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Completed

NCT Number: NCT05141669

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigational Site

East Hanover, New Jersey, 07936-1080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingolimod

Drug

Participants who initiated fingolimod to treat multiple sclerosis (MS)

Primary outcomes

  1. Number of Multiple Sclerosis (MS) relapses

    Time frame: 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 (MS) relapses were reported to estimate the effect of fingolimod adherence on the odds of MS relapse in a 12-month period

Secondary outcomes

  1. Number of Multiple Sclerosis-related inpatient admission

    Time frame: 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 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.

  2. Number of Multiple Sclerosis-related Emergency Room (ER) visits

    Time frame: 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 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.

  3. All-cause total (medical plus pharmacy) health care costs

    Time frame: 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 (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.

  4. All-cause medical health care costs

    Time frame: 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)

    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.

  5. All-cause total (medical plus pharmacy) health care costs excluding fingolimod

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2021
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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