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.

Jan B Pietzsch,Charly Gaul,Abigail Garner,Arne May

doi:10.1186/s10194-015-0530-8

Abstract

BackgroundIn 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.MethodsClinical 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.ResultsSPG 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.ConclusionsOur 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.

Highlights

In the recent Pathway Cluster headache (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
In line with the results of the long-term data available to-date [9, 10], long-term effectiveness of SPG stimulation for accomplishing pain relief was assumed to remain constant over time, and to be identical to the effectiveness observed in the Pathway CH-1 study
Base case results Over the 5-year time horizon of the analysis, discounted total direct medical costs for the SPG stimulation cohort were €42,187, compared to €41,298 for the simulated medical management cohort, for a total additional cost of €889

Summary

Introduction

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. Treatment of chronic cluster headache (cCH) is guided by the dual objectives of ending acute attacks and decreasing attack frequency. Electrical stimulation of the sphenopalatine ganglion (SPG) has recently been proposed as an alternative treatment approach for cluster headache, relying on an implantable on-demand stimulator that is activated by the Pietzsch et al The Journal of Headache and Pain (2015) 16:48 patients themselves This study found the therapy to have dual clinical benefits of acute pain relief and attack prevention, while demonstrating an acceptable safety profile comparable to similar surgical procedures. In the United States, a pivotal study is currently recruiting patients (NCT02168764)

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