PND15 Cost-Effectiveness of Buccolam® (Licensed Oromucosal Midazolam) Compared to Benzodiazepines for the Treatment of Acute Prolonged Epileptic Seizures in Germany

Abstract

BUCCOLAM (oromucosal midazolam) is approved for the treatment of prolonged, acute, convulsive seizures in children and was the first product to receive a Paediatric-Use Marketing Authorisation (PUMA) in September 2011. The product label includes use by parents and other carers such as teachers. Current care in Germany for first line treatment consists mainly of rectal diazepam with some use of buccal lorazepam, clonazepam and chloral hydrate. Some non-family carers can be reluctant to administer these products due to concerns about social acceptability, dignity or labelling issues. A decision tree model has been developed to assess the cost of BUCCOLAM compared to current care for prolonged acute convulsive seizures initially occurring in the community setting. The model evaluates costs along the treatment pathway when a child has a seizure including whether or not carers administer treatment, whether an ambulance is required and whether or not patients are taken to hospital and require an inpatient stay. Data were obtained from a variety of sources including clinical effectiveness estimates from McIntyre et al. 2005, and a Delphi panel. Costs were taken from published sources. Estimates of the total eligible population were taken from epilepsy prevalence data and the Delphi panel. Over one year, compared to the mix of treatments representing current care, BUCCOLAM showed a reduction in per patient costs of €3,469. Compared to treatment with rectal diazepam alone, the most commonly used treatment, BUCCOLAM showed a cost reduction of €3,533. It was expected that ∼36,000 patients would be eligible. At an uptake of 20% BUCCOLAM would reduce health care expenditure by €19.4 million in the first year. Treatment with BUCCOLAM is cost-saving compared to current care and treatment with rectal diazepam through a reduction in the need for ambulance call-outs and hospital stays.