The economic impact of levothyroxine dose adjustments: the CONTROL HE study
Open accessAbstract
BACKGROUND: In general, hypothyroidism can be adequately treated with a consistent daily dose of levothyroxine. However, the need for levothyroxine dose adjustments is frequent in clinical practice. The extent to which levothyroxine dose adjustments increase the utilization of healthcare resources has not previously been described in the clinical literature. OBJECTIVE: The primary objective of our study was to measure the effect of levothyroxine dose adjustments in terms of their utilization of healthcare resources including direct and indirect costs. A secondary goal was to identify any differences in patient characteristics that may be responsible for levothyroxine dose adjustments. METHODS: A retrospective medical chart review was conducted among patients of selected healthcare providers in the USA. Patients who were recently started on levothyroxine therapy (<6 months) were excluded to avoid situations that were more likely attributable to treatment initiation than inadequate therapeutic effect. Trained nurses extracted data from patient charts and electronic medical record systems for review. We analyzed the cost of resources consumed by the frequency of levothyroxine dose changes over 24 months: 0 dose changes (no dose adjustment group); one dose change, two dose changes, three or more dose changes (≥1 dose adjustment group). RESULTS: The study included 454 patients. Overall estimated resource utilization was higher per patient in the ≥1 dose adjustment group (US$5824) vs. the no dose adjustment group (US$3166) during the 24-month study period. When direct and indirect costs were combined, overall costs of care were greatest in patients requiring three or more dose adjustments (US$8220/patient). Patients in this cohort incurred 2.5-fold greater total costs compared with patients requiring no dose adjustments (US$8220 vs. US$3166). Among the 58 patients in the group requiring three or more dose adjustments, mean direct medical costs were significantly higher than in the patients requiring no dose adjustments (US$6387 vs. US$2182). Patients with at least one dose adjustment experienced a 40.3% increase in lost productivity vs. patients who had no dose adjustments (US$1381 vs. US$984). Loss of productivity was highest among patients with three or more levothyroxine dose adjustments. Among this cohort, there was an 86.4% increase in lost productivity vs. patients who had no levothyroxine dose adjustments (US$1833 vs. US$984). CONCLUSIONS: Patients experiencing multiple levothyroxine dose adjustments were shown to consume more healthcare resources, resulting in higher costs than those who required no dose adjustments. Each care episode contributed to lost time and wages with total estimated lost productivity escalating with increasing levothyroxine dose adjustments over a 24-month period.
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In a retrospective study of 99 randomly selected hypothyroid patients who switched from tablet to SG, the rate of LT4 dose adjustment was significantly reduced or absent in most cases, with concomitant improvement of symptoms control.
“The authors reviewed a series of 99 randomly selected hypothyroid patients who switched from tablet to SG for several reasons (i.e., adverse effects, inadequate biochemical, or hypothyroid symptom control) and found that the rate of LT4 dose adjustment was significantly reduced or absent in most cases, with a concomitant improvement of symptoms control.”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [36]
The Methods (Selection of Patients and Inclusion/Exclusion Criteria; page unavailable) describe 454 records, with 227 patients per dose-adjustment group—not 99 patients who switched formulations. The study excluded current or past users of levothyroxine gel caps, so it cannot establish the claimed improvement after a switch to softgel. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredIncreased healthcare costs have been observed when patients switch from a brand name to generic and a further increase when they frequently change the dose.
“Finally, increased healthcare costs have been observed when patients switch from a brand name to generic and a further increase when they frequently change the dose ((36), this study was funded by industry).”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [36]
The Results (Direct Medical Costs by Dose Stratification; Total Cost of Care, Table 6; page unavailable) associate dose adjustments with higher costs, particularly for patients with three or more adjustments. The Methods (Methods/Cost Variations; page unavailable) account for branded and generic formulations when estimating medication costs, but the passages do not report a cost increase specifically from switching from brand-name to generic levothyroxine. Costs also did not rise at every successive dose-adjustment level. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIndirect costs of changing brand or formulations (medical costs and higher consumption of healthcare resources) have been recognized.
“In addition, the indirect costs of changing brand or formulations (medical costs and higher consumption of healthcare resources) has been recognized ((28, 36), this latter study was funded by industry).”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [36]
The Results (Direct Medical Costs by Dose Stratification; page not provided) report higher direct medical costs and differences in healthcare-resource use across levothyroxine dose-adjustment cohorts. The Study Limitations section says the study did not establish why patients needed adjustments, so these findings do not establish the costs of changing brands or formulations specifically. The paper also classifies medical costs as direct costs; its indirect-cost estimate concerns lost productivity. (LLM, conf=0.88)
Experimental — accuracy not yet measuredHypothyroid treatment not covered by insurance typically costs €15-€50 per month or €180-€600 per year, depending on dosage, form, country, and brand name.
“More specifically, hypothyroid treatment that is not covered by insurance typically costs €15–€50 per month or €180–€600 per year, depending on the dosage, form, country, and brand name (35, 36, 37, 38, 39).”
From ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (2025) · cites this paper as [36]
The Methods/Cost Variations section says levothyroxine medication costs vary by dose strength and generic or branded formulation. It does not give a €15–€50 monthly or €180–€600 annual range, or establish costs for treatment not covered by insurance across countries. The Results report medication costs in US dollars for the study cohorts instead. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn CONTROL HE, a retrospective study of 454 patients receiving levothyroxine for greater than 1 year, Ernst et al. reported a significant relationship between the number of levothyroxine dose or formulation changes and increased cost of patient care including drug therapy, laboratory tests, physician visits, and other healthcare costs (P < 0.05).
“In CONTROL HE, a retrospective study of 454 patients receiving levothyroxine for greater than 1 year, Ernst et al. reported a significant relationship between the number of levothyroxine dose or formulation changes and increased cost of patient care including drug therapy, laboratory tests, physician visits, and other healthcare costs (P < 0.05).”
From Diagnosis and management of treatment-refractory hypothyroidism: an expert consensus report (2017) · cites this paper as [104]
Concerning interfering medication-induced undertreated hypothyroidism, few data are available on metabolic/cardiovascular complications and costs of frequent assays to monitor L-T4 therapy.
“Concerning IM-induced UTH, few data are available on two issues (23, 44, 98, 99): (i) metabolic/cardiovascular complications, (ii) costs of frequent assays to monitor L-T4 therapy.”
From L-T4 therapy in the presence of pharmacological interferents (2020) · cites this paper as [99]
Overall resource utilization is higher in hypothyroid patients with ≥1 L-T4 dose adjustment ($5,824/patient) than in controls ($3,166/patient), peaking in the ≥3-dose-adjustment subgroup ($8,220/patient).
“Overall resource utilization was higher in the ≥1-dose-adjustment group ($5,824/patient) vs. controls (USD 3,166/patient), peaking in the ≥3-dose-adjustment subgroup ($8,220/patient).”
From L-T4 therapy in the presence of pharmacological interferents (2020) · cites this paper as [99]
Compared with no-dose-adjustment controls, significantly more hypothyroid patients needing L-T4 dose adjustments were taking interacting medications causing L-T4 malabsorption (PPIs, H2-receptor antagonists, calcium or iron supplements).
“Compared with the no-dose-adjustment patients (controls), significantly more patients needing dose adjustments (75 vs. 86%), were taking IM causing L-T4 malabsorption (PPIs, H2-receptor antagonists, calcium or iron supplements) (99).”
From L-T4 therapy in the presence of pharmacological interferents (2020) · cites this paper as [99]
The ≥1-dose-adjustment group experienced a 40.3% increase in lost productivity vs controls ($1,381 vs $984), with a peak in the ≥3-dose adjustment subgroup ($1,833).
“The ≥1-dose-adjustment group experienced a 40.3% increase in lost productivity vs. controls ($1,381 vs. $984), with a peak in the ≥3-dose adjustment subgroup ($1,833).”
From L-T4 therapy in the presence of pharmacological interferents (2020) · cites this paper as [99]
Compared to controls, patients requiring L-T4 dose adjustments had significantly higher TSH (5.07 ± 11.04 vs. 2.57 ± 2.51 U/ml) and more frequent TSH tests (84 vs. 73%).
“Compared to controls, patients requiring adjustments had significantly higher TSH (5.07 ± 11.04 vs. 2.57 ± 2.51 U/ml), and more frequent TSH tests (84 vs. 73%) (99).”
From L-T4 therapy in the presence of pharmacological interferents (2020) · cites this paper as [99]
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- Authors
- Ernst, F. R., Barr, P., Elmor, R., Sandulli, W., Thevathasan, L., Sterman, A. B., Goldenberg, J., & Vora, K.
- Affiliations
- University of Oxford (GB)
- Corresponding author
- Ernst, Frank R.
- ORCID
- Ernst, Frank R.
- Venue
- Clinical Drug Investigation
- Published
- 2016-10-31
- Volume
- 37
- Issue
- 1
- Pages
- 71-83
- ISSN
- 0114-2402 (ISSN-L)
- 1173-2563
- 1179-1918
- PMC
- PMC5209418
- OpenAlex
- W2542623532
- Cited by
- 53
- References
- 47
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 6 · 2023: 3 · 2022: 5 · 2021: 9 · 2020: 8 · 2019: 4 · 2018: 5 · 2017: 3 · 2016: 1
- FWCI
- 4.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Drug Investigation (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Akrimax Pharmaceuticals, LLC
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- levothyroxine, dose adjustment, hypothyroidism, health care costs, healthcare resource utilization, productivity loss, indirect costs, direct medical costs, economic burden, electronic health records, medical chart review, primary care patients
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Health Resources, Humans, Male, Middle Aged, Retrospective Studies, Thyrotropin, Thyroxine, Drug Costs, Health Care Costs
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