title: Economic evaluation of everolimus and mycophenolate mofetil versus azathioprine in de novo heart transplantation.
abstract: Both the proliferation signal inhibitor everolimus (1.5 mg/day) and mycophenolate mofetil (MMF) (3 g/day) have shown superior efficacy versus azathioprine in de novo heart transplantation. The cost-effectiveness of everolimus and MMF versus azathioprine was assessed to 6 months posttransplantation.
  
  
  METHODS
  The evaluation was performed from the German health insurance payer perspective. The composite efficacy endpoint in the everolimus trial was death, graft loss/retransplantation, biopsy-proven acute rejection (BPAR) grade>or=3A, rejection with hemodynamic compromise, and loss to follow-up. The composite endpoint in the MMF trial included only death, retransplantation, and BPAR with hemodynamic compromise. To mimic the everolimus endpoint, an estimated number of patients with BPAR>or=3A was added to the MMF trial results, using two mapping scenarios.
  
  
  RESULTS
  The incremental 6-month cost versus azathioprine was euro2535 for everolimus and euro3007 for MMF. The absolute reduction in efficacy failure versus azathioprine was 10.4% for everolimus and 9.8% and 10.1% for MMF, respectively, using scenarios 1 and 2. The incremental cost per efficacy failure avoided (ie, the incremental cost versus azathioprine divided by the reduction in efficacy failure) was euro24,457 for everolimus, and euro30,628 and euro29,912 for MMF in scenarios 1 and 2.
  
  
  CONCLUSIONS
  This analysis, based on findings from two clinical trials, suggested that everolimus was more cost-effective than MMF versus azathioprine in the first 6 months after heart transplantation. Data from a head-to-head trial are required to confirm these results.
authors: Ghent University, Ghent, Belgium. lieven.annemans@ugent.be
authors: L
authors: L
authors: Annemans
authors: H
authors: H
authors: Lemkuhl
authors: G
authors: G
authors: Tenderich
authors: U
authors: U
authors: Schulz
authors: X L
authors: XL
authors: Yang
authors: J F
authors: JF
authors: Ricci
authors: R
authors: R
authors: Hetzer
mesh_terms: D000208:Acute Disease; D000328:Adult; D001379:Azathioprine / Q000191:economics / Q000627:therapeutic use; D001530:Belgium; D002311:Cardiomyopathy, Dilated / Q000601:surgery; D003327:Coronary Disease / Q000601:surgery; D017281:Cost of Illness; D004311:Double-Blind Method; D000068338:Everolimus; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D016027:Heart Transplantation / Q000191:economics / Q000276:immunology* / Q000401:mortality; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D016019:Survival Analysis; D017211:Treatment Failure
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D009173:Mycophenolic Acid; D001379:Azathioprine; D020123:Sirolimus