CLINICAL STUDY 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 P Mernagh, S Campbell, M Dietlein 1 , M Luster 2 , E Mazzaferri 3 and A R Weston Health Technology Analysts Pty Ltd, PO Box 133, Balmain, Sydney 2041, Australia, 1 Department of Nuclear Medicine, University of Cologne, Cologne, Germany, 2 Department of Nuclear Medicine, University of Wu ¨rzburg, Wu ¨rzburg, Germany and 3 Department of Medicine, University of Florida, Gainesville, Florida, USA (Correspondence should be addressed to P Mernagh; Email: pmernagh@htanalysts.com) Abstract Objective: This investigation evaluated the cost-effectiveness of radioiodine remnant ablation following preparation with recombinant human TSH (rhTSH), compared with the standard preparation, whereby patients are rendered hypothyroid. Design: The economic evaluation relates to patients with well differentiated thyroid cancer who have undergone thyroidectomy, but have no metastases. The evaluation takes a societal perspective, considering costs and benefits to all parties. The benefits were expressed in units of quality-adjusted life years (QALY), so differences in life expectancy were captured with consideration of quality of life. Methods: A lifetime Markov model with Monte Carlo simulation of 100 000 patients was used to assess cost per QALY gained. The clinical inputs were sourced from a multi-centre, randomised controlled trial comparing remnant ablation success after rhTSH-preparation with hypothyroid preparation. The model applied German unit costs, however, the structure is generalisable to other jurisdictions. The additional cost of rhTSH procurement and administration is considered relative to the clinical benefits and cost offsets. These included avoidance of hypothyroidism, increased work productivity, earlier discharge from radioprotection and a theoretical reduction in the risk of secondary malignancy. The latter two benefits relate to faster radioiodine clearance after rhTSH preparation. Results: The additional benefits of rhTSH (0.0495 QALY) are obtained with an incremental societal cost of V47, equating to an incremental cost per QALY of V958. Sensitivity analyses had only a modest impact upon cost-effectiveness, with all one-way sensitivity results remaining under V15 000/QALY. Conclusions: The use of rhTSH prior to radioiodine ablation represents good value-for-money with the benefits to patient and society obtained at modest net cost. European Journal of Endocrinology 155 405–414 Introduction Total or near total thyroidectomy followed by 131 I radioiodine ablation remains the primary treatment for differentiated thyroid cancer. The aim of radioiodine ablation is to destroy thyroid remnants, which is facilitated by the selective uptake of iodine into this tissue. To achieve optimal uptake of radioiodine into the remnant thyroid tissue, patients have traditionally undergone ablation therapy in the hypothyroid state (without thyroid hormone-replacement therapy), which elevates serum thyroid-stimulating hormone (TSH) and results in increased radioiodine uptake by remnants (1). To achieve an adequate TSH level after surgery, patients forgo thyroid hormone replacement for 3–6 weeks prior to ablation. In Germany, this typically commences immediately after thyroidectomy (2). However, in countries where access to radio-protective wards is more limited, patients may commence thyroid hormone therapy after thyroidectomy, only to withdraw at a later date in preparation for their ablation therapy. However, without thyroid hormone therapy, patients are rendered hypothyroid, which may invoke a range of adverse clinical effects and can lead to significant morbidity. This may include severe lethargy and fatigue, cognitive problems, inability to concentrate, consti- pation, cold intolerance and depression in the young, and ataxia, ambulation problems, falls, cardiac and renal problems in the elderly. As these symptoms may be severe, patients are often unable to perform their normal activities at home or work (1,3–6). An alternative to rendering the patient hypothyroid is to commence thyroid hormone-replacement therapy immediately after thyroidectomy and provide exogenous TSH in the form of recombinant human TSH (rhTSH). Several investigators have shown that exogenous rhTSH can sufficiently stimulate 131 I uptake in thyroid remnants to result in successful remnant ablation European Journal of Endocrinology (2006) 155 405–414 ISSN 0804-4643 q 2006 Society of the European Journal of Endocrinology DOI: 10.1530/eje.1.02223 Online version via www.eje-online.org