Trial Outcomes & Findings for Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients (NCT NCT05870956)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1798 participants

Primary outcome timeframe

At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.

Results posted on

2024-10-01

Participant Flow

Retrospective cohort study using United States (US) Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) administrative claims to characterize the trajectory of adherence to nintedanib in Idiopathic Pulmonary Fibrosis (IPF) patients as measured during the first year following initiation. The study uses data covering the period of 01-Oct-2013 to 31-12-2020, capturing the first use of nintedanib (index date) between 01-Oct-2014 and 31-Oct-2018.

Patients that met all inclusion criteria and none of the exclusion criteria were followed 12 months before the first use of nintedanib (baseline period) to 24 months after its initiation.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	781	202	190	255	370
Overall Study COMPLETED	781	202	190	255	370
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Nintedanib Adherence n=781 Participants 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.	Moderate Nintedanib Adherence n=202 Participants 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-then-poor Nintedanib Adherence n=190 Participants 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.	Delayed-poor Nintedanib Adherence n=255 Participants 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 n=370 Participants 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.	Total n=1798 Participants Total of all reporting groups
Age, Continuous	74.65 Years STANDARD_DEVIATION 5.36 • n=5 Participants	75.21 Years STANDARD_DEVIATION 5.45 • n=7 Participants	75.89 Years STANDARD_DEVIATION 5.60 • n=5 Participants	76.29 Years STANDARD_DEVIATION 5.61 • n=4 Participants	76.21 Years STANDARD_DEVIATION 5.62 • n=21 Participants	75.40 Years STANDARD_DEVIATION 5.53 • n=10 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	89 Participants n=7 Participants	66 Participants n=5 Participants	117 Participants n=4 Participants	177 Participants n=21 Participants	700 Participants n=10 Participants
Sex: Female, Male Male	530 Participants n=5 Participants	113 Participants n=7 Participants	124 Participants n=5 Participants	138 Participants n=4 Participants	193 Participants n=21 Participants	1098 Participants n=10 Participants
Race/Ethnicity, Customized Non-hispanic white	718 Participants n=5 Participants	183 Participants n=7 Participants	171 Participants n=5 Participants	237 Participants n=4 Participants	329 Participants n=21 Participants	1638 Participants n=10 Participants
Race/Ethnicity, Customized Not non-hispanic white	63 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	18 Participants n=4 Participants	41 Participants n=21 Participants	160 Participants n=10 Participants

PRIMARY outcome

Timeframe: At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.

Population: Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.

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.

Outcome measures

Outcome measures
Measure	High Nintedanib Adherence n=781 Participants 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.	Moderate Nintedanib Adherence n=202 Participants 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-then-poor Nintedanib Adherence n=190 Participants 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.	Delayed-poor Nintedanib Adherence n=255 Participants 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 n=370 Participants 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.
Total All-cause Medical Costs	12647.73 United States dollars Standard Deviation 16996	13580.61 United States dollars Standard Deviation 18479	17549.74 United States dollars Standard Deviation 27854	15375.10 United States dollars Standard Deviation 16999	18110.14 United States dollars Standard Deviation 26365

SECONDARY outcome

Timeframe: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.

Population: Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.

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.

Outcome measures

Outcome measures
Measure	High Nintedanib Adherence n=781 Participants 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.	Moderate Nintedanib Adherence n=202 Participants 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-then-poor Nintedanib Adherence n=190 Participants 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.	Delayed-poor Nintedanib Adherence n=255 Participants 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 n=370 Participants 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.
Total IPF-related Medical Costs	3239.75 United States dollars Standard Deviation 6313	2935.82 United States dollars Standard Deviation 4574	6011.81 United States dollars Standard Deviation 16239	3696.54 United States dollars Standard Deviation 6525	3860.62 United States dollars Standard Deviation 12947

SECONDARY outcome

Timeframe: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.

Population: Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.

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.

Outcome measures

Outcome measures
Measure	High Nintedanib Adherence n=781 Participants 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.	Moderate Nintedanib Adherence n=202 Participants 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-then-poor Nintedanib Adherence n=190 Participants 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.	Delayed-poor Nintedanib Adherence n=255 Participants 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 n=370 Participants 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.
All-cause Inpatient Hospitalization	20.4 Percentage of participants	22.8 Percentage of participants	30.0 Percentage of participants	29.4 Percentage of participants	26.8 Percentage of participants

SECONDARY outcome

Timeframe: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.

Population: Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.

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.