OBJECTIVES: ALS is a progressive neuromuscular disease with an unavoidable decline in muscle strength which may result in the need for assistance from durable medical equipment (DME). FORTITUDE-ALS was a large, double-blind, placebo-controlled, dose ranging clinical trial of reldesemtiv in ALS with an active treatment period of 12 weeks. Data on the need for DME such as manual wheelchair (MW), power wheelchair (PW), gastrostomy tube (GT), non-invasive ventilator (NIV), and augmentative communication device (ACD) were collected in the trial. The main objective of this analysis is to perform a cost analysis of reldesemtiv's impact on the utilization of DME compared to placebo during the trial period.

METHODS: We performed within trial cost analysis of reldesemtiv versus placebo. Retail price of each DME was collected from published studies. All costs were expressed in 2019 US dollars. Notably, patients were similar between groups for baseline characteristics including baseline ALS disease progression.

RESULTS: Data from 456 patients (reldesemtiv: n=342, placebo: n=114) was included in this analysis. The number of DME were [MW=10, PW=10, GT=10, NIV=10, ACD=2] and [MW=22, PW=17, GT=18, NIV=22, ACD=7] for placebo and reldesemtiv, respectively. The average cost for the placebo and reldesemtiv were $3,846.04 and $2,390.88, respectively. Individuals in the reldesemtiv group had saved $1455.16 in costs for DME compared with the placebo group in a 12-week period.

CONCLUSIONS: Reldesemtiv was a cost saving intervention with respect to durable medical equipment compared to placebo for patients with ALS during FORTITUDE-ALS. Since this was a 12-week follow up and did not account for other direct and indirect costs of ALS, a comprehensive cost analysis for a longer follow up period is warranted to further define DME cost saving potential of reldesemtiv therapy.