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

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT05870956

1199-0520

Details and patient eligibility

About

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.

Enrollment: 1,798 patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,798 participants in 5 patient groups

High nintedanib adherence

Description:

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.

Treatment:

Drug: Nintedanib

Moderate nintedanib adherence

Description:

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.

Treatment:

Drug: Nintedanib

High-then-poor nintedanib adherence

Description:

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.

Treatment:

Drug: Nintedanib

Delayed-poor nintedanib adherence

Description:

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.

Treatment:

Drug: Nintedanib

Early-poor nintedanib adherence

Description:

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.

Treatment:

Drug: Nintedanib