title: Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial.
abstract: Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomized controlled trial (RCT).
  
  
  
  To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG.
  
  
  
  Quality of life (QoL, EuroQoL five dimensions three level questionnaire, EQ-5D-3L) and resource data were collected as part of the STOP GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and quality-adjusted life years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective.
  
  
  
  In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs [net cost: -£1160; 95% confidence interval (CI) -2991 to 672] and improvement in QoL (net QALYs: 0·055; 95% CI 0·018-0·093). However, this finding appears driven by a minority of patients with large lesions (≥ 20 cm2) (net cost: -£5310; 95% CI -9729 to -891; net QALYs: 0·077; 95% CI 0·004-0·151). The incremental cost-effectiveness of ciclosporin for the majority of patients with smaller lesions was £23 374/QALY, although the estimate is imprecise: the probability of being cost-effective at a willingness-to-pay of £20 000/QALY was 43%.
  
  
  
  Consistent with the clinical findings of the STOP GAP trial, patients with small lesions should receive treatment guided by the side-effect profiles of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, ciclosporin-initiated treatment may be more cost-effective for patients with large lesions.
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, CV4 7AL, U.K.
authors.forename: J M
authors.identifier: 0000-0001-9210-4082
authors.initials: JM
authors.lastname: Mason
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, NG7 2NR, U.K.
authors.forename: K S
authors.identifier: 0000-0001-7785-7465
authors.initials: KS
authors.lastname: Thomas
authors.affiliation: Division of Applied Medicine, Aberdeen University, Aberdeen, AB24 2ZD, U.K.
authors.forename: A D
authors.initials: AD
authors.lastname: Ormerod
authors.affiliation: Department of Dermatology, NHS Forth Valley, Stirling, FK8 2AU, U.K.
authors.forename: F E
authors.initials: FE
authors.lastname: Craig
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2UH, U.K.
authors.forename: E
authors.initials: E
authors.lastname: Mitchell
authors.affiliation: Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, EH16 4TU, U.K.
authors.forename: J
authors.initials: J
authors.lastname: Norrie
authors.affiliation: Centre of Evidence Based Dermatology, University of Nottingham, NG7 2NR, U.K.
authors.forename: H C
authors.initials: HC
authors.lastname: Williams
mesh_terms: D003362:Cost-Benefit Analysis; D016572:Cyclosporine / Q000191:economics*; D003879:Dermatologic Agents / Q000191:economics* / Q000627:therapeutic use; D000078336:Facilities and Services Utilization; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006304:Health Status; D006801:Humans; D011239:Prednisolone / Q000191:economics* / Q000627:therapeutic use; D017511:Pyoderma Gangrenosum / Q000188:drug therapy / Q000191:economics*; D019057:Quality-Adjusted Life Years; D016037:Single-Blind Method; D013222:State Medicine / Q000191:economics; D006113:United Kingdom
chemical_list: D003879:Dermatologic Agents; D016572:Cyclosporine; D011239:Prednisolone