OBJECTIVES: The objective of the analysis is to develop a full Health Technology Assessment of Equistasi® for the improve balance in subjects affected by parkinsonian post-dyskinesia falls.

METHODS: in order to develop a full HTA, a multidisciplinary group of researchers was established with the aim to apply the European network for Health Technology Assessment (EUnetHTA) core model for the treatment available for patients with parkinsonian post-dyskinesia falls. A Systematic literature review were developed in order to identify the main alternative for the treatment and management of these patients and estimates the main clinical and economic information available for the alternatives analysed. Epidemiological and economic model were developed in order to quantify patients eligible for the new device and economic consequences of Equistasi® introduction in Italy.

RESULTS: Equistasi® is an innovative medical device, approved by the Ministry of Health in 2010 and it is based on vibrational technology (self-generates focal mechanical vibrations at a non-constant frequency of about 9000 Hz, within the limits imposed by Legislative Decree 81/08). In terms of safety, literature demonstrated that Equistasi® wasn’t associated with any potential implantation problems or safety risk. Clinical studies showed a significant reduction of: the average falls (from 3.2 to 0.65 rate/month), fracture rate (T0 =16.5%; T1 =3.4%) and improvement in the average speed (pValue =.0002). Epidemiological model estimates a total of 95,516 Parkinsonian patients with postural instability (35% of parkinsonians over 65) for an yearly overall cost of 80,1 million. Economic evaluation model demonstrates potential cost reduction in the short and medium term from both social and payer perspective in Italy.

CONCLUSIONS: This HTA represents the first preliminary national-level analysis focused on a relevant health issue as fractures post- dyskinesias in PD patients. The use of Equistasi® represents an efficacy and sustainable alternatives from the NHS and payer perspective in Italy.