title: Paucity and Inconsistency: A Systematic Review and Critique of Budget Impact Analyses of Disease-Modifying Therapies for Multiple Sclerosis in the UK and the Implications for Policy in the UK.
abstract: OBJECTIVE
  Budget impact analysis (BIA) has become an essential part of economic evaluation within health technology assessment. Several disease-modifying therapies (DMTs) are now available for the treatment of multiple sclerosis (MS). This study sought to identify the inputs and assumptions used in existing BIAs for DMTs in the UK, and the uncertainty and variation in these, to allow critique within the context of UK policy.
  
  
  METHODS
  MEDLINE and the Economic Evaluations Database from the Cochrane Library were searched systematically on 15 December 2014 to identify BIAs of DMTs licensed for MS in the UK. In addition, the National Institute for Health and Care Excellence (NICE) and National Health Service (NHS) England websites were searched for relevant publications and grey literature searching was undertaken. Sources and assumptions from the included analyses were extracted, compared and critiqued.
  
  
  RESULTS
  The database searches produced 115 de-duplicated results. An additional 12 results were identified from the NICE and NHS England websites. No BIAs of DMTs for MS in the UK were identified in the literature. All ten included studies were from the NICE website, comprising manufacturer submissions for each DMT and corresponding NICE costing templates. There are considerable uncertainties in the inputs and assumptions used in the BIAs, but limited sensitivity analyses were undertaken.
  
  
  CONCLUSIONS
  Data limitations were not highlighted in the results, failing to present the uncertainty in the results to users clearly. It is to be welcomed that NICE has recently consulted on a process change to allow additional critique of the costing templates.
authors.affiliation: Costello Medical Consulting Ltd, Cambridge, UK.
authors.forename: Stephen
authors.identifier: http://orcid.org/0000-0002-8481-5850
authors.initials: S
authors.lastname: Montgomery
authors.affiliation: Costello Medical Consulting Ltd, Cambridge, UK.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Kusel
authors.affiliation: Novartis Pharmaceuticals UK Ltd, 200 Frimley Business Park, Camberley, Surrey, GU16 7SR, UK.
authors.forename: Felicity
authors.initials: F
authors.lastname: Allen
authors.affiliation: Novartis Pharmaceuticals UK Ltd, 200 Frimley Business Park, Camberley, Surrey, GU16 7SR, UK. nicholas.adlard@novartis.com.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Adlard
mesh_terms: D002017:Budgets; D003362:Cost-Benefit Analysis; D005102:Health Expenditures; D006291:Health Policy / Q000191:economics*; D006801:Humans; D009103:Multiple Sclerosis / Q000191:economics* / Q000628:therapy; D006113:United Kingdom