Research-Human-Clinical Studies: Editor's Choice
Surgical Management of Trigeminal Neuralgia: Use and Cost-Effectiveness From an Analysis of the Medicare Claims Database
Sivakanthan, Sananthan BS*; Van Gompel, Jamie J. MD‡; Alikhani, Puya MD*; van Loveren, Harry MD*; Chen, Ren PhD, MPH§; Agazzi, Siviero MD, MBA*
*Department of Neurosurgery and Brain Repair, Morsani College of Medicine, University of South Florida, Tampa, Florida;
‡Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;
§Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida
Correspondence: Siviero Agazzi, MD, MBA, Department of Neurosurgery and Brain Repair, USF Health South Tampa Center, 2 Tampa General Circle, Tampa, FL 33606. E-mail: email@example.com
Received October 10, 2013
Accepted April 21, 2014
BACKGROUND: Trigeminal neuralgia is a relatively common neurosurgical pathology with multiple management options. Microvascular decompression (MVD) is nonablative and is considered the gold standard. However, stereotaxic radiosurgery (SRS) and percutaneous stereotaxic rhizotomy (PSR) are 2 noninvasive but ablative options that have rapidly gained support.
OBJECTIVE: To use Medicare claims data in conjunction with a literature review to assess the usage, effectiveness, and cost-effectiveness of the 3 different invasive treatments for trigeminal neuralgia.
METHODS: All of the claims of trigeminal neuralgia treatment were extracted from the 2011 5% Inpatient and Outpatient Limited Data Set. Current Procedural Terminology, 4th Edition/International Classification of Diseases, Ninth Revision codes for the 3 different surgical treatment modalities were used to further classify these claims. Kaplan-Meier survival curves in key articles were used to calculate quality-adjusted life years and cost-effectiveness for each procedure.
RESULTS: A total of 1582 claims of trigeminal neuralgia were collected. Ninety-four (6%) patients underwent surgical intervention. Forty-eight (51.1%) surgical patients underwent MVD, 39 (41.5%) underwent SRS, and 7 (7.4%) underwent PSR. The average weighted costs for MVD, SRS, and PSR were $40 434.95, $38 062.27, and $3910.64, respectively. The quality-adjusted life years were 8.2 for MVD, 4.9 for SRS, and 6.5 for PSR. The cost per quality-adjusted life year was calculated as $4931.1, $7767.8, and $601.64 for MVD, SRS, and PSR, respectively.
CONCLUSION: This study shows that the most frequently used surgical management of trigeminal neuralgia is MVD, followed closely by SRS. PSR, despite being the most cost-effective, is by far the least utilized treatment modality.
ABBREVIATIONS: BNI, Barrow Neurological Institute
ICD-9, International Classification of Diseases, Ninth Revision
MVD, microvascular decompression
PSR, percutaneous stereotaxic rhizotomy
QALY, quality-adjusted life year
SRS, stereotaxic radiosurgery
TN, trigeminal neuralgia
Trigeminal neuralgia (TN) is a relatively common pathology in the United States with a reported incidence of 4.3 in 100 000.1 Although the pathophysiology of idiopathic TN has not been fully elucidated, the symptoms are believed to arise from vascular compression near the root entry zone of the trigeminal nerve; however, this still remains theory.2,3 The result is a highly debilitating and well-characterized facial pain. Medical therapy for TN includes carbamazepine, baclofen, and gabapentin.4 The initial response rate for this therapy is around 70%, while the remaining 30% usually have some transient response.5 Eventually, however, patients' TN can become medically refractory and require surgical treatment.6
Currently, surgical treatments are divided into nonablative and ablative therapies based on the need to ablate or injure the nerve to resolve the pain.7 The only nonablative procedure is microvascular decompression (MVD). Ablative procedures include percutaneous stereotaxic rhizotomy (PSR) and stereotaxic radiosurgery (SRS).
There is a substantial amount of discussion in the current literature describing the efficacy of each of these surgical strategies.8-10 However, to date, there is no good evidence on how these treatments are utilized in practice. To our knowledge, only 2 articles have been published on a cost-effectiveness analysis of TN. Fransen11 reports on the European perspective. Pollock and Ecker12 report on the experience of 1 institution in the United States. There is no published report on national data.
With the use of the Medicare Claims Database and clinical results from landmark scientific articles, this study aims at determining for each surgical treatment: (1) its relative use across the United States and (2) its cost-effectiveness based on quality-adjusted life years (QALYs).
The 2011, 5% sample, inpatient and outpatient limited data sets were obtained from the Center for Medicare/Medicaid Services (http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/index.html?redirect=/LimitedDataSets/). Full data sets and limited data sets for both inpatient and outpatient claims are available to the public for purchase for research purposes only. SAS (SAS Institute, Cary, North Carolina) statistical software was used to analyze the data. First, all incidences of TN were collected by using the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code 350.1. These claims were further classified by using the Current Procedural Terminology, 4th Edition (for outpatient procedures) and International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes (for inpatient procedures) for the 3 treatment modalities. All of the procedure codes for the diagnosis were tabulated and then defined using the American Medical Association database for CPT codes.13 Two codes were identified for MVD: 04.41 and 03.09. PSRs were coded by 61790 and 61791. Finally, 5 different codes were found for SRS: 61796, 77371, G0173, G0251, and G0339.
When a complete list of patients undergoing the 3 treatments was collected, the claims were further classified by state, facility type, sex, race, date of birth, and total average charge.
A thorough search was conducted of all PubMed/Medline indexed published reports from 1951 to present. The following keywords were searched for: “Trigeminal Neuralgia,” “Microvascular Decompression,” “Radiosurgery,” and “Rhizotomy.” Utilizing this search, we isolated 1 article from each treatment group meeting the following inclusion criteria for QALY analysis: (1) The article had to present pain-free survival in the form of a Kaplan-Meier curve. (2) Patients needed to have at least 10 years of follow-up. (3) The largest patient series meeting criteria 1 and 2. The 3 articles chosen for analysis were the largest (in patient volume) and most cited scientific study for the respective treatment categories. A systematic review was not used, because our calculations required a Kaplan-Meier curve, which can only be derived from original data.
In order to make an accurate comparison, surgical outcomes from the selected articles needed to be defined. Ablative procedures use the Barrow Neurological Institute (BNI) pain scale to report reduction in pain after surgery.14 The BNI pain scale defines a score of 5 as postoperative pain (failure of surgery) and a score of 1 as pain-free without medication. The equivalent to BNI 1 in the MVD literature is simply the time pain-free. Thus, the time pain-free or “Excellent Outcome” from the nonablative literature was compared with BNI 1 from the ablative literature.
Quality-Adjusted Life Years
The QALY is a measurement of health care outcomes that is reported as a value from 0 to 1. It assumes 1 is a year of life lived in perfect health and 0 is death. In our investigation, perfect health was equivalent to the time pain-free without medication or BNI pain scale of 1. Mathematically, the QALY was defined as the area under the Kaplan-Meier survival curve at 10 years normalized to the total area available at 10 years (see Equation 1). Conceptually, the area under a survival curve represents the percentage of patients who are able to maintain an optimal outcome of complete freedom from pain over a certain period of time. We have selected 10 years, because these data are available for most procedures and appear to be the most robust follow-up.
To accomplish this, the Kaplan-Meier curves from the selected articles were imported into Adobe Photoshop version CS4. Magic Wand tool was utilized to select the area under the curve out to 0 years, and normalized to the total area available at 10 years (Figure 1). Given that QALY is a measurement over 1 year and that we defined our investigation over a 10-year follow-up period, the graphically derived QALY was multiplied by 10 (Equation 1).
Because more than 1 code was found for each 1 of the 3 categories of procedures, we had to first calculate the cost of each code. From this, the cost of each procedure could be derived for the cost-effectiveness analysis. The weighted cost per code represents the percentage of incidence of codes for a particular procedure times the cost for each code (Equation 2). Subsequently, all of the weighted costs per code of each procedure can be summed to arrive at the weighted cost per procedure (Equation 3). This number was divided by the QALY for the procedure to arrive at the cost-effectiveness of the procedure (Equation 4).
From our 5% random sample, we collected 1582 claims with the principal diagnosis of TN by using the ICD-9 diagnosis code of 350.1. A total of 94 of 1582 patients (6%) underwent surgical intervention. Of those, 48 (51.1%) underwent MVD, 39 (41.5%) underwent SRS, and 7 (7.4%) underwent PSR. The management of the remaining claims was not procedural, and, thus, the ICD-9 coding system was unable to reveal any further information.
Within the 48 claims of MVD, 20 patients were male and 28 patients were female. The largest represented age group was patients between 65 and 69 (28 patients), while the smallest was patients between 75 and 79 (6 patients) (Figure 2). The average number of claims per month was 8, with the most claims coming in October (13 patients) and the fewest in March (3 patients). Using Equations 2 and 3, the average weighted cost for MVDs was calculated to be $40 434.95.
Thirty-nine patients were found undergoing stereotactic radiosurgery. The male-to-female ratio was 12:27. Only 3 patients were younger than 75 (Figure 2). There was no discernible pattern in the temporal distribution. The average weighted cost was $38 062.27 for SRS.
Only 7 patients underwent percutaneous procedures; 2 were male and 5 were female. Three patients were younger than 74, and the remaining 4 were older (Figure 2). All of the claims occurred between April and October. For PSR, the average weighted cost was calculated as $3910.64.
Geographical location and month of claim were also examined and found to show no significant trends.
QALY and Cost-Effectiveness
Our PubMed search found 7 PSR studies, 11 MVD studies, and 3 SRS studies with at least 100 patients and at least 5 years of follow-up. Starting with the largest series in each modality, we attempted to isolate an article from each modality that presented pain freedom as a Kaplan-Meier curve. We were able to isolate the following 3 articles meeting all criteria necessary for inclusion in the QALY calculation: (1) “The long-term outcome of microvascular decompression for trigeminal neuralgia” by Barker et al published in the New England Journal of Medicine in 199615; (2) “Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgia: 25-year experience with 1600 patients” by Kanpolat et al published in Neurosurgery in 200116; and (3) “Gamma knife stereotactic radiosurgery for idiopathic trigeminal neuralgia” by Kondziolka et al published in the Journal of Neurosurgery in 2010.17 Entering these published results in Equation 1, the QALYs for the 3 procedures were calculated to be 8.2 for MVD, 4.9 for SRS, and 6.5 for PSR. Using Equation 4, the cost per QALY (cost-effectiveness) was calculated as $4931.1, $7767.8, and $601.64 for MVD, SRS, and PSR, respectively (Figure 3).
The methodology of our study behooved us to use only 1 Kaplan-Meier curve from a single study per treatment modality. This imperative prevented us from utilizing the entire body of knowledge on the surgical treatment of TN. To ensure the validity of our results, we compared the studies we used with a recent review of the literature published by Tatli et al10 in 2008. Of the 4884 patients they found undergoing MVD, the average pain-free rate at 6.7 years (on average) was 76.6%. They found 107 patients undergoing SRS who were followed up for 5 years having a pain-free rate of 58%. Finally, between radiofrequency thermorhizotomy and percutaneous balloon compression, they found 5240 patients followed up for, on average, 6.6 years. They found a pain freedom rate of 65.4% for percutaneous procedures. A more focused and detailed analysis of the published outcome data is described below.
With the use of the Medicare Claims Database, our study revealed that, in 2011, MVD was the most frequently utilized surgical treatment for TN (51.1%) followed closely by SRS (41.5%), while PSR was only used in 7.4% of the patients. The average weighted cost for 1 MVD was $40 434.95, for 1 SRS was $38 062.27, and for 1 PRS was $3910.64. Using outcome data from 3 large peer-reviewed published studies on each treatment modality, we found that the cost per QALY (or cost-effectiveness) for MVD was $4931.1, for SRS was $7767.8, and for PSR was $601.64.
These results confirm that, in a snapshot of the 2011 clinical practice, microvascular decompression was still the most effected and most utilized interventional treatment for TN.18 The Janetta series,15 the most cited and well-studied evidence base for MVD outcomes data, reported immediate and complete pain relief in 98% of patients. Absolute pain freedom without medication was 88% after 1 year and 74% after 10 years. The most common complications in this series were postoperative meningismus (16%), cerebrospinal fluid leak (1.4%), and permanent ipsilateral hearing loss (1.1%). Two patients died. Kondo,19 Lee et al,20 Zakrzewska et al,21 and Sindou et al22 all reported similar results. In these reports, with 146 to 362 patients, the initial pain relief rate was reported as low as 86% and as high as 92.9%. The response rate at last follow-up was 80% to 89% over an average 7-year follow-up time. The most common complications were hearing loss (average 1.9%) and death (average 0.9%).
Although MVD showed the best results and was the most widely utilized surgical treatment for TN in 2011, this study also indicates that PSR, albeit significantly less well utilized, was the most cost-effective surgical treatment modality. We identified the Kanplot series16 of 1600 patients undergoing percutaneous radiofrequency rhizotomy as the most representative of the PSR case series. Of these patients, 97.6% experienced acute pain relief, but, unfortunately, the authors did not present the percentage of patients who were acutely BNI 1. By the 5th year, the cure rate dropped to 57.7% and then to 52.3% by the 10th year. The most common postoperative complications were absence of corneal reflex in 5.7% of patients, masseter paresis/paralysis in 4.1%, and painful dysesthesia in 1.0%. No patients died. Twelve patients experienced anesthesia dolorosa. Other large PSR series include studies by van Loveren et al23 with 700 patients, Taha and Tew24 with 500 patients, and Broggi et al25 with 1000 patients, where the total average follow-up was 8.1 years. The initial acute response rate was 81% to 98%, which dropped to 74% on average at last follow-up. Again, these results were not reported on a strict BNI pain scale. Major complications included dysesthesia in up to 5% of patients, keratitis in up to 4% of patients, and anesthesia dolorosa in up to 1.5% of patients. It would seem that PSR has a low rate of complications but also a low rate of long-term efficacy.
SRS was, in 2011, the second most commonly used surgical treatment for TN. The most extensive sampling of SRS evidence is reported in the Kondziolka series17 of 503 patients undergoing gamma knife radiosurgery. They reported a 40% initial success rate with complete pain relief (BNI 1). At 5-year follow-up, 46% of patients had a BNI pain score of either 1, 2, 3A, or 3B. Unfortunately, the authors did no report the 5-year rate of BNI 1 alone. By the last follow-up at year 10, only 28.6% of patients were reported to be pain-free; 10.5% of patients developed bothersome numbness, and 1 patient developed anesthesia dolorosa. There was zero mortality. The only other reports with at least 5 years of follow-up are those by Urgosik et al26 and Dhople et al27 reporting on 107 and 112 patients, respectively. The BNI 1 initial response rate was 80.4% as reported by Urgosik et al and 64% as reported by Dhople et al. By the end of the follow-up period, Urgosik et al reported a 58% pain-free rate and Dhople et al reported a 22% pain-free rate at 7 years. Hyperesthesia was reported as the major complication occurring at an average rate of 13%.
QALY calculations are aimed at providing a common language to compare different interventions, understanding that both the quality of the outcome and the duration of the outcome participate in the overall success of any treatment. To try and compare the clinical value of each surgical treatment, we explored the possibility of retroactively calculating the QALY for each intervention by using historical case series. Based on the degree of pain relief and the duration of the pain relief, we found that the QALYs of MVD, SRS, and PSR were 8.22, 4.92, and 6.53, respectively.
After we established the clinical value of each treatment, we investigated the cost-effectiveness (or cost per QALY) offered by each procedure. The cost per QALY for MVD, SRS, and PRS was $4931.1, $7767.8, and $601.64, respectively. By establishing the cost per QALY, it became evident that PSR was by far the most cost-effective method for treating TN. Its cost-effectiveness was superior by a factor of 8 in comparison with MVD and by a factor of 13 in comparison with SRS. These results are corroborated by the only other 2 published studies evaluating the cost-effectiveness of these treatments modalities.11,12
Our results have to be interpreted with an understanding of the limitations of the study.
In our investigation, QALY was defined as complete freedom from pain. We recognize that some patients may subjectively feel adequate pain relief with a BNI 2 or even BNI 3, but for the purpose of an accurate comparison of either ablative procedure to MVD, we had to find a common ground. Given that results in the MVD literature are reported as “pain free without medication,” we had to restrict excellent outcome to BNI 1 in the PSR or SRS literature. Furthermore, QALY, in our study also did not take into consideration facial numbness, a potential determinant of quality of life that clearly differentiates results between ablative and nonablative procedures.
In our estimation of QALY, only 3 articles were used. We tried to adjust for this shortcoming by choosing the largest and most cited articles of their respective treatment categories that provided the most robust follow-up and outcomes data in the form of a Kaplan-Meier survival curve. Among the 3 of them are 3822 patients followed for over 10 years for a total of 38 220 data points. Although it is true that the number of articles selected is minimal, the data represented in those articles are substantial. In light of the fact that randomized controlled trials comparing the 3 treatments do not exist, we considered this choice as the second best way to compare results. It should be noted that the results presented in the representative articles follow the trend of the literature at large, as outlined in the discussion above. Additionally, a review by Tatli et al10 independently selected the same 3 articles for comparison, as presented in the discussion.
Finally, this study relies on the accuracy of billing codes, which may introduce error owing to the potential for incorrect or nonuniform coding. Additionally, the database is not able to distinguish first operation from second operation.
One additional limitation that is important to recognize is the overall limited number of patients undergoing surgical treatment of TN that were included in our calculations. This number could have been increased by purchasing the “full data set” of Medicare claims and by purchasing several years worth of claims. Nevertheless, the prohibitive cost of those additional data ($10 100 per full data set per year) forced us to limit the study to the 2011 limited data set.
Our study is a preliminary attempt at addressing the difficult question of cost-effectiveness in the care we offer to TN patients. Analysis of the Medicare claims data has demonstrated that, in 2011, MVD was the most widely used surgical treatment modality for TN, followed closely by SRS. Our calculations also revealed that, albeit PSRs are on average 11.5 times more cost-effective than either of the other 2 interventions, they are by far the least utilized of all surgical modalities. Although these results need to be examined with some level of critique, this article provides the best assessment to date of the relative utilization and cost-effectiveness of the 3 surgical modalities used for the management of TN in the United States.
The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.
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The authors have utilized the Medicare claims database to explore the utilization and cost of 3 surgical options for trigeminal neuralgia. In this limited set of 94 patients, the vast majority (>90%) underwent either MVD or radiosurgery. However, the authors conclude that percutaneous procedures are the most cost-effective surgery. Ablative percutaneous procedures, such as radiofrequency gangliorhyzolysis and balloon microcompression, have a high initial success rate with a longevity of benefit that rivals ablative radiosurgical outcomes. Percutaneous procedures should be discussed among the key management options for trigeminal neuralgia: medical management, microvascular decompression, and ablative surgery.
Adam O. Hebb
This article is one of the first to address an important issue in neurosurgical practice: health care costs for various surgical procedures. While it is based on a relatively small number of health claims coded for trigeminal neuralgia, and even fewer surgeries for tic, these have been obtained from across the United States and in a random fashion, and therefore are likely representative of the US Medicare system. The authors use the quality-adjusted life year or QALY, a well-established measure of health care outcomes, along with the Barrow Neurological Institute pain scale and Kaplan-Meier survival curves to define the parameters of the QALY. Unfortunately there are relatively few articles on tic surgery that use Kaplan-Meier statistics to report outcomes, but the authors used the best data available. While larger databases should also be queried to confirm findings of this study, the apparent underutilization of percutaneous rhizotomy in the United States is important and deserves more discussion. This procedure was found to be 13 times as cost-effective as stereotactic radiosurgery to which it can be realistically compared. We can speculate on possible reasons, including (1) the lack of training of residents (in both neurosurgery and anesthesia) on these procedures, (2) the perception among neurosurgeons, neurologists, and/or patients of too high a risk of adverse events (eg, anesthesia dolorosa), (3) which may be related to marketing by radiosurgery centers, or (4) percutaneous rhizotomy does not pay well enough, so if the same neurosurgeon can provide all surgical options for trigeminal neuralgia, they are more likely to recommend those procedures that provide higher surgical fees. Of course, this is unlikely unique to tic surgery, neurosurgery, or any aspect of medicine. However, it is the aspect of health care we are most reluctant to discuss publicly.
As a group we should address the reasons for underutilization and not wait for health care payers to do so on our behalf. We can train our residents how to do all surgical procedures for tic. We can reeducate our colleagues and patients about the real risks of the various procedures, and counterbalance marketing with data. Finally, although, as a group, we do not have a good record of cost containment and rarely train in health economics, funding should not be the driving force for selection of procedures. Cost-benefit should be, and I look forward to more publications on this topic from our neurosurgical organizations.
Zelma H.T. Kiss
Calgary, Alberta, Canada
The authors have examined the treatment of trigeminal neuralgia in the United States by using 2011 data from the Medicare Claims Database in conjunction with the clinical results from previously reported, important scientific articles. They specifically wished to examine utilization, effectiveness, and cost-effectiveness of microvascular decompression (MVD), stereotactic radiosurgery (SRS), and percutaneous stereotaxic rhizotomy (PSR). They demonstrate that MVD is the most frequently utilized, carries the highest average weighted cost, and has intermediate cost-effectiveness based on quality-adjusted life years (QALYs). Conversely, PSR was the least frequently utilized, least costly, and most cost-effective in terms of QALYs.
Health care in the United States is currently in a state of transition and is predicted to be radically altered in the coming years. A focus on the quality of patient care has brought objective data and associated analyses into the spotlight for patients, health care providers, and insurance companies. Additionally, in an effort to contain the escalating costs of health care in the United States, the value of care (outcomes relative to costs) is receiving increasing attention among all stakeholders. The present study is a timely contribution that provides a meaningful, but preliminary attempt at examining the care of patients afflicted with trigeminal neuralgia.
The authors nicely highlight many of the limitations of the present study. The study used only 1 year of Medicare data and only a 5% sample of the total data available for that year. Consequently, few patients were included in the analysis (for example, only 7 patients underwent PSR). Clearly, the data sample is limited and patients not covered under Medicare undergo treatment for their trigeminal neuralgia each year in the United States. Additionally, only 3 articles total (1 per modality) were used for the QALY calculations. The use of QALY is also limited as a measure of cost-effectiveness (facial numbness is not factored in, the definition of adequate pain relief as implemented has shortcomings, etc). The impact of recurrences following SRS and PSR and the cost of re-treatment is not clearly factored into the cost-effectiveness analysis.
The above notwithstanding, the authors are to be congratulated for their contribution which should provide impetus for further investigation—not only specifically for trigeminal neuralgia, but also for many common conditions treated by neurosurgeons as well.
Aaron S. Dumont
New Orleans, Louisiana
Cost-effectiveness; Quality-adjusted life year; Trigeminal neuralgia
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