Clinical trial NCT05870956: Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
Official title: Economic Burden Associated With Nintedanib Non-adherence Among Medicare Beneficiaries With IPF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 1798
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total All-cause Medical Costs
timeFrame: At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Secondary outcomes:
measure: Total IPF-related Medical Costs
timeFrame: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
measure: All-cause Inpatient Hospitalization
timeFrame: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
measure: IPF-related Inpatient Hospitalization
timeFrame: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Other outcomes:
Locations:
city: Milton
country: United States
facility: Medicus Economics, LCC
state: Massachusetts
Study officials:
References: