Abstract

Multiple sclerosis (MS) is an autoimmune chronic progressive disease causing a high socioeconomic burden. Associated symptoms to the growing nerve damage, such as spasticity (muscle rigidity) are moderate to severe in about 1/3 of the patients. This study evaluates the impact on costs and health related quality of life of a 1:1 ratio delta-9-tetrahidrocannabinol + cannabidiol (THC+CBD) oromucosal spray for the management of resistant MS spasticity. A Markov model-based cost-utility analysis comparing THC+CBD spray plus standard spasticity care versus standard spasticity care alone was performed over a 5-year time horizon from a Belgian healthcare payer perspective. We used epidemiological and utility data from a recent clinical trial (SAVANT). Costs were based on unit costs updated for 2019 and resource use input from an ad-hoc Delphi panel. The probabilistic sensitivity analysis was implemented using a bootstrap approach over the clinical trial data and the Delphi responses so that the correlation between model parameters was maintained. Adding THC+CBD spray to standard spasticity care was found to dominate standard spasticity care alone, with cost savings of € 7530/patient and a quality adjusted life year (QALY) gain of 0.162 over the 5 year time horizon. The probabilistic sensitivity analyses showed that the probability of THC+CBD spray being cost-saving increased from 50% in the first year to 91% in the third year and 98% in the fifth year. In addition, the probability of adding THC+CBD spray being superior to standard-of-care treatment alone in terms of QALY gains was in access of 99% for all years. This analysis shows that under the modelled conditions the add-on use of THC+CBD spray is a dominant strategy, with both cost-savings and QALY gains, compared to current standard-of-care treatment alone for patients with resistant MS spasticity in Belgium, making it a valuable treatment available for them.

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