To evaluate the cost-effectiveness of spinal cord stimulation (SCS) and conventional medical management (CMM) compared with CMM alone for patients with failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), peripheral arterial disease (PAD), and refractory angina pectoris (RAP).
Markov models were developed to evaluate the cost-effectiveness of SCS vs CMM alone from the perspective of a Canadian provincial Ministry of Health. Each model followed costs and outcomes in 6-month cycles. Health effects were expressed as quality-adjusted life years (QALYs). Costs were gathered from public sources and expressed in 2012 Canadian dollars (CAN$). Costs and effects were calculated over a 20-year time horizon and discounted at 3.5% annually, as suggested by the National Institute of Clinical Excellence. Cost-effectiveness was identified by deterministic and probabilistic sensitivity analysis (50,000 Monte-Carlo iterations). Outcome measures were: cost, QALY, incremental net monetary benefit (INMB), incremental cost-effectiveness ratio (ICER), expected value of perfect information (EVPI), and strategy selection frequency.
The ICER for SCS was: CAN$ 9,293 (FBSS), CAN$ 11,216 (CRPS), CAN$ 9,319 (PAD), CAN$ 9,984 (RAP) per QALY gained, respectively. SCS provided the optimal economic path. The probability of SCS being cost-effective compared with CMM was 75-95% depending on pathology. SCS generates a positive INMB for treatment of pain syndromes. Sensitivity analyses demonstrated that results were robust to plausible variations in model costs and effectiveness inputs. Per-patient EVPI was low, indicating that gathering additional information for model parameters would not significantly impact results.
SCS with CMM is cost-effective compared with CMM alone in the management of FBSS, CRPS, PAD, and RAP.
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.
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.
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.
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.
Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain.
Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score =5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead (Medtronic Inc., Minneapolis, MN, USA) will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with =50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work, healthcare utilization including medication usage, and patient satisfaction. Data on adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Healthcare use data will be used to assess costs and long-term cost-effectiveness.
Recruitment began in January 2013 and will continue until 2016.
In 2006, the Canadian Neuromodulation Society was formed. The present survey characterizes the practice of spinal cord stimulator (SCS) and intrathecal analgesic delivery pump (IADP) implantation for pain management in different centres across Canada.
A structured questionnaire was designed to examine the funding source, infrastructure and patient screening process in different centres implanting SCSs and IADPs. Centres that performed more than 10 implants per year were surveyed. The survey was centre-based, ie, each centre received one questionnaire regardless of the number of staff involved in neuromodulation practice.
Fourteen centres were identified and 13 responded. Implantation of SCS and IADP was performed in 12 and 10 centres, respectively. In most centres, failed back surgery syndrome was the most frequent indication for SCS and IADP implantation. For SCS, all centres always performed a trial; the majority used percutaneous electrode (83%) before the SCS implantation. Routine psychological screening was performed in 25% of centres before any SCS trial procedure. For IADP, all centres performed a trial injection or infusion before implantation. Five centres (50%) performed psychological screening in almost all patients. Continuous infusion techniques were the most popular (50%) used for the trial.
The present survey provides a 'snapshot' of the practice of SCS and IADP implantation in Canada. A review of SCS and IADP trials indicated that Canadian practices are mostly, but not always, consistent with those elsewhere.
Cites: N Engl J Med. 2000 Aug 31;343(9):618-2410965008
There is limited available research measuring the cost-effectiveness of spinal cord stimulation (SCS), compared with best medical treatment/conventional pain therapy (CPT). The purpose of this study was to tabulate the actual costs (in Canadian dollars) for a consecutive series of patients treated with SCS in a constant health care delivery environment and to compare the costs with those for a control group treated in the same controlled environment.
We present a consecutive series of 104 patients with failed back syndrome. Within this group, 60 patients underwent SCS electrode implantation, whereas 44 patients were designated as control subjects. We monitored these patients for a 5-year period and tabulated the actual costs incurred in diagnostic imaging, professional fees paid to physicians, implantation (including the costs for hardware), nursing visits for maintenance of the stimulators, physiotherapy, chiropractic treatments, massage therapy, and hospitalization for treatment of breakthrough pain. From these data, the cumulative costs for each group were calculated for a 5-year period. An analysis of Oswestry questionnaire results was also performed, to evaluate the effects of treatment on the quality of life.
The actual mean cumulative cost for SCS therapy for a 5-year period was $29,123/patient, compared with $38,029 for CPT. The cost of treatment for the SCS group was greater than that for the CPT group in the first 2.5 years. The costs of treating patients with SCS became less than those for CPT after that period and remained so during the rest of the follow-up period. In addition, 15% of SCS-treated patients were able to return to employment, because of superior pain control and lower drug intake. No patients in the control group were able to return to employment of any kind.
SCS is cost-effective in the long term, despite the initial high costs of the implantable devices.