Background: Although substantial progress has been made in recent decades in eliminating iodine deficiency, iodine deficiency disorders (IDDs) are still prevalent in European countries. Challenges include ineffective public health programs and discontinuation of IDD prevention. However, the barriers against the implementation and continuation of prevention and monitoring of IDD remain unclear. Therefore, the objective of our study was to identify potential barriers against pan-European IDD prevention and monitoring programs and to find solutions for the different challenges. Methods: We conducted a Delphi study consisting of three rounds. We identified potential participants with expertise and experience in relevant fields from all European countries, including policy makers, health care professionals, health scientists, and patient representatives. The Delphi method was conducted with open-ended questions and item ranking to achieve group consensus on potential barriers against national and pan-European IDD prevention and monitoring programs and related solutions to overcome those barriers. The answers of the Delphi rounds were analyzed using qualitative content analysis and descriptive analysis methods. In addition, we conducted two expert interviews to analyze and discuss the study results. Results: Eighty experts from 36 countries and different fields of work participated in the first Delphi round, 52 in the second, and 46 in the third. Potential barriers include challenges in the fields of knowledge and information, implementation and management, communication and cooperation, political support, and differences between the European countries. Ranked solutions addressing these barriers include cooperation with different stakeholders, gaining knowledge, sharing information, the development of a European program with national specification, European guidelines/recommendations, and European monitoring. The ranking gives a first overview as to which of these barriers would need to be solved most urgently and which solutions may be most helpful. Conclusion:In our study, we derived key information and first insights with regard to barriers against IDD prevention programs from a broad range of stakeholders. Most barriers were found in the category of implementation and management. Also a lack of political support seems to play an important role. The findings of our study may help decision makers in health policy to develop more effective IDD prevention and monitoring strategies.

Background: Iodine deficiency is one of the most prevalent causes of intellectual disability and can lead to impaired thyroid function and other iodine deficiency disorders (IDDs). Despite progress made on eradicating iodine deficiency in the last decades in Europe, IDDs are still prevalent. Currently, evidence-based information on the benefit/harm balance of IDD prevention in Europe is lacking. We developed a decision-analytic model and conducted a public health decision analysis for the long-term net benefit of a mandatory IDD prevention program for the German population with moderate iodine deficiency, as a case example for a European country. Methods: We developed a decision-analytic Markov model simulating the incidence and consequences of IDDs in the absence or presence of a mandatory IDD prevention program (iodine fortification of salt) in an open population with current demographic characteristics in Germany and with moderate ID. We collected data on the prevalence, incidence, mortality, and quality of life from European studies for all health states of the model. Our primary net-benefit outcome was quality-adjusted life years (QALYs) predicted over a period of 120 years. In addition, we calculated incremental life years and disease events over time. We performed a systematic and comprehensive uncertainty assessment using multiple deterministic one-way sensitivity analyses. Results: In the base-case analysis, the IDD prevention program is more beneficial than no prevention, both in terms of QALYs and life years. Health gains predicted for the open cohort over a time horizon of 120 years for the German population (82.2 million inhabitants) were 33 million QALYs and 5 million life years. Nevertheless, prevention is not beneficial for all individuals since it causes additional hyperthyroidism (2.7 million additional cases). Results for QALY gains were stable in sensitivity analyses. Conclusions: IDD prevention via mandatory iodine fortification of salt increases quality-adjusted life expectancy in a European population with moderate ID, and is therefore beneficial on a population level. However, further ethical aspects should be considered before implementing a mandatory IDD prevention program. Costs for IDD prevention and treatment should be determined to evaluate the cost effectiveness of IDD prevention.

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Objective: More than 30 percent of the German population suffers from mild to moderate iodine deficiency causing goiter and other iodine deficiency disorders (IDDs). The economic burden of iodine deficiency is still unclear. We aimed to assess costs for prevention, monitoring and treatment of IDDs in Germany. Design: We performed a comprehensive cost analysis. Methods: We assessed direct medical costs and direct non-medical costs for inpatient and outpatient care of IDDs and costs for productivity loss due to absence of work in 2018 Euro. Additionally, we calculated total costs for an IDD prevention program comprising universal salt iodization (USI). We performed threshold analyses projecting how many cases of IDDs or related treatments would need to be avoided for USI to be cost saving. Results: Annual average costs per case in the year of diagnosis were EUR 211 for goiter/thyroid nodules; EUR 308 for hyperthyroidism; and EUR 274 for hypothyroidism. Average one-time costs for thyroidectomy were EUR 4,184 and EUR 3,118 for radioiodine therapy. Average costs for one case of spontaneous abortion were EUR 916. Annual costs of intellectual disability were 14,202 Euro. In the German population, total annual costs for USI would amount to 8 million Euro. To be cost saving, USI would need to prevent, for example, 37,900 cases of goiter/thyroid nodules. Conclusion: USI potentially saves costs, if a minimum amount of IDDs per year could be avoided. In order to recommend the implementation of USI, a full health-economic evaluation including a comprehensive benefit-harm assessment is needed.

and quality-adjusted life years(QALYs), considering the time spent in each state combined with costs and health-state utilities (HSU) values derived from EQ-5D data from MONALEESA-2. HSU was assumed to be the same regardless of treatment, differing based on the state and time spent in the state. For letrozole, parametric survival distributions best fitted to individual patient failure-time data were defined based on fit statistics, visual inspection, hazard functions, time dependent hazard ratios, diagnostic plots for treatment effects and clinical plausibility. The effects of ribociclib or palbociclib plus letrozole were modelled based on hazard ratios from network meta-analysis using efficacy data from MONALEESA-2, PALOMA-1 and PALOMA-2 trials. The costs considered included the costs of drugs acquisition, disease monitoring, subsequent treatment lines, end of life care, and the management for adverse events. Half-cycle corrections and 5% discount rate were applied. Uncertainty of the parameters and robustness of the results were evaluated using deterministic and probabilistic sensitivity analyses. Results: Ribociclib plus letrozole was dominant versus palbociclib plus letrozole, with a cost saving of 28,619 USD (1USD=3.97BRL/May/2019) and a gain of 0.14 QALYs and 0.22 LYs. The results of the sensitivity analyses showed robustness of the model, with the main uncertain parameters represented by discount rates. Conclusions: From the BPHS perspective, ribociclib plus letrozole is a cost-saving alternative to palbociclib plus letrozole for the first-line treatment of postmenopausal women HR+/HER2-ABC.