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Published in: Endocrine 2/2020

01-05-2020 | Levothyroxine | Original Article

Generic levothyroxine initiation and substitution among Medicare and Medicaid populations: a new user cohort study

Authors: Nan Huo, Li Chen, Ahmed Ullah Mishuk, Chao Li, Richard A. Hansen, Ilene Harris, Zippora Kiptanui, Zhong Wang, Sarah K. Dutcher, Jingjing Qian

Published in: Endocrine | Issue 2/2020

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Abstract

Purpose

Generic levothyroxine has been approved and available since 2004 but its substitution remains controversial. Therefore, the objective was to examine patterns of and identify factors associated with initiation and substitution of generic levothyroxine treatment.

Methods

This was a retrospective observational study, including new users of brand and generic levothyroxine in 2013–2015 Medicare (n = 15,877) or 2011–2012 Medicaid (n = 9390) administrative claim databases. The primary outcomes included (1) generic levothyroxine initiation, and (2) among brand-new users, generic levothyroxine substitution in 12 months. The factors associated with generic levothyroxine initiation and substitution were measured.

Results

Among all levothyroxine new users, Medicare beneficiaries had a higher proportion of generic levothyroxine initiation than Medicaid beneficiaries (66.40% vs. 44.04%, respectively). Medicare beneficiaries’ demographic factors, and health service utilizations were associated with generic levothyroxine initiation. Medicaid beneficiaries who were male and residing in the northeast region and rural areas were more likely to initiate generic levothyroxine. Among brand levothyroxine new users, the generic substitution rate was higher in the Medicare than the Medicaid cohort (18.26 vs. 3.88%). Medicare brand levothyroxine new users’ demographic factors and health service utilizations were associated with generic levothyroxine substitution. Medicaid brand levothyroxine new users who were residing in the northeast region, with more prior hospitalization, and initiating a lower dosage of brand levothyroxine, had higher rates of generic substitution.

Conclusion

Patient demographic factors and health service utilizations are associated with generic levothyroxine initiation and substitution. Educational outreach programs targeted to increase generic levothyroxine use and prescription savings should be tailored based on different patient populations.
Literature
2.
go back to reference Y. Aoki, R.M. Belin, R. Clickner, R. Jeffries, L. Phillips, K.R. Mahaffey, Serum TSH and total T4 in the United States population and their association with participant characteristics: National Health and Nutrition Examination Survey (NHANES 1999-2002). Thyroid 17(12), 1211–1223 (2007). https://doi.org/10.1089/thy.2006.0235 CrossRefPubMed Y. Aoki, R.M. Belin, R. Clickner, R. Jeffries, L. Phillips, K.R. Mahaffey, Serum TSH and total T4 in the United States population and their association with participant characteristics: National Health and Nutrition Examination Survey (NHANES 1999-2002). Thyroid 17(12), 1211–1223 (2007). https://​doi.​org/​10.​1089/​thy.​2006.​0235 CrossRefPubMed
4.
go back to reference J.G. Hollowell, N.W. Staehling, W.D. Flanders, W.H. Hannon, E.W. Gunter, C.A. Spencer, L.E. Braverman, Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J. Clin. Endocrinol. Metab. 87(2), 489–499 (2002). https://doi.org/10.1210/jcem.87.2.8182 CrossRefPubMed J.G. Hollowell, N.W. Staehling, W.D. Flanders, W.H. Hannon, E.W. Gunter, C.A. Spencer, L.E. Braverman, Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J. Clin. Endocrinol. Metab. 87(2), 489–499 (2002). https://​doi.​org/​10.​1210/​jcem.​87.​2.​8182 CrossRefPubMed
5.
go back to reference H.J. Baskin, R.H. Cobin, D.S. Duick, H. Gharib, R.B. Guttler, M.M. Kaplan, R.L. Segal, American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr. Pract. 8(6), 457–469 (2002)CrossRef H.J. Baskin, R.H. Cobin, D.S. Duick, H. Gharib, R.B. Guttler, M.M. Kaplan, R.L. Segal, American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr. Pract. 8(6), 457–469 (2002)CrossRef
6.
go back to reference J.R. Garber, R.H. Cobin, H. Gharib, J.V. Hennessey, I. Klein, J.I. Mechanick, R. Pessah-Pollack, P.A. Singer, K.A. Woeber, Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr. Pract. 18(6), 988–1028 (2012). https://doi.org/10.4158/ep12280.gl CrossRefPubMed J.R. Garber, R.H. Cobin, H. Gharib, J.V. Hennessey, I. Klein, J.I. Mechanick, R. Pessah-Pollack, P.A. Singer, K.A. Woeber, Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr. Pract. 18(6), 988–1028 (2012). https://​doi.​org/​10.​4158/​ep12280.​gl CrossRefPubMed
8.
go back to reference American Thyroid Association, The Endocrine Society and American Association of Clinical Endocrinologists. Joint statement on the U.S. Food and Drug Administration’s decision regarding bioequivalence of levothyroxine sodium. Thyroid. 14(7), 486 (2004). https://doi.org/10.1089/1050725041517138 American Thyroid Association, The Endocrine Society and American Association of Clinical Endocrinologists. Joint statement on the U.S. Food and Drug Administration’s decision regarding bioequivalence of levothyroxine sodium. Thyroid. 14(7), 486 (2004). https://​doi.​org/​10.​1089/​1050725041517138​
9.
go back to reference S. Benvenga, A. Carlé, Levothyroxine formulations: pharmacological and clinical implications of generic substitution. Adv. Ther. 36(Suppl 2), 59–71 (2019) S. Benvenga, A. Carlé, Levothyroxine formulations: pharmacological and clinical implications of generic substitution. Adv. Ther. 36(Suppl 2), 59–71 (2019)
20.
go back to reference J.J. Gagne, J.M. Polinski, A.S. Kesselheim, N.K. Choudhry, D. Hutchins, O.S. Matlin, A. Tong, W.H. Shrank, Patterns and predictors of generic narrow therapeutic index drug use among older adults. J. Am. Geriatrics Soc. 61(9), 1586–1591 (2013). https://doi.org/10.1111/jgs.12399 CrossRef J.J. Gagne, J.M. Polinski, A.S. Kesselheim, N.K. Choudhry, D. Hutchins, O.S. Matlin, A. Tong, W.H. Shrank, Patterns and predictors of generic narrow therapeutic index drug use among older adults. J. Am. Geriatrics Soc. 61(9), 1586–1591 (2013). https://​doi.​org/​10.​1111/​jgs.​12399 CrossRef
21.
go back to reference W.H. Shrank, N.K. Choudhry, J. Agnew-Blais, A.D. Federman, J.N. Liberman, J. Liu, A.S. Kesselheim, M.A. Brookhart, Fischer MAJHa, State generic substitution laws can lower drug outlays under. Medicaid 29(7), 1383–1390 (2010) W.H. Shrank, N.K. Choudhry, J. Agnew-Blais, A.D. Federman, J.N. Liberman, J. Liu, A.S. Kesselheim, M.A. Brookhart, Fischer MAJHa, State generic substitution laws can lower drug outlays under. Medicaid 29(7), 1383–1390 (2010)
28.
go back to reference S.H. Kaplan, S. Greenfield, B. Gandek, W.H. Rogers, J.E. Ware Jr, Characteristics of physicians with participatory decision-making styles. Ann. Intern. Med. 124(5), 497–504 (1996)CrossRef S.H. Kaplan, S. Greenfield, B. Gandek, W.H. Rogers, J.E. Ware Jr, Characteristics of physicians with participatory decision-making styles. Ann. Intern. Med. 124(5), 497–504 (1996)CrossRef
29.
go back to reference D.L. Roter, M. Stewart, S.M. Putnam, M. Lipkin Jr, W. Stiles, T.S. Inui, Communication patterns of primary care physicians. JAMA 277(4), 350–356 (1997)CrossRef D.L. Roter, M. Stewart, S.M. Putnam, M. Lipkin Jr, W. Stiles, T.S. Inui, Communication patterns of primary care physicians. JAMA 277(4), 350–356 (1997)CrossRef
33.
go back to reference P.N. Taylor, A. Iqbal, C. Minassian, A. Sayers, M.S. Draman, R. Greenwood, W. Hamilton, O. Okosieme, V. Panicker, S.L. Thomas, Falling threshold for treatment of borderline elevated thyrotropin levels–balancing benefits and risks: evidence from a large community-based study. JAMA Intern. Med. 174(1), 32–39 (2014)CrossRef P.N. Taylor, A. Iqbal, C. Minassian, A. Sayers, M.S. Draman, R. Greenwood, W. Hamilton, O. Okosieme, V. Panicker, S.L. Thomas, Falling threshold for treatment of borderline elevated thyrotropin levels–balancing benefits and risks: evidence from a large community-based study. JAMA Intern. Med. 174(1), 32–39 (2014)CrossRef
34.
go back to reference P. dos Santos Vigário, F. Vaisman, C.M. Coeli, L. Ward, H. Graf, G. Carvalho, R.M. Júnior, M. Vaisman, Inadequate levothyroxine replacement for primary hypothyroidism is associated with poor health-related quality of life–a Brazilian multicentre study. Endocrine 44(2), 434–440 (2013)CrossRef P. dos Santos Vigário, F. Vaisman, C.M. Coeli, L. Ward, H. Graf, G. Carvalho, R.M. Júnior, M. Vaisman, Inadequate levothyroxine replacement for primary hypothyroidism is associated with poor health-related quality of life–a Brazilian multicentre study. Endocrine 44(2), 434–440 (2013)CrossRef
35.
go back to reference M. Katz, J. Scherger, S. Conard, L. Montejano, S. Chang, Healthcare costs associated with switching from brand to generic levothyroxine. Am. Health Drug Benefits 3(2), 127–134 (2010)PubMedPubMedCentral M. Katz, J. Scherger, S. Conard, L. Montejano, S. Chang, Healthcare costs associated with switching from brand to generic levothyroxine. Am. Health Drug Benefits 3(2), 127–134 (2010)PubMedPubMedCentral
36.
go back to reference S. Benvenga, F. Di Bari, R. Vita, Undertreated hypothyroidism due to calcium or iron supplementation corrected by oral liquid levothyroxine. Endocrine 56(1), 138–145 (2017)CrossRef S. Benvenga, F. Di Bari, R. Vita, Undertreated hypothyroidism due to calcium or iron supplementation corrected by oral liquid levothyroxine. Endocrine 56(1), 138–145 (2017)CrossRef
37.
go back to reference A. Roos, S.P. Linn-Rasker, R.T. van Domburg, J.P. Tijssen, A. Berghout, The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial. Arch. Intern. Med. 165(15), 1714–1720 (2005)CrossRef A. Roos, S.P. Linn-Rasker, R.T. van Domburg, J.P. Tijssen, A. Berghout, The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial. Arch. Intern. Med. 165(15), 1714–1720 (2005)CrossRef
Metadata
Title
Generic levothyroxine initiation and substitution among Medicare and Medicaid populations: a new user cohort study
Authors
Nan Huo
Li Chen
Ahmed Ullah Mishuk
Chao Li
Richard A. Hansen
Ilene Harris
Zippora Kiptanui
Zhong Wang
Sarah K. Dutcher
Jingjing Qian
Publication date
01-05-2020
Publisher
Springer US
Keyword
Levothyroxine
Published in
Endocrine / Issue 2/2020
Print ISSN: 1355-008X
Electronic ISSN: 1559-0100
DOI
https://doi.org/10.1007/s12020-020-02211-w

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