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Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)

Author

Listed:
  • Silvia Messina
  • Claudio Solaro
  • Isabella Righini
  • Roberto Bergamaschi
  • Simona Bonavita
  • Roberto Bruno Bossio
  • Vincenzo Brescia Morra
  • Gianfranco Costantino
  • Paola Cavalla
  • Diego Centonze
  • Giancarlo Comi
  • Salvatore Cottone
  • Maura Chiara Danni
  • Ada Francia
  • Alberto Gajofatto
  • Claudio Gasperini
  • Mauro Zaffaroni
  • Loredana Petrucci
  • Elisabetta Signoriello
  • Giorgia Teresa Maniscalco
  • Gabriella Spinicci
  • Manuela Matta
  • Massimiliano Mirabella
  • Graziella Pedà
  • Letizia Castelli
  • Marco Rovaris
  • Edoardo Sessa
  • Daniele Spitaleri
  • Damiano Paolicelli
  • Alfredo Granata
  • Mario Zappia
  • Francesco Patti
  • on behalf of the SA.FE. study group

Abstract

Background: The approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients. Methods: We collected data of patients from 30 MS centres across the country starting Sativex between January 2014 and February 2015. Data were collected from the mandatory Italian Medicines Agency (AIFA) web-registry. Predictors of treatment discontinuation were assessed using a multivariate Cox proportional regression analysis. Results: During the observation period 631 out of 1597 (39.5%) patients discontinued Sativex. The Kaplan-Meier estimates curve showed that 333 patients (20.8%) discontinued treatment at 4 weeks while 422 patients (26.4%) discontinued at 6 weeks. We found after adjusted modeling that a higher NRS score at T1 (adjHR 2.23, 95% 2.07–2.41, p

Suggested Citation

  • Silvia Messina & Claudio Solaro & Isabella Righini & Roberto Bergamaschi & Simona Bonavita & Roberto Bruno Bossio & Vincenzo Brescia Morra & Gianfranco Costantino & Paola Cavalla & Diego Centonze & Gi, 2017. "Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)," PLOS ONE, Public Library of Science, vol. 12(8), pages 1-10, August.
    • Handle: RePEc:plo:pone00:0180651
    DOI: 10.1371/journal.pone.0180651
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    Cited by:

    1. Mark Oppe & Daniela Ortín-Sulbarán & Carlos Vila Silván & Anabel Estévez-Carrillo & Juan M. Ramos-Goñi, 2021. "Cost-effectiveness of adding Sativex® spray to spasticity care in Belgium: using bootstrapping instead of Monte Carlo simulation for probabilistic sensitivity analyses," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 22(5), pages 711-721, July.

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