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PLoS One. 2017 Aug 1;12(8):e0180651. doi: 10.1371/journal.pone.0180651. eCollection 2017.

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

Author information

1
Department of Medical, Surgical Science and Advanced Technology "GF Ingrassia"-University of Catania, Catania, Italy.
2
Neurology Unit, Department Head And Neck, ASL3 Genova, Italy.
3
Department NEUROFARBA-University of Florence, Florence, Italy.
4
Department of Neurology-Neurology Institute C Mondino, Pavia, Italy.
5
I clinic Neurology-II University of Naples, Naples, Italy.
6
Neurology Operating Unit and Multiple Sclerosis Center-Provincial Health Authority of Cosenza, Cosenza, Italy.
7
Multiple Sclerosis Centre-University Federico II, Naples, Italy.
8
Demyelinating Diseases Centre-Foggia Hospital, Foggia, Italy.
9
A.O.U: Cittàdella Salute e dellaScienza di Torino, Torino, Italy.
10
Neuroscience Department-University Tor Vegata, Rome, Italy.
11
Unit of Neurology and of Neurorehabilitation, IRCCS Neuromed, Pozzilli (IS), Italy.
12
Department of Neurology-San Raffaele Hospital, Milan, Italy.
13
Neuroimmunology Unit-Villa Sofia-Cervello Hospital, Palermo, Italy.
14
Neurology Clinic-Ancona Hospital, Ancona, Italy.
15
Multiple Sclerosis Center, Dept. Neurol. Psich-Sapienza University, Rome, Italy.
16
Department of Neuroscience, Biomedicine and Movement Multiple Sclerosis Centre-University of Verona, Verona, Italy.
17
Neurology Division-San Camillo Hospital, Rome, Italy.
18
Multiple Sclerosis Centre-Sant'Antonio Abate Hospital, Gallarate, Italy.
19
Multiple Sclerosis Centre-University Hospital Pisa, Pisa, Italy.
20
Multiple Sclerosis Center-Second University of Naples, Naples, Italy.
21
Multiple Sclerosis Centre-Cardarelli Hospital, Naples, Italy.
22
Department of Medical Sciences-University of Cagliari, Cagliari, Italy.
23
Multiple Sclerosis Centre (CRESM)-San Luigi Gonzaga Hospital, Orbassano, Italy.
24
Multiple Sclerosis Centre-Cattolica University, Rome, Italy.
25
Multiple Sclerosis Centre-Vaio Hospital, Fidenza, Italy.
26
Multiple Sclerosis Centre-S. Andrea Hospital, Rome, Italy.
27
Multiple Sclerosis Centre-IRCCS Don Gnocchi Foundation, Milan, Italy.
28
Multiple Sclerosis Centre-IRCCS-Bonino Pulejo Centre, Messina, Italy.
29
Multiple Sclerosis Centre-San G. Moscati Hospital, Avellino, Italy.
30
Department of Basic Medical Sciences, Neuroscience and Sense Organs-University of Bari "Aldo Moro" Bari, Italy.
31
Department of Medical Sciences, Institute of Neurology-University "Magna Graecia", Catanzaro, Italy.

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.

PMID:
28763462
PMCID:
PMC5538735
DOI:
10.1371/journal.pone.0180651
[Indexed for MEDLINE]
Free PMC Article

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