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

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 ManiscalcoGabriella Spinicci, Manuela Matta, Massimiliano Mirabella, Graziella Pedà, Letizia Castelli, Marco Rovaris, Edoardo Sessa, Daniele Spitaleri, Damiano Paolicelli, Alfredo Granata, Mario Zappia, Francesco Patti

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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>0.001) and a lower baseline NRS score (adjHR 0.51 95% CI 0.46-0.56, p>0.001) were predictive of treatment discontinuation. Conclusion These data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation.

Original languageEnglish
Article numbere0180651
JournalPLoS One
Volume12
Issue number8
DOIs
Publication statusPublished - Aug 1 2017

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sclerosis
Multiple Sclerosis
Population
Costs
Regression analysis
Medicine
Cost Sharing
tetrahydrocannabinol-cannabidiol combination
Costs and Cost Analysis
Kaplan-Meier Estimate
Therapeutics
Health Care Costs
health services
Italy
Registries
medicine
regression analysis
Industry
Regression Analysis
Observation

ASJC Scopus subject areas

  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

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Sativex in resistant multiple sclerosis spasticity : Discontinuation study in a large population of Italian patients (SA.FE. study). / Messina, Silvia; Solaro, Claudio; Righini, Isabella; Bergamaschi, Roberto; Bonavita, Simona; Bossio, Roberto Bruno; Morra, Vincenzo Brescia; Costantino, Gianfranco; Cavalla, Paola; Centonze, Diego; Comi, Giancarlo; Cottone, Salvatore; Danni, Maura Chiara; Francia, Ada; Gajofatto, Alberto; Gasperini, Claudio; Zaffaroni, Mauro; Petrucci, Loredana; Signoriello, Elisabetta; Maniscalco, Giorgia Teresa; Spinicci, Gabriella; Matta, Manuela; Mirabella, Massimiliano; Pedà, Graziella; Castelli, Letizia; Rovaris, Marco; Sessa, Edoardo; Spitaleri, Daniele; Paolicelli, Damiano; Granata, Alfredo; Zappia, Mario; Patti, Francesco.

In: PLoS One, Vol. 12, No. 8, e0180651, 01.08.2017.

Research output: Contribution to journalArticle

Messina, S, Solaro, C, Righini, I, Bergamaschi, R, Bonavita, S, Bossio, RB, Morra, VB, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, MC, Francia, A, Gajofatto, A, Gasperini, C, Zaffaroni, M, Petrucci, L, Signoriello, E, Maniscalco, GT, Spinicci, G, Matta, M, Mirabella, M, Pedà, G, Castelli, L, Rovaris, M, Sessa, E, Spitaleri, D, Paolicelli, D, Granata, A, Zappia, M & Patti, F 2017, 'Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)', PLoS One, vol. 12, no. 8, e0180651. https://doi.org/10.1371/journal.pone.0180651
Messina, Silvia ; Solaro, Claudio ; Righini, Isabella ; Bergamaschi, Roberto ; Bonavita, Simona ; Bossio, Roberto Bruno ; Morra, Vincenzo Brescia ; Costantino, Gianfranco ; Cavalla, Paola ; Centonze, Diego ; Comi, Giancarlo ; Cottone, Salvatore ; Danni, Maura Chiara ; Francia, Ada ; Gajofatto, Alberto ; Gasperini, Claudio ; Zaffaroni, Mauro ; Petrucci, Loredana ; Signoriello, Elisabetta ; Maniscalco, Giorgia Teresa ; Spinicci, Gabriella ; Matta, Manuela ; Mirabella, Massimiliano ; Pedà, Graziella ; Castelli, Letizia ; Rovaris, Marco ; Sessa, Edoardo ; Spitaleri, Daniele ; Paolicelli, Damiano ; Granata, Alfredo ; Zappia, Mario ; Patti, Francesco. / Sativex in resistant multiple sclerosis spasticity : Discontinuation study in a large population of Italian patients (SA.FE. study). In: PLoS One. 2017 ; Vol. 12, No. 8.
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title = "Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)",
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>0.001) and a lower baseline NRS score (adjHR 0.51 95{\%} CI 0.46-0.56, p>0.001) were predictive of treatment discontinuation. Conclusion These data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation.",
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T1 - Sativex in resistant multiple sclerosis spasticity

T2 - Discontinuation study in a large population of Italian patients (SA.FE. study)

AU - Messina, Silvia

AU - Solaro, Claudio

AU - Righini, Isabella

AU - Bergamaschi, Roberto

AU - Bonavita, Simona

AU - Bossio, Roberto Bruno

AU - Morra, Vincenzo Brescia

AU - Costantino, Gianfranco

AU - Cavalla, Paola

AU - Centonze, Diego

AU - Comi, Giancarlo

AU - Cottone, Salvatore

AU - Danni, Maura Chiara

AU - Francia, Ada

AU - Gajofatto, Alberto

AU - Gasperini, Claudio

AU - Zaffaroni, Mauro

AU - Petrucci, Loredana

AU - Signoriello, Elisabetta

AU - Maniscalco, Giorgia Teresa

AU - Spinicci, Gabriella

AU - Matta, Manuela

AU - Mirabella, Massimiliano

AU - Pedà, Graziella

AU - Castelli, Letizia

AU - Rovaris, Marco

AU - Sessa, Edoardo

AU - Spitaleri, Daniele

AU - Paolicelli, Damiano

AU - Granata, Alfredo

AU - Zappia, Mario

AU - Patti, Francesco

PY - 2017/8/1

Y1 - 2017/8/1

N2 - 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>0.001) and a lower baseline NRS score (adjHR 0.51 95% CI 0.46-0.56, p>0.001) were predictive of treatment discontinuation. Conclusion These data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation.

AB - 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>0.001) and a lower baseline NRS score (adjHR 0.51 95% CI 0.46-0.56, p>0.001) were predictive of treatment discontinuation. Conclusion These data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation.

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