Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

Detailed Description
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The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates used to select the propensity matched patients will include: age; gender; health plan type and region; DCI score; presence/absence of nephropathy; ischemic heart disease; cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont pre-index period. Claims information about patients selected for the study will be followed longitudinally to the end of data availability. This data stream will be used to determine treatment patterns for Metanx®, healthcare resource utilization, and cost.

Official Title
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Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Conditions
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Diabetic Peripheral Neuropathy (DPN)

Intervention / Treatment
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* Other: Metanx® (a medical food)
* Other: Not treated with Metanx®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have pharmacy claims for >120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date. Patients must have a diagnosis of diabetes prior to or including the index date. Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder. Patients must have a diagnosis of lower limb ulcer. Exclusion Criteria: Patients will be excluded if they have <18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility. Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with >1mg folic acid.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test Cohort<br>100 randomized subjects administered Metanx® | Other: Metanx® (a medical food)<br>* Patient cohort compliant on Metanx® BID therapy for >120 days<br>|
| Control Cohort<br>400 subjects with diabetes mellitus meeting the same inclusion and exclusion criteria as the test cohort who have not been treated with Metanx®. | Other: Not treated with Metanx®<br>* Non-treated comparative cohort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Health Plan Costs | Total healthcare utilization and costs for patients treated with Metanx® will be compared to total healthcare utilization and costs for control patients who did not receive Metanx®. Cost data will be presented as Mean (SD) and median. | 12 months post-index period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Attributable Resoure Use and Cost | Disease attributable resource use and costs will be defined as medical claims associated with ICD-9 codes for disease(s) of interest. Total attributable resource use (units) and cost (allowed or paid), if available, will include: pharmacy (medication related to disease of interest); laboratory tests (all claims); office-based encounters and costs; emergency room visits and cost; other outpatient facility (e.g. clinic, home health); in-patient hospitalization; and durable medical equipment. | 12 month post-index period | 
| Demographics of Patients Taking Metanx® | Statistical data including age (at index date); gender; comorbidities; prior and concomitant medications; and Metanx® utilization (e.g. dispensing quantity, number of fills, compliance, and persistency) will be collected to provide a descriptive analysis of the typical Metanx® patient characteristics. | >120 continuous days Metanx® therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metanx®, diabetes, neuropathy, peripheral neurological disorder, peripheral circulation disorder, folic acid, folate, L-methylfolate, vitamin B6, Pyridoxal 5'-phosphate, vitamin B12, methylcobalamin