Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy
DOI:
https://doi.org/10.7175/fe.v17i3.1264Keywords:
Radioiodine ablation, Recombinant human thyroid stimulating hormone, ThyroidectomyAbstract
BACKGROUND: Radioiodine ablation is an adjuvant procedure used to treat patients with differentiated thyroid cancer. For ablation to be successful, patients must have elevated levels of thyroid stimulating hormone (TSH). This can be achieved by withholding thyroid hormone therapy (endogenous stimulation), or by administration of recombinant human thyroid stimulating hormone (rhTSH; Thyrogen®; exogenous stimulation) to patients in the euthyroid state.
AIM: To compare the estimated health benefits, cost and cost-effectiveness of TSH stimulation with and without Thyrogen® in the Italian setting.
METHODS: A cost-utility analysis was undertaken to assess the impact of exogenous vs. endogenous TSH stimulation before radioiodine remnant ablation of patients with newly diagnosed, well-differentiated papillary or follicular thyroid cancer who have undergone total or near-total thyroidectomy. A Markov model was developed to simulate treatment costs and health outcomes associated with exogenous and endogenous stimulation in four distinct health states: pre-ablation, ablation, post-ablation, and well/recovery. Treatment was stratified by patients who receive high- and low-activity (30-100 mCi, respectively) in the ablation state. The Italian National Health System perspective was adopted in the base case scenario while the impact of indirect costs was explored in a sensitivity analysis. Costs and quality-adjusted life years (QALY) specific to each health state were estimated, summarized and converted into a corresponding incremental cost-effectiveness ratio (ICER).
RESULTS: We calculated a cost-effectiveness ratio of 18,357.18 €/QALY gained whereas the inclusion of indirect cost and accident cost produced reductions of the ICER to € 14,609.51 and € 15,515.26 per QALY, respectively. Finally, all results in the sensitivity analysis are below the lower bound of national and international cost- effective threshold.
CONCLUSION: Thyrogen® represents a cost-effective option for patients with differentiated thyroid cancer who underwent total or near-total thyroidectomy in Italy. Our findings are consistent with other cost-utility analyses.
References
Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid 2016; 26: 1-133. http://dx.doi.org/10.1089/thy.2015.0020
Schlumberger M, Catargi B, Borget I, et al. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med 2012; 366: 1663-73; http://dx.doi.org/10.1056/NEJMoa1108586
Smith CD, Grondin R, LeMaster W, et al. Reversible cognitive, motor, and driving impairments in severe hypothyroidism. Thyroid 2015; 25: 28-36; http://dx.doi.org/10.1089/thy.2014.0371
Luster M, Felbinger R, Dietlein M, et al. Thyroid hormone withdrawal in patients with differentiated thyroid carcinoma: a one hundred thirty-patient pilot survey on consequences of hypothyroidism and a pharmacoeconomic comparison to recombinant thyrotropin administration. Thyroid 2005; 15: 1147-55; http://dx.doi.org/10.1089/thy.2005.15.1147
Pacini F, Ladenson PW, Schlumberger M, et al. Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinoma: results of an international, randomized, controlled study. J Clin Endocrinol Metab 2006; 91: 926-32; http://dx.doi.org/10.1210/jc.2005-1651
Menzel C, Kranert WT, Döbert N, et al. rhTSH stimulation before radioiodine therapy in thyroid cancer reduces the effective half-life of (131)I. J Nucl Med 2003; 44: 1065-8
Borget I, Remy H, Chevalier J, et al. Length and cost of hospital stay of radioiodine ablation in thyroid cancer patients: comparison between preparation with thyroid hormone withdrawal and Thyrogen. Eur J Nucl Med Mol Imaging 2008; 34: 1457-63; http://dx.doi.org/10.1007/s00259-008-0754-9
Vallejo Casas JA, Mena Bares LM, Gálvez MA, et al. Treatment room length-of-stay and patient throughput with radioiodine thyroid remnant ablation in differentiated thyroid cancer: comparison of thyroid-stimulating hormone stimulation methods. Nucl Med Commun 2011; 32: 840-6; http://dx.doi.org/10.1097/MNM.0b013e32834863b0
Mallick U, Harmer C, Yap B, et al. Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer. N Engl J Med 2012; 366: 1674-85; http://dx.doi.org/10.1056/NEJMoa1109589
Tu J, Wang S, Huo Z, et al. Recombinant human thyrotropin-aided versus thyroid hormone withdrawal-aided radioiodine treatment for differentiated thyroid cancer after total thyroidectomy: a meta-analysis. Radiother Oncol 2014; 110: 25-30; http://dx.doi.org/10.1016/j.radonc.2013.12.018
Committee for Medicinal Products for Human Use (CHMP). Assessment report EMA/CHMP/709596/2012. European Medicines Agency: 2012
Mernagh P, Campbell S, Dietlein M, et al. Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective. Eur J Endocrinol 2006; 155: 405-14; http://dx.doi.org/10.1530/eje.1.02223
Mernagh P, Suebwongpat S, Silverberg J, et al. Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer: The Canadian perspective. Value In Health 2010; 13: 180-7; http://dx.doi.org/10.1111/j.1524-4733.2009.00650.x
Sohn SY, Jang HW, Cho YY, et al. Economic Evaluation of Recombinant Human Thyroid Stimulating Hormone Stimulation vs. Thyroid Hormone Withdrawal Prior to Radioiodine Ablation for Thyroid Cancer: The Korean Perspective. Endocrinol Metab (Seoul) 2015; 30: 531-42; http://dx.doi.org/10.3803/EnM.2015.30.4.531
Hanscheid H, Lassmann M, Luster M, et al. Iodine biokinetics and dosimetry in radioiodine therapy of thyroid cancer: Procedures and results of a prospective international controlled study of ablation after rhTSH or hormone withdrawal. J Nucl Med 2006; 47: 648-54
Luster M, Sherman SI, Skarulis MC, et al. Comparison of radioiodine biokinetics following the administration of recombinant human thyroid stimulating hormone and after thyroid hormone withdrawal in thyroid carcinoma. Eur J Nucl Med Mol Imaging 2003; 30: 1371-7; http://dx.doi.org/10.1007/s00259-003-1230-1
Berg G, Lindstedt G, Suurkula M, et al. Radioiodine ablation and therapy in differentiated thyroid cancer under stimulation with recombinant human thyroid stimulating hormone. J Endocrinol Invest 2002; 25: 44-52; http://dx.doi.org/10.1007/BF03343960
Brazier J, Usherwood T, Harper R, et al. Deriving a preference-based single index from the UK SF-36 Health Survey. J Clin Epidemiol 1998; 51: 1115-28; http://dx.doi.org/10.1016/S0895-4356(98)00103-6
Schroeder PR et al. A comparison of short term changes in health-related quality of life in thyroid carcinoma patients undergoing diagnostic evaluation with rhTSH compared to thyroid hormone withdrawal. J Clin Endocrinol Metab 2006; 91: 878-84; http://dx.doi.org/10.1210/jc.2005-2064
Pacini F, Schlumberger M, Dralle H, et al. European consensus for the management of patients with differentiated thyroid carcinoma of the follicular epithelium. Eur J Endocrinol 2006; 154: 787-803; http://dx.doi.org/10.1530/eje.1.02158
Health Service Lombardia Region. Nomenclatore Tariff. Updated with DGR n. 2989 del 23.12.14
Informatore Farmaceutico 2015. Available at: www.codifa.it (last accessed December 2015)
Determina AIFA del 17.07.14. Regime di rimborsabilità e prezzo a seguito di nuove indicazioni terapeutiche del medicinale per uso umano «Thyrogen». GU Serie Generale n.175 del 30-7-2014
Campennì A, Giovanella L, Pignata SA, et al. Thyroid remnant ablation in differentiated thyroid cancer: searching for the most effective radioiodine activity and stimulation strategy in a real-life scenario. Nucl Med Commun 2015; 36: 1100-6; http://dx.doi.org/10.1097/MNM.0000000000000367
McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: what it is and what that means. Pharmacoeconomics 2008; 26: 733-44; http://dx.doi.org/10.2165/00019053-200826090-00004
Italian Health Economics Association (AIES) Italian guidelines proposal on how to conduct economic evaluation studies of health programs. Pharmacoecon Ital Res Artic 2009; 11: 83-93; http://dx.doi.org/10.1007/BF03320660
Reiners C, Lassmann M, Luster M. Recombinant human thyrotropin: safety and quality of life evaluation. J Endocrinol Invest 2012; 35(6 Suppl): 30-5
Dietlein M, Busemeyer S, Kobe C, et al. Recombinant human TSH versus hypothyroidism. Cost-minimization-analysis in the follow-up care of differentiated thyroid carcinoma. Nuklearmedizin 2010; 49: 216-24; http://dx.doi.org/10.3413/nukmed-0321-1005
Banach R, Bartès B, Farnell K, et al., for the Thyroid Cancer Alliance. Results of the Thyroid Cancer Alliance international patient/survivor survey: Psychosocial/informational support needs, treatment side effects and international differences in care. Hormones (Athens) 2013; 12: 428-38
Drummond MF, Sculpher MJ, Claxton K, et al. Methods for the Economic Evaluation of Health Care Programmes (4th edition). Oxford: Oxford University Press, 2015
Borget I, Bonastre J, Catargi B, et al. Quality of Life and Cost-Effectiveness Assessment of Radioiodine Ablation Strategies in Patients With Thyroid Cancer: Results From the Randomized Phase III ESTIMABL Trial. J Clin Oncol 2015; 33: 2885-92; http://dx.doi.org/10.1200/JCO.2015.61.6722
Borget I, Corone C, Nocaudie M, et al. Sick leave for follow-up control in thyroid cancer patients: comparison between stimulation with Thyrogen and thyroid hormone withdrawal. Eur J Endocrinol 2007; 156: 531-8; http://dx.doi.org/10.1530/EJE-06-0724
Dueren C, Dietlein M, Luster M, et al. The use of thyrogen in the treatment of differentiated thyroid carcinoma: an intraindividual comparison of clinical effects and implications of daily life. Exp Clin Endocrinol Diabetes 2010; 118: 513-9; http://dx.doi.org/10.1055/s-0029-1234086
Published
How to Cite
Issue
Section
License
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. The Publication Agreement can be downloaded here, and should be signed by the Authors and sent to the Publisher when the article has been accepted for publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (see The Effect of Open Access).
- Authors are permitted to post their work online after publication (the article must link to publisher version, in html format)
