Evolution of the Treatment Landscape for Patients Diagnosed with Amyotrophic Lateral Sclerosis in the United States
Malgorzata Ciepielewska1, Aastha Chandak2, Artak Khachatryan2, Alekhya lavu2, Polina DaSilva1
1Mitsubishi Tanabe Pharma America, Inc., 2Certara
Objective:
Describe the evolution of the treatment landscape for patients diagnosed with amyotrophic lateral sclerosis (ALS).
Background:
Treatment options for ALS aim at modifying disease, alleviating symptoms, and improving quality of life. Over the past decade, United States Food and Drug Administration (FDA)-approved treatments for ALS have evolved.
Design/Methods:
Patients aged ≥12 years with incident ALS between January 2016 through December 2022 were identified using the Inovalon closed claims database sourced through HealthVerity. Patients were required to have continuous enrollment for 6 months before and after incident ALS diagnosis. FDA-approved ALS treatments, including riluzole, Mitsubishi Tanabe Pharma America (MTPA) IV (intravenous) and oral edaravone (Radicava® IV and Radicava ORS®), and sodium phenylbutyrate and taurursodiol (withdrawn from the US market following this analysis period), initiated within 6 months of ALS diagnosis and on/after the incident ALS diagnosis were examined by ALS diagnosis year.
Results:
We observed an increase in the use of riluzole among patients with ALS diagnosed between 2016 and 2022, from 5.9% in 2016 to 24.8% in 2022. MTPA IV edaravone was introduced in 2017, and its use increased from 1% to 4.8% between 2017 and 2021. However, with the introduction of MTPA oral edaravone in 2022, use of MTPA IV edaravone decreased to 1%, while use of MTPA oral edaravone increased to 8.9%. Over the study period, a decrease was observed in untreated patients with ALS, from 87.1% in 2016 to 70.7% in 2022.
Conclusions:
During the 2016-2022 period, there was increased use of riluzole and a slow shift toward MTPA IV edaravone. With FDA approval of MTPA oral edaravone in 2022, there was a shift observed toward this newer option. Although many patients still had not received any FDA-approved treatments, that number has decreased, possibly due, in part, to the approval of MTPA oral edaravone.
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