Are We Ready for a New Approach to Comparing Coverage and Reimbursement Policies for Medical Nutrition in Key Markets: An ISPOR Special Interest Group Report.

OBJECTIVES: Healthcare policy makers should ensure optimal patient access to medical nutrition (MN) as part of the management of nutrition-related disorders and conditions. Questions remain whether current healthcare policies reflect the clinical and economic benefits of MN. The objective of this article is to characterize coverage and reimbursement of MN, defined as food for special medical purposes/medical food for a diverse set of countries, including Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Italy, Japan, The Netherlands, Singapore, Spain, United Kingdom, and United States. METHODS: Data sources included published literature and online sources. ISPOR's Nutrition Economics Special Interest Group developed a data collection form to guide data extraction that included reimbursement coverage, years that reimbursement policies were established, and presence of a formal health technology assessment (HTA) for MN technologies. RESULTS: Reimbursement coverage of MN technologies varied across the countries that were reviewed. All but 3 countries limited coverage to specific formulations of products, regardless of demonstrated clinical benefit. The year that reimbursement policies were established varied across countries (ranging from 1984 to 2017), and only 4 countries regularly update policies. France and Brazil are the only countries with a formal HTA process for MN technologies. CONCLUSIONS: Most countries have limited MN reimbursement, have not updated reimbursement policies, and lack HTA for MN technologies. These limitations may lead to suboptimal access to MN technologies where they are indicated to manage nutrition-related disorders and conditions, with the potential of negatively affecting patient and healthcare system outcomes.

Medical Nutrition Terminology and Regulations in the United States and Europe-A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group.

BACKGROUND: The term medical nutrition (MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN. OBJECTIVES: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued. METHODS: ISPOR's Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion. RESULTS: Of the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed. CONCLUSIONS: MN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.

The costs of disease related malnutrition in hospitalized children.

INTRODUCTION: Disease related malnutrition (DRM) is a serious medical condition which is associated with an increase in morbidity and mortality, augmenting resource use and associated costs. DRM can be detected by actively and fully assessing the nutritional status. Studies in adult malnourished patients have shown that the additional health care costs are about € 2 billion (€ 2000 million) per year. The objective of the current study was to estimate the annual additional costs of DRM for pediatric patients as was done for adults. METHODS: A cost-of-illness analysis was performed to calculate the annual additional costs of DRM in 2015 pediatric patients (aged 1 month up to and including 17 years) admitted to non-academic hospitals in The Netherlands. DRM was assessed with weight-for-age, weight-for-height and height-for-age. Input variables in the formula used were length of stay and prevalence of DRM. The costs were estimated per disease as classified in the International Classification of Diseases by the WHO (ICD-10), per gender and age group. The results were expressed as an absolute monetary value as well as a percentage of the Dutch national health expenditure. Robustness of the results was checked by a sensitivity analysis. RESULTS: The total additional direct medical costs of DRM in pediatric patients in 2013 were estimated to be € 51 million for acute malnutrition, € 46 million when focused on chronic malnutrition and € 80 million in case of overall malnourished children. This equals 5.6% of the total Dutch hospital costs for these hospitalized children. CONCLUSIONS: This study has shown that DRM in hospitalized children is associated with an increase in annual hospital costs with an additional amount of € 80 million, of which acute malnutrition account for the largest part.

Selected nutrients and their implications for health and disease across the lifespan: a roadmap.

Worldwide approximately two billion people have a diet insufficient in micronutrients. Even in the developed world, an increasing number of people consume nutrient-poor food on a regular basis. Recent surveys in Western countries consistently indicate inadequate intake of nutrients such as vitamins and minerals, compared to recommendations. The International Osteoporosis Foundation's (IOF) latest figures show that globally about 88% of the population does not have an optimal vitamin D status. The Lancet's "Global Burden of Disease Study 2010" demonstrates a continued growth in life expectancy for populations around the world; however, the last decade of life is often disabled by the burden of partly preventable health issues. Compelling evidence suggests that improving nutrition protects health, prevents disability, boosts economic productivity and saves lives. Investments to improve nutrition make a positive contribution to long-term national and global health, economic productivity and stability, and societal resilience.

The economic value of enteral medical nutrition in the management of disease-related malnutrition: a systematic review.

Economic evaluations for medical nutrition, such as oral nutritional supplements (ONS), are relatively uncommon compared with other health technologies, and represent an area that has not been reviewed so far. In this systematic review, economic evaluations of enteral medical nutrition in the management of disease-related malnutrition (DRM) were reviewed and qualified to estimate the economic value. Initially, 481 studies were found, of which 37 full-text articles were assessed for eligibility and were rated on their quality using the Quality of Health Economic Studies (QHES) instrument. The final review focused on the high QHES quality economic evaluation studies. As both the studied medical nutrition intervention and the form of the economic evaluation varied, a quantitative synthesis (meta-analysis) was not attempted but a critical analysis and comparison of the individual study results were performed. ONS was the most studied intervention, covering several patient populations and different health care settings. Outcomes included cost savings (n = 3), no significant extra costs per unit of clinical and/or functional improvement (n = 1), or significantly higher costs per unit of clinical and/or functional improvement but still cost-effective for the used threshold (n = 4). This review shows that the use of enteral medical nutrition in the management of DRM can be efficient from a health economic perspective.

The economic costs of disease related malnutrition.

BACKGROUND & AIMS: Disease related malnutrition (under-nutrition caused by illness) is a worldwide problem in all health care settings with potentially serious consequences on a physical as well as a psycho-social level. In the European Union countries about 20 million patients are affected by disease related malnutrition, costing EU governments up to € 120 billion annually. The aim of this study is to calculate the total additional costs of disease related malnutrition in The Netherlands. METHODS: A cost-of-illness analysis was used to calculate the additional total costs of disease related malnutrition in adults (>18 years of age) for The Netherlands in 2011 in the hospital, nursing- and residential home and home care setting, expressed as an absolute monetary value as well as a percentage of the total Dutch national health expenditure and as a percentage of the total costs of the studied health care sectors in The Netherlands. RESULTS: The total additional costs of managing adult patients with disease related malnutrition were estimated to be € 1.9 billion in 2011 which equals 2.1% of the total Dutch national health expenditure and 4.9% of the total costs of the health care sectors analyzed in this study. CONCLUSIONS: The results of this study show that the additional costs of disease related malnutrition in adults in The Netherlands are considerable.

The budget impact of oral nutritional supplements for disease related malnutrition in elderly in the community setting.

A health economic analysis was performed to assess the economic impact on the national health care budget of using oral nutritional supplements (ONS), being a food for special medical purposes also known as medical nutrition, for the treatment of disease related malnutrition (DRM) in the community in the Netherlands. An economic model was developed to calculate the budget impact of using ONS in community dwelling elderly (>5 years) with DRM in the Netherlands. The model reflects the costs of DRM and the cost reductions resulting from improvement in DRM due to treatment with ONS. Using ONS for the treatment of DRM in community dwelling elderly, leads to a total annual cost savings of € 13 million (18.9% savings), when all eligible patients are treated. The additional costs of ONS (€ 57 million) are more than balanced by a reduction of other health care costs, e.g., re-/hospitalization (€ 70 million). Sensitivity analyses were performed on all parameters, including duration of treatment with ONS and the prevalence of DRM. This budget impact analysis shows that the use of ONS for treatment of DRM in elderly patients in the community may lead to cost savings in the Netherlands.