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Table.  
Characteristics of Survey Participants
Characteristics of Survey Participants
1.
World Health Organization, Essential Medicines and Health Products, available at: http://www.who.int/medicines/services/essmedicines_def/en/. Accessed October 2, 2018.
2.
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(13):1400-1402.PubMedGoogle ScholarCrossref
3.
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(22):2331-2333.PubMedGoogle ScholarCrossref
4.
Piette  JD, Heisler  M, Wagner  TH.  Problems paying out-of-pocket medication costs among older adults with diabetes.  Diabetes Care. 2004;27(2):384-391.PubMedGoogle ScholarCrossref
5.
Moffet  HH, Adler  N, Schillinger  D,  et al.  Cohort Profile: The Diabetes Study of Northern California (DISTANCE)--objectives and design of a survey follow-up study of social health disparities in a managed care population.  Int J Epidemiol. 2009;38(1):38-47.PubMedGoogle ScholarCrossref
6.
Kennedy  J, Morgan  S.  Cost-related prescription nonadherence in the United States and Canada: a system-level comparison using the 2007 International Health Policy Survey in Seven Countries.  Clin Ther. 2009;31(1):213-219.PubMedGoogle ScholarCrossref
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    Research Letter
    December 3, 2018

    Cost-Related Insulin Underuse Among Patients With Diabetes

    Author Affiliations
    • 1Yale College, New Haven, Connecticut
    • 2Yale School of Medicine, New Haven, Connecticut
    • 3Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
    • 4Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
    JAMA Intern Med. Published online December 3, 2018. doi:10.1001/jamainternmed.2018.5008

    Insulin is lifesaving for people with diabetes and is included on the Model List of Essential Medicines formulated by the World Health Organization.1 This means it should be available at all times at a price the individual and the community can afford.1 However, over the past decade, insulin prices have tripled in the United States, while out-of-pocket costs per prescription doubled.2,3 High costs of medications can contribute to nonadherence,4 but the prevalence of cost-related insulin underuse is unknown.

    Methods

    We administered a survey to patients with type 1 or type 2 diabetes for whom insulin was prescribed within the past 6 months and who had an outpatient visit at the Yale Diabetes Center (YDC) between June and August of 2017. The YDC serves a diverse patient population from New Haven, Connecticut and surrounding counties. The survey questions were based on previously validated surveys5,6 and review of prior literature and refined based on cognitive interviews. The Yale University Human Investigations Committee approved the study. Written informed consent was obtained from participants.

    The primary outcome was cost-related underuse in the past 12 months, defined by a positive response to any 1 of 6 questions: did you…(1) use less insulin than prescribed, (2) try to stretch out your insulin, (3) take smaller doses of insulin than prescribed, (4) stop using insulin, (5) not fill an insulin prescription, or (6) not start insulin…because of cost? We examined the association between sociodemographic, economic, and clinical factors and cost-related underuse using multivariable logistic regression.

    We then examined the association between cost-related underuse and poor glycemic control (HbA1c ≥9% obtained at time of visit or within 3 months) adjusting for sex, body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), diabetes duration, and income using a separate multivariable logistic regression model. We performed all analyses using R statistical software (version 3.1.1, R Foundation).

    Results

    Of 354 eligible patients (184 [52.0%] women, 191 [54.0%] white, 123 [34.8%] type 1 diabetes), 199 (56.2%) completed the survey (101 [50.8%] women, 121 [60.8%] white, 83 [41.7%] type 1 diabetes). Of these patients, 51 (25.5%) reported cost-related insulin underuse. The type of prescription drug coverage was not significantly associated with cost-related underuse (Table). Patients with cost-related underuse were more likely to report lower incomes; 31 [60.8%] of these patients discussed the cost of insulin with their clinician and 15 [29.4%] changed insulin type owing to cost. Patients who reported cost-related underuse (vs those who did not) were more likely to have poor glycemic control in the multivariable analysis (22 [43.1%] vs 41 [28.1%]; odds ratio = 2.96; 95% CI, 1.14-8.16; P = .03). Of the 199 patients, 2 had missing HbA1c levels.

    Discussion

    One in 4 patients at an urban diabetes center reported cost-related insulin underuse and this was associated with poor glycemic control. These results highlight an urgent need to address affordability of insulin.

    More than one-third of patients who experienced cost-related underuse did not discuss this with their clinician. These findings are consistent with a previous study, which found that 37% of patients did not speak to clinicians about cost issues.4 Patients with lower incomes were more likely to report cost-related underuse; nearly two-thirds of these patients also experienced difficulty affording diabetes equipment, indicating broader cost barriers to diabetes management.

    This study has limitations. This single-center study may be limited in its broader generalizability. Given its cross-sectional design, a causal relationship between cost-related underuse and poor glycemic control cannot be established.

    Insulin is a life-saving, essential medicine, and most patients cannot act as price-sensitive buyers. Regulators and the medical community need to intervene to ensure that insulin is affordable to patients who need it. At minimum, individual clinicians should screen all patients for cost issues to help them address these challenges.

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    Article Information

    Corresponding Author: Kasia J. Lipska, MD, MHS, Section of Endocrinology, Department of Internal Medicine, Yale School of Medicine, PO Box 208020, 333 Cedar St, New Haven, CT 06520 (kasia.lipska@yale.edu).

    Accepted for Publication: August 3, 2018.

    Published Online: December 3, 2018. doi:10.1001/jamainternmed.2018.5008

    Author Contribution: Dr Lipska had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Herkert and Vijayakumar contributed equally to the work.

    Study concept and design: Herkert, Vijayakumar, Schwartz, Rabin, DeFilippo, Lipska.

    Acquisition, analysis, or interpretation of data: Herkert, Vijayakumar, Luo, Rabin, Lipska.

    Drafting of the manuscript: Herkert, Vijayakumar, Luo.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Herkert, Vijayakumar.

    Obtained funding: Herkert.

    Administrative, technical, or material support: Vijayakumar, Lipska.

    Study supervision: Luo, Lipska.

    Conflict of Interest Disclosures: Dr Lipska receives support from the Centers of Medicare and Medicaid Services (CMS) to develop publicly reported quality measures. Dr Luo receives support from Health Action International and Alosa Health. No other disclosures are reported.

    Funding/Support: This project was supported by the Global Health Field Experiences Award, the Yale College Fellowship for Research in Global Health Studies, and the Global Health Field Experiences Seed Funding Award. Dr Lipska receives support from the National Institute on Aging and the American Federation of Aging Research through the Paul Beeson Career Development Award (K23AG048359) and the Yale Claude D. Pepper Older Americans Independence Center (P30AG021342). Pavithra Vijayakumar is supported by National Institute of Diabetes and Digestive and Kidney Diseases under Award Number T35DK104689.

    Role of the Funder/Sponsor: The funding institutions had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    References
    1.
    World Health Organization, Essential Medicines and Health Products, available at: http://www.who.int/medicines/services/essmedicines_def/en/. Accessed October 2, 2018.
    2.
    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(13):1400-1402.PubMedGoogle ScholarCrossref
    3.
    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(22):2331-2333.PubMedGoogle ScholarCrossref
    4.
    Piette  JD, Heisler  M, Wagner  TH.  Problems paying out-of-pocket medication costs among older adults with diabetes.  Diabetes Care. 2004;27(2):384-391.PubMedGoogle ScholarCrossref
    5.
    Moffet  HH, Adler  N, Schillinger  D,  et al.  Cohort Profile: The Diabetes Study of Northern California (DISTANCE)--objectives and design of a survey follow-up study of social health disparities in a managed care population.  Int J Epidemiol. 2009;38(1):38-47.PubMedGoogle ScholarCrossref
    6.
    Kennedy  J, Morgan  S.  Cost-related prescription nonadherence in the United States and Canada: a system-level comparison using the 2007 International Health Policy Survey in Seven Countries.  Clin Ther. 2009;31(1):213-219.PubMedGoogle ScholarCrossref
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