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

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.

Study Overview

• Status: Terminated
• Conditions: Fibromyalgia; Painful Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: prior authorization; Other: no prior authorization

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Osteoporosis Medical Center
    • Lomita, California, United States, 90717
      • Torrence Clinical Research
    • Orange, California, United States, 92868
      • Joo-Hyung Lee, MD
    • Santa Maria, California, United States, 93455
      • Thomas M Dawes Jr. MD
    • Tulare, California, United States, 93274
      • Tulare Family Practice Medical Group
    • West Hills, California, United States, 91307
      • Affiliates of Medical Specialties
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Primary Care Specialists LLC
    • Augusta, Georgia, United States, 30906
      • Southern Family Medical Center, PC
    • Hiram, Georgia, United States, 30141
      • WeCareMD, P.C.
    • Stockbridge, Georgia, United States, 30281
      • Pain Care LLC
  • Indiana
    • Anderson, Indiana, United States, 46012
      • Broadway Family Medicine
    • Chesterton, Indiana, United States, 46304
      • Duneland Health and Wellness Institute
  • New Hampshire
    • No Conway, New Hampshire, United States, 03860
      • Alan S. Goldenhar, DPM
  • New York
    • Smithtown, New York, United States, 11787
      • Endocrine Associates of Long Island, P.C.
  • Ohio
    • Miamisburg, Ohio, United States, 45342
      • Mound Family Practice
    • Piqua, Ohio, United States, 45356
      • Piqua Family Practice
  • Virginia
    • Ettrick, Virginia, United States, 23803
      • Ettrick Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

There are six practice types that are expected to be able to provide patients to this study. Of these, four (internal medicine, family/general practitioners, neurologists, and anesthesia/pain physicians) will be expected to enroll patients into both pDPN and FM disease groups. The fifth group, rheumatology physicians, will be expected to enroll patients into the FM cohort only and the sixth group, endocrinologists, will be expected to enroll patients into the pDPN cohort only.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place	Other: prior authorization; This is a naturalistic study. The physician will prescribe medication(s) as appropriate
2; Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place	Other: no prior authorization; This is a naturalistic study. The physician will prescribe medication(s) as appropriate
3; Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place	Other: prior authorization; This is a naturalistic study. The physician will prescribe medication(s) as appropriate
4; Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place	Other: no prior authorization; This is a naturalistic study. The physician will prescribe medication(s) as appropriate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Fibromyalgia; Painful Diabetic Peripheral Neuropathy; Real World Data; Policy; Prior authorization
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: A0081247