BackgroundThe CONTROL Surveillance Project was a comprehensive patient-based survey conducted among hypothyroid patients undergoing treatment. The primary objective of the study was to specifically quantify the prevalence of factors adversely affecting levothyroxine therapy.MethodsParticipants were selected from a large proprietary database. Those eligible for the study completed a 21-question survey.ResultsOf the eligible hypothyroid patients, 925 (92.5 %) were being treated with levothyroxine monotherapy. The mean age was 60.4 years; 755 (81.6 %) were female and 168 (18.2 %) were male. Almost half of those receiving levothyroxine (435, 47.0 %) had at least one comorbid condition that could adversely affect its absorption: gastroesophageal reflux disease (33.8 % of patients), irritable bowel syndrome (9.7 %), lactose intolerance (7.8 %), or a history of gastric bypass surgery or bowel resection (3.0 %). Other factors reported by many patients that could adversely affect levothyroxine absorption included use of prescription medications (20.6 %) and over-the-counter medications (34.3 %) used to treat comorbid gastrointestinal (GI) conditions; use of dietary supplements (51.8 %, primarily calcium and iron); and intake of foods/beverages high in fiber, iodine, or soy (68.0 %). Of the 13.4 % who reported difficulty controlling their hypothyroid symptoms, significantly more patients with comorbid GI conditions reported such difficulty (7.8 versus 5.6 %, P < 0.01). Frequent changes in levothyroxine dosing (two or more dose changes in the past year) were reported by 8.0 % of survey participants. Those with GI comorbidities were nearly twice as likely to have such changes (5.0 versus 3.0 %, P < 0.01).ConclusionBetter initial workup of patients, including identification of relevant GI comorbidities and allergies, may help in the early detection of factors that may affect the performance of levothyroxine.

BackgroundIn 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.ObjectiveThe 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.MethodsA 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).ResultsThe 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).ConclusionsPatients 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.Electronic supplementary materialThe online version of this article (doi:10.1007/s40261-016-0462-3) contains supplementary material, which is available to authorized users.

IntroductionMedication changes involving levothyroxine—either dose titrations or switching formulations—occur frequently in patients with erratic thyroid-stimulating hormone (TSH) levels and persistent hypothyroid symptoms. We investigated whether switching patients from levothyroxine tablets to a gel cap formulation of levothyroxine might reduce dose adjustments and improve tolerability and efficacy outcomes.ObjectivesPrimary study objectives included quantifying the percentage of patients achieving TSH levels within a pre-specified range, median dose changes experienced, and the percentage of patients with improved hypothyroid symptom control after switching from levothyroxine tablets to levothyroxine gel caps.MethodsA retrospective medical chart review was conducted among 99 randomly selected hypothyroid patients who were switched from a tablet to a gel cap formulation of levothyroxine. Patients were required to have been on levothyroxine monotherapy for ≥1 year prior to the medication switch. Data was collected for 6 months pre-switch and up to 6 months post-switch.ResultsOf the 99 patients studied, the majority (51.5%) experienced no documented change in TSH status after the switch (P < 0.0001). However, there was a decrease in the mean number of dose changes experienced (1.61 ± 0.96 vs. 0.73 ± 0.96; P < 0.0001). Improved hypothyroid symptom control was reported among 61.6% of patients (61 of 99; P < 0.0001).ConclusionThe results of CONTROL Switch support a strategy of switching patients who may experience tolerability or efficacy problems with standard levothyroxine tablets to the levothyroxine gel cap formulation.

Objective: To determine the budget impact of incorporating levothyroxine gel caps in the treatment plan of patients diagnosed with hypothyroidism who experience multiple levothyroxine dose or formulation changes annually due to inadequate efficacy or tolerability.Methods: Cost estimates of levothyroxine formulations were obtained. Estimated utilization patterns and costs of physician services, laboratory tests, ancillary healthcare services, and lost productivity were quantified based on published literature and government/public sources. The patient population was based on epidemiology reports and estimates from the American Association of Clinical Endocrinology and the American Thyroid Association. All calculations of economic outcomes were determined using a budget impact model constructed in a MS Excel platform.Results: The economic model demonstrated for a population of 500,000 persons, there are 23,000 (4.6%) people with hypothyroidism, of which 18,400 (80.0%) receive pharmacologic treatment, including 17,480 (95.0%) that receive levothyroxine. The proportion of patients requiring ≥ 1 dosage changes annually is 31.4%, producing 5,489 "hard-to-treat" patients. Similarly, the proportion of patients requiring ≥ 2 dosage changes annually is 8.0% or 1,398 "harder-to-treat" patients. Using evidence-based data of the tolerability and absorption characteristics of levothyroxine gel caps, changing 20.0% of the target cohort to the gel cap formulation produced annual net cost savings of $542,901 in direct medical costs and $564,650 in lost productivity for "hard-to-treat" patients and savings of $409,107 in direct medical costs and $441,926 in lost productivity for "harder-to-treat" patients. Conclusions:Consideration of switching levothyroxine product from a tablet to a gel cap formulation is justified on an economic and therapeutic basis for hypothyroid patients at risk of subadequate drug efficacy or tolerability as measured by the need for one or more annual levothyroxine dosage or formulation adjustments.

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