Abstract
In the majority of children and adolescents with epilepsy, optimal drug therapy adequately controls their condition. However, among the remaining patients who are still uncontrolled despite mono-, bi- or tri-therapy with chronic anti-epileptic treatment, a rescue medication is required. In Western Europe, the licensed medications available for first-line treatment of prolonged acute convulsive seizures (PACS) vary widely, and so comparators for clinical and economic evaluation are not consistent. No European guidelines currently exist for the treatment of PACS in children and adolescents and limited evidence is available for the effectiveness of treatments in the community setting. The authors present cost-effectiveness data for BUCCOLAM® (midazolam oromucosal solution) for the treatment of PACS in children and adolescents in the context of the treatment pathway in seven European countries in patients from 6 months to 18 years. For each country, the health economic model consisted of a decision tree, with decision nodes informed by clinical data and expert opinion obtained via a Delphi methodology. The events modelled are those associated with a patient experiencing a seizure in the community setting. The model assessed the likelihood of medication being administered successfully and of seizure cessation. The associated resource use was also modelled, and ambulance call-outs and hospitalisations were considered. The patient’s quality of life was estimated by clinicians, who completed a five-level EuroQol five dimensions questionnaire from the perspective of a child or adolescent suffering a seizure. Despite differences in current therapy, treatment patterns and healthcare costs in all countries assessed, BUCCOLAM was shown to be cost saving and offered increased health-related benefits for patients in the treatment of PACS compared with the current local standard of care.
Highlights
Even in a relatively homogeneous region such as Western Europe, with similar population demographics and state-provided healthcare systems, differences in culture, legislation and financial incentives can mean that the treatment of patients with the same condition varies between countries
Base case results The base case analysis showed that BUCCOLAM dominated current care, rectal diazepam and unlicensed buccal midazolam in all countries
This dominance over current care indicates that BUCCOLAM is both less costly and more beneficial for patients in all of the countries included in the analyses (Table 6)
Summary
Even in a relatively homogeneous region such as Western Europe, with similar population demographics and state-provided healthcare systems, differences in culture, legislation and financial incentives can mean that the treatment of patients with the same condition varies between countries. Across Europe, 130,000 new cases of epilepsy are recorded each year among children and adolescents (an incidence rate of 70–80 per 100,000) [2,3]. Anti-epileptic drug therapy is the primary treatment for children with epilepsy, with the aim of preventing seizures [4], and approximately 70% of patients become seizure-free with optimal drug therapy [3,5]. Patients do not always receive optimal drug therapy and approximately 50–60% of patients with epilepsy experience breakthrough seizures during the course of a year, some of whom will require a prescription for rescue medication [2]. Symptomatic epilepsy are those who are most commonly prescribed rescue medication [6]
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