Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries

Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.

Abstract

Objective: Assess the cost effectiveness of budesonide/formoterol (BUD/FORM) Turbuhaler(®)+tiotropium (TIO) HandiHaler(®) vs. placebo (PBO)+TIO in patients with chronic obstructive pulmonary disease (COPD) eligible for inhaled corticosteroids/long-acting β2-agonists (ICS/LABA).

Methods: The cost-effectiveness analysis was based on the 12-week, randomised, double-blind CLIMB trial. The study included 659 patients with pre-bronchodilator forced expiratory volume in 1 s ≤ 50% and ≥1 exacerbation requiring systemic glucocorticosteroids or antibiotics the preceding year. Patients received BUD/FORM 320/9 μg bid + TIO 18 μg qd or PBO bid + TIO 18 μg qd. Effectiveness was defined as the number of severe exacerbations (hospitalisation/emergency room visit/systemic glucocorticosteroids) avoided. A sub-analysis included antibiotics in the definition of an exacerbation. Resource use from CLIMB was combined with Danish (DKK), Finnish (€), Norwegian (NOK) and Swedish (SEK) unit costs (2010). The incremental cost-effectiveness ratios (ICERs) for BUD/FORM + TIO vs. PBO + TIO were estimated using descriptive statistics and uncertainty around estimates using bootstrapping. Analyses were conducted from the societal and healthcare perspectives in Denmark, Finland, Norway and Sweden.

Results: From a societal perspective, the ICER was estimated at €174/severe exacerbation avoided in Finland while BUD/FORM + TIO was dominant in the other countries. From the healthcare perspective, ICERs were DKK 1580 (€212), €307 and SEK 1573 (€165) per severe exacerbation avoided for Denmark, Finland and Sweden, respectively, while BUD/FORM + TIO was dominant in Norway. Including antibiotics decreased ICERs by 8-15%. Sensitivity analyses showed that results were overall robust.

Conclusion: BUD/FORM + TIO represents a clinical and economic benefit to health systems and society for the treatment of COPD in the Nordic countries. (ClinicalTrials.gov Identifier: NCT00496470).

Keywords: Budesonide/formoterol; COPD; Cost effectiveness; Nordic; Tiotropium.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-2 Receptor Agonists / economics
  • Adrenergic beta-2 Receptor Agonists / therapeutic use
  • Adult
  • Aged
  • Bronchodilator Agents / economics
  • Bronchodilator Agents / therapeutic use*
  • Budesonide / economics
  • Budesonide / therapeutic use*
  • Cost of Illness
  • Cost-Benefit Analysis
  • Double-Blind Method
  • Drug Combinations
  • Drug Costs / statistics & numerical data
  • Drug Therapy, Combination
  • Ethanolamines / economics
  • Ethanolamines / therapeutic use*
  • Formoterol Fumarate
  • Glucocorticoids / economics
  • Glucocorticoids / therapeutic use
  • Health Care Costs / statistics & numerical data*
  • Health Resources / statistics & numerical data
  • Humans
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / economics
  • Scandinavian and Nordic Countries
  • Scopolamine Derivatives / economics
  • Scopolamine Derivatives / therapeutic use*
  • Sick Leave / statistics & numerical data
  • Tiotropium Bromide
  • Treatment Outcome

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Bronchodilator Agents
  • Drug Combinations
  • Ethanolamines
  • Glucocorticoids
  • Scopolamine Derivatives
  • Budesonide
  • Formoterol Fumarate
  • Tiotropium Bromide

Associated data

  • ClinicalTrials.gov/NCT00496470