Systemic Opioid Prescribing Patterns and Total Cost of Care in Patients Initiating Spinal Cord Stimulation Therapy: A Retrospective Analysis.

BACKGROUND: Few studies have evaluated patterns of systemic opioid use among patients initiating spinal cord stimulation therapy for chronic pain. This study evaluated systemic opioid discontinuation and/or dose reduction and total health care cost after the start of spinal cord stimulation therapy. METHODS: Using a commercial insurance claims database (2008-2017), we analyzed opioid utilization patterns in patients initiating spinal cord stimulation therapy over a 1-year baseline and 2-year follow-up. The primary end point was defined as either discontinuation (≥365-day gap between prescription fills or total days' supply in follow-up ≤30 days) or ≥50% reduction in average daily morphine milligram equivalent dose. "Costs" were defined as total payer plus patient out-of-pocket payments. RESULTS: A total of 5,878 patients met the selection criteria. Of these, 152 (2.6%) showed no opioid prescription data at any point in the study period. Among patients with one or more prescriptions, 42.0% met the primary end point (22.0% discontinued, and 20.0% reduced their dose by 50% or more). Mean total adjusted costs were significantly reduced in years 1 and 2 of follow-up relative to baseline (excluding device insertion costs). The average time to breakeven when accounting for device trial and permanent insertion cost was 3.1 years among those who met the composite end point and 4.2 years among those who did not. CONCLUSIONS: This analysis shows that among patients who continued spinal cord stimulation therapy for at least 2 years, a significant proportion were able to reduce and/or discontinue systemic opioid use, with costs after the start of therapy significantly reduced relative to baseline.

Using Lower Amplitudes to Maintain Effective High Dose Spinal Cord Stimulation Therapy (SCS Dosing Pilot Study).

BACKGROUND: Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. This study characterized the minimum amplitude level that maintained SCS therapy satisfaction and pain relief when stimulating at 1000 Hz and 90 µsec. MATERIALS AND METHODS: Qualified patients had back and leg pain, an implanted neurostimulator programmed to 1000 Hz and 90 µsec, and were very or somewhat satisfied with the therapy, and an average overall VAS pain score ≤ 4 from a daily diary. Patients received four blinded amplitudes (titrated from 80%, 60%, 40%, and 20% of baseline perception threshold), approximately two weeks each, with 1000 Hz and 90 µsec and position-adaptive stimulation enabled. Patients' satisfaction and overall VAS pain scores were collected for each period. All patients continued through the study, even after reporting lack of therapy satisfaction or pain relief. RESULTS: The minimum amplitude, which maintained therapy satisfaction, was 80% of perception threshold for two patients, 60% for one patient, and 20% for 21 patients. Additionally, six patients lost satisfaction changing from their baseline amplitude to 80% perception threshold. The minimum amplitude level, which maintained overall pain relief, was 80% perception threshold for three patients, 60% perception threshold for one patient, 40% perception threshold for two patients, and 20% perception threshold for 19 patients. Five patients required the setting they were programmed to during the baseline period. CONCLUSION: The qualified study patients defined an implanted population reporting good pain relief and satisfaction using HD SCS therapy at baseline. The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude. Amplitudes below perception threshold could potentially maintain effective SCS therapy with HD stimulation in a subset of patients.

Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study.

BACKGROUND AND OBJECTIVES: Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach. MATERIALS AND METHODS: Vectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction. RESULTS: There was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit. CONCLUSIONS: Long-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03345472.

Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis.

OBJECTIVE: The study evaluated systemic opioid utilization before and after initiation of intrathecal drug therapy in patients with chronic, noncancer pain, as well as the effect of opioid elimination on payer costs. METHODS: This was a retrospective cohort analysis of administrative claims data (2011-2016), evaluating patients using systemic opioids for chronic, noncancer pain, newly implanted with an intrathecal drug-delivery system. Patients were excluded for spasticity, cancer, and device explant. The primary outcome was reduction or discontinuation of systemic morphine milligram equivalents during a 395-day follow-up period. The secondary outcome was total commercial insurer payments. RESULTS: Of 9223 total patients, 631 met selection criteria. From baseline to 395-day follow-up, average daily morphine milligram equivalents decreased in 81.5% of patients, and 43.3% discontinued systemic opioid therapy entirely. Among patients who continued systemic opioids, average daily morphine milligram equivalents decreased in 74.9% of patients. Logistic regression found that morphine milligram equivalents of <50 mg/day prior to initiation of intrathecal drug delivery was associated with two times the odds of discontinuation vs. ≥90 mg/day (odds ratio = 2.08, 95% confidence interval 1.42-3.02, p = 0.001). Mean annual payer costs were reduced 29% for patients who discontinued vs. continued systemic opioids (-$11,115 per patient). CONCLUSIONS: A meaningful proportion of patients discontinue or decrease systemic opioid use following initiation of intrathecal drug delivery. Standard of care should include opioid dose tapering prior to intrathecal drug delivery to maximize the probability of systemic opioid discontinuation.

Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures.

OBJECTIVE: To compare health-care expenditures over a 12-month horizon for chronic pain patients with implanted intrathecal drug delivery systems (IDDS) who eliminated or continued systemic opioids postimplant. METHODS: Claims data from commercial and Medicare databases were searched for patients who had an IDDS, used systemic opioids before implant, and had 12 months pre- and 13 months postimplant continuous medical and pharmacy coverage. The number and characteristics of patients who eliminated or continued systemic opioids were determined at four times postimplant: 30 days (allowing a systemic opioid washout period), 120 days, 150 days, and 210 days. Multivariable models evaluated the effect of eliminating opioids on health-care expenditures at each of those times. RESULTS: Three hundred eighty-nine patients met inclusion criteria, and 51% completely eliminated systemic opioids (12% within the 30-day washout and an additional 39% by the end of the one-year horizon). Systemic opioid elimination within 120 to 210 days postimplant was associated with a reduction of $3,388 to $4,465 in inpatient and outpatient expenditures, and $4,689 to $5,571 in inpatient, outpatient, and drug expenditures. CONCLUSIONS: Fifty-one percent of patients completely eliminated systemic opioids in the year after IDDS implant. This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures.