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Insulin Access and Affordability Working Group: Conclusions and Recommendations

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Cefalu, William T., Dawes, Daniel E., Gavlak, Gina, Goldman, Dana, Herman, William H., Van Nuys, Karen, Powers, Alvin C., Taylor, Simeon I. +2 more·2018·Diabetes Care
DOI 10.2337/dci18-0019PMC PMC13060039
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Abstract

There are more than 30 million Americans with diabetes, a disease that costs the U.S. more than $327 billion per year (1,2). Achieving glycemic control and controlling cardiovascular risk factors have been conclusively shown to reduce diabetes complications, comorbidities, and mortality. To achieve these desired outcomes, the medical community now has available many classes of medications and many formulations of insulin to effectively manage the metabolic abnormalities for people with diabetes. However, the affordability of medications in general, and for insulin specifically, is currently of great concern to people with diabetes, their families, health care providers, insurers, and employers. For millions of people living with diabetes, including all individuals with type 1 diabetes, access to insulin is literally a matter of life and death. The average list price of insulin has skyrocketed in recent years, nearly tripling between 2002 and 2013 (3). The reasons for this increase are not entirely clear but are due in part to the complexity of drug pricing in general and of insulin pricing in particular. As the price of insulin continues to rise, individuals with diabetes are often forced to choose between purchasing their medications or paying for other necessities, exposing them to serious short- and long-term health consequences (4–9). To find solutions to the issue of insulin affordability, there must be a better understanding of the transactions throughout the insulin supply chain, the impact each stakeholder has on what people with diabetes pay for insulin, and the relative efficacy of therapeutic options. Thus, as the nation’s leading voluntary health organization whose mission is “to prevent and cure diabetes and to improve the lives of all people affected by diabetes,” the American Diabetes Association (ADA) is committed to finding ways to provide relief for individuals and families who lack affordable access …

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  • From 2012 to 2016, the average list price of insulins increased by 14-17% per year in the USA.

    “From 2012 to 2016, the average list price of insulins increased by 14–17% per year in the USA.”

    From 100 years of insulin: celebrating the past, present and future of diabetes therapy (2021) · cites this paper as [143]

    The Background: Scope of the Problem section reports that the average U.S. list price of four insulin categories increased by 15%–17% per year from 2012 to 2016. This supports the period, location, measure, and annual increase, but not the claimed 14% lower bound. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • The increases in insulin list prices are often driven by gaps between the list price and the net price ultimately received by manufacturers, largely attributed to rebates and discounts negotiated between stakeholders in a supply chain with poor transparency.

    “These increases are often driven by gaps between the list price and the net price ultimately received by manufacturers, which have been largely attributed to rebates and discounts negotiated between stakeholders in a supply chain with poor transparency143.”

    From 100 years of insulin: celebrating the past, present and future of diabetes therapy (2021) · cites this paper as [143]

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Research works printed but not linked: 20

  1. [3]Hua X, Carvalho N, Tew M, Huang ES, Herman WH, Clarke P. Expenditures and prices of antihyperglycemic medications in the United States: 2002-2013. JAMA 2016; 315: 1400– 1402 27046369 PMC4886177
  2. [9]QuickStats: Percentage* of adults aged ≥45 years who reduced or delayed medication to save money† in the past 12 months among those who were prescribed medication, by diagnosed diabetes status and age§ - National Health Interview Survey, 2015. MMWR Morb Mortal Wkly Rep 2017; 66: 679 28662017 PMC5687498
  3. [12]Goldman DP, Jena AB, Philipson T, Sun E. Drug licenses: a new model for pharmaceutical pricing. Health Aff (Millwood) 2008; 27: 122– 129 18180487 PMC3756826
  4. [14]Beran D, Ewen M, Laing R. Constraints and challenges in access to insulin: a global perspective. Lancet Diabetes Endocrinol 2016; 4: 275– 285 26857998
  5. [18]Luo J, Avorn J, Kesselheim AS. Trends in Medicaid reimbursements for insulin from 1991 through 2014. JAMA Intern Med 2015; 175: 1681– 1686 26301721
  6. [19]Lipska KJ, Hirsch IB, Riddle MC. Human insulin for type 2 diabetes: an effective, less-expensive option. JAMA 2017; 318: 23– 24 28604935
  7. [25]United States Code. 2008 Edition, Title 42, Section 1396r-8. Payment for covered outpatient drugs. Washington, DC, U.S. Government Printing Office, 2008
  8. [26]Karter AJ, Parker MM, Solomon MD,. Effect of out-of-pocket cost on medication initiation, adherence, and persistence among patients with type 2 diabetes: the Diabetes Study of Northern California (DISTANCE). Health Serv Res 2017; 53: 1227– 1247 28474736 PMC5867086
  9. [27]Iuga AO, McGuire MJ. Adherence and health care costs. Risk Manag Healthc Policy 2014; 7: 35– 44 24591853 PMC3934668
  10. [29]Salas M, Hughes D, Zuluaga A, Vardeva K, Lebmeier M. Costs of medication nonadherence in patients with diabetes mellitus: a systematic review and critical analysis of the literature. Value Health 2009; 12: 915– 922 19402848
  11. [30]Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA 2007; 298: 61– 69 17609491 PMC6375697
  12. [31]Kesselheim AS, Huybrechts KF, Choudhry NK,. Prescription drug insurance coverage and patient health outcomes: a systematic review. Am J Public Health 2015; 105: e17– e30 25521879 PMC4318289
  13. [32]Raisch DW, Klaurens LM, Hayden C, Malagon I, Pulliam G, Fass R. Impact of a formulary change in proton pump inhibitors on health care costs and patients’ symptoms. Dig Dis Sci 2001; 46: 1533– 1539 11478507
  14. [35]Thorpe KE, Allen L, Joski P. Out-of-pocket prescription costs under a typical silver plan are twice as high as they are in the average employer plan. Health Aff (Millwood) 2015; 34: 1695– 1703 26438746
  15. [37]Dowlat HA, Kuhlmann MK, Khatami H, Ampudia-Blasco FJ. Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications. Diabetes Obes Metab 2016; 18: 737– 746 27097592
  16. [38]Lipska KJ, Ross JS, Van Houten HK, Beran D, Yudkin JS, Shah ND. Use and out-of-pocket costs of insulin for type 2 diabetes mellitus from 2000 through 2010. JAMA 2014; 311: 2331– 2333 24915266 PMC4133975
  17. [42]Merck. Merck announces U.S. FDA grants tentative approval for LUSDUNA Nexvue (insulin glargine injection), a follow-on biologic basal insulin [press release], 20 July 2017. Keniworth, NJ, Merck & Co
  18. [45]Lakdawalla DN, Eber MR, Forma FM,. Measuring the value of better diabetes management. Am J Manag Care 2013; Mar-Apr:19 Spec No. 2:E11 23725237
  19. [46]Blumenthal DM, Goldman DP, Jena AB. Outcomes-based pricing as a tool to ensure access to novel but expensive biopharmaceuticals. Ann Intern Med 2017; 166: 219– 220 27951598
  20. [47]Spaulding A, Fendrick AM, Herman WH,. A controlled trial of value-based insurance design—the MHealthy: Focus on Diabetes (FOD) trial. Implement Sci 2009; 4: 19 19351413 PMC2673203

Cited by

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Authors
Cefalu, W. T., Dawes, D. E., Gavlak, G., Goldman, D., Herman, W. H., Van Nuys, K., Powers, A. C., Taylor, S. I., Yatvin, A. L., & on behalf of the Insulin Access and Affordability Working Group
Affiliations
  • American Diabetes Association (US)
  • Morehouse School of Medicine (US)
  • North Coast Health, Lakewood, OH
  • University of Southern California (US)
  • University of Michigan (US)
  • USC Schaeffer Center for Health Policy & Economics, Los Angeles, CA
  • Vanderbilt University Medical Center (US)
  • University of Maryland, Baltimore (US)
  • Popper & Yatvin, Philadelphia, PA
Corresponding author
Cefalu, William T.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2018-05-11
Volume
41
Issue
6
Pages
1299-1311
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dci18-0019
PMC
PMC13060039
OpenAlex
W2800602175
Cited by
256
References
2
Citations by year
2026: 4 · 2025: 12 · 2024: 23 · 2023: 29 · 2022: 49 · 2021: 56 · 2020: 49 · 2019: 24 · 2018: 9
FWCI
52.45
Type
journal article
Language
en
Update notices
correction (2018-08-01)
Open access
Licence
www.diabetesjournals.org/content/license (vor, 10 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion)
Funders
  • National Institutes of Health (5p60dk020593-31)
  • National Institute of Diabetes and Digestive and Kidney Diseases (P60-DK020593)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Healthcare Policy and Management
Keywords
insulin affordability, insulin access, insulin pricing, drug pricing, type 1 diabetes, drug costs, health care costs, glycemic control
MeSH terms
Diabetes Mellitus, Health Planning Guidelines, Health Services Accessibility, Humans, Hypoglycemic Agents, Insulins

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