Langham S, Wright A, Shaw H, Bryson S, O’Leary S. Budget impact analysis of oral glycopyrronium bromide (Sialanar™) for the symptomatic treatment of severe sialorrhoea (drooling) in the UK setting. Value Health 2017;20(9):A720

Abstract

Objectives: Oral glycopyrronium bromide 400 micrograms/ml (Sialanar™) is indicated for the symptomatic treatment of severe sialorrhoea (drooling) in children and young people with chronic neurological disorders. It is the only licensed medication in Europe and has been launched in the UK. The market had previously been dominated by use of unlicensed products or preparations made by specials manufacturers or pharmacists. It is not possible, using routinely collected data, to assess use of unlicensed products for this indication, therefore we carried out an evaluation of budget impact utilising real world evidence to validate assumptions around input parameters.

Methods: A budget impact model was developed for the UK setting using local epidemiological and cost data from multiple published and unpublished sources. It was assumed that licensed oral glycopyrronium bromide 400 micrograms/ml would displace unlicensed products. Data on use of unlicensed products were derived from a sample of patients receiving treatment for sialorrhoea identified in a UK observational database (Clinical Practice Research Datalink). Annual net budget impact over 5 years, from the perspective of the UK National Health Service, was estimated.

Results: The budget impact of the newly licensed oral glycopyrronium bromide over 5 years was estimated to be cost saving, even under assumptions of increasing prescription rates over time. Certain displacement scenarios (e.g. areas with a high prescription rate of the tablet form of an unlicensed product) resulted in substantial cost savings.

Conclusions: The introduction of oral glycopyrronium bromide 400 micrograms/ml may lead to substantial cost savings for the UK healthcare service. Use of real world evidence to understand clinical practice and treatment decisions is critical to validate assumptions around input parameters when estimating the budget impact of introducing a newly licensed product into a previously unlicensed market. This allows national and local decision makers to make informed decisions on use for their patient population.