“Sometimes I try to fudge it, meaning if I should take 25 units of insulin, I try to get by on 20 units because of the price of insulin,” says Bell, who pays $450 per month for his various prescriptions, costs which his Medicare plan won’t cover after deductibles, copays, and the Part D coverage gap. “If I just sit in my recliner then I’m going to need that 25 units.” Bell isn’t alone. In light of rising insulin prices, many healthcare providers are concerned that more people with diabetes are rationing their insulin, increasing their risk of serious hospitalization and early death. “I’ve had patients who will cut their insulin doses in half,” says Joshua D. Miller, MD, the medical director of diabetes care at Stony Brook Medicine in Stony Brook, New York. “I have had patients on a regular basis tell me that they avoid eating carbohydrates because they know that if they eat carbohydrates they have to take insulin to cover the carbs, and therefore they can’t afford the insulin.” For the past 20 years, Dr. Miller has managed a personal diagnosis of type 1 diabetes, and he says he has struggled with insulin costs in the past. The average yearly cost of insulin for people with type 1 diabetes, who do not make their own insulin and thus must take it to survive, doubled between 2012 and 2016, from $2,864 to $5,705, according to Health Care Cost Institute. Meanwhile, during the same period, the median real personal income, which adjusts for inflation, rose by only 5 percent, to $32,000 before taxes in 2016, according to the Federal Reserve Bank of St. Louis. These rising costs have affected insulin-dependent people with type 2 diabetes as well, as evidenced by Bell’s predicament. From 2002 to 2013, the average price per milliliter of insulin has more than tripled, according to a study published in April 2016 in the Journal of the American Medical Association (JAMA). That may be why, like Bell, some of the 6 million people in the United States who are insulin-dependent are fudging it, suggest data from the American Diabetes Association. An estimated 1 in 4 people who are prescribed insulin may be using less than needed because of the cost, according to a study published in January 2019 in JAMA Internal Medicine. “What are people supposed to do?” says Bell, who’s been using insulin to manage type 2 diabetes since 1993. “There’s so many people in America today that can’t afford these drugs. They don’t take them because they can’t afford it — and that shortens their life spans. Now, is that right?” “My son died because he could not afford his insulin,” Smith-Holt told CBS of her son Alec. Indeed, insulin rationing can wreak havoc on a person’s health and endanger his or her life. “At its most extreme, you see people with diabetes who are on insulin and [who ration their supply] end up in what we call hyperglycemic crisis,” or in other words, their blood sugar (glucose) level is dangerously high, says Miller. Hyperglycemia is the medical term for high blood glucose, and among the crises that can occur when there isn’t enough insulin to lower it are diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar nonketotic syndrome (HHNS). According to MedlinePlus, DKA occurs when the body doesn’t have enough insulin to convert glucose into energy and begins to break down fat into acids known as ketones for fuel. In those who don’t have enough (or any) insulin, the amount of ketones can accumulate to dangerous levels. A person whose blood sugar is above 250 milligrams per deciliter (mg/dl) should have their urine tested for ketones. “I’ve had patients admitted to the ICU in DKA because they haven’t had enough insulin — or any insulin … it’s life-threatening,” says Miller. According to the Centers for Disease Control and Prevention, DKA hospitalization rates for people with diabetes rose 54.9 percent from 2009 to 2014, reversing a prior trend of decline, though in-hospital fatality rates continued to fall through 2014. The agency called for further study to identify the causes. Hyperglycemic hyperosmolar nonketotic syndrome is another condition that occurs when insulin deficiency causes blood sugars to exceed 600 mg/dl, notes Summit Medical Group. The body responds by excreting the extra blood glucose in the urine, leading to severe dehydration and an imbalance of electrolytes. Brain swelling, seizures, organ failure, coma, and even death can occur. Miller says he has seen his patients admitted to the ICU due to hyperglycemic crises brought on by insulin rationing. “Thank God I have not had a patient die yet, and I say yet because if the crisis continues, it’s a matter of time.” In 1978 “human insulin” was synthesized with recombinant DNA technology, and was marketed beginning in 1982. Human insulins currently on the market include rapid-acting regular (Humulin R, Novolin R), which is taken with meals; and human NPH (Humulin N, Novolin N). In the 1990s scientists engineered insulin analogs to have a more reliable duration of action through the modification of amino acid chains, according to the article. Popular analogs currently on the market include fast-acting Novolog (insulin aspart), Apidra (insulin glulisine), Humalog (insulin lispro); as well as intermediate and long-acting Levemir (detemir); Tresiba (degludec); and Lantus, Toujeo, and Basaglar (glargine). Rising in popularity, analogs represented two-thirds of all insulin used in high-income countries by 2009, notes an article published in February 2016 in the Lancet Diabetes & Endocrinology. But on average they cost more than twice as much as traditional human insulins, in terms of cash price (what is usually paid by the consumer at the pharmacy) per unit, according to an analysis by the prescription-drug discount app GoodRx. Increasing use of analogs is among the reasons why average insulin costs have risen so precipitously for patients in recent years, according to a June 2018 Diabetes Care report by the Insulin Access and Affordability Working Group of the American Diabetes Association’s board of directors. Yet it isn’t the only reason, the group writes. As the working group explains, the insulin supply chain leading from manufacturer to consumer is complex, with numerous parties — including wholesalers, pharmacy benefit managers (PBMs), employers, insurance health plans, and pharmacies in between — that stand to gain or lose based on insulin sales. Another potential contributing factor is that today only three manufacturers provide insulin to the U.S. market: Eli Lilly, Novo Nordisk, and Sanofi. Typically with drug pricing, a manufacturer sets the list price and sells the product to wholesalers, who handle distribution to pharmacies, though some pharmacy chains deal directly with the manufacturer. Pharmacies distribute the medications to consumers and collect whatever insurance-plan copays are due (or the full purchase price if a patient isn’t covered by insurance). Yet a description of the process isn’t complete without describing the role of the PBMs. They often manage the pharmacy benefit portion of a health plan on behalf of payers for healthcare, including large employers; health insurers that provide pharmacy benefits to Medicare enrollees or cover state Medicaid program enrollees; and health insurance plans sold directly to individuals. As part of the process, they develop the formulary, a continually updated list of drugs that the PBM approves for reimbursement. Drug manufacturers negotiate discounts of their drugs’ list prices through cost-lowering rebates with the PBMs (the three largest being CVS Caremark, Express Scripts, and OptumRx), in hopes of maintaining a desirable placement within the formulary. PBMs retain a portion of the rebates, according to the working group report. But there isn’t much transparency about how much money from the drug list price that PBMs retain. “The current pricing and rebate system encourages high list prices,” the Diabetes Care paper reads; the authors note that the rise in the list prices for insulin products has significantly outpaced net price increases in recent years. For instance, the list price of Eli Lilly’s Humalog increased by 138 percent between 2009 and 2015, while the net price to the manufacturer, after rebates, increased by 6 percent, Bloomberg reports. “The widening gap between the net and list price of insulin in recent years appears to be the result of increasing rebates and discounts negotiated between stakeholders,” the authors stated. Aaron Heilaman, a pharmacist in Ada, Oklahoma, is blunter about potential incentives that manufacturers may have to keep raising list prices. “The PBM will offer preferred formulary placement to whichever drug maker agrees to pay the higher kickback. These rebates … that the drug manufacturers have to pay the PBMs absolutely drive up costs for patients and plan sponsors,” Heilaman says. “Every day, Americans — particularly our seniors — pay more than they need to for their prescription drugs because of a hidden system of kickbacks to middlemen,” said the Health and Human Services secretary, Alex Azar, in a January 2019 news release. “President Trump is proposing to end this era of backdoor deals in the drug industry, bring real transparency to drug markets, and deliver savings directly to patients when they walk into the pharmacy.” JDRF, a research and advocacy organization for people with type 1 diabetes, is “pleased HHS has proposed ending the use of rebates in federally funded healthcare programs,” said Cynthia Rice, the senior vice president of advocacy and policy, in an email statement. The Pharmaceutical Care Management Association, a trade association representing the PBMs, expressed concern that the rule would “increase drug costs and force Medicare beneficiaries to pay higher premiums and out-of-pocket expenses, unless there is a viable alternative for PBMs to negotiate on behalf of beneficiaries.” On February 15, 2019, a U.S. district judge in New Jersey allowed a class-action lawsuit to proceed against Eli Lilly, Novo Nordisk, and Sanofi, Bloomberg reported. The 67 plaintiffs, who have diabetes, allege consumer fraud by the drug makers and contend that they are illegally raising drug prices to provide rebates for PBMs. Meanwhile, the idea of offering rebates directly to consumers at the point of sale is picking up steam. In 2018, UnitedHealthcare and Aetna announced that they would begin offering such rebates to some members of commercial plans this year. JDRF called on an additional 23 of largest health insurance companies in the United States to follow suit in November 2018. “JDRF advocates prompted Blue Cross Blue Shield of North Carolina to pass on rebates as well,” Rice said. Heilaman says offering consumers rebates seems great in theory, but he’s skeptical that anything will cut into the profits of the PBMs and bring real savings to consumers. “What we really need is legislation to remove unnecessary middlemen who provide little-to-no service from all aspects of healthcare,” he says. During a Senate Finance Committee hearing on February 26, 2019, drug manufacturer CEOs, including the head of Sanofi, also blamed rebates to PBMs for rising prices of medications and insulin. Meanwhile, bills aimed at bringing down drug costs are stalled in the U.S. Congress. Rebates weren’t the only factor to which the ADA working group attributed rising insulin costs. Additional concerns raised included “a lack of transparency throughout the insulin supply chain,” making it hard to pinpoint who is profiting and by how much; and “burdensome” regulations for the development and approval of biosimilar insulins, which are analogous to generic drugs, per an October 2012 article in Clinical Diabetes. In January, the Food and Drug Administration finalized its guidance for regulating insulin as a biologic product, opening an approval pathway for makers of biosimilar insulin starting in 2020. Luo is a corresponding author of a January 2019 retrospective cohort study of more than 13,000 Medicare recipients with type 2 diabetes that was published in JAMA. It found that switching from analogs to older, human insulin only raised the study participants’ hemoglobin A1C levels by 0.14 percent, which is likely not “clinically important,” the authors wrote. A1C is a measure of how much glucose attaches to the hemoglobin in your red blood cells, on average, over the past two to three months. People with type 2 diabetes who must take insulin and are struggling to afford it should at least have a conversation with their doctor, says Luo. Switching from an analog back to insulin isn’t for everyone; for instance, if a person has problems with hypoglycemia (blood sugar that drops too low), they may not do as well on human insulin products, he says. But “if they’re on a fixed income, if they’re having problems paying rent, their electricity bills, their copay or their coinsurance for their insulin, I would strongly encourage them to consider switching to less expensive, but clinically equivalent human insulin.” Bell, the retired sales account manager living with type 2 diabetes, says he has switched from rapid-acting Humalog to an over-the-counter fast-acting human insulin to help save money, but because his Medicare insurance doesn’t cover the $50 cost for two bottles every month, it still takes a bite out of his wallet. Miller doesn’t believe that’s the answer. “Yes, those insulins can keep people out of the hospital, but as far as quality of life, I am a strong believer that a switch to [human insulin] N and R is a switch backwards.” There are signs that people in search of additional savings on insulin are looking beyond chain pharmacies. A survey published in February 2019 in JAMA Internal Medicine suggests that some people with diabetes are turning to over-the-counter insulin, which Walmart sells. The authors wrote that this trend “likely reflects the fact that the Walmart brand is considerably less expensive than other brands of insulin sold at chain pharmacies.” However, T1International, a UK-based advocacy group, released a statement in June 2018 that “Walmart insulin” can be less reliable than analogs, requiring the use of more blood glucose testing strips at additional cost. Suggesting that patients should switch back exacerbates “a two-tiered system where the rich get the ‘better insulin’ and the poor are forced to use the older, and often more problematic, insulin,” the group says in its statement.
1. Take Advantage of a Patient Assistance Program
Many drug manufacturers offer such programs. The American Diabetes Association lists contact information for a number of them here. The National Institute of Diabetes and Digestive and Kidney Diseases has a resource page covering insurance options, federal programs and more. Medicare has a database that allows you to look up assistance programs by drug name. Check these resources to see if you are eligible and learn what processes you must go through to get assistance.
2. Consider Administering Your Insulin With a Lower-Cost Method
But important to note is that switching may come with additional burdens. The lowest cost delivery method is using a vial and injecting yourself by syringe. It also can be the most painful and difficult method, with the greatest room for errors leading to hypoglycemic episodes. A prefilled syringe that you use to inject yourself in the fatty tissue with a very thin needle is a more expensive but convenient option, with less room for error in dosage. For comparison: a vial of Humulin R costs $191 per vial, or $0.19 per unit; while a Humulin R Kwikpen costs $358 per pen and $0.24 per unit, according to the prescription-drug coupon app GoodRx. A computerized pump, which delivers insulin 24 hours a day through a catheter placed under the skin, most closely mimics the body’s own way of releasing insulin. It is also the most expensive — about $6,000 for the device, plus an additional $1,500 per year in supplies — and not always covered by insurance. Plus, you must still pay for the insulin.
3. Consider Getting Insulin Outside the U.S.
“If you live close to Canada, I’d say drive up to Canada and buy it there for a lower price for the same thing, made by the same company,” advises Luo. The FDA has guidelines for importing prescription medication into the country from abroad. Typically, you won’t run into problems if you have a three-month supply or less.
4. Ask Your Healthcare Team About Your Treatment Options
Do ask your doctor to review your course of treatment and see if there are any lower-cost insulins or delivery systems that she or he can prescribe that will allow you to maintain the same level of health and a quality of life that is acceptable to you. Be sure that the conversation is thorough and covers any hidden costs, such as extra testing strips. These individual cost-saving measures won’t stop insulin prices from rising for people like Terry Bell, and as far as he’s concerned, the problem should be up to drug companies, not patients, to solve. “I know they’ve got to make a profit,” he says, “but they don’t have to make a killing on what they sell things for.” For more tips on affording your diabetes management supplies, check out Diabetes Daily’s article “Ways to Save on Diabetes Supplies”!
