Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

Study Overview
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Brief Summary
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The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher healthcare resource use and cost compared to patients without such restrictions on pregabalin in a naturalistic setting. The randomization will occur at the physician level and not the patient level.

Detailed Description
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This trial was terminated prematurely on April 2, 2012, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns.

Official Title
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Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

Conditions
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Fibromyalgia, Painful Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: prior authorization
* Other: no prior authorization
* Other: prior authorization
* Other: no prior authorization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A physician-confirmed diagnosis of either pDPN or FM, but not both. Initiation of a medication for pDPN or FM is clinically indicated, either as monotherapy or in combination with other treatments, as determined by the treating physician, and agreed to by the patient. No prior pregabalin use or pregabalin PA requests. Exclusion Criteria: Age < 18 years at time of study enrollment. Females or are partners of males currently pregnant/lactating or intending to become pregnant in the next 6 months Physician-confirmed diagnosis of both pDPN and FM.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| 1<br>Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place | Other: prior authorization<br>* This is a naturalistic study. The physician will prescribe medication(s) as appropriate<br>|
| 2<br>Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place | Other: no prior authorization<br>* This is a naturalistic study. The physician will prescribe medication(s) as appropriate<br>|
| 3<br>Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place | Other: prior authorization<br>* This is a naturalistic study. The physician will prescribe medication(s) as appropriate<br>|
| 4<br>Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place | Other: no prior authorization<br>* This is a naturalistic study. The physician will prescribe medication(s) as appropriate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the between-group difference (baseline to 6 mo.) in direct all-cause medical costs for patients with pDPN and FM in real-world treatment settings with a prior authorization (PA) versus no PA policy in place restricting access to |  | 6 months | 
| pregabalin |  | 6 months | 
| Evaluate the within-group differences (baseline to 6 mo.) in pain alleviation (using the 11 point numerical rating scale) in patients with pDPN and FM in real-world settings with a PA versus no PA policy in place restricting access to |  | 6 months | 
| pregabalin. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe how pharmacologic treatment patterns for pDPN or FM differ between groups with PA and without PA in patients being treated in a naturalistic outpatient care setting, and who are followed for 6 mo. |  | 6 months | 
| Describe non-pharmacologic treatment patterns in pDPN and FM patients in groups with PA versus no PA while being treated in a naturalistic outpatient care setting, and who are followed for 6 mo. |  | 6 months | 
| Subset of patients who have at least 6 mo. pre-study time in the HIRD (HealthCore Integrated Research DatabaseSM) a within-group costs analysis (all cause) comparing pre-study healthcare utilization costs for the 6 mo. pre-baseline with on-study |  | 6 months | 
| healthcare utilization costs (baseline to 6 mo.). |  | 6 months | 
| Assess changes (baseline through 6 mo.) in other PRO measures in pDPN and FM patients subject to PA requirements for pregabalin versus those with no PA. |  | 6 months | 
| Compare the within-group differences (baseline to 6 mo.) in pain alleviation (using the NRS-11 scale) between groups (PA versus no PA), by condition (pDPN or FM). |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prior authorization, Fibromyalgia, Painful Diabetic Peripheral Neuropathy, Policy, Real World Data