Economic Burden Associated With Nintedanib Non-adherence Among Medicare Beneficiaries With IPF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,798
- 试验地点
- 1
- 主要终点
- Total All-cause Medical Costs
研究概览
简要总结
This study has two objectives:
- To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF).
- To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF.
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
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly initiated nintedanib during 10/01/2014 to 12/31/2018
- •Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)
- •Qualified for Medicare based on age
- •Had at least 12 months of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months after the index date (follow-up period)
- •Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF (ICD-10-CM: J84.112; ICD-9-CM: 516.31) during the baseline period
排除标准
- •Had any history of pirfenidone or nintedanib use during the baseline period
- •Had any history of lung transplant during the baseline, index date or follow-up periods
- •Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period
- •Had evidence (≥2 ICD-9-CM or ICD-10-CM diagnosis codes on different dates) during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period
- •Had dual eligibility of Medicare and Medicaid
- •Had history of using pirfenidone at the same time with nintedanib during follow-up
研究组 & 干预措施
High nintedanib adherence
Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.
干预措施: Nintedanib (Drug)
Moderate nintedanib adherence
Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.
干预措施: Nintedanib (Drug)
High-then-poor nintedanib adherence
Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.
干预措施: Nintedanib (Drug)
Delayed-poor nintedanib adherence
Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.
干预措施: Nintedanib (Drug)
Early-poor nintedanib adherence
Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.
干预措施: Nintedanib (Drug)
结局指标
主要结局
Total All-cause Medical Costs
时间窗: At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Total all-cause medical costs per patient calculated as the sum of the total amounts paid for all medical services by the payer and the patient. The types of medical services covered by Medicare included inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visits, and other physician services covered under the Part B benefit. The costs with prescriptions covered under Part D benefit were excluded from this outcome analysis.
次要结局
- Total IPF-related Medical Costs(At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.)
- All-cause Inpatient Hospitalization(At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.)
- IPF-related Inpatient Hospitalization(At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.)