Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib

Registration Number: NCT05870956

Lead Sponsor: Boehringer Ingelheim

Brief Summary: This study has two objectives:

1. 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).

2. 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1798

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-then-poor nintedanib adherence	Nintedanib	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.
Moderate nintedanib adherence	Nintedanib	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.
High nintedanib adherence	Nintedanib	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.
Delayed-poor nintedanib adherence	Nintedanib	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.
Early-poor nintedanib adherence	Nintedanib	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.

Primary Outcome Measures

Name	Time	Method
Total All-cause Medical Costs	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.

Secondary Outcome Measures

Name	Time	Method
Total IPF-related Medical Costs	At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.	The total Idiopathic Pulmonary Fibrosis (IPF) related medical costs per patient were calculated as the sum of the total amounts paid by the payers and the patients for all medical services for an IPF-related reason containing at least one IPF diagnosis code.
All-cause Inpatient Hospitalization	At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.	Percentage of patients with at least one inpatient hospitalization for any cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.
IPF-related Inpatient Hospitalization	At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.	Percentage of patients with at least one inpatient hospitalization for any Idiopathic Pulmonary Fibrosis (IPF)-related cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.