Exorbitant price diabetic insulin has been driving Americans into debt. According to a recent survey conducted by Carityrx, diabetic insulin prices have been rising annually in the US for years, with the country maintaining the highest average price for insulin around the world by a staggering margin. The Affordable Insulin Now Act, which will go into effect in late 2022, will offer reprieve for many Americans by capping copays. Yet, unfortunately the legislation does not lower the actual price of insulin, leaving behind the many American diabetics who do not have health insurance.
Diabetes affects 1 in 10 Americans, taking a serious toll on both quality of life and personal finances for many. According to the CDC, people with diagnosed diabetes have more than twice the average medical costs than those without diabetes.
The United States far surpasses the global community when it comes to average prices for insulin, and sadly, pricing has only risen year over year. The high cost of this vital, life-saving medication has led far too many American diabetics to struggle financially. When comparing the US to countries around the world, the cost of insulin in the US is 8 times higher than the combined average of other high-income nations.
According to the survey:
- 79 percent say that insulin has posed a financial difficulty for them personally, or for those in their care,
- 4 in 5 have taken on credit card debt to afford insulin,
- US$9,000 is the average amount of debt people have taken on to cover insulin costs.
The exorbitant pricing of insulin in the U.S. has forced many diabetics and their caregivers to make difficult decisions and compromises that put their health and/or livelihood at risk. Of the 4 in 5 who’ve struggled financially due to insulin pricing:
83 percent say they’ve feared not being able to pay for living expenses due to high insulin costs, cutting expenses such as clothing (55 percent), food costs (50 percent) and for some, even rent/mortgage (29 percent);
63 percent have felt pressure to sell prized, personal possessions (63 percent), put themselves in risky situations (50 percent) or to sell prescriptions or illicit drugs (32 percent) in order to obtain the money needed for insulin;
In an effort to lower costs, 62 percent have skipped and/or adjusted the dosage of insulin injections for themselves, or as a caregiver for someone else to cut down on costs;
Of those who’ve rationed their insulin, diabetics have experienced the following negative impacts on their day to day life:
- Inability to do everyday activities (54 percent)
- Inability to work (44 percent)
- Admission to the hospital for one or more days (38 percent)
- Inability to attend school (37 percent)
- Further, 38 percent have been admitted to the hospital for more than one day and 33 percent have become sick with an additional health issue as a result of insulin rationing.
The survey comes as a bipartisan group of Senators are working on legislation that would cap the cost of insulin, after President Biden reversed a Trump-era measure designed to lower out-of-pocket insulin costs for seniors on Medicare.
Oral insulin for diabetic patients
According to a 2019 media report, oral insulin, the Holy Grail of diabetes care that has alluded researchers for decades, is taking a major step towards becoming reality.
Oramed Pharmaceuticals Inc.(NASDAQ/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, is working to bring the first oral insulin product to market, providing a more convenient, effective and safer method for delivering insulin therapy.
The company has launched its largest and most advanced clinical trial under direction of the U.S. Food and Drug Administration (FDA) to date, involving 240 patients with type 2 diabetes in multiple centers throughout the U.S., including the CHEAR Center in the Bronx.
Oramed’s oral insulin is currently in a pivotal clinical study going through FDA regulatory channels and is considered a game-changer for the more than 100 million American adults living with diabetes or prediabetes.
“Our oral insulin is solving the drawbacks to injectable insulin, delivering it in a way that a needle could never replicate”, said Oramed CEO Nadav Kidron.
“Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin, but it also provides a more efficient and safer platform for delivering insulin by mimicking the body’s natural process of insulin going directly to the liver rather than via the bloodstream”.
The trial participants will take the oral pill for 90-days, with different groups following different dosing regimens at varying times throughout the day. The study is designed to show the product’s effectiveness at lowering glycated hemoglobin, a determinant of average blood sugar levels over three months and is considered the gold standard by the FDA when evaluating the drug’s efficacy.
As Kidron explained, early insulin therapy is ideal in order to decrease the burden on a diabetic’s pancreas, potentially allowing it to continue producing insulin for longer. However, doctors are often cautious when prescribing insulin by injection because it is a complex process that relies on patient compliance. Not only is there a danger of injecting too much insulin, but because the insulin is introduced directly into the bloodstream, only a fraction reaches the liver, often causing excess sugar to be stored in fat and muscle which results in weight gain. For this reason, injectable insulin is often viewed as a last resort.
With Oramed’s proprietary platform, the active insulin is protected as it travels through the stomach and into the intestine, and its absorption is increased along the intestinal wall. The result is better glucose control, reduced hyper and hypoglycemia, and less weight gain. In addition, oral insulin is easier for diabetics to incorporate into their daily routine because they simply take a pill, removing the need for multiple daily injections and continual glucose measurements.
“Right now, we know there are diabetics who would benefit with early insulin therapy who are simply not getting it due to the fact that, today, it is only available as an injection”, said Kidron. “By providing insulin in an effective pill form, we’re removing the barriers from both the physician and patient perspectives”.
An earlier trial for Oramed’s oral insulin – involving 180 patients across the US over 28 days – demonstrated strong promise for the technology, showing it to be a safe oral insulin delivery method with no serious adverse events related to the treatment. It also demonstrated a significant ability to lower glucose levels, including the glycated hemoglobin gold standard. The current trial – the first to be conducted over 90 days – is hoped to show an even greater impact.
“This is our most important study to date”, Kidron said. “A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection”.
David B. Bernard, MD, Principal Investigator at the CHEAR Center, called the clinical trial an important step forward in diabetes management. “We strongly believe that oral insulin will lead to better compliance and ultimately, healthier patients”, said Dr. Bernard, noting that the center sees approximately 250 diabetes patients each year for clinical study-related purposes.
