Impact of Fingolimod Adherence on Outcomes

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Observational

Funder types: Industry

Identifiers

NCT05141669

CFTY720DUS45

Details and patient eligibility

About

This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.

Full description

The study sample comprised commercial and MAPD enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018. The date of the first fingolimod pharmacy claim during the identification period was the index date.

All patients were continuously enrolled in the health plan for 24 months. The 6-month pre-index period, ending the day before the index date, was used to assess patients' clinical characteristics (e.g., comorbid conditions and MS symptoms). The 18-month post-index period started on the index date. The first 6 months of the post-index period (initiation period) were used to assess MS symptoms and adherence. Months 7 - 18 of the post-index period (post-initiation period) were used to measure adherence and outcomes. The 24-month observation period for each patient comprised the 6-month pre-index and 18-month post-index periods.

Enrollment: 694 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old during year of index date with valid gender and geographic information

• Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)

• CE with medical and pharmacy benefits for ≥18 months (540 days) beginning on the index date (post-index period)

  • All patients had uniform 6-month pre-index and 18-month post-index periods

• ≥1 medical claim with an MS diagnosis codei in any position during the pre-or post-index periods

• ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)

  • By requiring ≥1 medical claim with an MS diagnosis code and ≥2 claims with an NDC for fingolimod, the inclusion criteria essentially incorporated the preferred/overall best performing MS case-finding definition validated by Culpepper et al. The criteria for that definition required at least 3 separate encounters from any of the following: MS-related ambulatory visits, MS-related inpatient stays, and DMT claims during a 12-month period. Slightly higher accuracy was found when a 24-month period was used.

Exclusion criteria

•≥1 pharmacy or medical claim for any MS DMT during the pre-index period

Trial design

694 participants in 2 patient groups

Fingolimod

Description:

Participants who initiated fingolimod to treat multiple sclerosis (MS)

Treatment:

Drug: Fingolimod

Non-fingolimod Disease Modifying Treatment (DMT)

Description:

All patients with ≥ 1 medical or pharmacy claim for a DMT other than fingolimod. Among patients included in the study that those with ≥ 1 pharmacy or medical claim for any MS DMT during pre-index would be excluded.