Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGNintedanib
Nintedanib
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 781 |
| 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. | 202 |
| 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. | 190 |
| 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. | 255 |
| 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. | 370 |
| Total | 1,798 |
Baseline characteristics
| Characteristic | High Nintedanib Adherence | Moderate Nintedanib Adherence | High-then-poor Nintedanib Adherence | Delayed-poor Nintedanib Adherence | Early-poor Nintedanib Adherence | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 74.65 Years STANDARD_DEVIATION 5.36 | 75.21 Years STANDARD_DEVIATION 5.45 | 75.89 Years STANDARD_DEVIATION 5.6 | 76.29 Years STANDARD_DEVIATION 5.61 | 76.21 Years STANDARD_DEVIATION 5.62 | 75.40 Years STANDARD_DEVIATION 5.53 |
| Race/Ethnicity, Customized Non-hispanic white | 718 Participants | 183 Participants | 171 Participants | 237 Participants | 329 Participants | 1638 Participants |
| Race/Ethnicity, Customized Not non-hispanic white | 63 Participants | 19 Participants | 19 Participants | 18 Participants | 41 Participants | 160 Participants |
| Sex: Female, Male Female | 251 Participants | 89 Participants | 66 Participants | 117 Participants | 177 Participants | 700 Participants |
| Sex: Female, Male Male | 530 Participants | 113 Participants | 124 Participants | 138 Participants | 193 Participants | 1098 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Total All-cause Medical Costs
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Nintedanib Adherence | Total All-cause Medical Costs | 12647.73 United States dollars | Standard Deviation 16996 |
| Moderate Nintedanib Adherence | Total All-cause Medical Costs | 13580.61 United States dollars | Standard Deviation 18479 |
| High-then-poor Nintedanib Adherence | Total All-cause Medical Costs | 17549.74 United States dollars | Standard Deviation 27854 |
| Delayed-poor Nintedanib Adherence | Total All-cause Medical Costs | 15375.10 United States dollars | Standard Deviation 16999 |
| Early-poor Nintedanib Adherence | Total All-cause Medical Costs | 18110.14 United States dollars | Standard Deviation 26365 |
p-value: 0.51695% CI: [-1880.17, 3745.94]ANOVA
p-value: 0.0295% CI: [767.6, 9036.43]ANOVA
p-value: 0.02695% CI: [323.48, 5131.27]ANOVA
p-value: 095% CI: [2520.93, 8403.9]ANOVA
Secondary
All-cause Inpatient Hospitalization
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Nintedanib Adherence | All-cause Inpatient Hospitalization | 20.4 Percentage of participants |
| Moderate Nintedanib Adherence | All-cause Inpatient Hospitalization | 22.8 Percentage of participants |
| High-then-poor Nintedanib Adherence | All-cause Inpatient Hospitalization | 30.0 Percentage of participants |
| Delayed-poor Nintedanib Adherence | All-cause Inpatient Hospitalization | 29.4 Percentage of participants |
| Early-poor Nintedanib Adherence | All-cause Inpatient Hospitalization | 26.8 Percentage of participants |
p-value: 0.46395% CI: [-4, 8.9]Chi-squared
p-value: 0.00895% CI: [2.5, 16.8]Chi-squared
p-value: 0.00595% CI: [2.8, 15.3]Chi-squared
p-value: 0.01995% CI: [1.1, 11.7]Chi-squared
Secondary
IPF-related Inpatient Hospitalization
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Nintedanib Adherence | IPF-related Inpatient Hospitalization | 10.8 Percentage of participants |
| Moderate Nintedanib Adherence | IPF-related Inpatient Hospitalization | 11.4 Percentage of participants |
| High-then-poor Nintedanib Adherence | IPF-related Inpatient Hospitalization | 19.5 Percentage of participants |
| Delayed-poor Nintedanib Adherence | IPF-related Inpatient Hospitalization | 14.1 Percentage of participants |
| Early-poor Nintedanib Adherence | IPF-related Inpatient Hospitalization | 12.2 Percentage of participants |
p-value: 0.80195% CI: [-4.3, 5.5]Chi-squared
p-value: 0.00595% CI: [2.7, 14.8]Chi-squared
p-value: 0.1795% CI: [-1.4, 8.2]Chi-squared
p-value: 0.48995% CI: [-2.6, 5.4]Chi-squared
Secondary
Total IPF-related Medical Costs
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Nintedanib Adherence | Total IPF-related Medical Costs | 3239.75 United States dollars | Standard Deviation 6313 |
| Moderate Nintedanib Adherence | Total IPF-related Medical Costs | 2935.82 United States dollars | Standard Deviation 4574 |
| High-then-poor Nintedanib Adherence | Total IPF-related Medical Costs | 6011.81 United States dollars | Standard Deviation 16239 |
| Delayed-poor Nintedanib Adherence | Total IPF-related Medical Costs | 3696.54 United States dollars | Standard Deviation 6525 |
| Early-poor Nintedanib Adherence | Total IPF-related Medical Costs | 3860.62 United States dollars | Standard Deviation 12947 |
p-value: 0.43995% CI: [-1074.77, 466.9]ANOVA
p-value: 0.02195% CI: [422.1, 5122.02]ANOVA
p-value: 0.32895% CI: [-458.64, 1372.21]ANOVA
p-value: 0.38295% CI: [-771.77, 2013.51]ANOVA