Impact of Fingolimod Adherence on Outcomes

Multiple Sclerosis Clinical Trial

Official title:

Impact of Fingolimod Adherence on Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141669
• Other study ID #: CFTY720DUS45
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 694
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Fingolimod
Participants who initiated fingolimod to treat multiple sclerosis (MS)

Locations

Country	Name	City	State
United States	Novartis Investigational Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Results for CFTY720DUS45 from the Novartis Clinical Trials Website