Impact of Fingolimod Adherence on Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 694
- 试验地点
- 1
- 主要终点
- Number of Multiple Sclerosis (MS) relapses
研究概览
简要总结
This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •≥1 pharmacy or medical claim for any MS DMT during the pre-index period
研究组 & 干预措施
Fingolimod
Participants who initiated fingolimod to treat multiple sclerosis (MS)
干预措施: Fingolimod (Drug)
结局指标
主要结局
Number of Multiple Sclerosis (MS) relapses
时间窗: 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
次要结局
- All-cause total (medical plus pharmacy) health care 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(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(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 inpatient admission(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(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))