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

NCT05870956 | Completed Results FDA Drug

• 1 other identifier: 1199-0520
• Study Type: observational
• Target: 1,798
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two objectives:

1. 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. 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Total IPF-related Medical Costs

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

• All-cause Inpatient Hospitalization

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

• IPF-related Inpatient Hospitalization

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

Study Arms (5)

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.

Drug: Nintedanib

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.

Drug: Nintedanib

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.

Drug: Nintedanib

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.

Drug: Nintedanib

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.

Drug: Nintedanib

Interventions

Nintedanib DRUG

Nintedanib

Also known as: Ofev®

Delayed-poor nintedanib adherence; Early-poor nintedanib adherence; High nintedanib adherence; High-then-poor nintedanib adherence; Moderate nintedanib adherence

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IPF patients in United States which were newly initiated on nintedanib during 10-Jan-2014 to 31-Dec-2018.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Medicus Economics, LCC

Milton, Massachusetts, 02186, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study limitations included: the data source was composed of administrative claims; the adherence exposure was based on prescription fill data; the outcomes were measured contemporaneously with nintedanib adherence; the outcomes consisted of inpatient hospitalization and total medical spending; the early-poor adherence group consisted of a smaller sample; sample selection bias due to the time frame chosen for patient selection; COVID-19 might have impacted health care consumption patterns.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: May 16, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)