Estimated Prevalence of First-Dose Cardiac Observation in Patients Taking Ponesimod

Background: Ponesimod (20 mg) is a new sphingosine-1-phosphate (S1P) modulator highly selective to S1P1. Per the United States Prescribing Information, upon initiation of ponesimod, first-dose 4-hour monitoring is only recommended for patients with Relapsing Multiple Sclerosis (RMS) with sinus bradycardia (heart rate <55 beats per minute), first- or second-degree atrioventricular (AV) block, or a history of myocardial infarction (MI) or heart failure (HF). The expected percentage of patients in real world clinical practice who are recommended for first-dose 4-hour monitoring prior to starting ponesimod has not been robustly evaluated.

Objectives: To estimate the prevalence of patients in the real world, using a commercial claims dataset, who have conditions that would require first-dose 4-hour monitoring upon initiating ponesimod.

Methods: This retrospective cohort study utilized real-world claims data from 4 US-based administrative claims databases, including IBM® MarketScan® Commercial (CCAE), IBM Multi-State Medicaid (MDCD), IBM Medicare Supplemental (MDCR), and Optum Clinformatics® Data Mart Databases. Inclusion criteria were ICD-10-CM diagnosis of MS between 10/1/16 and the most recent available date, 2 diagnoses of MS within 365 days or an inpatient hospitalization for MS, and ≥365 days of observation data prior to index date. Analyses were descriptive and estimated the prevalence of the conditions that are recommended for first-dose 4-hour monitoring according to ICD-10-CM codes (ie, HF or MI any time prior to or on the index date, and bradycardia or AV block in the past 365 days prior to or on the index date) among all patients with MS and no ponesimod contraindications.

Results: Among 53,889 patients in the CCAE database with MS and no contraindications, 76.2% were female and the mean (standard deviation) age was 48.4 (11.0) years. In this population, 7.6% had conditions requiring first-dose 4-hour monitoring (HF, 2.4%; MI, 1.5%; bradycardia, 4.4%; AV block, 0.2%). Results were similar when also including patients with contradictions (9.0% with conditions requiring first-dose 4-hour monitoring). In databases of non-commercial patients (MDCD) and older populations (MDCR, Optum) the prevalence of patients with no contraindications requiring first-dose 4-hour monitoring tended to be higher (Optum, 14.8%; MDCD, 21.9%; MDCR, 24.3%).

Conclusions: Findings indicate that >90% of commercially-insured patients will not require first-dose 4-hour monitoring for treatment with ponesimod.