title: Assessing the cost-effectiveness of biologic agents for the management of moderate-to-severe rheumatoid arthritis in anti-TNF inadequate responders in Italy: a modelling approach.
abstract: OBJECTIVE
  The objective of this study is to assess cost-effectiveness of different biologic strategies in patients with moderate-to-severe active RA after an insufficient response to anti-TNF agents within the context of the Italian healthcare system.
  
  
  METHODS
  Simulation models were developed allowing for potential biologic therapy switch at each 6-month time point in case of an insufficient response to the previous biologic agent. Biologic treatments included etanercept, abatacept, adalimumab, rituximab or infliximab. Effectiveness criteria for these models were defined as achieving a state of low disease activity (LDAS) [DAS28 ≤3.2] or remission (RS) [DAS28<2.6]. Monte-Carlo simulations were performed for each sequence to manage data variability.
  
  
  RESULTS
  The biologic treatment sequence using abatacept after an insufficient response to a first anti-TNF agent appeared significantly more efficacious over 2 years (102 days in LDAS) compared to rituximab (82 days in LDAS). The sequence using abatacept after 2 anti-TNF agents appeared significantly more efficacious (63 days in LDAS) compared to using a third anti-TNF agent (32 days in LDAS). Mean cost-effectiveness ratios showed significantly lower costs per day in LDAS with abatacept used after one anti-TNF agent (€376) compared to rituximab (€456). The sequence using abatacept after 2 anti-TNF agents was also more cost-effective (€642 per day in LDAS) versus a sequential use of anti-TNF therapies (€1164 per day in LDAS). All comparisons were confirmed when using the remission effectiveness criteria.
  
  
  CONCLUSIONS
  The results of this health economics modelling study suggest that the biologic treatment sequence using abatacept after an insufficient response to a first anti-TNF agent appears significantly more effective and cost-effective versus a similar sequence using rituximab for achieving remission or LDAS. The results also indicate that in the case of an insufficient reponse to 2 anti-TNF agents, abatacept appears more effective and cost-effective than using a 3rd anti-TNF agent.
authors.affiliation: Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: M A
authors.initials: MA
authors.lastname: Cimmino
authors.forename: G
authors.initials: G
authors.lastname: Leardini
authors.forename: F
authors.initials: F
authors.lastname: Salaffi
authors.forename: M
authors.initials: M
authors.lastname: Intorcia
authors.forename: A
authors.initials: A
authors.lastname: Bellatreccia
authors.forename: D
authors.initials: D
authors.lastname: Dupont
authors.forename: A
authors.initials: A
authors.lastname: Beresniak
mesh_terms: D018501:Antirheumatic Agents / Q000191:economics* / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000276:immunology; D001688:Biological Products / Q000191:economics* / Q000627:therapeutic use*; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D057915:Drug Substitution / Q000191:economics; D006302:Health Services Research; D006801:Humans; D007558:Italy; D018803:Models, Economic; D009010:Monte Carlo Method; D009313:National Health Programs / Q000191:economics; D010043:Outcome and Process Assessment, Health Care / Q000191:economics*; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D017211:Treatment Failure; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha