title: Is dibotermin alfa a cost-effective substitute for autologous iliac crest bone graft in single level lumbar interbody spine fusion?
abstract: OBJECTIVE
  To evaluate the cost-effectiveness of dibotermin alfa compared with autologous iliac crest bone graft (ICBG) for patients undergoing single level lumbar interbody spinal fusion in a UK hospital setting.
  
  
  METHODS
  An individual patient data (IPD) meta-analysis of six randomized controlled clinical trials and two single arm trials compared dibotermin alfa on an absorbable collagen implantation matrix (ACIM) (n = 456) and ICBG (n = 244) on resource use, re-operation rates, and SF-6D (Short form 6-dimension) health utility (total N = 700). Failure-related second surgery, operating time, post-operative hospital stay, and quality-adjusted life years (QALYs) derived from the IPD meta-analysis were included as inputs in an economic evaluation undertaken to assess the cost-effectiveness of dibotermin alfa/ACIM versus ICBG for patients undergoing single level lumbar interbody spinal fusion. A four year time horizon and the United Kingdom (UK) National Health Service (NHS) and Personal Social Services (PSS) perspective was adopted in the base case, with sensitivity analyses performed to gauge parameter uncertainty.
  
  
  RESULTS
  In the base case analysis, patients treated using dibotermin alfa/ACIM (12 mg pack) accrued 0.055 incremental QALYs at an incremental cost of £ 737, compared with patients treated with ICBG. This resulted in an incremental cost-effectiveness ratio (ICER) of £ 13,523, indicating that at a willingness-to-pay threshold of £ 20,000, dibotermin alfa/ACIM is a cost-effective intervention relative to ICBG from the NHS and PSS perspective.
  
  
  CONCLUSIONS
  In a UK hospital setting, dibotermin alfa/ACIM is a cost-effective substitute for ICBG for patients who require lumbar interbody arthrodesis.
authors.affiliation: a a Mapi , Stockholm , Sweden.|b b Karolinska University Hospital, Department of Medicine , Stockholm , Sweden.
authors.forename: Axel
authors.initials: A
authors.lastname: Svedbom
authors.affiliation: a a Mapi , Stockholm , Sweden.
authors.forename: Daniel
authors.initials: D
authors.lastname: Paech
authors.affiliation: c c Medtronic Ltd , Watford , UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Leonard
authors.affiliation: d d Medtronic BioPharma BV , Heerlen , Netherlands.
authors.forename: David
authors.initials: D
authors.lastname: Donnell
authors.affiliation: e e Norwich Medical School, University of East Anglia , Norwich , Norfolk , UK.
authors.forename: Fujian
authors.initials: F
authors.lastname: Song
authors.affiliation: f f Nottingham University Hospital, Centre for Spinal Studies and Surgery , Nottingham , UK.
authors.forename: Bronek
authors.initials: B
authors.lastname: Boszcyk
authors.affiliation: g g Oxford University Hospitals NHS Trust and Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford , Oxford , UK.
authors.forename: Dominique A
authors.initials: DA
authors.lastname: Rothenfluh
authors.affiliation: h h Bladon Associates Ltd , Oxford , UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Lloyd
authors.affiliation: i i Medtronic International Trading SARL , Tolochenaz , Switzerland.
authors.forename: Benny
authors.initials: B
authors.lastname: Borgman
mesh_terms: D055396:Bone Morphogenetic Protein 2 / Q000008:administration & dosage*; D016025:Bone Transplantation / Q000379:methods*; D003094:Collagen / Q000378:metabolism; D003362:Cost-Benefit Analysis; D006801:Humans; D007085:Ilium; D007902:Length of Stay / Q000191:economics; D008159:Lumbar Vertebrae; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage; D013123:Spinal Fusion / Q000379:methods*; D016212:Transforming Growth Factor beta / Q000008:administration & dosage*; D014182:Transplantation, Autologous; D006113:United Kingdom
chemical_list: D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2; D003094:Collagen
keywords: Autograft; Bone morphogenetic protein-2; Health utility; ICBG; Lumbar arthrodesis; Spinal fusion; rhBMP-2