vision still impaired from recent complications of type 1 diabetes (T1D), White asked her mother to read it. It was then that she learned she would soon be kicked off her parents’ insurance.

In 2016, when she was 24, White’s eyesight began to fail. Her doctor said the insides of her eyes were bleeding and both retinas had begun to detach.

That day, White’s doctor injected her left eye with medication to slow the bleeding and performed laser treatment to prevent the retina from detaching. A week later, he performed the same measures to her right eye. White went through several of these treatments. However, her vision began to fail again, and shortly after 2017 began, she could not see. After 1 month of blindness, White had surgery to reattach her retinas.

“I thought my life was over. My body was in pieces,” said White in an interview with 

Her vision loss coupled with a rare gastrointestinal condition that can occur in people with T1D have left White unable to work for several years. This meant there was no opportunity to gain employer-sponsored coverage before she turned 26 and would no longer be able to stay on her parents’ health plan under the Affordable Care Act.

White applied for coverage through Medicare. Although most people become eligible for Medicare when they turn 65, the program does offer coverage for those under the age of 65 who have a disability, like blindness or low vision.

 But before White’s Medicare coverage took effect, there was a gap of 5 months in which she had no insurance. During that period, White said, her monthly insulin costs were $800, her other diabetes supplies cost over $150, and doctor visits cost $250.

Medicare eligibility has not solved all White’s problems. She’s struggled to gain coverage for her Dexcom continuous glucose monitoring system, which has been shown to help people with T1D achieve better glycemic control and reduce glycemic variability, 2 things especially important for something with White’s history of vision loss.

White’s T1D was diagnosed in 1999 when she was 7. The diagnosis was hard for White to accept, and she admits she sometimes ate whatever she wanted and lied when her doctors asked how her blood sugar had been doing. This behavior is common among teenagers with T1D; research shows that those in their early teen years often don’t follow nutritional guidelines

 and that many struggle during the transition toward taking over their own care.

Katharine Garvey, MD, MPH, of Boston Children’s Hospital, and Lori Laffel, MD, MPH, of Joslin Diabetes Center, wrote last year: “Lack of preparation during transition followed by unsuccessful transfer often results in gaps in diabetes care exceeding 6 months, deterioration in glycemic control, increase in emergency room use and hospitalization, and emergence of diabetes complications among older teens and young adults.”

Said White, “I didn’t want to accept that I had diabetes, but by the time I was ready, I started developing complications.”

Besides temporarily losing her eye sight, in 2016, she received a gastroparesis diagnosis. This rare condition can result from diabetes in which the stomach cannot properly empty itself of food. The condition cannot be cured, but medications can help.

 White had been having symptoms of gastroparesis—nausea, vomiting, and feeling full quickly when eating&mdash;since she graduated from college in June of 2015.

After graduating from the Institute of Culinary Education with a degree in hospitality management, White moved into an apartment and got a job at a hotel. Shortly after starting the job, she felt sick and passed out.

Over the next 4 months, White went from doctor to doctor, only to be told by most that she had a stomach virus. Because gastroparesis is rare, it’s likely that many doctors had never seen a case before hers. Unable to eat or digest food properly, White would throw up at the smell and texture of certain foods and had to sleep sitting up so that she would not choke on her own vomit. At one point, White weighed just 85 pounds. At age 24, she was on a feeding tube.

“At one point in time, I was just praying I would be home for 1 or 2 days before having to go back to the hospital,” said White. “I would normally be home for just 12, maybe 14 hours before having to go back to the ER [emergency room].”

When her gastroparesis was finally diagnosed, she was referred to a surgeon at Weill Cornell Medicine to have a gastric pacemaker inserted. Her gastroenterologist also recommended a medication she could get in Canada to ease her symptoms. The drug, domperidone, increases the movements or contractions of the stomach and bowel. It is not FDA approved and is available only in Canada and the United Kingdom or through FDA’s expanded access program.

“From the day I started taking that medicine, I gained my weight back, I got me back, I got my life back,” said White.

The diagnosis of diabetes can be hard for a teenager to accept. Add insulin affordability to the mix, and by the time a young adult learns to live with the disease, the complications have already arrived.

September 2019

JDRF's Kowalski Sees Hope in Bipartisan Support for Insulin Pricing Reform

Gathering Evidence on Insulin Rationing: Answers and Future Questions

For Young Adults With Type 1 Diabetes, Insulin Costs Can Mean Chasing Benefits, Not Dreams

As a Child, Diabetes Was Hard to Accept. Now She's Living With the Complications

How Prepared Is the United States for the Transition of Insulins to Regulation as Biologics?

Biosimilar Insulin Could Offer Patients Cost-Saving Options

Impact of Switching Analogue Insulin to Human Insulin in Diabetes

Could Aiming Insulin at the Liver Be an Answer to Using Less?

Examining the Reality of What Insulin Costs Do to Patients