Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether percutaneous vertebroplasty for vertebral lesions from osteoporosis or malignancy meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria.
1. The technology must have final approval from the appropriate governmental regulatory bodies.
Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval. Kyphon, Inc. has received 510(k) marketing clearance for a bone cement product to be used in vertebroplasty and kyphoplasty. Other bone cements and bone void-filling products used represent an off-label use of such products.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The available evidence is not sufficient to permit conclusions of the effect of percutaneous vertebroplasty (PVP) on health outcomes.
The published evidence describing the outcomes of vertebroplasty consists mostly of uncontrolled studies. These uncontrolled studies were mostly retrospective and enrolled heterogeneous patient populations. Such studies cannot eliminate placebo and natural history effects as explanations for the apparent effectiveness of PVP. Two studies raise the issue of such effects. In a nonrandomized study, patients undergoing PVP had immediate pain relief from the procedure. However, at 6 weeks of follow-up and at 612 months follow-up, there was no difference between the group undergoing PVP and another group of patients that had not undergone PVP. In another pilot study reported only in abstract form, patients did not respond to PVP, but did respond to a sham procedure. These studies raise concern that nonspecific placebo effects may be important in determining results following PVP.
A nonrandomized study comparing kyphoplasty to vertebroplasty showed improvements in pain with either procedure, but an improvement in disability score only with kyphoplasty that did not persist at 2 years. Lack of formal comparison in outcomes between the 2 procedures makes it impossible to make conclusions about the relative efficacy of the procedures from this study.
Except for these comparative studies, the remaining published literature on outcomes of vertebroplasty consists of case series studies. For the indication of osteoporosis, 11 case studies meeting selection criteria were reviewed that evaluated outcomes of 907 patients. Results were generally consistent in showing significant decreases in pain from an initial preoperative level of 8 to 9 on a visual analog scale (VAS) and decreasing to 2 to 4 within 1 day of the procedure. For the indication of osteolytic destruction due to metastasis, 3 studies evaluating a total of 70 patients were reviewed. Results were generally similar to the studies for osteoporosis, in that mean VAS pain scores went from 710 at baseline to 03 after the procedure.
Because of the results of the comparative studies suggesting placebo or natural history effects, case series studies are insufficient to make conclusions about the effect of vertebroplasty on health outcomes. Rigorous controlled studies would help determine the efficacy of vertebroplasty. Because of the variability in patient selection and exclusion criteria across studies, it is difficult to know what the natural history of patients symptoms in the absence of treatment, and difficult to know which subsets of patients actually derive benefit from treatment.
3. The technology must improve the net health outcome; and 4. The technology must be as beneficial as any established alternatives.
The available evidence does not permit conclusions regarding the effect of percutaneous vertebroplasty on health outcomes or compared with alternatives.
5. The improvement must be attainable outside the investigational settings.
It has not yet been demonstrated whether percutaneous vertebroplasty improves health outcomes in the investigational setting. Therefore, it cannot be demonstrated whether improvement is attainable outside the investigational settings.
For the above reasons, percutaneous vertebroplasty for vertebral fractures from osteoporosis or malignancy does not meet the TEC criteria.