Fibromyalgia, Painful Diabetic Peripheral Neuropathy
Conditions
Keywords
Prior authorization, Fibromyalgia, Painful Diabetic Peripheral Neuropathy, Policy, Real World Data
Brief summary
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
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.
Interventions
OTHERprior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
OTHERno prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| healthcare utilization costs (baseline to 6 mo.). | 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed