Cost effectiveness of a novel 10 kHz high-frequency spinal cord stimulation system in patients with failed back surgery syndrome (FBSS).

OBJECTIVES: Spinal cord stimulation (SCS) is an effective method of relieving chronic intractable pain, and one of its key indications is failed back surgery syndrome (FBSS). The objective of the current study was to evaluate the cost effectiveness of 10 kHz high-frequency SCS (HF10 SCS) compared to conventional medical management (CMM), reoperation, and traditional nonrechargeable (TNR-SCS) and rechargeable SCS (TR-SCS). METHODS: A health economic model of SCS in the United Kingdom was reproduced in the perspective of the health care system to simulate costs and quality adjusted life years (QALYs) over 15 years. In the model, both a decision tree and the Markov model were used to describe the health outcomes of the evaluated therapies. RESULTS: HF10 SCS therapy showed a favorable incremental cost-effectiveness ratio (ICER) of £3,153 per QALY gained as compared to CMM and established dominance (less costly, more QALYs) compared to TNR-SCS (£8,802 per QALY vs. CMM) and TR-SCS (£5,101 per QALY vs. CMM). CONCLUSION: This first analysis of the cost effectiveness of HF10 SCS suggests that it is more cost effective and provides a greater number of QALYs than both TNR-SCS and TR-SCS.

Clinical and resource utilization patterns in patients with refractory neuropathic pain prescribed pregabalin for the first time in routine medical practice in primary care settings in Spain.

CONTEXT AND OBJECTIVE: To describe clinical and resource utilization patterns in patients with refractory neuropathic pain (NeP) who were prescribed pregabalin for the first time in routine medical practice in primary care settings. METHODS: Post-hoc analysis of a 12-week prospective observational study including pregabalin naïve adult patients with refractory chronic NeP of at least 6-months duration. Self-reported pain intensity, disability, sleep disturbances, symptoms of anxiety and depression, disability, health-related quality of life (HRQoL), health care resource utilization, and corresponding costs were assessed in this post-hoc analysis. RESULTS: One thousand three hundred fifty-four patients were enrolled in the study, and three treatment groups were identified: (1) 598 patients replaced prior pain treatments with pregabalin as monotherapy; (2) 589 added pregabalin to their existing pain treatments; and (3) 167 other pain treatments were prescribed according with physician routine medical practice. Statistically significant differences were reported at baseline for intensity of pain, patient disability, severity of depressive symptoms, and HRQoL (P < 0.01 in all cases). No statistically significant differences were reported among the three treatment groups for anxiety severity or sleep disturbances. Subjects who received add-on pregabalin had greater use of direct and indirect resources vs the other groups, resulting in significantly higher quarterly overall costs per patient: €2,397 (2,308), €2,470 (1,857), and €3,110 (2,496), respectively (P < 0.001). CONCLUSION: These findings suggest that primary care physicians chose pregabalin as an option for treating refractory patients who tended to have much more severe NeP profiles, costing society more than when they chose other therapeutic strategies not including pregabalin.

Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Chronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS. METHODS/DESIGN: The SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management ('SQS arm') versus optimized medical management alone ('OMM arm') in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline. DISCUSSION: The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014. TRIAL REGISTRATION: ClinicalTrials.gov NCT01711619.

A cost utilization analysis of intrathecal therapy for refractory cancer pain: identifying factors associated with cost benefit.

OBJECTIVE: Intrathecal therapy (ITT) for cancer pain is characterized by high initial cost followed by low maintenance costs. Non-ITT pain management is associated with steadily increasing cumulative cost that can equal the cost of ITT over time. The intent of this modeling project is to identify factors associated with relatively rapid achievement of cost-benefit with ITT. DESIGN: A retrospective chart review was performed on 36 patients with cancer pain who underwent ITT and survived beyond 4 weeks. METHODS: Data on the cost of conventional opioid therapy prior to ITT and at 4-6 weeks were collected and projected over time. ITT costs included all intrathecal pump implantation and maintenance costs. Pre-ITT opioid regimens were stratified into high-cost conventional (HCC-high-dose, nongeneric, or use of intravenous patient-controlled analgesia, N = 12) and low-cost conventional (low-dose or generic, N = 24) regimens. RESULTS: The median daily cost of opioid medications pre-ITT was $21.26 (25th-75th percentile $10.31-78.85, range 0-$971.97) vs $0 (25th-75th percentile $0-0.70), P = 0.007, post-ITT. In the HCC group, the median daily cost was $172.47 (25th-75th percentile $67.29-406.20). The median daily cost of ITT medications was $16.01 (25th-75th percentile $9.52-23.23).When these data were used to model costs over the long term, including pump implantation costs, cost-benefit for all patients compared with conventional therapy was predicted at 344 months but at 7.4 months in the HCC group. Seven patients (19%) achieved cost equivalence within 6 months and three of these within the first 3 months. CONCLUSIONS: In selected patients on high-cost opioid regimens, ITT may become cost-beneficial within 6 months. Factors associated with earlier attainment of ITT cost-benefit include the use of parenteral therapy, high-dose opioids, and the use of nongeneric opioid products.

Effect of pregabalin in the treatment of refractory neck pain: cost and clinical evidence from medical practice in orthopedic surgery and rehabilitation clinics.

BACKGROUND: The study aims to prospectively analyze the effect of adding pregabalin upon costs and consequences in the treatment of refractory neck pain under routine medical practice. METHODS: A secondary analysis was carried out including patients over 18 years, with 6-month chronic neck pain refractory from a prospective, naturalistic, 12-week two-visit study. The analysis compared patients adding pregabalin to its therapy vs. usual care. Severity of pain, healthcare resources utilization, lost workday equivalents (LWDE) because of pain, and related cost-adjusted reductions were assessed. RESULTS: A total of 312 patients (65.3% women, age 54.2 [12.1] years), 78.2% receiving pregabalin, were analyzed. Adding pregabalin was associated with higher adjusted reduction in pain severity: -3.2 (1.8) points, 55.4% responders (≥50% baseline pain reduction) vs. -2.3 (2.0) and 38.2%, respectively; P<0.001, yielding a higher reduction in mean LWDE: 20.1 (23.1) vs. 8.2 (22.4); P=0.014, which produced significant reductions in the indirect components of cost: €1,041.0 (1,222.8) vs. €457.3 (1,132.1), P=0.028. The costs of pregabalin (€309.8 [193.2] vs. €26.4 [79.6], P<0.001) was offset by higher numerical reductions in the other components of costs, producing similar direct cost reductions in both groups at the end of the study: €66.8 (1,080.8) and €143.5 (1,922.4), respectively; P=0.295. CONCLUSION: Compared with usual care, the addition of pregabalin to treat refractory neck pain seems to be associated with a higher reduction in pain severity and lost work-days equivalents, which in turn results in a greater reduction of the indirect components of cost while maintaining similar healthcare cost levels despite its higher price.

Financial impact of spinal cord stimulation on the healthcare budget: a comparative analysis of costs in Canada and the United States.

OBJECT: Many institutions with spinal cord stimulation (SCS) programs fail to realize that besides the initial implantation cost, budgetary allocation must be made to address annual maintenance costs as well as complications as they arise. Complications remain the major contributing factor to the overall expense of SCS. The authors present a formula that, when applied, provides a realistic representation of the actual costs necessary to implant and maintain SCS systems in Canada and the US. METHODS: The authors performed a retrospective analysis of 197 cases involving SCS (161 implanted and 36 failed trial stimulations) between 1995 and 2006. The cost of patient workup, initial implantation, annual maintenance, and resources necessary to resolve complications were assessed for each case and a unit cost applied. The total cost allocated for each case was determined by summing across healthcare resource headings. Using the same parameters, the unit cost was calculated in both Canadian (CAD) and US dollars (USD) at 2007 prices. RESULTS: The cost of implanting a SCS system in Canada is $21,595 (CAD), in US Medicare $32,882 (USD), and in US Blue Cross Blue Shield (BCBS) $57,896 (USD). The annual maintenance cost of an uncomplicated case in Canada is $3539 (CAD), in US Medicare $5071 (USD), and in BCBS $7277 (USD). The mean cost of a complication was $5191 in Canada (range $136-18,837 [CAD]). In comparison, in the US the figures were $9649 (range $381-28,495) for Medicare and $21,390 (range $573-54,547) for BCBS (both USD). Using these calculations a formula was derived as follows: the annual maintenance cost (a) was added to the average annual cost per complication per patient implanted (b); the sum was then divided by the implantation cost (c); and the result was multiplied by 100 to obtain a percentage (a + b / c x 100). To make this budgetary cap universally applicable, the results from the application of the formula were averaged, resulting in an 18% premium. CONCLUSIONS: For budgeting purposes the institution should first calculate the initial implantation costs that then can be "grossed up" by 18% per annum. This amount of 18% should be in addition to the implantation costs for the individual institution for new patients, as well as for each actively managed patient. This resulting amount will cover the costs associated with annual maintenance and complications for every actively managed patient. As the initial cost of implantation in any country reflects their current economics, the formula provided will be applicable to all implanters and policy makers alike.

Humanistic, utilization, and cost outcomes associated with the use of botulinum toxin for treatment of refractory migraine headaches in a managed care organization.

BACKGROUND: Few patients with migraine syndrome receive treatment with preventive medication regimens, and some of these patients fail to gain adequate migraine relief. Botulinum toxin has been suggested to be effective in the treatment of migraine for a select population. An integrated health system created a medical policy and a supporting preauthorization form that permits coverage of botulinum toxin for the off-label treatment of migraine for patients who (1) fail at least 3 drug classes for acute treatment, (2) fail at least 4 different preventive medication classes, and (3) receive consultation from a neurologist. OBJECTIVES: To (1) evaluate the impact of botulinum toxin therapy on quality-of-life (QOL) measures evaluated by direct member survey results, and (2) assess the use and cost of migraine-related medications and overall medical and pharmacy services pre- and post-botulinum toxin therapy. METHODS: The study was a retrospective analysis of administrative claims data from a 500,000-member integrated health system for the time period January 1, 2003, to October 31, 2007. Administrative claims data were used to identify members with a billing code (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]) for migraine (346.xx), tension headache (307.81), or headache (784.0) diagnosed by a neurologist. Administrative claims data for these patients were then queried for the use of botulinum toxin for dates of service from January 1, 2003, through October 31, 2006. A survey was sent to the identified patients (N=54) to assess 6 QOL measures associated with the use of botulinum toxin. Self-reported symptomatic improvement was assessed using a 5-point Likert scale for 6 questions regarding headache severity, headache frequency, use of rescue medications, productivity/absenteeism, recreational activities, and life enjoyment. For the subset of patients (n = 32) who maintained health plan eligibility from 18 months before through 18 months after the first botulinum toxin therapy claim (index date), medical and pharmacy claims data were used to assess the utilization and cost of specific medications and overall pharmacy and medical costs for the 18-month pre-index and post-index periods. Cost was defined as allowed charge, which is the sum of plan cost and member cost. RESULTS: Of 54 surveys sent to all patients identified as having used botulinum toxin for the treatment of migraine from January 1, 2003, to October 31, 2006, 34 surveys were returned (63%). Almost 3 of 4 respondents (73%) reported moderate or better improvement in overall migraine or headache QOL measures, and 27% reported little or no improvement. For the 32 patients with continuous eligibility for the total observation period of 36 months, the average migraine-related pharmacy utilization, excluding botulinum toxin, increased by 50.5%, from 1.84 claims per patient per month (PPPM) in the 18-month pre-index period to 2.77 claims PPPM in the 18-month post-index period (P = 0.011) and by 59.5% by mean days supply (42.58 days to 67.93, P=0.008). Total migraine-related pharmacy cost increased by 80.9%, from $142.08 PPPM to $256.97 PPPM (P=0.013). Acute-treatment migraine-related pharmacy utilization increased from 1.23 claims PPPM to 1.92 claims PPPM (P=0.004). There was no significant change in either the number of claims for migraine prophylaxis medications (0.61 PPPM to 0.85 PPPM, P=0.121) or the use of hospital emergency room services related to migraine or headache (0.07 PPPM vs. 0.10 PPPM, P=0.449). The mean migraine-related and nonmigraine-related (i.e., all-cause) combined medical/hospital and pharmacy expense, including botulinum toxin, increased by 111.3%, from $651.13 PPPM in the pre-index period to $1,376.05 PPPM in the post-index period (P<0.001). CONCLUSION: The majority of patients who received botulinum toxin for refractory migraine reported improvement in disease-specific symptoms and overall QOL, but total medical and pharmacy costs were higher in the period after treatment, and there was no reduction in the use of other migraine-related medications.

Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact.

OBJECT: The long-term success of spinal cord stimulation is impeded by the high incidence of adverse events. The cost of complications to the healthcare budget is influenced by the time course needed to reverse the effect, and by the type of corrective measures required. Understanding the mechanism of complications and reducing them can improve the overall success rate and the cost factor. METHODS: The authors performed a retrospective analysis of data obtained in 160 patients treated during a 10-year period. For each category of complication, the level of healthcare resource use was assessed for each case and a unit cost was applied. The total cost of each complication was determined by summing across healthcare resource headings. All cost calculations were performed in Canadian dollars at 2005 prices. To understand the mechanics of various hardware-related complications and how to avoid them, the authors have utilized the results of bench tests conducted at Medtronic, Inc. Fifty-one adverse events occurred in 42 of the 160 patients. The complications were classified as either hardware related (39 events) or biological (12 events). The mean cost of complications during the 10-year study period was dollar 7092 (range dollar 130 - dollar 22,406). CONCLUSIONS: Complications not only disrupt the effect of pain control but also pose an added expense to the already high cost of therapy. It is possible to reduce the complication rate, and thus improve the long-term success rate, by following the suggestions made in this paper, which are supported by the biomechanics of the human body and the implanted material.

Damned if they do, damned if they don't: the need for a comprehensive public policy to address the inadequate management of pain.

Amy Dilcher examines the need for a comprehensive pain policy and argues that opioids--highly effective drugs for pain management--should be legally and practicably accessible to medical professionals and their patients, as and when needed to provide relief from pain. The article synthesizes a number of perspectives regarding the regulation of pain management and demonstrates that the inadequate treatment of pain stems from a multitude of barriers. After reviewing Congressional action on the topic, Ms. Dilcher concludes with recommendations for a more comprehensive pain policy that would enhance the management of pain.

Effectiveness and cost-effectiveness of comprehensive rehabilitation programs.

Comprehensive rehabilitation involving multidisciplinary involvement of healthcare professionals is available to patients with rheumatic diseases. Studies were reviewed on the effectiveness of such programs for patients with chronic low back pain, widespread pain, and rheumatoid arthritis. When effects on the various outcome measures are demonstrated, improvements can only with difficulty be attributed to a specific component of a comprehensive program. Economic analyses for the effectiveness of comprehensive programs are scarce, but are needed by policy makers to allow optimal allocation of resources. Preferably the overall performance of comprehensive rehabilitation programs, not the individual components, should be evaluated.

Self-treatment with oral transmucosal fentanyl citrate to prevent emergency room visits for pain crises: patient self-reports of efficacy and utility.

Ninety (90) patients with chronic pain who were treated with a long-acting opioid were instructed on use of oral transmucosal fentanyl citrate (OTFC) for self-treatment of emergency pain flares. Eighty-six (95.6%) believed OTFC was effective and safe for self-treatment of emergency pain flares, and 71 (78.8%) believed they had prevented one or more emergency room visits for treatment of pain flares. A subgroup of 45 patients who had collectively used OTFC for 375 months, based on their past experience, estimated they had prevented 1.26 emergency room visits per month per patient. OTFC should be further studied for cost-savings and effectiveness in self-treatment of emergency pain flares.

Pain and disability under Social Security: time for a new standard.

Some degree of pain is a part of every individual's life. Many people, however, live in chronic debilitating pain. This Article examines concepts of pain and its treatment and implications for victims of pain under the Social Security system. The Article discusses inconsistencies within the Social Security Administration and in the courts when attempting to set standards for evaluating pain and determining disability.

Managing intractable pain with an intrathecal catheter and injection port: technique and guidelines.

The objective of our study was to describe an effective technique for the management of chronic intractable pain in patients with intermediate life expectancy or as a long-term screening device prior to implantable pump therapy. In the study, an InDura intraspinal catheter is connected to a BardPort, which is accessed transdermally. We describe our surgical technique, recommended dosage calculations, cost comparison to an implantable infusion pump, and our experience with 13 cases. In our series of 13 patients, there was one seroma and one dural leak. There were no infections, and all were functioning well in the 12 cancer patients until their deaths. One case was converted to an implantable pump. There were no malfunctions or infections of the intrathecal infusion system in the 12 cancer patients. This intrathecal drug infusion system should be considered in the treatment armamentarium for chronic intractable pain and cancer pain.

Brief courses of palliative radiotherapy for metastatic bone pain: a pilot cost-minimization comparison with narcotic analgesics.

The use of radiotherapy to treat metastatic bone pain is being challenged by claims of high cost and by more readily available, noninvasive treatment approaches. The authors assessed the effectiveness of brief courses of radiotherapy in reducing pain and estimated cost data for a pilot comparison between radiotherapy and narcotic analgesics in patients with cancer. A representative group of outpatients undergoing brief courses of radiotherapy with Karnofsky scores above 70 and without serious comorbidities were recruited from 1995 through 1996. Patients indicated their pain at rest and with movement on a scale of from 1 to 10 both before and up to 12 months after radiotherapy. Radiotherapy costs were estimated from Medicare-allowable charges. Narcotic analgesia costs were estimated from published values. In 66 patients with 131 individually treated sites, median at rest pain score decreased by about 4 points after treatment (5.58 [-/+3.28] before treatment vs. 1.55 [-/+1.8] after treatment; p < 0.05). Median with movement pain score was about 5 points lower after treatment (7.32 [-/+2.72] before treatment vs. 1.94 [-/+2.07] after treatment; p < 0.05). No differences were found when stratifying by type of pain, tumor histologic type, or skeletal site. The estimated cost per patient ranged from $1,200 to $2,500 for radiotherapy. This compares with an estimated cost of $9,000 to $36,000 for 9 months of narcotics. In this pilot study, a brief course of radiotherapy significantly reduced pain and appeared to be cost effective when compared with narcotic analgesia. A full economic evaluation is warranted.