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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Economic Burden Associated With Nintedanib Non-adherence Among Medicare Beneficiaries With IPF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05870956
• Other study ID #: 1199-0520
• Status: Completed
• Start date: May 16, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1798
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
United States	Medicus Economics, LCC	Milton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause medical costs	All-cause medical costs will be calculated as the sum of total amounts paid (by payers and patients) for all medical services which include inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visit etc.	up to 1 year after initiation of nintedanib.
Primary	All-cause inpatient hospitalization		up to 1 year after initiation of nintedanib.
Secondary	Total IPF-related medical costs	Total IPF-related medical costs will be calculated as the sum of total amounts paid (by payers and patients) for all medical services for an IPF-related reason (at least one IPF diagnosis code).	up to 1 year after initiation of nintedanib.
Secondary	IPF-related inpatient hospitalization		up to 1 year after initiation of nintedanib.

External Links

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