The Wall Street Journal recently reported on a study published in the NEJM that showed no clinical benefit from vertebroplasty versus placebo. How much impact will it really have? Unlike Vioxx or Tysabri, it’s not like the procedure has been shown to cause harm or adverse events among patients. There is no risk of it being pulled from the market, and the major spine companies (Depuy/JNJ, Synthes, Medtronic/Kyphon) will still be permitted to market the technology. Surgeons and patients will testify to the benefits it provides for the pain associated with vertebral compression fractures, regardless of what the study showed. In the current environment, though, the focus is on eliminating unnecessary healthcare costs. If vertebroplasty is not shown to provide a medical benefit in a study like this, should Medicare pay for it?

Many cast doubt on the accuracy of the study. The sample size was too small, patient selection was biased, measurement of pain cannot be accurate… When it comes down to it, a definitive study that accounts for these errors will need to be conducted before drastic cuts in reimbursement are likely to be taken. That said, the attention the study has garnered will likely make surgeons think twice before choosing vertebroplasty for a patient.

A comparison can be made between this situation and the ENHANCE study that came out in January 2008. When the ENHANCE study was released showing that Vytorin was no more effective than simvastatin monotherapy, the same questions surfaced. What would happen to Vytorin’s formulary status and reimbursement? The PGR network indicated that the status would likely remain unchanged, but the biggest impact would be from a decrease in the number of new prescriptions written for the drug.

In the same way, the PGR network indicates that the number of vertebroplasty and kyphoplasty procedures will likely go down, regardless of reimbursement cuts. Physicians will be more careful when choosing patients for the procedure (some patient types do really benefit), especially given the increased scrutiny that comes with a procedure that they may be financially incentivized to do. While companies were once able to get away with marketing their products to the masses, they do not want to be hit with independent studies such as this. The shift is towards defining the patient profile more accurately and taking a more personalized approach to medicine. How this will play out is still a big question, but it will start with more narrowly defined patient populations in clinical studies and an increased emphasis on pharmacogenomics.

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