THE INSULIN PRICING CRISIS, SELF-MEDICATING VIA RATIONING, AND LEGISLATIVE FIXES

Author: Sarah Mustian, Associate Editor

Around 37.3 million people in the United States, or 11.3% of the population, are estimated to have diabetes.[i] Diabetes is a chronic illness where one’s pancreas is unable to produce enough insulin (Type 1 diabetes) or properly utilize insulin (Type 2 diabetes).[ii] When this occurs, the body is unable to break down glucose into the bloodstream. This results in high blood sugar, known as hyperglycemia.[iii] Untreated hyperglycemia can lead to severe complications, including vision issues, nerve damage, kidney disease, and cardiovascular disease.[iv] Diabetes is the seventh leading cause of death in the United States, and is the leading cause of kidney failure, blindness, and lower limb amputation in adults.[v]

Prior to the discovery of insulin, diabetics primarily treated their illness through exercise and diet.[vi] Although these treatment methods are still encouraged by physicians today, the discovery of insulin in 1922 eventually led to its promotion as the primary therapy used in the treatment of Type 1 diabetes.[vii] Type 2 diabetics often turn to insulin therapy if other methods of treatment, such as diet and exercise, are unable to keep blood glucose levels within a healthy range.[viii] Insulin comes in various forms, but is usually prescribed as either fast-acting or slow-acting.[ix] Depending on a person’s health and lifestyle, they can either receive insulin through multiple self-injections per day, or by using a computerized pump system that delivers continuous doses.[x] More than eight million people in the United States require daily dosages of fast-acting insulin to manage their diabetes.[xi]

These fast-acting insulin analogs were first approved by the FDA in 1996, and produced by major pharmaceutical companies such as Eli Lilly.[xii] Initial list prices for insulin analogs were as low as $21[xiii] or $24 a vial.[xiv] Insulin was considered a relatively affordable medicine for both insured and uninsured diabetics, although its prices continued to rise over the years.[xv]

In 2022, a vial of insulin costs as little as $3.69 to produce.[xvi] For uninsured diabetics or those who haven’t met their insurance deductibles, they can expect to pay as much as $289.36 per vial.[xvii] Depending on the type of diabetes a patient has, they can expect to use between two to six vials a month, or possibly more if they have higher insulin resistance.[xviii] Some reports have found that insulin list prices have tripled in the past two decades,[xix] while others have found that they’ve quadrupled due to inflation.[xx]  

Due to the high costs and limited insurance coverage options for insulin, many diabetics have taken to skipping doses and rationing insulin to save money when possible.[xxi] Doctors highly discourage this practice due to the negative effects that low insulin levels can have on diabetics, increasing the chances of hyperglycemia.[xxii] Diabetics are aware of these concerns, but see rationing insulin as their last resort due to being unable to afford the out-of-pocket-costs.[xxiii] Low-income diabetics who earn too much money to qualify for Medicaid but are unable to afford insurance are often hit by insulin prices the highest, with marginalized and minority communities being disproportionately affected.[xxiv]

To combat rising insulin prices, some states have introduced legislation to limit out-of-pocket costs for insulin for those residents who have state-regulated health insurance plans.[xxv] Colorado was the first state to implement such a law in 2020, and twenty others have followed since, along with Washington D.C.[xxvi] Kentucky’s own insulin-cap law went into effect on January 1, 2022, limiting the cost of a 30-day supply of insulin to $30 for people on state-regulated healthcare plans, state employees, and those under certain group plans.[xxvii] Those who not eligible for coverage under the law continue to either pay hundreds of dollars per month, or ration whatever vials they may have.[xxviii] Ohio introduced a similar bill in August of 2021 that would set a price cap of $35 for a 30-day supply of insulin.[xxix] Unlike Kentucky, the Ohio law would apply this insulin price cap to all health insurers, not just those on the state market. However, this bill has remained in committee since September 2021.[xxx]

Numerous bills have been introduced at the federal level to reduce copays for insulin or revert insulin prices to their pre-inflation status.[xxxi] However, these bills have stalled in committees and subcommittees with no progress.[xxxii] The insulin price crisis was eventually addressed with the Inflation Reduction Act of 2022, a law targeting climate change, tax initiatives, and healthcare policy in light of the recent and widespread economic inflation.[xxxiii] The proposed law places a price cap of $35 for a 30-day supply of insulin for Medicare patients.[xxxiv] Although the legislation was praised for taking steps to address the insulin price crisis, Republicans in Congress were criticized for removing provisions that would have extended the price cap to those with private coverage.[xxxv] Even with caps on insurance co-pays, uninsured diabetics would be forced to pay the full list price for insulin.[xxxvi]

With insulin prices continuing to rise, the future of treatment for those who do not qualify for co-pay caps and the uninsured remains in flux.[xxxvii] Many of the top pharmaceutical companies that sell insulin offer savings cards, but require customers to meet specific income criteria or have certain types of insurance to qualify.[xxxviii] Discount and coupon programs through the pharmacies themselves are often utilized to combat the high cost of insulin.[xxxix]

Most diabetes advocacy groups agree that state and federal legislature is likely the strongest path to fixing the insulin price crisis.[xl] However, the focus on placing caps on insurance co-pays leaves out a significant portion of the diabetic population in the uninsured.[xli] With no end to the inflation crisis and the ongoing rise in the price of insulin, uninsured and unqualified diabetics will continue to turn to rationing their insulin supply, risking their health due to the cost of this life-saving medicine.[xlii]

[i] National Diabetes Statistics Report, Centers for Disease Control and Prevention, https://www.cdc.gov/diabetes/data/statistics-report/index.html (last updated July 7, 2022).

[ii] Mayo Clinic Staff, Diabetes treatment: Using insulin to manage blood sugar, Mayo Clinic (Aug. 7, 2021), https://www.mayoclinic.org/diseases-conditions/diabetes/in-depth/diabetes-treatment/art-20044084.

[iii] Id.

[iv] Madhu Badireddy and Michelle Mouri, Hyperglycemia, StatPearls, https://www.ncbi.nlm.nih.gov/books/NBK430900/ (last updated April 28, 2022).

[v] Matt McConnell, “If I’m Out of Insulin, I’m Going to Die” United States’ Lack of Regulation Fuels Crisis of Unaffordable Insulin, Human Rights Watch (Apr. 12, 2022), https://www.hrw.org/report/2022/04/12/if-im-out-insulin-im-going-die/united-states-lack-regulation-fuels-crisis.

[vi] Krisha McCoy, The History of Diabetes, Everyday Health (Nov. 3, 2009), https://www.everydayhealth.com/diabetes/understanding/diabetes-mellitus-through-time.aspx.

[vii] Id.

[viii] Mayo Clinic Staff, supra note ii.

[ix] Id.

[x] Id.

[xi] McConnell, supra note v.

[xii] Celeste C. Quianzon and Issam Cheikh, MD, History of insulin, Journal of Community Hosp. Internal Med. Perspectives (2012), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714061/.

[xiii] Danielle K. Roberts, The Deadly Costs of Insulin, The American Journal of Managed Care (June 10, 2019), https://www.ajmc.com/view/the-deadly-costs-of-insulin.

[xiv] Irl B. Hirsch, Insulin in America: A Right or a Privilege?, Diabetes Spectrum 130 (August 2016).

[xv] Quianzon and Cheikh, supra note xii.

[xvi] Zoe Witt, Insulin Legislation Is Leaving Out Many Diabetics: What to Know, Teen Vogue (Nov. 4, 2022), https://www.teenvogue.com/story/insulin-legislation-diabetics.

[xvii] Id.

[xviii] David Tridgell, Insulin is too expensive for many of my patients. It doesn’t have to be., The Washington Post (June 22, 2017), https://www.washingtonpost.com/outlook/insulin-is-too-expensive-for-many-of-my-patients-it-doesnt-have-to-be/2017/06/22/c5091c42-56cf-11e7-a204-ad706461fa4f_story.html.

[xix] Id.

[xx] McConnell, supra note v.

[xxi] Andrew Briskin, Insulin: No More Rationing, diaTribe (Oct. 24, 2022, 3:21 PM), https://diatribe.org/insulin-no-more-rationing.

[xxii] Id.

[xxiii] McConnell, supra note v.

[xxiv] Id.

[xxv] Louise Norris, State and Federal Programs to Cap Insulin Out-of-Pocket Costs, Verywell Health (July 27, 2022), https://www.verywellhealth.com/programs-to-cap-insulin-costs-5667166.

[xxvi] Id.

[xxvii] Kentucky Law Capping Insulin Cost for Many Goes Into Effect, US News (Jan. 1, 2022, 12:24 PM), https://www.usnews.com/news/best-states/kentucky/articles/2022-01-01/kentucky-law-capping-insulin-cost-for-many-goes-into-effect.

[xxviii] Julia Sandor, High prices causing some Kentuckians to ration insulin to save money, WKYT (Oct. 19, 2022, 3:46 PM), https://www.wkyt.com/2022/10/19/high-prices-causing-some-kentuckians-ration-insulin-save-money/.

[xxix] Jake Zuckerman, Bipartisan senators introduce bill to price cap insulin cost share, The Ohio Capital Journal (Sep. 2, 2021, 12:35 AM), https://ohiocapitaljournal.com/2021/09/02/bipartisan-senators-introduce-bill-to-price-cap-insulin-costs/.

[xxx] Id.

[xxxi] Bills Addressing Drug and Insulin Affordability Endorsed by American Diabetes Association®, American Diabetes Association (Jan. 15, 2020), https://diabetes.org/newsroom/press-releases/2020/drug-insulin-affordability.

[xxxii] Jessica Zelitt, Pay or Die: Evaluating the United States Insulin Pricing Crisis and Realistic Solutions to End It, 50 Stetson L. Rev. 453, 66 (2021).

[xxxiii] Simmone Shah, Why Insulin Is So Expensive in the U.S.—And What the Inflation Reduction Act Does About It, Time (Aug. 16, 2022, 4:58 PM), https://time.com/6206569/insulin-prices-inflation-reduction-act/.

[xxxiv] Id.

[xxxv] Id.

[xxxvi] Allison Winter, As insulin costs soar, diabetics say a $35 cap on co-pays is not enough, Ohio Capital Journal (June 15, 2022, 3:30 AM), https://ohiocapitaljournal.com/2022/06/15/as-insulin-costs-soar-diabetics-say-a-35-cap-on-co-pays-is-not-enough/.

[xxxvii] Id.

[xxxviii] Zelitt, supra note xxxii, at 470.

[xxxix] Id., at 471.

[xl] Winter, supra note xxxvi.

[xli] Id.

[xlii] McConnell, supra note v.