Nuedexta for the Treatment of Pseudobulbar Affect: Estimating the Financial Impact to the Scottish NHS

Abstract

apy. Methods: Observational, non-interventional, prospective, single-center study of 1 year follow-up from ITB implant onward. Results: 20 consecutive patients with ITB indication were recruited; 13 received an ITB implant during the study period; 1 implant was rejected and thus explanted. 12 patients, of whom 10 had spasticity due to spinal-cord injury, 1 to multiple sclerosis and 1 to adrenoleukodistrophy, provided data for the study and 9 completed follow-up. After 12 months of ITB, mean changes from baseline were: -2.6 on the Penn scale (p= 0.011), -1.1 (p= 0.059) and -2.8 (p= 0.011) on the Ashworth upper and lower scale, respectively and +4.4 on the FIM scale (p= 0.075). Mean utility gain, assessed with the HUI3 scale, was 0.054 (p= 0.091) after 1 year. Mean total ITB test and permanent implant cost per patient were € 528 and € 14,225, respectively. Mean quarterly spending on oral antispastics decreased by € 42 at month 12, while consumption of intrathecal baclofen stabilized after 6 months at € 39. At baseline, 4 patients received botulinum injections, while none did at the end of follow-up. Catheter-related adverse events occurred in 2 out of 12 patients, with a total mean cost per event of € 2.387. While waiting to receive ITB, spasticity-related hospitalizations due to urological complications occurred in 2 out of 20 patients, with a mean cost of € 9.044 per event; no such events were observed after ITB implant. ConClusions: Clinical outcomes of patients with N-FDS improved after ITB. Initial therapy costs were considerable, but were partially offset by savings in drugs and spasticity-related events after 1 year follow-up. Results should be interpreted cautiously because of the small number of observations. objeCtives: To assess clinical outcomes, health care resource utilization and associated costs of intrathecal baclofen therapy (ITB) for the treatment of non-focal disabling spasticity (N-FDS) in patients who are resistant or intolerant to oral ther-