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Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

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Abstract

Introduction

Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients.

Objective

Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients.

Methods

A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon.

Results

Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months’ treatment and 0.127 (0.080) after 6 months’ treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve.

Conclusion

The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.

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Acknowledgements

The authors would like to thank BioMed Proofreading® for the support in copyediting the manuscript. The Members of the SA.FE. study group: Patti F, Messina S, Solaro C, Amato MP, Bergamaschi R, Bonavita S, Bruno Bossio R, Brescia Morra V, Costantino GF, Cavalla P, Centonze D, Comi G, Cottone S, Danni M, Francia A, Gajofatto A, Gasperini C, Ghezzi A, Iudice A, Lus G, Maniscalco GT, Marrosu MG, Matta M, Mirabella M, Montanari E, Pozzilli C, Rovaris M, Sessa E, Spitaleri D, Trojano M, Valentino P, Zappia M, Benedetti MD, Bertolotto A, Berra E, Bianco A, Buttari F, Cerqua R, Florio C, Fuiani A, Guareschi A, Ippolito D, Nuara A, Palmieri V, Paolicelli D, Petrucci L, Pontecorvo S, Saccà F, Salomone G, Signoriello E, Spinicci G, Russo M, Tavazzi E, Trabucco E, Trotta M, Zaffaroni M.

Author information

Authors and Affiliations

  1. Research Centre on Public Health (CESP), University of Milano Bicocca, Villa Serena, Via Pergolesi 33, 20900, Monza, Italy

    Lorenzo G. Mantovani & Paolo A. Cortesi

  2. Fondazione Charta, Milan, Italy

    Lorenzo G. Mantovani, Paolo Cozzolino & Paolo A. Cortesi

  3. Department of Medical, Surgical Science and Advanced Technology “GF Ingrassia”, University of Catania, Catania, Italy

    Francesco Patti

Authors
  1. Lorenzo G. Mantovani
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  2. Paolo Cozzolino
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  3. Paolo A. Cortesi
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  4. Francesco Patti
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Consortia

the SA.FE. study group

  • F. Patti
  • , S. Messina
  • , C. Solaro
  • , M. P. Amato
  • , R. Bergamaschi
  • , S. Bonavita
  • , R. Bruno Bossio
  • , V. Brescia Morra
  • , G. F. Costantino
  • , P. Cavalla
  • , D. Centonze
  • , G. Comi
  • , S. Cottone
  • , M. Danni
  • , A. Francia
  • , A. Gajofatto
  • , C. Gasperini
  • , A. Ghezzi
  • , A. Iudice
  • , G. Lus
  • , G. T. Maniscalco
  • , M. G. Marrosu
  • , M. Matta
  • , M. Mirabella
  • , E. Montanari
  • , C. Pozzilli
  • , M. Rovaris
  • , E. Sessa
  • , D. Spitaleri
  • , M. Trojano
  • , P. Valentino
  • , M. Zappia
  • , M. D. Benedetti
  • , A. Bertolotto
  • , E. Berra
  • , A. Bianco
  • , F. Buttari
  • , R. Cerqua
  • , C. Florio
  • , A. Fuiani
  • , A. Guareschi
  • , D. Ippolito
  • , A. Nuara
  • , V. Palmieri
  • , D. Paolicelli
  • , L. Petrucci
  • , S. Pontecorvo
  • , F. Saccà
  • , G. Salomone
  • , E. Signoriello
  • , G. Spinicci
  • , M. Russo
  • , E. Tavazzi
  • , E. Trabucco
  • , M. Trotta
  •  & M. Zaffaroni

Contributions

Conceptualization, LGM and FP; methodology, LGM, PC, and PAC; data curation: PC; formal analysis, PC and PAC; writing Sativex original draft preparation, PAC and PC; writing Sativex review and editing, LGM and FP; funding acquisition: LGM.

Corresponding author

Correspondence to Paolo A. Cortesi.

Ethics declarations

Funding

This study was supported by an unrestricted research grant from Almirall S.p.A.

Conflict of interest

PAC received a research grant from Baxalta now part of Shire and speaking honoraria from Pfizer and Roche in areas other than Multiple Sclerosis; L.G.M. has received grants from MSD and Janssen and honoraria from Bayer in areas other than Multiple Sclerosis. F.P. received honoraria for speaking activities and/or serving as advisor board member by Almirall, Bayer, Biogen, Celgene, Merck, Myalin, Novartis, Roche, Sanofi-Genzyme, and TEVA. He was also granted for research projects by MIUR, University of Catania, FISM and ISS. P.C. have nothing to declare.

Additional information

The Members of the SA.FE. study group are listed in acknowledgements section.

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Mantovani, L.G., Cozzolino, P., Cortesi, P.A. et al. Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis. Clin Drug Investig 40, 319–326 (2020). https://doi.org/10.1007/s40261-020-00895-6

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  • DOI: https://doi.org/10.1007/s40261-020-00895-6

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