RSS-Feed abonnieren
DOI: 10.3413/nukmed-0321-1005
Recombinant human TSH versus hypo thyroidism
Cost-minimization-analysis in the follow-up care of differentiated thyroid carcinomaRekombinantes humanes TSH im Vergleich zur Hypo thyreoseKostenanalyse in der Nachsorge des differenzierten SchilddrüsenkarzinomsPublikationsverlauf
received:
28. Mai 2010
accepted in revised form:
13. September 2010
Publikationsdatum:
24. Januar 2018 (online)
Summary
The primary aim of this study was to compare pharmacoeconomic effects of hypothyroidism secondary to hormone withdrawal (THW) and recombinant human TSH (rhTSH) for followup WBS in patients with differentiated thyroid cancer (DTC). The second aim was to determine patients' preference for one procedure or the other. Patients, methods: This retrospective survey included 327 patients with DTC who underwent at least one in-hospital WBS with rhTSH between 1999 and 2006. They had also undergone THW for WBS. Patients received a two-page questionnaire via mail addressing five symptoms and ten items regarding managing their daily life which was answered by 61.6%. The responder group did not differ from the entire group. The medical and societal cost of both procedures for diagnostic WBS was calculated including direct and all ascertainable indirect cost for the reference year 2005. A sensitivity analysis included the German DRG system of 2007 and 2010. Results: After THW, 94% of patients reported hypothyroid symptoms. Using rhTSH, symptoms occurred significantly less. As a result, 97% of patients favored rhTSH over THW. Mean absence from salaried work was 12.3 days after THW compared to 4 days with rhTSH. Family members of salaried employees missed 3 and 0.7 workdays after THW and rhTSH, respectively. Almost twice as often, medical attention was sought after THW (36%) compared to rhTSH (19 %). Undergoing THW, 48% of patients still used their car while hypothyroid. Our cost calculation revealed a slight benefit of about 89.00 Euro in favour of rhTSH stimulation. Conclusion: Hypothyroidism after THW causes significant morbidity and safety risks. The clinical and societal benefits associated with rhTSH are roughly gained at equivalent overall cost to that of THW.
Zusammenfassung
Diese Studie hatte zum Ziel, bei Patienten mit differenziertem Schilddrüsenkarzinom (DTC) die pharmakoökonomischen Aspekte der diagnostischen 131I-Ganzkörperszintigraphie (WBS) unter Hypothyreose im Vergleich zur Euthyreose mit rhTSH-Stimulation zu untersuchen. Ein weiteres Ziel der Studie war, die Präferenz der Patienten für eine der beiden Vorgehensweisen zu ermitteln. Patienten, Methoden: Diese retrospektive Untersuchung berücksichtigt 327 Patienten mit DTC, bei denen zumindest eine 131I WBS nach rhTSH-Stimulation zwischen 1999 und 2006 durchgeführt wurde. Die Patienten hatten sich auch einer WBS in Hypothyreose unterzogen. Sie erhielten per Post einen zweiseitigen Fragebogen, der fünf Hypothyreosesymptome und zehn Fragen zur Bewältigung des täglichen Lebens umfasste. Etwa zwei Drittel (61,6%) beantworteten den Fragebogen. Diese Gruppe wies keine Unterschiede zur Gesamtgruppe auf. Die medizinischen und gesellschaftlichen Kosten beider Verfahren zur Vorbereitung auf die diagnostische WBS wurden unter Hinzuziehung der direkten und aller erfassbaren indirekten Kosten für das Referenzjahr 2005 berechnet. Außerdem erfolgte eine Sensitivitätsanalyse, die auch das deutsche DRG-System von 2007 und 2010 einschloss. Ergebnisse: Unter Schilddrüsenhormonentzug nannten 94% der Patienten Hypothyreosesymptome. Nach rhTSH-Stimulation traten diese Symptome signifikant seltener auf mit dem Ergebnis, dass 97% der Patienten rhTSH gegenüber dem Hormonentzug präferierten. Die mittlere Fehlzeit erwerbstätiger Patienten betrug 12,3 Tage nach THW im Vergleich zu 4 Tagen mit rhTSH. Familienmitglieder von Erwerbstätigen mit THW versäumten 3 Arbeitstage und nach rhTSHStimulation 0,7 Arbeitstage. Zusätzliche Arztbesuche waren nach Hormonentzug etwa doppelt so häufig (36%) im Vergleich zur rhTSH-Stimulation (19%). Während des Hormonentzugs benutzten 48% der Patienten ihr Fahrzeug trotz bestehender Hypothyreose. Die pharmakoökonomische Berechnung ergab einen leichten Kostenvorteil von ca. 89,00 Euro für die rhTSH-Stimulation. Schlussfolgerung: Die Hypothyreose nach Hormonentzug führt zu einer erhöhten Morbidität und zusätzlichen Sicherheitsrisiken. Der klinische und gesellschaftliche Nutzen durch den Einsatz von rhTSH wird mit Gesamtkosten erreicht, die in etwa denen des Hormonentzugs entsprechen.
-
References
- 1 Biermann M, Pixberg MK, Riemann B. et al. Clinical outcome of adjuvant external-beam radiotherapy for differentiated thyroid cancer. Results after 874 patient-years of follow-up in the MSDS-trial. Nuklearmedizin 2009; 48: 89-98.
- 2 Blamey S, Barraclough B, Delbridge L. et al. Using recombinant human thyroid-stimulating hormone for the diagnosis of recurrent thyroid cancer. ANZ J Surg 2005; 75: 10-20.
- 3 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: 531-538.
- 4 Botella-Carretero JI, Gómez-Bueno M, Barrios V. et al. Chronic thyrotropin-suppressive therapy with levothyroxine and short-term overt hypothyroid- ism after thyroxine withdrawal are associated with undesirable cardiovascular effects in patients with differentiated thyroid carcinoma. Endocr-Relat Cancer 2004; 11: 345-356.
- 5 Brent G, Larsen R. Normalization of TSH may require up to 8 weeks, but complete recovery usually requires several months. In: Braverman L, Utiger R. (eds). Werner & Ingbar. The Thyroid: A Fundamental and Clinical Text. 2000. Philadelphia: Lippincott, Williams and Wilkins; 855.
- 6 Busemeyer S. Rekombinantes humanes TSH in der Nachsorge des differenzierten Schilddrüsenkarzinoms. Inaugural-Dissertation. Medizinische Fakultät der Universität zu Köln. 2009
- 7 Cohen O, Dabhi S, Karasik A. et al. Compliance with follow-up and the informative value of diagnostic whole-body scan in patients with differentiated thyroid carcinoma given recombinant human TSH. Eur J Endocrin 2004; 150: 285-290.
- 8 Constant EL, De Volder AG, Ivanoiu A. et al. Cerebral blood flow and glucose metabolism in hypothyroidism: a positron emission tomography study. J Clin Endocrinol Metab 2001; 86: 3864-3870.
- 9 Cooper DS, Doherty GM, Haugen BR. et al. Revised American Thyroid Association Management Guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid 2009; 19: 1167-1214.
- 10 Dedecjus M, Kolomecki K, Brzezinski J. et al. Influence of L-thyroxine administration on poor-platelet plasma VEGF concentrations in patients with induced short-term hypothyroidism, monitored for thyroid carcinoma. Endocrine J 2007; 54: 63-69.
- 11 Den Hollander JG, Wulkan RW, Mantel MJ. et al. Correlation between severity of thyroid dysfunction and renal function. Clin Endocrinol 2005; 62: 423-427.
- 12 Dietlein M, Dressler J, Eschner W. et al. Procedure guideline for iodine-131 whole-body scintigraphy for differentiated thyroid cancer (version 3). Nuklearmedizin 2007; 46: 206-212.
- 13 Dietlein M, Dressler J, Eschner W. et al. Procedure guidelines for radioiodine therapy of differentiated thyroid cancer (Version 3). Nuklearmedizin 2007; 46: 213-219.
- 14 Dow KH, Ferrell BR, Anello C. Quality of life changes in patients with thyroid cancer after withdrawal of thyroid hormone therapy. Thyroid 1997; 7: 613-619.
- 15 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: 513-519.
- 16 Duntas LH, Biondi B. Short-term hypothyroidism after Levothyroxine-withdrawal in patients with differentiated thyroid cancer: clinical and quality of life consequences. Eur J Endocrinol 2007; 156: 13-19.
- 17 Haugen BR, Pacini F, Reiners C. et al. A comparison of recombinant human thyrotropin and thyroid hormone withdrawal for the detection of thyroid remnant or cancer. J Clin Endocrinol Metab 1999; 84: 3877-3885.
- 18 Koopmanschap MA, Rutten FFH, van Ineveld BM. et al. The friction cost method for measuring indirect costs of disease. J Health Econ 1995; 14: 171-189.
- 19 Lorenz R, Dietlein M, Reiners C. Stationäre nuklearmedizinische Therapie in Deutschland- Analyse der strukturierten Qualitätsberichte 2004 bis 2008. Nuklearmedizin 2010; 49: 49-57.
- 20 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: 1147-1155.
- 21 Luster M, Clarke SE, Dietlein M. et al. Guidelines for radioiodine therapy of differentiated thyroid cancer. Eur J Nucl Med Mol Imaging 2008; 35: 1941-1959.
- 22 Mazzaferri EL. An overview of the management of papillary and follicular thyroid carcinoma. Thyroid 1999; 9: 421-427.
- 23 Memagh 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: 405-414.
- 24 Münte TF, Lill C, Otting G. et al. Cognitive changes in short-term hypothyroidism assessed with event- related brain potentials. Psychoneuroendocrinol- ogy 2004; 29: 1109-1118.
- 25 Nijhuis TF, van Weperen W, de Klerk JMH. Costs associated with the withdrawal of thyroid hormone suppression therapy during the follow-up treatment of well-differentiated thyroid cancer. Tijdschr Nucl Geneeskd 1999; 21: 98-100.
- 26 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.
- 27 Pacini F, Castagna MG. Diagnostic and therapeutic use of recombinant human TSH (rhTSH) in differentiated thyroid cancer. Best Pract Res Clin Endocrinol Metab 2008; 22: 1009-1021.
- 28 Pacini F, Castagna MG, Brilli L. et al. Differentiated thyroid cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009; 20: 143-146.
- 29 Regalbuto C, Alagona C, Maiorana R. et al. Acute changes in clinical parameters and thyroid funtion peripheral markers following L-T4 withdrawal in patients totally thyreoidectomized for thyroid cancer. J Endocrinol Invest 2006; 29: 32-40.
- 30 Schicha H, Hellmich M, Lehmacher W. et al. Should all patients with thyroid nodules > 1 cm undergo fine-needle aspiration biopsy?. Nuklearmedizin 2009; 48: 79-83.
- 31 Schlumberger MJ, Incerti C, Pacini F. et al. The role of recombinant thyroid-stimulating hormone (rhTSH) in the detection and management of well- differentiated thyroid carcinoma: A roundtable discussion. J Endocrinol Invest 1999; 22: 35-41.
- 32 Schroeder PR, Haugen BR, Pacini F. et al. A comparison of short-term changes in health-related quality of life in thyroid carcinoma patients undergoing diagnostic evaluation with recombinant human thyrotropin compared with thyroid hormone withdrawal. J Clin Endocrinol Metab 2006; 91: 878-884.
- 33 Tagay S, Herpertz S, Langkafel M. et al. Health-related quality of life, anxiety and depression in thyroid cancer patients under short-term hypothy- roidism and TSH-suppressive levothyroxine treatment. Eur J Endocrinol 2005; 153: 755-763.
- 34 Taïeb D, Sebag F, Cherenko M. et al. Quality of life changes and clinical outcomes in thyroid cancer patients undergoing radioiodine remnant ablation (RRA) with recombinant human TSH (rhTSH): a randomized controlled study. Clin Endocrinol 2009; 71: 115-123.
- 35 Thomsen AF, Kvist TK, Andersen PK. et al. Increased risk of developing affective disorder in patients with hypothyroidism: a register-based study. Thyroid 2005; 15: 700-707.
- 36 Verburg FA, de Keizer B, de Klerk JMH. et al. Value of diagnostic radioiodine scintigraphy and thyroglo- bulin measurement after rhTSH injection. Nuklearmedizin 2009; 48: 26-29.
- 37 Verburg FA, Terkooijen RBT, Stokkel MPM, van Isselt JW. The success of 131I ablation in thyroid cancer patients is significantly reduced after a diagnostic activity of 40 MBq 131I. Nuklearmedizin 2009; 48: 138-142.