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OpenTrials
Completed

NCT Number: NCT05870956

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

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.

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Key information

Age range

66 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicus Economics, LCC

Milton, Massachusetts, 02186, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nintedanib

Drug

Nintedanib

Other names: Ofev®

Primary outcomes

  1. Total All-cause Medical Costs

    Time frame: 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 outcomes

  1. Total IPF-related Medical Costs

    Time frame: 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.

  2. All-cause Inpatient Hospitalization

    Time frame: 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.

  3. IPF-related Inpatient Hospitalization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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