MARKET ACCESS PATHWAY FOR MEDICAL NUTRITION IN EUROPE AND THE US

Author(s)

Chevrou Séverac H1, Droeschel D2, Walzer S2
1Takeda Pharmaceuticals International, Zurich, Switzerland, 2MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany

OBJECTIVES This analysis aims at presenting different market access pathways of Medical Nutrition (MN) products in the US, France, Germany and the UK. METHODS Systematic review of submission processes for MN and food for special medical purpose (FSMP), combined with experience of the authors from previous research on health economics, Market Access and reimbursement. RESULTS When considering MN delivered in the ambulatory care setting, only in France, innovative MN presenting with therapeutic value faces the medical device reimbursement process. In the UK, the process is handled by the ACBS and focus mainly on clinical outcome and safety; additionally this process sets a reimbursed price. In the US and Germany, there are reimbursed categories for MN linked to composition of the product and dedicated to patients with inability to have their nutritional needs covered by normal food intake (set by CMS in the US and G-BA in Germany). Creating new reimbursed categories linked to new MN either bringing innovative therapeutic value or targeting new disease area is highly difficult in all countries. For MN delivered in hospital settings, products delivered enterally or orally are mainly covered by hospital budget. The budget can be either from the hospital’s kitchen for thickened and thickening products, under the diagnosis-related group funding scheme related to each countries, by the nutritionist budget (mainly UK and US) or by the hospital’s pharmacy budget for specialties. For standard products, access is obtained based on tenders. In long-term care and nursing home, coverage and funding are more heterogeneous: they vary from highly regulated reimbursed scheme based on composition of the products and disease area to per diem fee per patient covering both food and MN. CONCLUSIONS The market access pathways for granting reimbursement or coverage of the medical nutrition category are very heterogeneous between the analyzed countries.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP146

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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