A health technology assessment of personalized nutrition interventions using the EUnetHTA HTA Core Model.

OBJECTIVES: Poor nutrition links to chronic diseases, emphasizing the need for optimized diets. The EU-funded project PREVENTOMICS, introduced personalized nutrition to address this. This study aims to perform a health technology assessment (HTA) comparing personalized nutrition interventions developed through this project, with non-personalized nutrition interventions (control) for people with normal weight, overweight, or obesity. The goal is to support decisions about further development and implementation of personalized nutrition. METHODS: The PREVENTOMICS interventions were evaluated using the European Network for HTA Core Model, which includes a methodological framework that encompasses different domains for value assessment. Information was gathered via [1] different statistical analyses and modeling studies, [2] questions asked of project partners and, [3] other (un)published materials. RESULTS: Clinical trials of PREVENTOMICS interventions demonstrated different body mass index changes compared to control; differences ranged from -0.80 to 0.20 kg/m2. Long-term outcome predictions showed generally improved health outcomes for the interventions; some appeared cost-effective (e.g., interventions in UK). Ethical concerns around health inequality and the lack of specific legal regulations for personalized nutrition interventions were identified. Choice modeling studies indicated openness to personalized nutrition interventions; decisions were primarily affected by intervention's price. CONCLUSIONS: PREVENTOMICS clinical trials have shown promising effectiveness with no major safety concerns, although uncertainties about effectiveness exist due to small samples (n=60-264) and short follow-ups (10-16 weeks). Larger, longer trials are needed for robust evidence before implementation could be considered. Among other considerations, developers should explore financing options and collaborate with policymakers to prevent exclusion of specific groups due to information shortages.

Economic Evaluation of a Personalized Nutrition Plan Based on Omic Sciences Versus a General Nutrition Plan in Adults with Overweight and Obesity: A Modeling Study Based on Trial Data in Denmark.

BACKGROUND: Since there is no diet that is perfect for everyone, personalized nutrition approaches are gaining popularity to achieve goals such as the prevention of obesity-related diseases. However, appropriate choices about funding and encouraging personalized nutrition approaches should be based on sufficient evidence of their effectiveness and cost-effectiveness. In this study, we assessed whether a newly developed personalized plan (PP) could be cost-effective relative to a non-personalized plan in Denmark. METHODS: Results of a 10-week randomized controlled trial were combined with a validated obesity economic model to estimate lifetime cost-effectiveness. In the trial, the intervention group (PP) received personalized home-delivered meals based on metabolic biomarkers and personalized behavioral change messages. In the control group these meals and messages were not personalized. Effects were measured in body mass index (BMI) and quality of life (EQ-5D-5L). Costs [euros (€), 2020] were considered from a societal perspective. Lifetime cost-effectiveness was assessed using a multi-state Markov model. Univariate, probabilistic sensitivity, and scenario analyses were performed. RESULTS: In the trial, no significant differences were found in the effectiveness of PP compared with control, but wide confidence intervals (CIs) were seen [e.g., BMI (-0.07, 95% CI -0.51, 0.38)]. Lifetime estimates showed that PP increased costs (€520,102 versus €518,366, difference: €1736) and quality-adjusted life years (QALYs) (15.117 versus 15.106, difference: 0.011); the incremental cost-utility ratio (ICUR) was therefore high (€158,798 to gain one QALY). However, a 20% decrease in intervention costs would reduce the ICUR (€23,668 per QALY gained) below an unofficial gross domestic product (GDP)-based willingness-to-pay threshold (€47,817 per QALY gained). CONCLUSION: On the basis of the willingness-to-pay threshold and the non-significant differences in short-term effectiveness, PP may not be cost-effective. However, scaling up the intervention would reduce the intervention costs. Future studies should be larger and/or longer to reduce uncertainty about short-term effectiveness. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT04590989).

Attitudes Toward the Adoption of Remote Patient Monitoring and Artificial Intelligence in Parkinson's Disease Management: Perspectives of Patients and Neurologists.

OBJECTIVE: Early detection of Parkinson's Disease (PD) progression remains a challenge. As remote patient monitoring solutions (RMS) and artificial intelligence (AI) technologies emerge as potential aids for PD management, there's a gap in understanding how end users view these technologies. This research explores patient and neurologist perspectives on AI-assisted RMS. METHODS: Qualitative interviews and focus-groups were conducted with 27 persons with PD (PwPD) and six neurologists from Finland and Italy. The discussions covered traditional disease progression detection and the prospects of integrating AI and RMS. Sessions were recorded, transcribed, and underwent thematic analysis. RESULTS: The study involved five individual interviews (four Italian participants and one Finnish) and six focus-groups (four Finnish and two Italian) with PwPD. Additionally, six neurologists (three from each country) were interviewed. Both cohorts voiced frustration with current monitoring methods due to their limited real-time detection capabilities. However, there was enthusiasm for AI-assisted RMS, contingent upon its value addition, user-friendliness, and preservation of the doctor-patient bond. While some PwPD had privacy and trust concerns, the anticipated advantages in symptom regulation seemed to outweigh these apprehensions. DISCUSSION: The study reveals a willingness among PwPD and neurologists to integrate RMS and AI into PD management. Widespread adoption requires these technologies to provide tangible clinical benefits, remain user-friendly, and uphold trust within the physician-patient relationship. CONCLUSION: This study offers insights into the potential drivers and barriers for adopting AI-assisted RMS in PD care. Recognizing these factors is pivotal for the successful integration of these digital health tools in PD management.

The Potential Cost-Effectiveness of a Cell-Based Bioelectronic Implantable Device Delivering Interferon-ß1a Therapy Versus Injectable Interferon-ß1a Treatment in Relapsing-Remitting Multiple Sclerosis.

BACKGROUND: Current first-line disease-modifying therapies (DMT) for multiple sclerosis (MS) patients are injectable or oral treatments. The Optogenerapy consortium is developing a novel bioelectronic cell-based implant for controlled release of beta-interferon (IFNß1a) protein into the body. The current study estimated the potential cost effectiveness of the Optogenerapy implant (hereafter: Optoferon) compared with injectable IFNß1a (Avonex). METHODS: A Markov model simulating the costs and effects of Optoferon compared with injectable 30 mg IFNß1a over a 9-year time horizon from a Dutch societal perspective. Costs were reported in 2019 Euros and discounted at a 4% annual rate; health effects were discounted at a 1.5% annual rate. The cohort consisted of 35-year-old, relapsing-remitting MS patients with mild disability. The device is implanted in a daycare setting, and is replaced every 3 years. In the base-case analysis, we assumed equal input parameters for Optoferon and Avonex regarding disability progression, health effects, adverse event probabilities, and acquisition costs. We assumed reduced annual relapse rates and withdrawal rates for Optoferon compared with Avonex. Sensitivity, scenario, value of information, and headroom analysis were performed. RESULTS: Optoferon was the dominant strategy with cost reductions (- €26,966) and health gains (0.45 quality-adjusted life-years gained). A main driver of cost differences are the acquisition costs of Optoferon being 2.5 times less than the costs of Avonex. The incremental cost-effectiveness ratio was most sensitive to variations in the annual acquisition costs of Avonex, the annual withdrawal rate of Avonex and Optoferon, and the disability progression of Avonex. CONCLUSION: Innovative technology such as the Optoferon implant may be a cost-effective therapy for patients with MS. The novel implantable mode of therapeutic protein administration has the potential to become a new mode of treatment administration for MS patients and in other disease areas. However, trials are needed to establish safety and effectiveness.

Diabetes prevalence in populations of South Asian Indian and African origins: a comparison of England and the Netherlands.

BACKGROUND: We determined whether the overall lower prevalence of type II diabetes in England versus the Netherlands is observed in South-Asian-Indian and African-Caribbean populations. Additionally, we assessed the contribution of health behavior, body size, and socioeconomic position to observed differences between countries. METHODS: Secondary analyses of population-based standardized individual-level data of 3386 participants were conducted. RESULTS: Indian and African-Caribbean populations had higher prevalence rates of diabetes than whites in both countries. In cross-country comparisons (and similar to whites), Indians residing in England had a lower prevalence of diabetes than those residing in the Netherlands; the prevalence ratio (PR) was 0.35 (95% confidence interval = 0.22 to 0.55) in women and 0.74 (0.50 to 1.10) in men after adjustment for other covariates. Among people of African descent as well, diabetes prevalence was lower in England than in the Netherlands; for women, PR = 0.43 (0.20 to 0.89) and for men, 0.57 (0.21 to 1.49). CONCLUSIONS: : The increasing prevalence of diabetes after migration may be modified by the context in which ethnic minority groups live.

Comparing methodologies for the allocation of overhead and capital costs to hospital services.

BACKGROUND: Typically, little consideration is given to the allocation of indirect costs (overheads and capital) to hospital services, compared to the allocation of direct costs. Weighted service allocation is believed to provide the most accurate indirect cost estimation, but the method is time consuming. OBJECTIVE: To determine whether hourly rate, inpatient day, and marginal mark-up allocation are reliable alternatives for weighted service allocation. METHODS: The cost approaches were compared independently for appendectomy, hip replacement, cataract, and stroke in representative general hospitals in The Netherlands for 2005. RESULTS: Hourly rate allocation and inpatient day allocation produce estimates that are not significantly different from weighted service allocation. CONCLUSIONS: Hourly rate allocation may be a strong alternative to weighted service allocation for hospital services with a relatively short inpatient stay. The use of inpatient day allocation would likely most closely reflect the indirect cost estimates obtained by the weighted service method.

Cost-Effectiveness of Ibrutinib Compared With Obinutuzumab With Chlorambucil in Untreated Chronic Lymphocytic Leukemia Patients With Comorbidities in the United Kingdom.

BACKGROUND: Ibrutinib shows superiority over obinutuzumab with chlorambucil (G-Clb) in untreated patients with chronic lymphocytic leukemia with comorbidities who cannot tolerate fludarabine-based therapy. However, ibrutinib is relatively more expensive than G-Clb. In this study we evaluated the cost-effectiveness of ibrutinib compared with G-Clb from the United Kingdom (UK) health care perspective. MATERIALS AND METHODS: A 3-state semi-Markov model was parameterized to estimate the lifetime costs and benefits associated with ibrutinib compared with G-Clb as first-line treatment. Idelalisib with rituximab was considered as second-line treatment. Unit costs were derived from standard sources, (dis)utilities from UK elicitation studies, progression-free survival, progression, and death from clinical trials, and postprogression survival and background mortality from published sources. Additional analyses included threshold analyses with ibrutinib and idelalisib at various discount rates, and scenario analysis with ibrutinib as second-line treatment after G-Clb. RESULTS: An average gain of 1.49 quality-adjusted life-years (QALYs) was estimated for ibrutinib compared with G-Clb at an average additional cost of £112,835 per patient. To be cost-effective as per the UK thresholds, ibrutinib needs to be discounted at 30%, 40%, and 50% if idelalisib is discounted at 0%, 25%, and 50% respectively. The incremental cost-effectiveness ratio was £75,648 and £-143,279 per QALY gained for the base-case and scenario analyses, respectively. Sensitivity analyses showed the robustness of the results. CONCLUSION: As per base-case analyses, an adequate discount on ibrutinib is required to make it cost-effective as per the UK thresholds. The scenario analysis substantiates ibrutinib's cost-savings for the UK National Health Services and advocates patient's access to ibrutinib in the UK.

The cost-effectiveness of blue-light therapy in the treatment of mild-to-moderate psoriasis.

AIM: To investigate the cost-effectiveness of blue-light therapy versus a two-compound formulation (TCF) (Dovobet® gel [calcipotriol and betamethasone]) in mild-to-moderate psoriasis. METHODS: A Markov model was applied to describe the course of disease among Dutch patients with a Psoriasis Area and Severity Index (PASI) score ≤ 10 over a 52-week time horizon. Patients received either 12-week blue-light therapy or two 4-week treatments with TCF. Patients, experiencing no PASI reduction after either therapy, were assumed to receive 12-week ultraviolet B phototherapy. RESULTS: There was no significant difference in PASI reduction between two interventions (71 vs 72%). However, blue-light therapy was associated with a cost savings of EU€248. CONCLUSION: Treatment of mild-to-moderate chronic plaque psoriasis using blue-light therapy may be more cost-effective than TCF.

Cost-effectiveness of prevention and treatment of the diabetic foot: a Markov analysis.

OBJECTIVE: To estimate the lifetime health and economic effects of optimal prevention and treatment of the diabetic foot according to international standards and to determine the cost-effectiveness of these interventions in the Netherlands. RESEARCH DESIGN AND METHODS: A risk-based Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with newly diagnosed type 2 diabetes managed with care according to guidelines for their lifetime. Mean survival time, quality of life, foot complications, and costs were the outcome measures assessed. Current care was the reference comparison. Data from Dutch studies on the epidemiology of diabetic foot disease, health care use, and costs, complemented with information from international studies, were used to feed the model. RESULTS: Compared with current care, guideline-based care resulted in improved life expectancy, gain of quality-adjusted life-years (QALYs), and reduced incidence of foot complications. The lifetime costs of management of the diabetic foot following guideline-based care resulted in a cost per QALY gained of < 25,000 US dollars, even for levels of preventive foot care as low as 10%. The cost-effectiveness varied sharply, depending on the level of foot ulcer reduction attained. CONCLUSIONS: Management of the diabetic foot according to guideline-based care improves survival, reduces diabetic foot complications, and is cost-effective and even cost saving compared with standard care.

A cross-national comparative study of blood pressure and hypertension between English and Dutch South-Asian- and African-origin populations: the role of national context.

BACKGROUND: We compare patterns of blood pressure (BP) and prevalence of hypertension between white-Dutch and their South-Asian and African minority groups with their corresponding white-English and their South-Asian and African ethnic minority groups; and the contribution of physical activity, body sizes, and socioeconomic position (SEP); and the quality of BP treatment that may underlie differences in mean BP. METHODS: Secondary analyses of population-based studies of 13,999 participants from the United Kingdom and the Netherlands. RESULTS: Compared with Dutch South-Asians, all English South-Asian men and women had lower BP and prevalence of hypertension except for systolic BP in English-Indian men. Among Africans, the systolic BP did not differ, but the diastolic BP levels were lower in English-Caribbean and English- (sub-Sahara) African men and women than in their Dutch-African counterparts. English-Caribbeans had a lower prevalence of hypertension than Dutch-Africans. Compared with white-Dutch, white-English men and women had higher systolic BP levels, but lower diastolic BP levels. There were no differences in the prevalence of hypertension between the white groups. Most differences remained unchanged after adjustment for SEP, lifestyle, and body sizes in all ethnic groups. BP control rates were substantially lower among Dutch-African and Dutch South-Asian hypertensives than among their English counterparts (except Indians). CONCLUSIONS: We found marked variations in BP and hypertension prevalence between comparable ethnic groups in England and the Netherlands. Poor BP control among Dutch South-Asians and Africans contributed to their disadvantage of the relatively high BP levels.