Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database

Study Overview
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Brief Summary
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Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs. The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and length of therapy and the likelihood of acute urinary retention (AUR), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and Medicare population. The null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs. The data source for this analysis is the MarketScan database, which contains medical and pharmacy claims for commercial health plan members and Medicare recipients. Medical and pharmacy claims data are sourced directly from health plans and employers. The database represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid enrollees from multiple states. The database includes the Medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary. The study design is a retrospective cohort analysis. Each patient's index date was defined as the date of the first fill for a 5ARI prescription.

Official Title
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Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: 5ARI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age 65 or older A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx) A prescription claim for a 5ARI for at least 60 days during the observation period Continuous eligibility for 6 months prior to and at least 91 days after the index date Exclusion Criteria: A prostate cancer diagnosis A procedure cost for any prostate-related surgical procedure prior to the index date

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Patients adherent to 5-alpha reductase inhibitor (5ARI)<br>Patients with benign prostate hyperplasia (BPH) who are adherent (as measured by a medication possession ratio (MPR)) based on 3 MPR threshold values of 70%, 75% and 80% | Drug: 5ARI<br>* dutasteride or finasteride<br>* Other names: Avodart® (dutasteride);|
| Patients who are non-adherent to 5ARI therapy<br>Patients with BPH who are not adherent to 5ARI therapy as measured by 3 MPR threshold values of 70%, 75%, and 80% | Drug: 5ARI<br>* dutasteride or finasteride<br>* Other names: Avodart® (dutasteride);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery | AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP) | 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted benign prostatic hyperplasia (BPH)-related costs | Differences in cost will be compared across cohorts. BPH-related costs include those associated with ICD-9-CM codes 222.2x or 600.xx | 1 year following the first therapy date | 
| Medication Possession Ratio (MPR) | A measure of medication adherence (compliance and discontinuation) in patients taking monotherapy versus early combination therapy. Discontinuation is defined as a 30-day gap in therapy | 1 year following the first therapy date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hyperplasia, acute urinary retention, adherence, 5-alpha reductase inhibitor, enlarged prostate, surgery