Quality of Life and Cost-Effectiveness Assessment of Radioiodine Ablation Strategies in Patients With Thyroid Cancer: Results From the Randomized Phase III ESTIMABL Trial

Borget, Isabelle; Bonastre, Julia; Catargi, Bogdan; Deandreis, Désirèe; Zerdoud, Slimane; Rusu, Darian; Bardet, Stéphane; Leenhardt, Laurence; Bastié, D.; Schvartz, Claire; Véra, Pierre; Morel, Olivier; Benisvy, D.; Bournaud, Claire; Bonichon, F.; Kelly, A.; Toubert, Marie Elisabeth; Leboulleux, Sophie; Journeau, Florence; Benhamou, E; Schlumberger, Martin

doi:10.1200/jco.2015.61.6722

Cited by 69 publications

(58 citation statements)

References 26 publications

(1 reference statement)

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“…Our findings are consistent with three cost-utility analyses conducted using the same model in the German, Canadian and Korean settings in which ICERs were equal to 958 €/QALY, 1,520 Canadian $/QALY and 26,697,361 W/QALY, respectively [12][13][14]. Most recently, a cost-effectiveness analysis performed in France alongside the ESTIMA-BL trial adopted a longer time horizon and considered the consecutive use of Thyrogen ® in both ablation and follow up procedures [31]. Results cannot be directly compared for a number of reasons.…”

Section: Sensitivity Analysissupporting

confidence: 64%

“…In both studies the average workday loss was between 11 and 12 days (vs. 3 to 4 days in case of Thyrogen ® use). Borget et al [32] documented a 8.1 days difference in 2007 whereas the ESTIMABL study [31] reported no difference. We speculate that sick leave duration is highly dependent of the clinical practice: in some cases is set on the basis of the disease (thyroid cancer) and not on the basis of the treatment.…”

Section: Sensitivity Analysismentioning

confidence: 96%

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Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

Danieli

Monari

Lazzarini

et al. 2016

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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.

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Section: Sensitivity Analysissupporting

confidence: 64%

Section: Sensitivity Analysismentioning

confidence: 96%

Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

Danieli

Monari

Lazzarini

et al. 2016

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“…23 For example, in the phase 3 randomised, placebo-controlled study of pazopanib monotherapy in patients with aRCC, there was no significant difference in EQ-5D when analysed by MMRM over the course of 48 weeks. 20 In a subsequent post hoc analysis, time to HRQoL deterioration from baseline, measured by the EQ-5D utility index, was also not significantly different between treatment groups.…”

Section: Discussionmentioning

confidence: 99%

Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial

Cella

Grünwald

Nathan

et al. 2016

The Lancet Oncology

205

121

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Summary Background In the phase 3 CheckMate 025 study, previously treated patients with advanced renal cell carcinoma (aRCC) randomised to nivolumab had an overall survival (OS) benefit versus everolimus. We compared health-related quality of life (HRQoL) between treatment arms and explored the relationship with OS. Methods In this open-label study (NCT01668784) in 146 oncology centres in 24 countries, patients with aRCC were randomised (1:1; block size of 4) to receive nivolumab 3 mg/kg by 60-minute intravenous infusion every 2 weeks or everolimus 10 mg tablet orally once daily. The study was stopped early at the planned interim analysis in July 2015 as the study met its primary endpoint. A protocol amendment permitted patients in the everolimus group to cross over to nivolumab treatment. All patients not on active study therapy are being followed for survival. At the interim analysis, HRQoL was assessed using the Functional Assessment of Cancer Therapy–Kidney Symptom Index–Disease Related Symptoms (FKSI-DRS) and European Quality of Life (EuroQol)-5 Dimensions (EQ-5D) questionnaires. FKSI-DRS completion rate was calculated using number of patients with at least one baseline assessment and at least one post-baseline assessment. FKSI-DRS completion was defined as completion of five or more items; otherwise data were treated as missing. FKSI-DRS symptom index score was prorated for missing items. No adjustments were made for EQ-5D missing data. Descriptive statistics and multivariate analyses, including mixed-effects model repeated-measures (MMRM) were used. Analyses were powered according to the original study protocol. A correlation between baseline HRQoL and OS was performed. Findings Patients were randomised from October 2012 through March 2014. HRQoL data were collected at baseline for 362 (88%) of 410 (nivolumab) and 344 (84%) of 411 (everolimus) randomised patients. The mean difference (95% CI) in FKSI-DRS score between nivolumab and everolimus arms was 1·6 (1·4–1·9, p<0·001) with descriptive statistics and 1·7 (1·2–2·1, p<0·001) with MMRM analysis. More patients experienced clinically meaningful HRQoL improvement with nivolumab versus everolimus (200 [55%] of 361 vs 126 [37%] of 343, respectively; p<0·001). Median (95% CI) time to improvement in HRQoL was shorter in patients treated with nivolumab (4·7 [3·7–7·5] months) versus everolimus (not reached [range not estimable]). A positive correlation between OS and FKSI-DRS (r=0·27; p≤0·001), EQ-5D utility (r=0·24, p≤0·001), and EQ-5D VAS (r=0·26, p≤0·001) baseline scores across both arms was observed. Interpretation Nivolumab treatment was associated with HRQoL improvement compared with everolimus in previously treated patients with aRCC. Funding Bristol-Myers Squibb. Dr. Motzer received support through the NIH/NCI Cancer Center Support Grant P30 CA008748.

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“…General rules obligatory in RAI treatment: the patient should be fully informed about the treatment goal, its course, including radiation safety procedures, possible consequences, and [54,56]. SoR: G1; QoE: +++; ATA GL R51 9.3.6.…”

Section: Commentarymentioning

confidence: 99%

Rekomendacje Polskich Towarzystw Naukowych „Diagnostyka i leczenie raka tarczycy”. Aktualizacja na rok 2018

Jarząb¹,

Dedecjus²,

Słowińska-Klencka³

et al. 2018

Endokrynologia Polska

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Quality of Life and Cost-Effectiveness Assessment of Radioiodine Ablation Strategies in Patients With Thyroid Cancer: Results From the Randomized Phase III ESTIMABL Trial

Abstract: rhTSH avoids the transient THW-induced deterioration of HRQoL but is unlikely to be cost effective at its current price.

Cited by 69 publications

References 26 publications

Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial

Rekomendacje Polskich Towarzystw Naukowych „Diagnostyka i leczenie raka tarczycy”. Aktualizacja na rok 2018

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