ISPOR Nutrition Economics Special Interest Group
Medical Nutrition – Terms, Definitions, Regulations & Emerging Good Practices
for Economic Evaluation Working Group

Medical Nutrition Terminology and Regulations in the US and European Union – A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group
Under review

Co-Chairs:
Karen Freijer, PhD
Nutritionist & Nutrition Economist,
School for Public Health and Primary Care (CAPHRI)
Maastricht University
Maastricht, The Netherlands
Sheri Volger, MS
Associate Director,
Clinical Development Immunology Gastroenterology
Janssen R&D
Spring House, PA, USA
Leadership Group:

Bhagwan Aggarwal, PhD, MSc, MPhil, MBA, Assistant Director, Indian Council of Medical Research (ICMR), Gandhinagar, India
Aurelie Danel, PharmD, Global Market Access & Health Economics, Nestle Health Science, Vevey, Switzerland
Silvia Evers, PhD, MSc, Professor, Maastricht University, Maastricht, The Netherlands
Scott Goates, PhD, MS, HEOR Manager, Abbott Nutrition, Columbus, OH, USA
Mickaël Hiligsmann, PhD, Assistant Professor, Department of Health Services Research of Maastricht University, The Netherlands
Suzanne Laplante, MSc, Director Health Economics, Baxter Healthcare Corporation, Deerfield, IL, USA 
Irene Lenoir-Wijnkoop, Senior Scientist Public Health Nutrition, Department of Pharmaceutical Sciences, Utrecht University, The Netherlands
Theresa Ofili, BS, PharmD, MPH, RN, Assistant Professor of Pharmacy Practice, Texas A&M HSC Irma Lerma Rangel College of Pharmacy, College Station, TX, USA
Jamie Partridge, PhD, MBA, BA, Director, Health Economics & Outcomes Research, Abbott Nutrition, Columbus, OH, USA
János G. Pitter, PhD, MD, Senior Researcher, Syreon Research Institute, Budapest, Hungary
Oznur Seyhun, MSc, BSc, MFE, Senior Market Access Manager, Abbott Nutrition, Istanbul, Turkey

Goal:

To define the terms used and provide a foundation for development of emerging good practices for the economic evaluation of medical nutrition products.

Background:

Medical nutrition comprises parenteral nutrition (regulated in pharmaceutical legislation), as well as all forms of enteral nutrition support that are regulated as "foods for special medical purposes" (FSMP), as defined by the European Commission Directive 1999/21/EC, independent of the route of application. Medical nutrition outcomes research includes clinical, economic, and health-related quality of life outcomes to assess the impact of medical nutrition products on patient health and disease.

Evidence on the use of medical nutrition for patients suffering from disease-related malnutrition (DRM) has demonstrated functional, as well as clinical, benefits. While cost-effectiveness analysis has become common practice for informing reimbursement decisions for pharmaceuticals, the use of health economic analyses for medical nutrition products is not yet common. Consequently, medical nutrition product interventions tend to be excluded in the current competitive health care funding as their value was previously unrecognized.

Nevertheless, evidence of the integral role of nutrition in disease progression, as well the onset and evolution of lifestyle-related disorders, has forced health care decision makers to realize the importance and impact of medical nutrition products. Consequently, economic evaluations of its effectiveness (i.e. cost effectiveness) have been conducted on an increasing basis.

The following article with illustrative figures and tables provides an excellent overview and introduction to the economic evaluation of medical nutrition.

Freijer K, Lenoir-Wijnkoop I, Russell CA, Koopmanschap MA, Kruizenga HM, Lhachimi SK, Norman K, Nuijten MJC, Schols JMGA. The view of European experts regarding health economics for medical nutrition in disease-related malnutrition. European Journal of Clinical Nutrition (2015); 69: 539-545. doi:10.1038/ejcn.2014.280. http://www.nature.com/ejcn/journal/v69/n5/full/ejcn2014280a.html

Outline

Activities

Nutrition Economics SIG Open Meeting
November 2017 – 20th Annual European Congress, Open Meeting, Glasgow, Scotland, UK

Medical Nutrition Terminology and Regulations in the US and Europe: A Scoping Review
May 2017 – 22nd Annual International Meeting, Poster Presentation, Boston, MA, USA
PHP190 (Health Care Use & Policy Studies - Health Care Research & Education )

The Do’s and Don’ts of Performing a Scoping Review
May 2016 – 21st Annual International Meeting, Forum Presentation, Washington, DC

Medical Nutrition – Terms, Definitions, Regulations & Emerging Good Practices for Economic Evaluation
November 9, 2015 – 18th Annual European Congress, Forum Presentation, Milan, Italy

Bibliography
Relevant publications on: nutrition economics, medical nutrition, cost of illness, etc.

Timeline:
Activity Date

Informal meeting at ISPOR European Congress Dublin to discuss potential Nutrition Economics Special Interest Group (NE SIG)

November 2013

Development of ISPOR NE SIG proposal & ISPOR CONNECTIONS article on nutrition economics

January – June, 2014

Nutrition economics article published in July-August issue of ISPOR CONNECTIONS

August 2014

ISPOR NE SIG launched

August 2014

Teleconference

September 2014

NE SIG meeting during ISPOR Amsterdam

Tuesday November 11, 2014

Outline development for ViH manuscript project

November 2014 - May 2015

NE SIG OPEN MEETING during ISPOR Philadelphia

Monday, May 19, 2015 

Comments on revised draft due

Wednesday, June 24, 2015

Revisions to outline and search strategy

End of June - mid July 2015

SIG meeting at ISPOR Milan: Search strategy reviewed and discussed

November 9 or 10, 2015

Assign sections of scoping review based on member preference (as much as possible)

November 25, 2015

Submission of completed assignment [review of titles and abstracts]

January 29, 2016

Co-chairs review completed assignments

January 30 - February 14, 2016

Teams download Full Articles from Included criteria list

February 15, 2016

Teams notify co-chairs of any Full Articles unable to download

February 22, 2016

Begin Full Article Review - record definitions and regulations found

March 22, 2016

SIG meeting at ISPOR Washington, DC

May 23-25, 2016

Formal outline developed and reviewed by leadership group

At ISPOR DC - May 2016

Scoping research completed

September 2016

SIG members review data analysis plan

October 2016

ISPOR Vienna Meeting

November 1, 2016

Data cleaning completed

November 2016

Conduct & finalize data analysis

December – January 2017

Authors develop sections of manuscript

December – May 2017

Draft reviewed by experts & leadership group

June 2017

Draft sent to NE SIG Review Group

Early July 2017

Revisions

July – August 2017

Revised draft sent to ISPOR NE SIG Review Group

Mid-July 2017

Comments received & discussed

Early August 2017

Revisions as per comments

August 2017

Co-authors sign-off on manuscript

Early September 2017

Final manuscript submitted to Value in Health

End of September 2017

Peer- review process at Value in Health

~ 8 weeks

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