title: The Pharmacoeconomic Evaluation Process in Ireland.
abstract: In Ireland, all new drugs are considered for a formal pharmacoeconomic evaluation (PE) prior to a reimbursement decision. All evaluations are conducted by the National Centre for Pharmacoeconomics (NCPE). The objectives of this study were to describe the evaluation process and to examine the movement of drugs through the process.
  
  
  
  The movement of all drugs submitted to the NCPE (from January 2010 to December 2015 inclusive) was investigated.
  
  
  
  A total of 230 Rapid Review submissions (each pertaining to one drug for one indication) were made. The Rapid Review process determines the requirement for a full PE. A full PE was deemed unnecessary in 108 cases (47 %). A positive reimbursement recommendation was made in 100 of these (a price reductions was advised in 25 cases and a recommendation to restrict/monitor usage was made in 35). The requirement for a full PE was recognised in 122 cases (53 %). In 12, subsequent payer-led price negotiations negated the requirement for a full PE, and reimbursement was recommended. In 24 cases, a timely full submission was not made; cost effectiveness could not be established. Fifteen interventions are currently going through the submission process. To date, 71 full PEs have been completed by the NCPE. Reimbursement was recommended in 19 and was not recommended in eight. Reimbursement was not recommended 'at the submitted price' in 44. Of these, reimbursement was subsequently approved in 34 (77 %) following price negotiations. To date, negotiations are on-going in a further six cases. In all, negotiations have been informed by the NCPE. A negative recommendation was reached in the remaining four.
  
  
  
  Over the study period, the NCPE evaluated 230 drugs for which reimbursement was sought. In total, a positive reimbursement recommendation has been made in 165 cases (72 % of all drugs submitted, or 79 % when drugs currently undergoing the process are excluded). A price reduction was deemed necessary in 71 (43 %) of the 165 cases, and a recommendation to restrict/monitor usage was made in 35 cases (21 %).
authors.affiliation: Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, Trinity College Dublin, St James's University Teaching Hospital, Dublin 8, Ireland. mcculllm@tcd.ie.|National Centre for Pharmacoeconomics, St James's University Teaching Hospital, Dublin 8, Ireland. mcculllm@tcd.ie.
authors.forename: Laura
authors.identifier: 0000-0001-8342-8739
authors.initials: L
authors.lastname: McCullagh
authors.affiliation: Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, Trinity College Dublin, St James's University Teaching Hospital, Dublin 8, Ireland.|National Centre for Pharmacoeconomics, St James's University Teaching Hospital, Dublin 8, Ireland.
authors.forename: Michael
authors.initials: M
authors.lastname: Barry
mesh_terms: D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003657:Decision Making; D017850:Economics, Pharmaceutical; D006291:Health Policy; D006801:Humans; D007494:Ireland; D004364:Pharmaceutical Preparations / Q000191:economics*; D011634:Public Health / Q000191:economics*; D012051:Reimbursement Mechanisms
chemical_list: D004364:Pharmaceutical Preparations