title: Three-year cost-effectiveness model for non-animal stabilized hyaluronic acid and dextranomer copolymer compared with sacral nerve stimulation after conservative therapy for the management of fecal incontinence.
abstract: BACKGROUND
  Two new therapies for fecal incontinence (FI) are now available: non-animal stabilized hyaluronic acid and dextranomer copolymer (NASHA/Dx) and sacral nerve stimulation (SNS).
  
  
  OBJECTIVE
  This study aimed to determine the cost-effectiveness of NASHA/Dx compared with SNS and conservative therapy (CT) for the treatment of FI after CT failure.
  
  
  METHODS
  Decision tree models with Markov subbranches were developed to compare all direct costs and outcomes during a 3-year period from the viewpoint of the US third-party payer. Costs (in 2013 US dollars) of devices, medical and surgical care, and hospitalization were included. Outcomes included quality-adjusted life-years (QALYs) and incontinence-free days (IFDs). Both costs and outcomes were discounted at an annual rate of 3%. The incremental cost-effectiveness ratio was calculated for each outcome. One-way and probabilistic sensitivity analyses were performed to examine robustness of results and model stability. A budget impact analysis was also undertaken to estimate the potential cost and savings of NASHA/Dx for a payer with 1,000,000 covered lives.
  
  
  RESULTS
  For the 3-year cost-effectiveness models, the expected cost was $9053 for CT, $14,962 for NASHA/Dx, and $33,201 for SNS. The numbers of QALYs were 1.769, 1.929, and 2.004, respectively. The numbers of IFDs were 128.8, 267.6, and 514.8, respectively. The incremental cost-effectiveness ratios per additional IFD gained were $42.60 for NASHA/Dx vs CT, $73.76 for SNS vs NASHA/Dx, and $62.55 for SNS vs CT. The incremental costs per QALY gained were $37,036 for NASHA/Dx vs CT, $244,509 for SNS vs NASHA/Dx, and $103,066 for SNS vs CT. The budget impact analysis evaluated the financial effect on the health care system of the use of NASHA/Dx and SNS. For the scenarios evaluated, when all of the patients receive NASHA/Dx, the net annual effect to the health care payer budget ranged from $571,455 to $2,857,275. When all of the patients receive SNS, the net annual effect to the health care payer budget ranged from $1,959,323 to $9,796,613.
  
  
  CONCLUSIONS
  Both NASHA/Dx and SNS have produced significant improvements in FI symptoms for affected patients. NASHA/Dx is a cost-effective and more efficient use of resources for the treatment of FI when compared with SNS. The budget impact analysis suggests that although reimbursement for NASHA/Dx treatment initially adds costs to the health care system, it is significantly less expensive than SNS for patients who are candidates for either treatment.
authors.affiliation: Department of Surgery, New York University Langone Medical Center, New York, New York.
authors.forename: Mitchell A
authors.initials: MA
authors.lastname: Bernstein
authors.affiliation: AHRM Inc, Buffalo, New York.
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Purdy
authors.affiliation: AHRM Inc, Buffalo, New York.
authors.forename: Alison
authors.initials: A
authors.lastname: Becker
authors.affiliation: AHRM Inc, Buffalo, New York. Electronic address: rmagar@ahrminc.com.
authors.forename: Raf
authors.initials: R
authors.lastname: Magar
mesh_terms: D003362:Cost-Benefit Analysis; D003663:Decision Trees; D003911:Dextrans / Q000627:therapeutic use*; D019468:Disease Management; D005242:Fecal Incontinence / Q000191:economics / Q000628:therapy*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D011788:Quality of Life; D019057:Quality-Adjusted Life Years
chemical_list: D003911:Dextrans; C487487:dextranomer-hyaluronic acid copolymer; D006820:Hyaluronic Acid
keywords: InterStim; NASHA/Dx; Solesta; budget impact analysis; cost-effectiveness; fecal incontinence; incontinence-free days; incremental cost-effectiveness ratio; quality-adjusted life-years; sacral nerve stimulation