Cost-effectiveness of Sativex in multiple sclerosis spasticity: new data and application to Italy

Abstract

Multiple sclerosis (MS) is a chronic progressive disease that carries a high socioeconomic burden. Spasticity (rigidity and spasms) is common in MS and contributes to MS-related disability. This study aims to evaluate the cost–effectiveness of Sativex^® (9-delta-tetrahydrocannabinol plus cannabidiol oromucosal spray) when used as add-on therapy for management of resistant MS-related spasticity in the context of the Italian healthcare system. A previously published Markov model-based analysis for the German and Spanish context was replicated, adapting it to the Italian setting. Model parameters were updated to reflect recent findings about MS-related spasticity and use of Sativex in daily clinical practice. The base case incremental cost–effectiveness ratio for Sativex use in Italy over a 5-year period was estimated to be €4968 per quality-adjusted life-year gained (year of costing: 2013). Sativex remained an efficient option in the Italian healthcare context – below the commonly accepted incremental threshold of €30,000 per quality-adjusted life-year gained – when deterministic and probabilistic sensitivity analyses were conducted. Sativex can be regarded as a cost-effective treatment option for patients with MS-related spasticity in Italy.

Keywords:

• cost-effectiveness
• Italy
• multiple sclerosis
• Sativex
• spasticity

Financial & competing interests disclosure

The study was funded by Almirall, Barcelona, Spain. J Slof received an honorarium from Laboratorios Almirall S.A. for preparing this article. L Ruiz and C Vila are full-time employees of Laboratorios Almirall S.A. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Editorial assistance was provided by Content Ed Net, Madrid, Spain and was funded by Almirall, Barcelona, Spain.

Key issues

• Current management of multiple sclerosis (MS) spasticity, based primarily on the use of oral medications in combination with physical therapy, is insufficiently effective in a substantial proportion of patients and this situation increases over time.

• Sativex^® is an endocannabinoid system modulator (9-δ-tetrahydrocannabinol and cannabidiol in a 1:1 ratio) formulated as an oromucosal spray for use in patients with resistant MS spasticity.

• Cost-effectiveness of Sativex has previously been assessed using Markov modeling for the UK, Germany, and Spain, with disparate findings. In these analyses, costs and quality-adjusted life-years associated with the current management of spasticity were compared with those for patients treated with add-on Sativex.

• This article recalibrates one of the earlier models with new data about MS-related spasticity and the use of Sativex in clinical practice, and applies it to the Italian healthcare setting.

• Sativex was found to be cost effective in Italy at approximately €5000 per quality-adjusted life-year gained.