Decreased Healthcare Resource Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch : A Retrospective Claims Analysis

Decreased Healthcare Resource Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis

Background:

ZTLido^® (lidocaine topical system 1.8%, “LTS”) and Lidoderm (lidocaine 5% patch, “LP”) are bioequivalent prescription lidocaine topical patches approved for the relief of pain associated with post-herpetic neuralgia (PHN), however, there is significant utilization in patients with lower back pain (LBP). Chronic LBP, which comprises both nociceptive and neuropathic pain, is often treated with topical lidocaine for the neuropathic component.

LTS and LP are identical in size and deliver the same amount of lidocaine through the skin, however the bioavailability of lidocaine from LTS is more than 10X compared to that from LP. The novel composition and design of LTS has demonstrated significantly better adhesion performance than branded and generic LP in comparative clinical studies (89-93% adhesion for LTS compared to 63% for branded LP and 27% for generic LP).  Poor adhesion impedes medication delivery and pain relief for patients.  As a result, lidocaine patches that adhere poorly or detach may result in ineffective pain management and potentially increased healthcare resource utilization.
 

Purpose/Objectives:

We sought to evaluate LTS’s superior adhesion performance seen in clinical studies, in the real world based on utilization data.  Using claims data, we evaluated the impact of LTS versus conventional LP on healthcare resource utilization, including office, outpatient and emergency room (ER)/urgent care visits.

Method:

This was a retrospective analysis using Optum's de-identified Normative Health Informatics (NHI) database consisting of commercial and Medicare Advantage claims from April 1, 2018 through March 31, 2023. The selected patient population was limited to patients 18 years of age or over with a diagnosis of  LBP and a first prescription fill (index) for a medication of interest (LTS or LP), and with at least 6 months of pre and post-index continuous medical and pharmacy eligibility. 

The change in pre- versus post-index healthcare utilization was compared for each treatment cohort (LTS and LP) in each of three settings:  outpatient (defined as outpatient to a hospital-based clinic, off-campus hospital affiliated clinic, or ambulatory surgical center), office (defined as office, federally qualified health center, or rural health clinic), and ER/urgent care.  Healthcare utilization metrics included the number of office visits, number of outpatient clinic visits, and number of ER/Urgent Care visits, evaluated for the 6-month look back and 6-month look forward periods before and after the first prescription fill, respectively.

Comparisons of count data in pre- and post-index settings were made with the Wilcoxon signed-rank test.  A random coefficient model with a Poisson distribution was used to determine if there was a statistical difference in change from pre- to post-index count between cohorts.

Results:

The final analysis included 19,487 patients (17,640 patients with a prescription for LP and 1,847 patients with a prescription for LTS) from the Optum Claims Database.

There was a 32.5% reduction in outpatient visits for LTS relative to LP in post-index outpatient visits after adjusting for pre-index visits (p< 0.001).  There was also a 15.1% reduction in ER/Urgent Care visits for LTS relative to LP (p< 0.001).  There was a 4.2% increase in office visits for LTS relative to LP (p=0.014).

Conclusions: Based on these findings, there was a slight increase in office visits with LTS vs with LP. Due to managed care restrictions for branded products, the LTS group may have included patients with more severe LBP and comorbidities, who thus had more pre-scheduled office visits that occurred after index treatment. A more significant association was seen in a decreased number of outpatient and ER/urgent care visits with LTS vs with LP, which may indicate an immediate effect of improved LBP symptom management with LTS.

References: Gudin J, Argoff C, Fudin J, et al. J Pain Res. 2020;13:1485-1496.
Gudin J, Webster LR, Greuber E, Vought K, Kuritzky L. J Pain Research. 2021:14:513-526.