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MSAC Decision on Balloon Kyphoplasty

31 October 2011

Medtronic Australasia is aware of the Medical Services Advisory Committee (MSAC) decision to not recommend government funding for balloon kyphoplasty in Australia. This decision leaves Australian patients without a Medicare funded treatment option for painful vertebral compression fracture.

On receiving the draft Assessment Report from MSAC, Medtronic Australasia identified several concerns related to selective reporting, inaccurate clinical assumptions and data misinterpretation which fundamentally compromised the integrity and accuracy of the Report. When Medtronic sought details of the MSAC internal review process (as recommended by the DoHA initiated Review of Health Technology Assessment in Australia*), we were informed that there is currently no formal appeal process.

Of particular concern was the comparison of balloon kyphoplasty with vertebroplasty, which we believe is inaccurate.

While both procedures involve the use of bone cement, there are important differences. Balloon kyphoplasty is a surgical procedure designed to restore vertebral height, correct angular deformity and stabilize the spine. Vertebroplasty is designed to stabilize the spine, but does not aim to correct the deformity.

According to the 2005 MSAC Assessment report, an estimated 2,000 Australians per year will experience a symptomatic vertebral fracture. Kyphotic deformity (a rounded or humped back) and progressive bone weakness increase the risk of additional fractures. In cases of pronounced kyphosis, the ability to breathe, walk, eat, or sleep properly may be adversely affected.

The body of evidence supporting balloon kyphoplasty continues to grow. However, several recent, clinically relevant publications were not considered during the MSAC evaluation.

It is also important to note that the well-known clinical studies by Buchbinder etc all. 2009; and Kallmes et al. 2009 do not relate to balloon kyphoplasty. These studies found that there was no beneficial effect of vertebroplasty when compared with a sham procedure.

Medtronic Australasia is disappointed in the outcome of the MSAC assessment and will continue to explore options to make balloon kyphoplasty available to Australian patients.

*Review of Health Technology Assessment in Australia December 2009 ($File/hta-review-report.pdf)

One Comment leave one →
  1. 4 January 2012 2:56 pm

    Here is a story of a lady who walked again because of kyphoplasty surgery

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