PND35 Buccolam® (Licensed Oromucosal Midazolam) Versus Rectal Diazepam for Acute Epileptic Seizures: Italian Cost-Effectiveness Analysis

Abstract

BUCCOLAM® (LICENSED OROMUCOSAL MIDAZOLAM) VERSUS RECTAL DIAZEPAM FOR ACUTE EPILEPTIC SEIZURES: ITALIAN COST-EFFECTIVENESS ANALYSIS Gladwell D1, Aneli M2, Batty A1, Lee D1 1BresMed, Sheffield, UK, 2Keypharma SRL, Milan, Lombardy, Italy OBJECTIVES: Current care in Italy for first-line treatment of seizures consists of rectal diazepam with some use of intravenous treatments (diazepam, midazolam and lorazepam) in a hospital setting. In the community there can be reluctance to administer rectal diazepam due to dignity and social acceptability issues. BUCCOLAM (oromucosal midazolam), the first product to receive a Paediatric-Use Marketing Authorisation (PUMA), is approved for the treatment of prolonged, acute, convulsive seizures (PACS) in children and may be used by parents and other carers. A decision-tree model was developed to assess the cost effectiveness of BUCCOLAM compared to rectal diazepam for the treatment of (PACS) initially occurring in the community setting. METHODS: The model allows for different routes though the treatment pathway that include whether or not 1) a carer administers treatment, 2) an ambulance is required and patients are taken to hospital; and 3) inpatient stay is re;uired. Clinical effectiveness data were obtained from McIntyre et al (2005) and a Delphi panel. Costs were taken from published sources. The price proposed for BUCCOLAM reimbursement to the Italian National Health Service is used. Rectal diazepam is not reimbursable therefore its cost is not included. Estimates of the number of seizures per year where BUCCOLAM might be used were taken from published sources. RESULTS: Over one year, compared to rectal diazepam, BUCCOLAM showed a reduction in per patient costs of €1,467. The largest saving came from an estimated reduction in inpatient costs of €919 per patient per year. Patients treated with BUCCOLAM also had a higher health related quality of life than those treated with rectal diazepam; treatment with BUCCOLAM is therefore dominant. CONCLUSIONS: Treatment with BUCCOLAM is cost saving, through a reduction in the need for ambulance call outs and hospital stays, and is more socially acceptable than treatment with rectal diazepam.