Trial Outcomes & Findings for Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients (NCT NCT05022784)

A Real world, non-interventional study based on existing data from administrative enrollment and claims data from the United States (U.S.) federal Medicare program for beneficiaries who were continuously enrolled in Original Medicare insurance coverage. The study aimed to identify adherence trajectories of nintedanib use among Idiopathic Pulmonary Fibrosis (IPF) patients and to understand characteristics of patients within each nintedanib adherence trajectory among IPF patients.

Only subjects that met all inclusion and none of the exclusion criteria were included.

Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis 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)

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.

Number of patients per sex according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.

Number of patients per Race/ethnicity according to adherence trajectories for the idiopathic pulmonary fibrosis (IPF) patients who were initiated on nintedanib is reported.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.