Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

Real-World Medication Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program.

This study has two objectives:

• Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients.
• Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Nintedanib

• Study Type: Observational
• Enrollment (Actual): 1798

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Milton, Massachusetts, United States, 02186
      • Medicus Economics, LCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study sample will consist of community-dwelling Medicare beneficiaries with Idiopathic Pulmonary Fibrosis (IPF) who initiate treatment with nintedanib.

Description

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 (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period)
• Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) 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 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Idiopathic Pulmonary Fibrosis Patients; Medicare beneficiaries with IPF who newly initiated treatment with nintedanib	Drug: Nintedanib; Nintedanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis (IPF) Patients	The number of IPF patients per adherence trajectories to nintedanib is presented. The first claim for nintedanib was used for defining the initiation date. For each 30-day month (12 months) following the nintedanib initiation date, the Proportions of Days Covered (PDC) were calculated as the sum of days with supply divided by 30, the monthly nintedanib proportion of days covered was then calculated. The twelve 30-days PDC values were used as outcomes in the Group-based trajectory model (GBTM), the probabilities that a given individual is in each of the latent clusters was calculated by the GBTM estimation procedure using the monthly binary PDC ≥ 0.8 indicators as outcomes. The reported types of trajectories to nintedanib were: Highly adherent (PDC ≈ 0.9); Medium adherent (PDC ≈ 0.4-0.6) - Gradual decliners (PDC bottoms out by month 11); Intermediate decliners (PDC bottoms out by month 8); Rapid decliners (PDC approaches zero by month 4)	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Characteristic: Age According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Age according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. Age for each patient was calculated by subtracting the year of birth from the year of index (i.e. Year of the index date- Year of birth). Year of index was defined as the year the patients where initiated on nintedanib treatment.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Demographic Characteristic: Sex According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients per sex according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
Demographic Characteristic: Race/Ethnicity According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients per Race/ethnicity according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
Demographic Characteristic: Census Region According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients per census region according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. The beneficiary's state of residence into Census regions (Northeast, South, Midwest, West and Puerto Rico) from the enrollment record and covering the index date.	Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
Demographic Characteristic: Social Deprivation Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Social deprivation index according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. Social deprivation index (SDI) was a continuous variable and ranged between 0 and 100 representing the SDI for the beneficiary's residential ZIP Code. Higher values for the SDI indicate more social deprivation. The SDI was calculated as a composite measure of seven demographic characteristics collected in the American Community Survey (ACS): percent living in poverty, percent with less than 12 years of education, percent single parent household, percent living in rented housing unit, percent living in overcrowded housing unit, percent of households without a car, and percent non-employed adults under 65 years of age.	Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
Clinical Characteristic: Combined Comorbidity Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Combined comorbidity index (CCI) according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. The CCI Gagne et al.'s (2011) scored ranging from 0 to 26 measured from comorbidity diagnosis codes on inpatient, outpatient and Carrier claims that occurred during the baseline period, Higher scores indicated a more severe condition. The 20 conditions (with their weights in parentheses) include: Metastatic cancer (5), Congestive heart failure (2), Dementia (2), Renal failure (2), Weight loss (2), Hemiplegia (1), Alcohol abuse (1), Any tumor (1), Cardiac arrhythmias (1), Chronic pulmonary disease (1), Coagulopathy (1), Complicated diabetes (1), Deficiency anemia (1), Fluid and electrolyte disorders (1), Liver disease (1), Peripheral vascular disease (1), Psychosis (1), Pulmonary circulation disorders (1), HIV/AIDS (-1), and Hypertension (-1). The cumulative weight of the 20 conditions yields the CCI.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic: Combined Comorbidity Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients per Combined comorbidity index (CCI) according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. The CCI Gagne et al.'s (2011) scored ranging from 0 to 26 as measured from comorbidity diagnosis codes in any position on inpatient, outpatient and Carrier claims that occurred during the baseline period, higher scores indicated a more severe condition. The 20 conditions in the CCI (with their weights in parentheses) include: Metastatic cancer (5), Congestive heart failure (2), Dementia (2), Renal failure (2), Weight loss (2), Hemiplegia (1), Alcohol abuse (1), Any tumor (1), Cardiac arrhythmias (1), Chronic pulmonary disease (1), Coagulopathy (1), Complicated diabetes (1), Deficiency anemia (1), Fluid and electrolyte disorders (1), Liver disease (1), Peripheral vascular disease (1), Psychosis (1), Pulmonary circulation disorders (1), HIV/AIDS (-1), and Hypertension (-1).	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic: Congestive Heart Failure According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Congestive heart failure according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Congestive heart failure on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic: Renal Failure According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Renal failure according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Renal failure on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Data collected at Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic: Cardiac Arrhythmias According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Cardiac arrhythmias according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Cardiac arrhythmias on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic: Peripheral Vascular Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Peripheral vascular disease according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Peripheral vascular disease on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic: Hypertension According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Hypertension according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Hypertension on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Comorbid Conditions: Asthma According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Asthma according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Asthma on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Comorbid Conditions: Chronic Obstructive Pulmonary Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Chronic obstructive pulmonary disease according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Chronic obstructive pulmonary disease on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Comorbid Conditions: Gastroesophageal Reflux Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Gastroesophageal reflux disease according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Gastroesophageal reflux disease on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Comorbid Conditions: Hypoxia According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Hypoxia according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Hypoxia on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Comorbid Conditions: Pulmonary Hypertension According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Pulmonary hypertension according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Pulmonary hypertension on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Comorbid Conditions: Sleep Apnea According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients with diagnosis of Sleep apnea according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a diagnosis code for Sleep apnea on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Medical Services: High-res CT (High-resolution Computed Tomography) Scan According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients that used the medical service: High-res CT (High-resolution computed tomography) scan according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had been performed a High-res CT scan on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Medical Services: Lung Biopsy According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients that were performed a Lung biopsy according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary had a Lung biopsy biopsy on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Clinical Characteristic- IPF Medical Services: Oxygen Therapy or Supplemental Oxygen According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Number of patients that received Oxygen therapy or supplemental oxygen according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. A binary indicator for whether the beneficiary received or not Oxygen therapy or supplemental oxygen on at least one inpatient, outpatient or Carrier claim that occurred during the baseline period.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Medication Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Medication count of the number of unique outpatient prescription medications for which beneficiary had claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Pharmacy Spending According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Total amount paid (Pharmacy spending) by all parties for outpatient prescription medications as reported in claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Pharmacy Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid out-of-pocket (Pharmacy spending - OOP) by the beneficiary for outpatient prescription medications as reported in Part D claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hospitalization According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	Inpatient hospitalization was a binary indicator for whether a beneficiary had at least one inpatient hospitalization for any cause during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The count of the number of inpatient hospitalizations for any cause a beneficiary had during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics -Inpatient Hospitalization Use and Spending: Inpatient Hosp - LOS According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The count of the number of days (length of stay (LOS)) a beneficiary was hospitalized in an inpatient facility during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. Length of stay for each inpatient hospitalization claim was calculated as the arithmetic difference between each claim's from and through dates.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp. Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid by all parties for all inpatient hospitalizations (for any cause) as reported in inpatient facility claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. This was calculated as the sum of the Medicare payment amount, the Medicare per diem amount, the non-Medicare payer amount, and the patient OOP amount.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp. Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid out-of-pocket (Inpatient hosp. spending - OOP) by the beneficiary for all inpatient hospitalizations (for any cause) as reported in inpatient facility claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Outpatient Facility Use and Spending: Outpatient Facility - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The count of the number of unique dates with an outpatient facility (Outpatient facility - count) for any cause claim a beneficiary had during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics: Outpatient Facility Use and Spending: Outpatient Facility Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid by all parties for outpatient facility claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. This was calculated as the sum of the Medicare payment amount, the blood deductible liability amount, the non-Medicare payer amount, and the patient OOP amount.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Outpatient Facility Use and Spending: Outpatient Facility Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid out-of-pocket by the beneficiary for services as reported in outpatient facility claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics -Home Health Use and Spending: Home Health - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The count of the number of home health visits a beneficiary had during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. It was calculated by summing the total visit count on each claim across claims.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Home Health Use and Spending: Home Health Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid by all parties (Home health spending - total) for home health claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. This was calculated as the sum of the Medicare payment amount, the blood deductible liability amount, the non-Medicare payer amount, and the patient OOP amount.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Part B Spending: Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid by all parties for Carrier and Durable Medical Equipment claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. It was calculated as the sum of the allowed amounts on each claim.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics -Part B Spending: Part B Spending - OOP: According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid out-of-pocket (Part B spending - OOP) by the beneficiary for Carrier and Durable Medical Equipment claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Total Spending: Total Medical Spending According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid by all parties for all medical services during the baseline period, including inpatient, outpatient, home health and Part B, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Total Spending: All Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid by all parties for all medical and pharmacy claims during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported. Was calculated as the sum of total pharmacy and total medical spending.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Beneficiary Characteristics - Total Spending: All Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib	The total amount paid out-of-pocket (OOP) by the beneficiary during the baseline period, according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.	Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Nintedanib
• Other Study ID Numbers: 1199-0471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No