title: The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial.
abstract: Abstract Background and aims: Intensification of basal insulin-only therapy in type 2 diabetes is often achieved through addition of bolus insulin 3-times daily. The FullSTEP trial demonstrated that stepwise addition (SWA) of bolus insulin aspart was non-inferior to full basal-bolus (FBB) therapy and reduced the rate of hypoglycemia. Here the cost-effectiveness and budget impact of SWA is evaluated.
  
  
  METHODS
  Cost-effectiveness and budget impact models were developed to assess the cost and quality-of-life (QoL) implications of intensification using SWA compared with FBB in the US setting. At assessment, SWA patients added one bolus dose to their current regimen if the HbA1c target was not met. SWA patients reaching three bolus doses used FBB event rates. Outcomes were evaluated at trial end and projected annually up to 5 years. Models captured hypoglycemic events, the proportion meeting HbA1c target, and self-measured blood glucose. Event rates and QoL utilities were taken from trial data and published literature. Costs were evaluated from a healthcare-payer perspective, reported in 2013 USD, and discounted (like clinical outcomes) at 3.5% annually. This analysis applies to patients with HbA1c 7.0-9.0% and body mass index <40 kg/m(2).
  
  
  RESULTS
  SWA was associated with improved QoL and reduced costs compared with FBB. Improvement in QoL and cost reduction were driven by lower rates of hypoglycemia. Sensitivity analyses showed that outcomes were most influenced by the cost of bolus insulin and QoL impact of symptomatic hypoglycemia. Budget impact analysis estimated that, by moving from FBB to SWA, a health plan with 77,000 patients with type 2 diabetes, of whom 7.8% annually intensified to basal-bolus therapy, would save USD 1304 per intensifying patient over the trial period.
  
  
  CONCLUSIONS
  SWA of bolus insulin should be considered a beneficial and cost-saving alternative to FBB therapy for the intensification of treatment in type 2 diabetes.
authors.affiliation: Ossian Health Economics and Communications , Basel , Switzerland.
authors.forename: Rhodri
authors.initials: R
authors.lastname: Saunders
authors.forename: Jean
authors.initials: J
authors.lastname: Lian
authors.forename: Boris
authors.initials: B
authors.lastname: Karolicki
authors.forename: William
authors.initials: W
authors.lastname: Valentine
mesh_terms: D000368:Aged; D002017:Budgets; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005060:Europe; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000191:economics; D007328:Insulin / Q000008:administration & dosage* / Q000191:economics; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D011788:Quality of Life
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Budget impact; Cost-effectiveness; Insulin; Type 2 diabetes