16.1 Introduction

VCFs are the most commonly occurring fractures worldwide in osteoporotic patients. ¹ The incidence of vertebral fractures is substantial and is often quoted as affecting one-third to one-half of patients over 50 years of age. ¹ In cancer patients, the incidence of vertebral fractures is more specific to the type and site of the primary cancer, but metastatic disease is common especially with some types of cancer including breast cancer where 20 to 50% of patients develop bony metastases, and 65% of bony metastases in breast cancer involve the spine. ² Vertebral fractures impose enormous societal costs, disrupt quality of life (QoL), and are associated with significant short-term mortality. ^{3 , 4}

The burden of vertebral fractures on health care cost, QoL, morbidity, and mortality has resulted in a variety of studies to evaluate the cost-effectiveness of treatment options. The treatments most commonly advocated for treating vertebral fractures are NSM, kyphoplasty, vertebroplasty, and instrumented fusion with or without surgical decompression. This review will focus solely on the first three treatments since cost-effectiveness of surgical decompression and instrumented fusion is beyond the focus of this chapter. Vertebral augmentation includes both kyphoplasty and vertebroplasty. For the purpose of this review, cost-effectiveness will be defined as the overall dollar expenditure as well as reduction in length of hospital stay, improvement in QoL, and decreased mortality per health care dollar spent. Because this review is inclusive of different disease states and both inpatient and outpatients, the review will summarize the best data available to make our conclusions as clear as possible.

Most patients admitted to the hospital with a painful VCF are managed with NSM. NSM has been shown to be not only ineffective in treating the symptoms of a painful VCF, but also more expensive due to the costs associated with prolonged bed rest, lengthier hospitalizations, and higher readmission rates. ^{5 – 8} For example, a systematic review of 622,675 hospitalized patients with VCFs reports an average length of stay of 10 days with approximately one-quarter of these patients hospitalized for greater than 2 weeks. ⁹ Additionally, 20% of patients hospitalized with VCF who were treated with NSM required readmission within 30 days. ^{10 , 11}

One of the only prospective evaluations of the cost of vertebral augmentation for osteoporotic compression fractures was done in Japan and published in 2017. ¹² This prospective series assessed the cost-effectiveness and improvement in QoL. They prospectively followed 163 patients with acute compression fractures and measured the health-related QoL and pain during 52 weeks’ observation using the European Quality of Life–5 Dimensions (EQ-5D), the Rolland–Morris Disability Questionnaire (RMD), the 8-item Short-Form health survey (SF-8), and visual analog scale (VAS).

They calculated the direct medical cost through the accounting system of the hospital and the Japanese health insurance system. The cost analysis did not take into account the lost time and money from work. They included the cost of the procedure (labor and material costs), hospitalization costs, examination and diagnosis (including imaging such as MR imaging, CT, biopsy, etc.), and other costs that could be counted such as meals were also included. The cost of the average vertebroplasty was listed as US$ 1,549, an amount that is similar to other Western countries. ¹²

They reported rapid improvement in the EQ-5D, SF-8, RMD, and VAS scores. ¹² Their findings suggest that vertebroplasty was cost-effective at improving QoL and pain in patients with acute osteoporotic compression fractures in Japan.

An analysis of several large cohort retrospective reviews from around the world presented data that supported reduced hospital stays and lower 30-day readmissions rates for patients with VCFs who were treated with vertebral augmentation. An analysis of 13,624 patients from The French Hospital National Database demonstrated that a greater number of patients who received vertebroplasty were discharged within a week in comparison to those who received NSM (68% for vertebral augmentation vs. 47% for NSM; p < 0.0001). ¹³ A nationwide cohort study from Taiwan involving 9,238 patients found a reduction in hospital length of stay by 2 days as well as a decrease in readmission rates at 7 and 30 days for patients who underwent vertebroplasty. ¹¹ The National Medicare Database in the United States has shown an average length of stay of 3 to 6 days for patients receiving augmentation, which is on average a 4- to 7-day reduction in length of stay when compared to traditional NSM data as presented above. ^{9 , 10} Intuitively, the length-of-stay decreases lead to less cost.

16.2 Cost-Effectiveness

We can clearly see that vertebral augmentation is associated with decreased short- and long-term mortality, but does it reduce cost? The most informative data on the cost-effectiveness of vertebral augmentation is derived from retrospective analyses of large patient populations (▶Table 16.1). ^{14 – 19} A review of this retrospective literature, while somewhat limited in sample size and breadth of scope, does indicate that vertebral augmentation is more cost-effective when compared to NSM. ^{20 – 23} This is particularly apparent when the mortality benefit of vertebral augmentation is included in this cost analysis.

Cost-effectiveness models comparing vertebral augmentation to NSM have also been performed and calculated that the cost per life-year gained ranged from US$ 1,863 to 13,543 for vertebral augmentation. ²⁰ A cohort study from the United Kingdom looked at patients hospitalized for VCFs and found that the cost per quality-adjusted life year of kyphoplasty versus vertebroplasty was €19,706 and concluded that kyphoplasty may be more cost-effective than both NSM and vertebroplasty (▶Table 16.2). ²¹ If one simply looks at health care dollars expended, NSM may appear more cost-effective, but when factoring the cost-effectiveness benefits of improved QoL and reduced mortality gained from vertebral augmentation, vertebral augmentation is clearly shown to be more cost-effective than NSM. ²¹ A prospective multicenter study from Sweden that lacked some of these adjustments and included only 63 patients failed to show the cost-effectiveness of kyphoplasty and computed an outrageously high cost per quality-adjusted life year of US$ 134,000. ²²

Borgström et al conducted a systematic analysis of peer-reviewed investigations of the cost-effectiveness of vertebral augmentation in patients with VCFs and osteoporosis. ²³ When compared to NSM, vertebral augmentation was found to be cost-effective in three of the five studies reviewed. Incremental cost-effectiveness ratios ranged from €3,337 to 92,154 (US$ 3,799–104,914) in four out of the five studies analyzed. ²³ Variations in cost-effectiveness were most affected by the time horizon of the study, time to realization of treatment effect, effect of treatment on QoL, reduction in length of stay, and mortality after vertebral augmentation. ²³

A cost analysis using Medicare claims from January 2005 to December 2008 in the United States found that the vertebral augmentation for the treatment of VCFs proves once again to be cost-effective. ²⁷ In this analysis, while all forms of vertebral augmentation proved cost-effective, kyphoplasty could impart more cost savings when compared with vertebroplasty. The differences in cumulative median costs for vertebroplasty and kyphoplasty compared with nonoperative management were US$ 8,300 to 28,820 for vertebroplasty and US$ 12,580 to 18,500 for kyphoplasty. ²⁷ These results were dependent on age and gender. The cost per life-year gained for kyphoplasty compared with NSM was US$ 1,863 to 6,687, and the cost per life-year gained for vertebroplasty compared with NSM was US$ 2,452 to 13,543. ²⁷ The cost-per-life-year-gained when comparing kyphoplasty versus vertebroplasty was US$ 284 to 2,399 for females and US$ 2,763 to 4,878 for males. ²⁷ These findings clearly indicate a lower cost-per-life-year-gained for kyphoplasty. Some variables including the cost of equipment and cost of the hospital vary greatly depending on the manufacturer, the location of the hospital, and the comorbidities of each patient. In addition, the lost work hours and the family cost of care to each patient are not represented and represent additional cost saving when appropriately taken into account.

A retrospective study by Masala et al showed that percutaneous vertebroplasty (PVP) in patients with osteoporotic vertebral fractures was more cost-effective than NSM. ²⁸ In the European Union, vertebral fractures are responsible for 8% of the hospital costs of all osteoporotic fractures, and the hospital cost of a vertebral fracture treated by NSM is approximately 63% of the mean hospital cost of a femoral fracture. ²⁸ In a patient population of 153 patients, 58 of which underwent PVP and 95 underwent NSM, Masala et al found PVP to be superior in outcome effectiveness, cumulative costs, and overall cost-effectiveness at 1 week and 3 and 12 months postprocedure. ²⁸ Cost-effectiveness was measured as the average cost per patient per reduction of 1 point on a reduction of pain (VAS) or improvement in the activities of daily living (ADL) scale. Costs were evaluated for each group by adding hospital care costs to all outpatient costs. PVP was more cost-effective at all three time points, statistically significant in all three categories at 1 week, and statistically significant for improved ADL scale at 3 months. It was also associated with earlier pain reduction, improvement of ambulation, and improvement of ability to perform ADL in the short and long term. The factors that most influenced cost were days of hospitalization, physical therapy, and the back brace for the NSM group. In the PVP group, costs were mainly affected by the hospital expenses of the procedure. ²⁸ Masala et al concluded that the improved clinical outcomes, along with the lower cost-effectiveness ratio of PVP in the short term and its comparable cost-effectiveness ratio with that of NSM in the long term make PVP a preferable procedure to NSM. ²⁸

When dealing with metastatic disease and vertebral pathologic compression fractures, there is even less long-term prospective data than with osteoporotic VCFs. The best literature review is by the Health Quality Ontario assessment done in May 2016. ²⁹ The objective of the Health Quality Ontario analysis was to determine the cost-effectiveness and budgetary impact of kyphoplasty or vertebroplasty compared with NSM for the treatment of VCFs in patients with cancer.

Upon completing a systemic review of health economic studies, they performed a primary cost-effectiveness analysis to assess the clinical benefits and costs of kyphoplasty or vertebroplasty compared with NSM in the same population from published sources. They also performed a 1-year budget impact analysis using data from the Health Quality Ontario administrative sources. They found that kyphoplasty and vertebroplasty used in patients with cancer may be a cost-effective strategy at commonly accepted willingness-to-pay thresholds. ²⁹

In conclusion, vertebral fractures are extremely common in patients older than 50 years, especially in patients with osteoporosis and metastatic cancer. The overall review of the literature supports vertebral augmentation as a cost-effective method that is superior and more cost-effective than NSM in patients with VCFs. Some of the major influences are the decreased length of stay and the overall lower rate of narcotic usage over time.