Impact of Fingolimod Adherence on Outcomes

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Fingolimod

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 694

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study comprised of commercial and Medicare Advantage with Part D (MAPD) enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fingolimod; Participants who initiated fingolimod to treat multiple sclerosis (MS)	Drug: Fingolimod; Participants who initiated fingolimod to treat multiple sclerosis (MS)
Non-fingolimod Disease Modifying Treatment (DMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Multiple Sclerosis (MS) relapses	Number of Multiple Sclerosis (MS) relapses were reported to estimate the effect of fingolimod adherence on the odds of MS relapse in a 12-month period	Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Multiple Sclerosis-related inpatient admission	Number of any Multiple Sclerosis-related inpatient admission were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.	Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
Number of Multiple Sclerosis-related Emergency Room (ER) visits	Number of Multiple Sclerosis-related ER visits were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.	Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause total (medical plus pharmacy) health care costs	All-cause total (i.e., pharmacy + medical costs) were computed as the combined health plan and patient paid amounts for all claims, regardless of diagnoses recorded. Medical costs comprised sub-categories of ambulatory costs (physician office and hospital outpatient), emergency services costs, inpatient costs, and other medical costs.	Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause medical health care costs	Medical health care costs were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.	Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)
All-cause total (medical plus pharmacy) health care costs excluding fingolimod	Total (medical plus pharmacy) health care costs excluding fingolimod were reported to estimate the effect of fingolimod adherence during a 12 month period for Disease Modifying Treatment (DMT) treatment-naïve adult MS patients in the commercial and MAPD populations.	Month 7 to Month 18 (12 months) of the post-index period. The date of the first fingolimod claim was the index date (01 January 2012 through 10 May 2018)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CFTY720DUS45 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720DUS45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No