(394) Improved outcomes in patients with multiple sclerosis initiating cladribine tablets compared with those denied health insurance coverage in the United States

Background: : Cladribine tablets (CladT) are indicated for relapsing forms of multiple sclerosis (MS), including relapsing-remitting and active secondary progressive disease. Despite clinical evidence demonstrating its effectiveness, safety, and benefits, barriers from third-party payers may limit access to CladT.

Objective: : To assess the impact of access to CladT versus denied coverage on clinical outcomes, health care resource utilization (HCRU), and costs among patients with MS (PwMS).

Methods: : This retrospective cohort study used US claims data from Kythera Labs between April 1, 2018, and December 31, 2024. Adult PwMS with ≥2 claims for MS at least 30 days apart were included. The index date was defined as the date of the first prescription dispensing for CladT (approved cohort) or first denied prescription claim for CladT (denied cohort). Continuous eligibility was required for 12 months pre- and 24 months post-index. Cohorts were matched 1:1 using nearest-neighbor propensity score matching (PSM). Outcomes included MS-related treatments, relapse measures (annualized relapse rate [ARR], time to first relapse), all-cause and MS-related HCRU, and health care costs, analyzed using generalized linear and Cox models post-PSM.

Results: : A total of 1,718 PwMS met the inclusion criteria. Of the 1,382 approved patients, 24.0% had at least one prior denial before gaining access to CladT. Among the 336 consistently denied patients, 69.3% had more than one denial of CladT. At baseline, the approved patients were older (mean age: 49.5 vs. 46.6 years), had higher comorbidity burden (mean Charlson Comorbidity Index: 0.41 vs. 0.26), and greater use of dalfampridine (9.8% vs. 3.9%) and disease-modifying therapies (38.9% vs. 34.5%) compared to the denied patients. Post-PSM, the approved patients exhibited a lower ARR than the denied patients (risk ratio=0.57; 95% confidence interval [CI]: 0.38, 0.84; p=0.03). The approved patients also had fewer physical therapy/rehabilitation claims per patient per year (PPPY; incidence rate ratio=0.51; 95% CI: 0.39, 0.67; p=0.013). All-cause outpatient costs (mean cost difference [MCD] PPPY: −$4,634; 95% CI: −$6,336, −$2,932; p< 0.001) and total medical costs (MCD PPPY: −$6,166; 95% CI: −$9,011, −$3,322; p< 0.001) were significantly lower in the approved versus denied patients.

Conclusions: : Initiation of CladT was associated with significant reductions in MS relapse rates, decreased rehabilitation services use, and lower total medical costs, particularly outpatient costs, compared with patients denied coverage.

Sponsorship:: EMD Serono (CrossRef Funder ID: 10.13039/100004755).