SPINE An International Journal for the study of the spine Publish Ahead of Print DOI : 10.1097/BRS.0000000000000989 Cost Effectiveness of Lumbar Epidural Steroid Injections
Leah Y. Carreon, MD, MSc, Kelly R. Bratcher RN, CCRP, Farah Ammous MPH, Steven D. Glassman MD Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, Kentucky 40202
Corresponding Author: Leah Y. Carreon MD, MSc, Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, Kentucky, 40202 Phone: 502 584 7525 Fax: 502 589 0849 email: [email protected]
The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. Relevant financial activities outside the submitted work: board membership, consultancy, employment, grants, travel/accommodations/meeting expenses, patents, royalties.
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ABSTRACT Study Design: Longitudinal Cohort Objectives: To determine the cost per quality-adjusted life-year (cost/QALY) for lumbar epidural steroid injections (LESI). Summary of Background Data: Despite being a widely performed procedure, there are few studies evaluating the cost-effectiveness of LESIs. Methods: Patients who had LESI between June 2012 and July 2013 with EQ-5D scores available before and after LESIs but before any surgical intervention were identified. Costs were calculated based on the Medicare Fee Schedule multiplied by the number of LESIs done between the two clinic visits. QALYs were calculated using the EQ-5D. Results: Of 421 patients who had pre-LESI EQ-5D data, 323 (77%) had post-LESI data available;200 females, 123 males, mean age 59.2 ± 14.2 years. Cost per LESI was $608, with most patients receiving three LESIs over one year (range 1 to 6). Mean QALY gained was 0.005. One hundred forty-five patients (45%) had a QALY gain (mean=0.117) at a cost of $62,175/QALY gained, 127 (40%) had a loss in QALY (mean=-0.120) and 51 (15%) had no change in QALY. Fourteen of the 145 patients who improved, and 29 of the 178 patients that did not, have medical comorbidities that precluded surgery. Thirty-two (22%) of 131 patients without medical comorbidities who improved; and 57 (32%) of the 149 patients without medical comorbidities who did not improve subsequently had surgery (p=0.015). Conclusions: LESI may not be cost-effective in patients with lumbar degenerative disorders. For the 145 patients who improved, cost per QALY gained was acceptable at $62,175. However for the 178 patients with no gain or a loss in QALY, the economics are not reportable with a cost per QALY gained being theoretically infinite. Further studies are needed in order to identify
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specific patient populations that will benefit from LESI, as the economic viability of LESI requires improved patient selection.
Key Words: lumbar epidural steroid injections; cost-effectiveness; EQ-5D; SF-6D; low back pain; health economics; QALY; non-operative treatment
Level of Evidence: 2
Introduction: Lumbar epidural steroid injections (LESIs) are widely used as part of the non-surgical treatment of lumbar degenerative disorders, radicular leg pain or spinal stenosis at a rate of 2,055 out of 100,000 Medicare enrollees in 2001 [1]. The premise is that local injection of anti-inflammatory drugs, such as steroids, lead to a reduction of inflammation through inhibiting the formation and release of inflammatory cytokines, leading to pain reduction. Recent systematic reviews and meta-analyses [2-5] have concluded that strong evidence for the clinical efficacy of LESIs is lacking. Moreover, despite being a widely performed procedure, there are very few studies evaluating the cost-effectiveness of LESIs [6-8]; and most physicians remain unfamiliar with the standard evaluation tools which drive economic healthcare policy. The current measure for comparing the value of competing healthcare interventions is the cost per Quality Adjusted Life Year (QALY) gained [9, 10]. Generally, interventions with a cost per QALY gained (cost/QALY) between $50,000 and $100,000, or less, are considered cost effective [11, 12]. Interventions with a cost per QALY gained (cost/QALY) less than the country’s per Capita Gross Domestic Product (GDP) may also be considered cost effective [13]. Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
The purpose of this study is to determine the cost per quality-adjusted life-year (cost per QALY) gained for LESIs. Secondary objectives are to determine whether LESIs decrease the risk of subsequent surgery; and if LESIs are effective in patients who have comorbid conditions precluding any surgical intervention. Methods: As part of standard clinical practice, the EuroQOL-5D - 3 Level (EQ5D-3L) [14], the Oswestry Disability Index (ODI) [15, 16], Back Pain Scores (BP, 0 to 10) and Leg Pain Scores (LP, 0 to 10) [17] are administered to all patients presenting with low back or lower extremity complaints. This includes both surgical and non-surgical patients seen at a single tertiary spine center with six spine-fellowship trained surgeons with similar practice patterns, representing a typical adult spine practice population. After receiving Institutional Review Board approval, patients who had an LESI between June 2012 and July 2013 and had EQ-5D [14] and ODI [15, 16] scores available before and after LESIs, but before any surgical intervention, were identified. Two anesthesiologists performed all LESIs.
Costs were calculated based on the Medicare Fee
Schedule multiplied by the number of LESIs done between the two clinic visits. Since there were no formal follow-up periods and the EQ-5D and ODIs were administered at varying time intervals in each patient, the calculation of QALYs were adjusted for the length of follow-up. The primary analysis was carried out using EQ-5D health state utility values. A secondary analysis calculating QALY based on the SF-6D derived from the ODI [18] was also performed. Results: Of the 421 patients who had a LESI and had EQ-5D and ODI data prior to the first LESI, 323 (77%) had EQ-5D and ODI data after their LESI but before any surgical intervention. There were 200 females and 123 males with a mean age of 59.2 ± 14.2 years (range, 18 to 88 years). Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
There were six (2%) patients who were being treated under Workman’s Compensation. The preinjection and post-injection outcomes are summarized in Table 1.
Although there was a
statistically significant difference between all pre-injection and post-injection clinical outcomes, the magnitude of change is small. Cost per LESI was $608, with most patients receiving three LESIs over the span of one year (range 1 to 6) (Table 2). The mean cumulative QALY gained was 0.005 using the EQ-5D. The EQ-5D gained was similar regardless of which anesthesiologists performed the procedure (p=0.402). The cost QALY gained for the entire cohort was $249,631. One hundred forty five patients (45%) had a gain in QALY (mean= 0.117) at a cost of $62,175 per QALY gained, 127 (40%) had a loss in QALY (mean = -0.120) and 51 (15%) had no change in QALY. There was no difference (p=0.548) in the distribution of specific spine pathologies between the patients who had a gain in QALY compared to those that did not (Table 3). The pre-operative ODI, back and leg pain scores were similar in the patients who had a gain in QALY and those that did not (Table 4). Fourteen of the 145 patients who improved, and 29 of the 178 patients that did not, had medical comorbidities that precluded surgery. These 43 patients who had comorbid conditions precluding surgery had a loss in QALYs with a mean change in QALY of -0.017. Thirty-two (22%) of 131 patients without medical comorbidities who improved; and 57 (32%) of the 149 patients without medical comorbidities who did not improve subsequently had surgery.
This proportion is
statistically significantly different at p=0.015. Although the patients who had surgery even after improvement with LESI had a lower mean QALY gain (0.105) compared to those that did not have surgery (0.118), this was not statistically significant (p=0.635).
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The mean cumulative QALY based on the SF-6D gained was 0.005; with similar gains between the two anesthesiologists (p=0.658). For the entire cohort, the cost per QALY gained based on SF-6D utilities is $273,624. One hundred and sixty-five patients (51%) had a gain in QALY (mean= 0.117) at a cost of $114,110 per QALY gained, 138 (43%) had a loss in QALY (mean = -0.119) and 20 (6%) had no change in QALY. Seventeen of the 165 patients who improved, and 26 of the 158 patients that did not, had medical comorbidities that precluded surgery. These patients who had comorbid conditions precluding surgery had a loss in QALYs with a mean change in QALY of -0.015.
Forty-three (29%) of 148 patients without medical comorbidities
who improved; and 50 (38%) of the 132 patients without medical comorbidities who did not improve subsequently had surgery. This proportion is not statistically significantly different at p=0.128. Although the patients who had surgery even after improvement with LESI had a lower mean QALY gain (0.036) compared to those that did not have surgery (0.040), this was not statistically significant (p=0.635). A sensitivity analysis looking at the number of steroid injections necessary to make LESI cost-effective in patients with a gain in QALY showed that three or less injections would be cost-effective when
EQ-5D valuations accrued and two
injections or less when SF-6D valuations are used (Table5). In addition, even with an increase in the number of LESIs administered, the change in EQ-5D score or SF-6D score was similar (Table 6). Discussion: Recent systematic reviews evaluating the comparative effectiveness of LESIs showed that the best available evidence regarding its efficacy is less than robust [2-5]. These systematic reviews are hindered by the heterogeneity of patient selection, mode of delivery, type and dose of steroid used, number and frequency of LESIs and outcome measures. Most randomized clinical trials Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
evaluating LESIs compare different approaches (caudal, interlaminar or transforaminal) [19], type [20, 21] or dose [22, 23] of steroid, or are limited by a lack of a true placebo group [24, 25, 26]. Earlier studies [26, 27] comparing epidural steroid to epidural saline injections showed a significant improvement at three weeks in patients receiving epidural steroid injections. However, by six weeks, the benefit of steroid injections was no longer evident. A more recent randomized placebo controlled trial comparing epidural steroid, epidural saline and sham showed no differences in outcomes among the three groups at any follow-up time point, up to one-year post injection [28]. The current study was undertaken to further evaluate the cost-effectiveness of lumbar epidural injections in a pragmatic clinical study. Performing a pragmatic study allows the clinician to assess the role of LESIs in the management of patients with lumbar degenerative disorders. QALYs were not determined based on specific pre-determined time-points but were adjusted based on standard of care clinical follow-up, allowing for real world evaluation of the efficacy of LESI. Despite the lack of formal follow-up time points, the results of the current study were similar or better than previously published prospective studies [26, 27, 28 29, 30]; with around half of the patients showing improvement.
However, with only half of patients showing
improvements or a gain in QALY, it would be difficult to conclude that LESI are cost-effective in patients, based upon commonly accepted indications. Looking at outcome measures, there was a statistically significant improvement in ODI, back and leg pain scores, but none of these would be considered clinically meaningful. The mean improvement in ODI was 3.5 points and mean improvement in back and leg pain was less than 1 point, none of which are clinically relevant [31].
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Adjusting for inflation and converting to US dollars, Udeh reported a cost per QALY of $37,758 [8], Whynes reported $48,537 [7] and Price reported $94,000 [8] for LESIs. Considering only patients who had a gain in QALY based on the EQ-5D, the cost per QALY calculated in this study of $62,175 was cost-effective. However, when QALY based on the SF-6D is used, the cost per QALY gained of $114,110 for patients that improved, is above the threshold considered to be cost effective [11, 12]. The mean change in SF-6D was only a third of the mean change in EQ-5D. This is consistent with previously published studies that have shown that the gain in utility when measured using the SF-6D is smaller than when measured by the EQ-5D [32]. In contrast to other studies [26, 27], in this study a statistically greater proportion of patients who did not improve with LESIs based on their EQ-5D (32%) elected to have surgery compared to those who improved (22%). Based on this data, it would seem that some patients improved enough with LESI that they deemed surgery unnecessary. However, if SF-6D valuations are used, this is not true. That is, the proportion of patients who elected to have surgery was similar in those who had improvements in SF-6D (38%) compare to those who did not (29%). Although it may be argued that these patients may not have been surgical candidates, the proportion of patients with nonspecific back pain was similar in patients who had EQ-5D improvements and those that did not; and the mean pre-injection ODI score was in the “Severe disability” category for ODI. In patients who had comorbid conditions precluding surgery, there was a relatively small loss in QALY even after an LESI. It would be difficult to ascertain if these patients would have deteriorated even further, with greater losses in QALYs if they did not have any LESIs. For the same reason, it would be difficult to ascertain if patients who improved with LESIs would have improved spontaneously, even without LESIs.
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Current practice guidelines recommend that the number of LESIs be tailored based on the individual patient response [24, 33]. A recent literature review however, showed that most providers perform a series of LESIs [34]. In the current study, 94% of patients received three or less injections. There does not seem to be a rational use of increasing number of injections, as there was no difference in the EQ-5 D or SF-6 D scores stratified by number of LESIs performed. Based on the current data, administration of one or at the most three LESIs may be cost-effective. Additional LESIs do not seem to increase effectiveness despite the additional cost. There are limitations to the study. Patients were seen at a tertiary spine specialty clinic, which may introduce selection bias; including patients who are more symptomatic and may have less response to LESIs. The diagnostic etiology prompting treatment with LESI was heterogeneous. However, the distribution of the different diagnostic etiologies was similar between the patients who improved and those that did not. Moreover, recent studies from a single group of authors have shown no difference in outcomes between LESI and control patients with disc herniation and radiculitis [35]; discogenic pain without disc herniation or radiculitis [36], post surgery syndrome [37] and spinal stenosis [38] The EQ-5D which is considered a long-ordinal scale with only 243 health states valued may not be sensitive enough to detect a change in health states in this specific population [14]. Although not specifically monitored and collected, the volume, dose and frequency of LESIs probably varied from patient to patient. This is not different from normal routine care. Only two specific anesthesiologists performed all the LESIs. This was done to mitigate a possible large amount of variation in technique. The results from this study showed that there was no difference in the amount of QALY gained between the two anesthesiologists.
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This study indicates that based on existing indications for treatment, LESI is not a cost-effective intervention. This stems from the fact that only 45% of patients obtained clinical benefit, and that the magnitude of improvement was modest. Examination of the subset that obtained clinical benefit demonstrated the potential for cost-effectiveness, as this group had a cost per QALYof $62,175 based on EQ-5D utility values. However, an alternative analysis using SF-6D utility values did not demonstrate cost-effectiveness, even in the clinical responders at a cost/QALY of $114,110. These findings emphasize the need to utilize LESI in a more targeted and judicious fashion. LESI is often advocated simply because it is not surgery. However, our data indicates that, even in the patients who obtained clinical benefit, surgical treatment was only marginally less frequent. Further, recent studies indicate that pre-surgical LESI may diminish the benefit of subsequent surgical treatment [39, 40] In summary, LESIs are not being used in a cost-effective manner. While there appears to be a subset of patients that benefit from LESI, that group needs to be more clearly defined. Even if the majority of patients improve after LESI, cost-effectiveness would still be dependent upon durability and the frequency at which injections are required.
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Table 1. Summary of pre and post-injection clinical outcome measures Outcome Measure
Pre-Injection
Post-Injection
Change
p-value
EQ-5D
0.505
0.538
0.033
0.014
SF-6D
0.538
0.549
0.011
0.032
47.52
43.98
3.540
0.001
Back Pain
6.28
5.55
0.739
0.001
Leg Pain
6.03
5.14
0.891
0.001
Oswestry Disability Index
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Table 2. Distribution of the number of Lumbar epidural steroids per patient over the span of one year. Number of LESI
Frequency
Percentage
One
98
30%
Two
96
30%
Three
107
33%
Four
13
4%
Five
6
2%
Six
3
1%
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Table 3. Distribution of diagnostic etiologies between patients who had a cumulative improvement in EQ-5D compared to those that did not (p=0.548) Diagnostic etiology
EQ-5D improvement
No EQ-5D improvement
12 (10%)
25 (14%)
8 (6%)
9 (5%)
23 (18%)
28 (16%)
10 8%)
5 (3%)
Disc herniation
16 (13%)
13 (7%)
Nonspecific back pain*
22 (18%)
27 (15%)
Stenosis
54 43%)
71 (40%)
Adjacent level degeneration Degenerative scoliosis Spondylolisthesis Mechanical disc collapse
*Patients diagnosed with nonspecific back pain have had advanced imaging studies and no specific diagnostic etiology causing the patient’ symptoms could be identified.
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Table 4. Comparison of pre-injection clinical outcome scores between patients who had a cumulative improvement in EQ-5D compared to those that did not No EQ-5D
p-value
EQ-5D improvement Outcome Measure
improvement
Oswestry Disability 46.60
48.71
0.312
Back Pain
6.36
6.22
0.643
Leg Pain
6.13
5.99
0.566
Index
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Table 5. Sensitivity analysis of cost per QALY with increasing number of LESIs Number of LESI
Cost per EQ-5D QALY
Cost per SF-6D QALY
One
26,912.63
51,467.00
Two
53,825.26
102,933.99
Three
80,737.90
154,400.99
Four
107,650.53
205,867.98
Five
134,563.16
257,334.98
Six
161,475.79
308,801.98
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Table 6. Mean Change in utility scores stratified by number of LESIs Mean EQ-5D Change ± Number of LESI
Frequency
Mean SF-6D Change ± SD SD
One
98
0.011 ± 0.174
0.009 ± 0.080
Two
96
0.016 ± 0.169
0.010 ±0.067
Three
107
0.006 ± 0.147
-0.002 ± 0.066
Four
13
-0.114 ± 0.278
0.002 ± 0.077
Five
6
-0.029 ± 0.196
-0.009 ± 0.071
Six
3
0.029 ± 0.119
-0.035 ± 0.003
323
0.005 ± 0.170
0.005 ± 0.071
0.206
0.717
Total p-value
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Leah Y. Carreon, MD, MSc, Kelly R. Bratcher RN, CCRP, Farah Ammous MPH, Steven D. Glassman MD Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, Kentucky 40202
Corresponding Author: Leah Y. Carreon MD, MSc, Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, Kentucky, 40202 Phone: 502 584 7525 Fax: 502 589 0849 email: [email protected]
The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. Relevant financial activities outside the submitted work: board membership, consultancy, employment, grants, travel/accommodations/meeting expenses, patents, royalties.
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ABSTRACT Study Design: Longitudinal Cohort Objectives: To determine the cost per quality-adjusted life-year (cost/QALY) for lumbar epidural steroid injections (LESI). Summary of Background Data: Despite being a widely performed procedure, there are few studies evaluating the cost-effectiveness of LESIs. Methods: Patients who had LESI between June 2012 and July 2013 with EQ-5D scores available before and after LESIs but before any surgical intervention were identified. Costs were calculated based on the Medicare Fee Schedule multiplied by the number of LESIs done between the two clinic visits. QALYs were calculated using the EQ-5D. Results: Of 421 patients who had pre-LESI EQ-5D data, 323 (77%) had post-LESI data available;200 females, 123 males, mean age 59.2 ± 14.2 years. Cost per LESI was $608, with most patients receiving three LESIs over one year (range 1 to 6). Mean QALY gained was 0.005. One hundred forty-five patients (45%) had a QALY gain (mean=0.117) at a cost of $62,175/QALY gained, 127 (40%) had a loss in QALY (mean=-0.120) and 51 (15%) had no change in QALY. Fourteen of the 145 patients who improved, and 29 of the 178 patients that did not, have medical comorbidities that precluded surgery. Thirty-two (22%) of 131 patients without medical comorbidities who improved; and 57 (32%) of the 149 patients without medical comorbidities who did not improve subsequently had surgery (p=0.015). Conclusions: LESI may not be cost-effective in patients with lumbar degenerative disorders. For the 145 patients who improved, cost per QALY gained was acceptable at $62,175. However for the 178 patients with no gain or a loss in QALY, the economics are not reportable with a cost per QALY gained being theoretically infinite. Further studies are needed in order to identify
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specific patient populations that will benefit from LESI, as the economic viability of LESI requires improved patient selection.
Key Words: lumbar epidural steroid injections; cost-effectiveness; EQ-5D; SF-6D; low back pain; health economics; QALY; non-operative treatment
Level of Evidence: 2
Introduction: Lumbar epidural steroid injections (LESIs) are widely used as part of the non-surgical treatment of lumbar degenerative disorders, radicular leg pain or spinal stenosis at a rate of 2,055 out of 100,000 Medicare enrollees in 2001 [1]. The premise is that local injection of anti-inflammatory drugs, such as steroids, lead to a reduction of inflammation through inhibiting the formation and release of inflammatory cytokines, leading to pain reduction. Recent systematic reviews and meta-analyses [2-5] have concluded that strong evidence for the clinical efficacy of LESIs is lacking. Moreover, despite being a widely performed procedure, there are very few studies evaluating the cost-effectiveness of LESIs [6-8]; and most physicians remain unfamiliar with the standard evaluation tools which drive economic healthcare policy. The current measure for comparing the value of competing healthcare interventions is the cost per Quality Adjusted Life Year (QALY) gained [9, 10]. Generally, interventions with a cost per QALY gained (cost/QALY) between $50,000 and $100,000, or less, are considered cost effective [11, 12]. Interventions with a cost per QALY gained (cost/QALY) less than the country’s per Capita Gross Domestic Product (GDP) may also be considered cost effective [13]. Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
The purpose of this study is to determine the cost per quality-adjusted life-year (cost per QALY) gained for LESIs. Secondary objectives are to determine whether LESIs decrease the risk of subsequent surgery; and if LESIs are effective in patients who have comorbid conditions precluding any surgical intervention. Methods: As part of standard clinical practice, the EuroQOL-5D - 3 Level (EQ5D-3L) [14], the Oswestry Disability Index (ODI) [15, 16], Back Pain Scores (BP, 0 to 10) and Leg Pain Scores (LP, 0 to 10) [17] are administered to all patients presenting with low back or lower extremity complaints. This includes both surgical and non-surgical patients seen at a single tertiary spine center with six spine-fellowship trained surgeons with similar practice patterns, representing a typical adult spine practice population. After receiving Institutional Review Board approval, patients who had an LESI between June 2012 and July 2013 and had EQ-5D [14] and ODI [15, 16] scores available before and after LESIs, but before any surgical intervention, were identified. Two anesthesiologists performed all LESIs.
Costs were calculated based on the Medicare Fee
Schedule multiplied by the number of LESIs done between the two clinic visits. Since there were no formal follow-up periods and the EQ-5D and ODIs were administered at varying time intervals in each patient, the calculation of QALYs were adjusted for the length of follow-up. The primary analysis was carried out using EQ-5D health state utility values. A secondary analysis calculating QALY based on the SF-6D derived from the ODI [18] was also performed. Results: Of the 421 patients who had a LESI and had EQ-5D and ODI data prior to the first LESI, 323 (77%) had EQ-5D and ODI data after their LESI but before any surgical intervention. There were 200 females and 123 males with a mean age of 59.2 ± 14.2 years (range, 18 to 88 years). Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
There were six (2%) patients who were being treated under Workman’s Compensation. The preinjection and post-injection outcomes are summarized in Table 1.
Although there was a
statistically significant difference between all pre-injection and post-injection clinical outcomes, the magnitude of change is small. Cost per LESI was $608, with most patients receiving three LESIs over the span of one year (range 1 to 6) (Table 2). The mean cumulative QALY gained was 0.005 using the EQ-5D. The EQ-5D gained was similar regardless of which anesthesiologists performed the procedure (p=0.402). The cost QALY gained for the entire cohort was $249,631. One hundred forty five patients (45%) had a gain in QALY (mean= 0.117) at a cost of $62,175 per QALY gained, 127 (40%) had a loss in QALY (mean = -0.120) and 51 (15%) had no change in QALY. There was no difference (p=0.548) in the distribution of specific spine pathologies between the patients who had a gain in QALY compared to those that did not (Table 3). The pre-operative ODI, back and leg pain scores were similar in the patients who had a gain in QALY and those that did not (Table 4). Fourteen of the 145 patients who improved, and 29 of the 178 patients that did not, had medical comorbidities that precluded surgery. These 43 patients who had comorbid conditions precluding surgery had a loss in QALYs with a mean change in QALY of -0.017. Thirty-two (22%) of 131 patients without medical comorbidities who improved; and 57 (32%) of the 149 patients without medical comorbidities who did not improve subsequently had surgery.
This proportion is
statistically significantly different at p=0.015. Although the patients who had surgery even after improvement with LESI had a lower mean QALY gain (0.105) compared to those that did not have surgery (0.118), this was not statistically significant (p=0.635).
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The mean cumulative QALY based on the SF-6D gained was 0.005; with similar gains between the two anesthesiologists (p=0.658). For the entire cohort, the cost per QALY gained based on SF-6D utilities is $273,624. One hundred and sixty-five patients (51%) had a gain in QALY (mean= 0.117) at a cost of $114,110 per QALY gained, 138 (43%) had a loss in QALY (mean = -0.119) and 20 (6%) had no change in QALY. Seventeen of the 165 patients who improved, and 26 of the 158 patients that did not, had medical comorbidities that precluded surgery. These patients who had comorbid conditions precluding surgery had a loss in QALYs with a mean change in QALY of -0.015.
Forty-three (29%) of 148 patients without medical comorbidities
who improved; and 50 (38%) of the 132 patients without medical comorbidities who did not improve subsequently had surgery. This proportion is not statistically significantly different at p=0.128. Although the patients who had surgery even after improvement with LESI had a lower mean QALY gain (0.036) compared to those that did not have surgery (0.040), this was not statistically significant (p=0.635). A sensitivity analysis looking at the number of steroid injections necessary to make LESI cost-effective in patients with a gain in QALY showed that three or less injections would be cost-effective when
EQ-5D valuations accrued and two
injections or less when SF-6D valuations are used (Table5). In addition, even with an increase in the number of LESIs administered, the change in EQ-5D score or SF-6D score was similar (Table 6). Discussion: Recent systematic reviews evaluating the comparative effectiveness of LESIs showed that the best available evidence regarding its efficacy is less than robust [2-5]. These systematic reviews are hindered by the heterogeneity of patient selection, mode of delivery, type and dose of steroid used, number and frequency of LESIs and outcome measures. Most randomized clinical trials Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
evaluating LESIs compare different approaches (caudal, interlaminar or transforaminal) [19], type [20, 21] or dose [22, 23] of steroid, or are limited by a lack of a true placebo group [24, 25, 26]. Earlier studies [26, 27] comparing epidural steroid to epidural saline injections showed a significant improvement at three weeks in patients receiving epidural steroid injections. However, by six weeks, the benefit of steroid injections was no longer evident. A more recent randomized placebo controlled trial comparing epidural steroid, epidural saline and sham showed no differences in outcomes among the three groups at any follow-up time point, up to one-year post injection [28]. The current study was undertaken to further evaluate the cost-effectiveness of lumbar epidural injections in a pragmatic clinical study. Performing a pragmatic study allows the clinician to assess the role of LESIs in the management of patients with lumbar degenerative disorders. QALYs were not determined based on specific pre-determined time-points but were adjusted based on standard of care clinical follow-up, allowing for real world evaluation of the efficacy of LESI. Despite the lack of formal follow-up time points, the results of the current study were similar or better than previously published prospective studies [26, 27, 28 29, 30]; with around half of the patients showing improvement.
However, with only half of patients showing
improvements or a gain in QALY, it would be difficult to conclude that LESI are cost-effective in patients, based upon commonly accepted indications. Looking at outcome measures, there was a statistically significant improvement in ODI, back and leg pain scores, but none of these would be considered clinically meaningful. The mean improvement in ODI was 3.5 points and mean improvement in back and leg pain was less than 1 point, none of which are clinically relevant [31].
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Adjusting for inflation and converting to US dollars, Udeh reported a cost per QALY of $37,758 [8], Whynes reported $48,537 [7] and Price reported $94,000 [8] for LESIs. Considering only patients who had a gain in QALY based on the EQ-5D, the cost per QALY calculated in this study of $62,175 was cost-effective. However, when QALY based on the SF-6D is used, the cost per QALY gained of $114,110 for patients that improved, is above the threshold considered to be cost effective [11, 12]. The mean change in SF-6D was only a third of the mean change in EQ-5D. This is consistent with previously published studies that have shown that the gain in utility when measured using the SF-6D is smaller than when measured by the EQ-5D [32]. In contrast to other studies [26, 27], in this study a statistically greater proportion of patients who did not improve with LESIs based on their EQ-5D (32%) elected to have surgery compared to those who improved (22%). Based on this data, it would seem that some patients improved enough with LESI that they deemed surgery unnecessary. However, if SF-6D valuations are used, this is not true. That is, the proportion of patients who elected to have surgery was similar in those who had improvements in SF-6D (38%) compare to those who did not (29%). Although it may be argued that these patients may not have been surgical candidates, the proportion of patients with nonspecific back pain was similar in patients who had EQ-5D improvements and those that did not; and the mean pre-injection ODI score was in the “Severe disability” category for ODI. In patients who had comorbid conditions precluding surgery, there was a relatively small loss in QALY even after an LESI. It would be difficult to ascertain if these patients would have deteriorated even further, with greater losses in QALYs if they did not have any LESIs. For the same reason, it would be difficult to ascertain if patients who improved with LESIs would have improved spontaneously, even without LESIs.
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Current practice guidelines recommend that the number of LESIs be tailored based on the individual patient response [24, 33]. A recent literature review however, showed that most providers perform a series of LESIs [34]. In the current study, 94% of patients received three or less injections. There does not seem to be a rational use of increasing number of injections, as there was no difference in the EQ-5 D or SF-6 D scores stratified by number of LESIs performed. Based on the current data, administration of one or at the most three LESIs may be cost-effective. Additional LESIs do not seem to increase effectiveness despite the additional cost. There are limitations to the study. Patients were seen at a tertiary spine specialty clinic, which may introduce selection bias; including patients who are more symptomatic and may have less response to LESIs. The diagnostic etiology prompting treatment with LESI was heterogeneous. However, the distribution of the different diagnostic etiologies was similar between the patients who improved and those that did not. Moreover, recent studies from a single group of authors have shown no difference in outcomes between LESI and control patients with disc herniation and radiculitis [35]; discogenic pain without disc herniation or radiculitis [36], post surgery syndrome [37] and spinal stenosis [38] The EQ-5D which is considered a long-ordinal scale with only 243 health states valued may not be sensitive enough to detect a change in health states in this specific population [14]. Although not specifically monitored and collected, the volume, dose and frequency of LESIs probably varied from patient to patient. This is not different from normal routine care. Only two specific anesthesiologists performed all the LESIs. This was done to mitigate a possible large amount of variation in technique. The results from this study showed that there was no difference in the amount of QALY gained between the two anesthesiologists.
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This study indicates that based on existing indications for treatment, LESI is not a cost-effective intervention. This stems from the fact that only 45% of patients obtained clinical benefit, and that the magnitude of improvement was modest. Examination of the subset that obtained clinical benefit demonstrated the potential for cost-effectiveness, as this group had a cost per QALYof $62,175 based on EQ-5D utility values. However, an alternative analysis using SF-6D utility values did not demonstrate cost-effectiveness, even in the clinical responders at a cost/QALY of $114,110. These findings emphasize the need to utilize LESI in a more targeted and judicious fashion. LESI is often advocated simply because it is not surgery. However, our data indicates that, even in the patients who obtained clinical benefit, surgical treatment was only marginally less frequent. Further, recent studies indicate that pre-surgical LESI may diminish the benefit of subsequent surgical treatment [39, 40] In summary, LESIs are not being used in a cost-effective manner. While there appears to be a subset of patients that benefit from LESI, that group needs to be more clearly defined. Even if the majority of patients improve after LESI, cost-effectiveness would still be dependent upon durability and the frequency at which injections are required.
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Table 1. Summary of pre and post-injection clinical outcome measures Outcome Measure
Pre-Injection
Post-Injection
Change
p-value
EQ-5D
0.505
0.538
0.033
0.014
SF-6D
0.538
0.549
0.011
0.032
47.52
43.98
3.540
0.001
Back Pain
6.28
5.55
0.739
0.001
Leg Pain
6.03
5.14
0.891
0.001
Oswestry Disability Index
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Table 2. Distribution of the number of Lumbar epidural steroids per patient over the span of one year. Number of LESI
Frequency
Percentage
One
98
30%
Two
96
30%
Three
107
33%
Four
13
4%
Five
6
2%
Six
3
1%
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Table 3. Distribution of diagnostic etiologies between patients who had a cumulative improvement in EQ-5D compared to those that did not (p=0.548) Diagnostic etiology
EQ-5D improvement
No EQ-5D improvement
12 (10%)
25 (14%)
8 (6%)
9 (5%)
23 (18%)
28 (16%)
10 8%)
5 (3%)
Disc herniation
16 (13%)
13 (7%)
Nonspecific back pain*
22 (18%)
27 (15%)
Stenosis
54 43%)
71 (40%)
Adjacent level degeneration Degenerative scoliosis Spondylolisthesis Mechanical disc collapse
*Patients diagnosed with nonspecific back pain have had advanced imaging studies and no specific diagnostic etiology causing the patient’ symptoms could be identified.
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Table 4. Comparison of pre-injection clinical outcome scores between patients who had a cumulative improvement in EQ-5D compared to those that did not No EQ-5D
p-value
EQ-5D improvement Outcome Measure
improvement
Oswestry Disability 46.60
48.71
0.312
Back Pain
6.36
6.22
0.643
Leg Pain
6.13
5.99
0.566
Index
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Table 5. Sensitivity analysis of cost per QALY with increasing number of LESIs Number of LESI
Cost per EQ-5D QALY
Cost per SF-6D QALY
One
26,912.63
51,467.00
Two
53,825.26
102,933.99
Three
80,737.90
154,400.99
Four
107,650.53
205,867.98
Five
134,563.16
257,334.98
Six
161,475.79
308,801.98
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Table 6. Mean Change in utility scores stratified by number of LESIs Mean EQ-5D Change ± Number of LESI
Frequency
Mean SF-6D Change ± SD SD
One
98
0.011 ± 0.174
0.009 ± 0.080
Two
96
0.016 ± 0.169
0.010 ±0.067
Three
107
0.006 ± 0.147
-0.002 ± 0.066
Four
13
-0.114 ± 0.278
0.002 ± 0.077
Five
6
-0.029 ± 0.196
-0.009 ± 0.071
Six
3
0.029 ± 0.119
-0.035 ± 0.003
323
0.005 ± 0.170
0.005 ± 0.071
0.206
0.717
Total p-value
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