title: Cost of Stem Cell-Based Tissue-Engineered Airway Transplants in the United Kingdom: Case Series.
abstract: Stem cell-based tissue-engineered tracheas are at an early stage in their product development cycle. Tens of patients have been treated worldwide in predominantly compassionate use settings, demonstrating significant promise. This potentially life-saving treatment is complex, and the cost and its implications for such treatments are yet to be fully understood. The costs are compounded by varying strategies for graft preparation and transplant, resulting in differing clinical and laboratory costs from different research groups. In this study, we present a detailed breakdown of the clinical and manufacturing costs for three of the United Kingdom (UK) patients treated with such transplants. All three patients were treated under Compassionate Use legislation, within the UK National Health Service (NHS) hospital setting. The total costs for the three UK patients treated ranged from $174,420 to $740,500. All three patients were in a state of poor health at time of treatment and had a number of complexities in addition to the restricted airway. This is the first time a cost analysis has been made for a tissue-engineered organ and provides a benchmark for future studies, as well as comparative data for use in reimbursement considerations.
authors.affiliation: 1 London Regenerative Medicine Network , London, United Kingdom .
authors.forename: Emily J
authors.initials: EJ
authors.lastname: Culme-Seymour
authors.affiliation: 2 Centre for Cutaneous Research, Blizard Institute of Cell and Molecular Science , London, United Kingdom .
authors.forename: Katrina
authors.initials: K
authors.lastname: Mason
authors.affiliation: 3 Clinical Trials Unit, University College London , United Kingdom .
authors.forename: Laura
authors.initials: L
authors.lastname: Vallejo-Torres
authors.affiliation: 4 Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital , London, United Kingdom .
authors.forename: Carla
authors.initials: C
authors.lastname: Carvalho
authors.affiliation: 4 Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital , London, United Kingdom .
authors.forename: Leanne
authors.initials: L
authors.lastname: Partington
authors.affiliation: 5 Ear Institute, University College London , Royal National Throat Nose and Ear Hospital, London, United Kingdom .
authors.forename: Claire
authors.initials: C
authors.lastname: Crowley
authors.affiliation: 5 Ear Institute, University College London , Royal National Throat Nose and Ear Hospital, London, United Kingdom .
authors.forename: Nick J
authors.initials: NJ
authors.lastname: Hamilton
authors.affiliation: 6 Great Ormond Street Hospital , Cardiothoracic Surgery, and Tracheal Services, London, United Kingdom .
authors.forename: Ed C
authors.initials: EC
authors.lastname: Toll
authors.affiliation: 6 Great Ormond Street Hospital , Cardiothoracic Surgery, and Tracheal Services, London, United Kingdom .
authors.forename: Colin R
authors.initials: CR
authors.lastname: Butler
authors.affiliation: 6 Great Ormond Street Hospital , Cardiothoracic Surgery, and Tracheal Services, London, United Kingdom .
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Elliott
authors.affiliation: 5 Ear Institute, University College London , Royal National Throat Nose and Ear Hospital, London, United Kingdom .
authors.forename: Martin A
authors.initials: MA
authors.lastname: Birchall
authors.affiliation: 4 Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital , London, United Kingdom .
authors.forename: Mark W
authors.initials: MW
authors.lastname: Lowdell
authors.affiliation: 7 Advanced Centre for Biochemical Engineering, University College London , London, United Kingdom .
authors.forename: Chris
authors.initials: C
authors.lastname: Mason
mesh_terms: D001705:Bioprosthesis / Q000191:economics*; D016022:Case-Control Studies; D003365:Costs and Cost Analysis; D003695:Delivery of Health Care / Q000191:economics*; D005260:Female; D006801:Humans; D008297:Male; D023822:Tissue Engineering / Q000191:economics*; D014132:Trachea; D006113:United Kingdom