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1 Scalpel. Scissors. Fork? Abstract book There is a new way to help treat certain diseases: Personalised medical nutrition. Back in 1866, Henri Nestlé was already reducing infant mortality with his innovative baby formula. Today, we expand his vision by developing personalised nutritional solutions that aim to help change and slow the progression of many chronic diseases, alleviate the side effects of some medical treatments and prevent specific diseases. Nestlé Health Science is well-positioned to lead change in the new field of personalised nutrition.

2 Nestlé Health Science Symposium Sunday, 24th of June th HTAi Annual Meeting 2012, Bilbao Medical nutrition as a cost-effective pillar IN therapeutic interventions Health Technology Assessments (HTA) have rarely focused on including medical nutrition therapy (also known as food for special medical purpose, FSMP) as a comprehensive part of medical intervention, even though disease-related malnutrition is highly prevalent in healthcare settings. Indeed, malnutrition is often perceived to be an issue for developing countries during dramatic periods of starvation. It is also a scandalous, hidden and long lasting issue in developed countries. Malnutrition is highly prevalent in all healthcare settings, ranging from 15 to 90% depending on the age and pathologies of the patients in the community and in hospitals. Malnutrition not only increases patients risk of developing comorbidities and consequently, hospital length of stay, but it can also increase death toll. In 2007, malnutrition was shown to cost 120 million for the EU, of which 50% was incurred by hospitals. In the UK, disease-related malnutrition costs reached 15 billion in 2007, double the social costs of overweight and obesity. In 2005, the National Institute for Health and Clinical Evidence (NICE) developed guidelines for malnutrition screening and implementation of medical nutrition in hospitals and the community. In their costing report, the NICE demonstrated that introducing malnutrition screening and medical nutrition interventions in hospitals at a national level would cost 47.4 million ( 32.3 million) which would mainly support implementation expenses, but would help save 66.9 million ( 45.6 million), thus resulting in a net savings of 19.5 million ( 13.3 million) for the NHS. Despite these guidelines, malnutrition remains an issue for hospitals, as highlighted again by the BCC in 2011, when they reported that more patients were malnourished when discharged from hospitals compared to those admitted to hospitals. Many initiatives to prevent malnutrition and introduce medical nutrition care protocols exist at the European, National and hospital level. Indeed, medical nutrition interventions have already been demonstrated by using usual HTA methods to be effective and cost-saving options to curb postoperative complications and speed up patient recovery. The aim of this symposium is to raise awareness of medical nutrition in therapeutic interventions and to demonstrate that FSMPs bring value-for-money to healthcare systems. The inclusion of medical nutrition interventions in therapeutic healthcare protocols should be a focus of HTA, as medical nutrition interventions are considered a pillar in cost-effective therapeutic protocols.

3 Nestlé Health Science Symposium Sunday, 24th of June th HTAi Annual Meeting 2012, Bilbao Medical nutrition : a cost-effective pillar in therapeutic interventions Nestlé Health Science Free Symposium Topics & Speakers Medical nutrition : the European regulatory viewpoint Patrick Coppens Director International Food and Health Law and Scientific Affairs EAS Brussels President of the Belgian National Food and Health Plan Undernutrition Task Force Medical nutrition in therapeutic interventions in inpatient and outpatient care, Prof. Dr. Mercè Planas Vila, MD Intensivist & Nutritionist, Prof. of Facultat de Ciències de la Salut. Universitat de Vic. Barcelona, Spain. Vice-President of SENPE (Sociedad Española de Nutrición Parenteral y Enteral) Council member of ESPEN (European Society for Clinical Nutrition and Metabolism) A public health perspective on a cost-saving intervention Prof. Dr. Mark Nuijten, MD, PhD CEO of Ars Accessus Medica, the Netherlands Founder of Minerva International Health Economic Network. HTA of immunonutrition in the hospital setting Prof. Dr. Jean-Blaise Wasserfallen, MD, PhD Medical Director, Head of the Health Technology Assessment Department, University Hospital of Lausanne, Switzerland Sunday 24th OF June 13:30-17:00 Medical nutrition: The EU regulatory viewpoint Patrick Coppens Director International Food and Health Law and Scientific Affairs EAS Brussels President of the Belgian National Food and Health Plan Undernutrition Task Force Patients admitted to hospital often need specifically formulated foods (called FSMPs) for the dietary management of their medical conditions or diseases. This is most obvious for people with inborn errors of the metabolism who are unable to metabolise specific food components, such as amino acids. Dietary management is often not achievable with the normal diet or normal foods and specifically formulated foods devoid or well controlled for the nutrient concerned are required. Also other conditions may require the use of FMSPs or medical nutrition, including renal disease, liver disease, decubitus, etc to help manage the disease or improve the general condition and recovery of the patient. Malnourished people are another far more substantial group of people that benefit from the use of concentrated and specifically, formulated foods. The importance of malnutrition in the hospital setting has been well recognized and more recently the focus has also shifted to increased risks in home care and care home settings. This health care problem is estimated to be of equal proportion to obesity and it mostly affects elderly people. Social isolation, reduced appetite, underlying pathologies, difficulties to chew and swallow, budget and availability of food are all factors that contribute to decreased food intake with age and increased risk of malnutrition. Intervention with medical nutrition has shown to significantly reduce morbidity and mortality and increase quality of life. Nevertheless the rate of medical nutrition use differs between the Member States. Reasons include the differences in health care organisation, level of awareness for the problem and modalities for reimbursement. The European Union has been addressing the requirements for dietetic foods since the 1970s. Medical foods, or with its legal term Foods for Special Medical Purposes (FSMPs) have been recognized as a specific category of dietetic foods in 1989 and a specific legislation entered into force in 1999 (Directive 1999/21). The compositional criteria and requirements have been based on an opinion by the EU Scientific Committee on Food published in FSMPs are legally divided into three categories: Nutritionally complete foods, both standard and nutrient adapted to specific diseases and nutritionally incomplete foods. Compositional criteria also distinguish between infants and other age groups. A key characteristic is that the composition is allowed to deviate from the criteria when needed for the intended use of the product. This enables quick innovation and implementation of new scientific findings into products to the benefit of the patient. This is acceptable as the products mostly are used under medical supervision. The legislation on dietetic foods is currently under revision and also the FSMP legislation will be reviewed. Despite the long experience and the good reputation of the companies involved, rules may become more strict and may even involve pre-marketing approval, as is the case with health claims. The consequences this could have for innovation in this area will have to be considered in detail.

4 Medical nutrition in therapeutic interventions: medical benefits for inpatients and outpatients Prof. Dr. Mercè Planas Vila, MD Medical nutrition: a public health perspective Prof. Dr. Mark Nuijten, MD, PhD Intensivist & Nutritionist, Prof. of Facultat de Ciències de la Salut. Universitat de Vic. Barcelona, Spain. Vice-President of SENPE (Sociedad Española de Nutrición Parenteral y Enteral) Council member of ESPEN (European Society for Clinical Nutrition and Metabolism) President of the ESPEN 2012 Congress Medical nutrition also is indicated for inborn errors of metabolism, such as phenylketonuria. It can also be prescribed by physicians in case of reduced food intake, difficulty in eating, swallowing, in digesting or in absorbing food such as during enteritis radiation a complication of radiation therapy in gastrointestinal cancer. It is also widely used in disease-related malnutrition (DRM). Indeed, it has been acknowledge by clinical nutrition guidelines that DRM can lead to starvation in patients, and increases the risk of mortality and morbidity. DRM can result from anorexia nervosa, cancer or chronic obstructive pulmonary disease, or acute injury such as burns and trauma, among others. Malnutrition can also be caused by the lack of information and sensitivity of health professionals when facing DRM. In order to better sensitize healthcare professionals, three scientific societies (European Society for Clinical Nutrition and Metabolism (ESPEN), the Austrian Society for Clinical Nutrition (AKE) and the Medical University of Vienna (MUW)) have set up the NutritionDay initiative ( ). This coordinated action aims at improving the screening and diagnostic of malnutrition in hospitalized patients worldwide. Indeed, from this survey on malnutrition, mortality has been shown to be up to 8 times higher and dependency at discharge up to 3 times more frequent in malnourished patients. In Spain, the PREDYCES study has also assessed the prevalence of hospital malnutrition and its associated costs in Spain, in 31 hospitals. Among the 1,597 patients screened, malnutrition was more prevalent in cancer patients (35%), in patients with respiratory system diseases (29%) and with circulatory system diseases (28%). In addition, the prevalence of malnutrition was much higher in the older hospitalized patients (37% above 70 years vs. 12.3% below 70 years). More patients were malnourished at hospitals discharge than at their admission (respectively 15% vs. 9.5%) with a higher cost of hospital stay in patients discharged malnourished ( 12,000 vs ). Most of the disease-related malnutrition can be treated thanks to FSMPs or usual food (dietary fortification, snacks and dietary advices). Indeed, many guidelines exist recommending enteral or oral nutrition feeding for patients with diseases at risk of DRM, such as Crohn s disease (2006, ESPEN guidelines), geriatric patients (2006, ESPEN guidelines). In a Cochrane meta-analysis (Cawood et al, 2012) of randomized clinical trials, the rate of complications was significantly lower in elderly taking high protein oral nutrition supplement after a hip fracture. CEO of Ars Accessus Medica, the Netherlands Founder of Minerva International Health Economic Network. Malnutrition is a prevalent public health problem, which is known for many years. Due to lack of adequate nutrition, acute or chronic diseases and/or treatment interventions, an individual may move from a good nutritional status to malnutrition also known as Disease Related Malnutrition (DRM). DRM is highly prevalent in the European healthcare system. An estimated 33 million people are at risk of malnutrition in Europe resulting in an estimated extra costs of 170 billion. DRM affects many people across all healthcare settings, from older people living in the community to patients in the hospital with specific conditions. Large-scale studies show that about 25% of patients in hospital are malnourished or at risk of DRM. Up to 90% of residents in care homes and 13%-30% at home are at risk of DRM. Malnutrition is common across a variety of patient and age groups, but older people are particularly at risk and with an ageing population malnutrition continues to be a major public health concern. The clinical consequences of DRM, if left untreated, are serious leading to increased complication rates, severe morbidity, mortality, hospital readmissions and increased length of hospital stay. These consequences result in an increased use of scarce healthcare resources (physicians visits, length of stay in hospitals, extra costs in care homes etc.) and also increased indirect costs due to lost productivity. Studies on treatment of DRM with medical nutrition show a reduction in the clinical consequences of DRM (reduction in mortality and complications and an increase of Quality of Life). As a consequence the appropriate use of DRM can lead to potential cost savings as a result of reduced healthcare use in both the hospital and the community setting. A Dutch health economic analysis showed that an annual cost saving of 40.4 million could be achieved only in the hospital setting in The Netherlands. In summary, DRM has a high prevalence and its clinical consequences may be severe and costly. Consequently inappropriate management of DRM may have a high economic impact. The benefits of medical nutrition are recognized by health authorities in Spain, which have been reimbursing them until now. Thus knowing the benefit of such cheap intervention (few Euros per intake), more focus should be given by healthcare professionals on nutritional status of patients in their therapeutic management, as well as by health authorities to better spend their cents.

5 HTA of immunonutrition in the hospital setting Prof. Jean-Blaise Wasserfallen, MD MPP Notes Medical Director and Head of Health Technology Assessment Unit University Hospital of Lausanne (CHUV), Switzerland Immunonutrition is defined as a special type of nutrient with immunomodulating properties. It presents in different formulas with different physiologic actions. As early initiation of enteral nutrition decreases infectious complications and hospital length of stay (LOS) and as early nutritional deficit causes alteration of the immune system, immunonutrition might lead to a further decrease in infectious complication and LOS. Available evidence of efficacy stems from a systematic review in high risk surgical patients, a meta-analysis in gastro-intestinal surgery and a systematic review of peri-operative use of arginine. These studies showed no impact on mortality, but a positive impact on reduction of post-operative infections rates (odds ratio ranging from 0.47 to 0.59) and LOS reductions ranging from to 2 to 3 days per patient. Cost-effectiveness data were derived from these studies, using either US or Swiss cost data. They showed net cost savings per patient ranging between US$ 300 and and CHF to 3 000, depending on the type of patient and the basal infection rate. As a consequence, immunonutrition can be considered as a health care technology as all others, assessed with similar techniques, and integrated into a global hospital strategy aiming at increasing efficiency of care while decreasing its costs.

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