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

Study Overview
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Brief Summary
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This study has two objectives: 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). 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.

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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Nintedanib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IPF patients initiated on nintedanib during 10/01/2014 to 12/31/2018<br> | Drug: Nintedanib<br>* Nintedanib<br>* Other names: Ofev®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| All-cause inpatient hospitalization |  | up to 1 year after initiation of nintedanib. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| IPF-related inpatient hospitalization |  | up to 1 year after initiation of nintedanib. |