Stanisław Klek1, Marek Kunecki2, Jacek Sobocki3, Konrad Matysiak4, Katarzyna Karwowska4, Krystyna Urbanowicz5. 1. General and Oncology Surgery Unit, Intestinal Failure Center, Stanley Dudrick's Memorial Hospital, Skawina, Poland. Electronic address: Klek@poczta.onet.pl. 2. Clinical Nutrition Department, M. Pirogow Hospital, Lodz, Poland. 3. Department of General Surgery and Clinical Nutrition Medical University of Warsaw, Poland. 4. Centre for Intestinal Failure, Department of General, Endocrinology and Gastroenterological Surgery, Poznan University of Medical Science, Poznan, Poland. 5. The Regional Specialist Hospital in Olsztyn, Center for Clinical Nutrition, Olsztyn, Poland.
Abstract
OBJECTIVE: Teduglutide is an active, glucagon-like peptide (GLP)-2 analog with proven clinical efficacy regarding intestinal adaptation in patients with short bowel syndrome (SBS). There are two factors that preclude its reimbursement, and thereby, its availability: its cost (reaching ∼$300,000/y)-which significantly exceeds the cost of home parenteral nutrition (HPN) in most countries-and the lack of clear guidelines. The aim of this study was to create evidence-based working criteria for the use of teduglutide that could be used in clinical settings. METHODS: Experts from the Polish Network of Intestinal Failure Centers analyzed available research and considered experience on the topic of HPN and intestinal failure to create guidelines. RESULTS: Experts agreed that there are two groups of HPN patients who can benefit from therapy with a GLP-2 analog: those with a good prognosis (in whom complete weaning from HPN may be possible) and those with a poor prognosis (the therapy would be lifesaving). Patient criteria comprise the following: inclusion and exclusion criteria, parameters that can be used for monitoring, outcome measures, and the rationale for the termination of the treatment. CONCLUSIONS: It was possible to describe inclusion criteria for both patient groups that justify the use of teduglutide from medical and economic perspectives.
OBJECTIVE:Teduglutide is an active, glucagon-like peptide (GLP)-2 analog with proven clinical efficacy regarding intestinal adaptation in patients with short bowel syndrome (SBS). There are two factors that preclude its reimbursement, and thereby, its availability: its cost (reaching ∼$300,000/y)-which significantly exceeds the cost of home parenteral nutrition (HPN) in most countries-and the lack of clear guidelines. The aim of this study was to create evidence-based working criteria for the use of teduglutide that could be used in clinical settings. METHODS: Experts from the Polish Network of Intestinal Failure Centers analyzed available research and considered experience on the topic of HPN and intestinal failure to create guidelines. RESULTS: Experts agreed that there are two groups of HPN patients who can benefit from therapy with a GLP-2 analog: those with a good prognosis (in whom complete weaning from HPN may be possible) and those with a poor prognosis (the therapy would be lifesaving). Patient criteria comprise the following: inclusion and exclusion criteria, parameters that can be used for monitoring, outcome measures, and the rationale for the termination of the treatment. CONCLUSIONS: It was possible to describe inclusion criteria for both patient groups that justify the use of teduglutide from medical and economic perspectives.