title: Cost-effectiveness of stimulation of the sphenopalatine ganglion (SPG) for the treatment of chronic cluster headache: a model-based analysis based on the Pathway CH-1 study.
abstract: BACKGROUND
  In the recent Pathway CH-1 study, on-demand stimulation of the sphenopalatine ganglion (SPG) by means of an implantable neurostimulation system was proven to be a safe and effective therapy for the treatment of chronic cluster headache. Our objective was to assess the cost-effectiveness of SPG stimulation in the German healthcare system when compared to medical management.
  
  
  METHODS
  Clinical data from the Pathway CH-1 study were used as input for a model-based projection of the cost-effectiveness of SPG stimulation through 5 years. Medical management as the comparator treatment was modeled on the basis of clinical events observed during the baseline period of CH-1. The costs of treatment were derived from a previously published cluster headache costing study and 2014 medication, neurostimulator, and procedure costs. We computed the 5-year incremental cost-effectiveness ratio (ICER) in euros per quality-adjusted life year (QALY), with costs and effects discounted at 3 % per year.
  
  
  RESULTS
  SPG stimulation was projected to add 0.325 QALYs over the study period, while adding €889 in cost, resulting in a 5-year ICER of €2,736 per QALY gained. Longer follow-up periods, higher baseline attack frequency, and higher utilization of attack-aborting medications led to overall cost savings. SPG stimulation was found either cost-effective or cost-saving across all scenarios investigated in sensitivity analyses.
  
  
  CONCLUSIONS
  Our model-based analysis suggests that SPG stimulation for the treatment of chronic cluster headache, under the assumption of sustained therapy effectiveness, leads to meaningful gains in health-related quality of life and is a cost-effective treatment strategy in the German healthcare system.
authors.affiliation: Wing Tech Inc., Menlo Park, CA, USA, jpietzsch@wing-tech.com.
authors.forename: Jan B
authors.initials: JB
authors.lastname: Pietzsch
authors.forename: Abigail
authors.initials: A
authors.lastname: Garner
authors.forename: Charly
authors.initials: C
authors.lastname: Gaul
authors.forename: Arne
authors.initials: A
authors.lastname: May
mesh_terms: D000328:Adult; D003027:Cluster Headache / Q000628:therapy*; D003362:Cost-Benefit Analysis; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D005260:Female; D005726:Ganglia, Parasympathetic; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D056739:Pterygopalatine Fossa / Q000294:innervation; D019057:Quality-Adjusted Life Years; D016896:Treatment Outcome; D055815:Young Adult