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 language | English |
|---|---|
| Article number | e0180651 |
| Journal | PLoS One |
| Volume | 12 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 1 2017 |
Fingerprint
ASJC Scopus subject areas
- Medicine(all)
- Biochemistry, Genetics and Molecular Biology(all)
- Agricultural and Biological Sciences(all)
Cite this
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 journal › Article
}
TY - JOUR
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.
UR - http://www.scopus.com/inward/record.url?scp=85026820588&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85026820588&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0180651
DO - 10.1371/journal.pone.0180651
M3 - Article
AN - SCOPUS:85026820588
VL - 12
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 8
M1 - e0180651
ER -