Almost five years to the day that it was removed from the MBS, moves are underway to have the controversial spinal fracture treatment vertebroplasty relisted for the treatment of osteoporotic spinal fractures.
The news comes hot on the heels of the release of the results of a trial that researchers claim substantiates the controversial procedure’s efficacy and safety.
Their findings were reported in The Lancet, with vertebroplasty proponent and Sydney-based interventional radiologist Dr William Clark leading the multicentre, randomised, double-blind, placebo-controlled trial known as the VAPOUR trial.
“Our trial demonstrates clinical efficacy for vertebroplasty in reducing pain from osteoporotic spinal fractures of less than 6 weeks when compared with a true placebo control,” the researchers concluded.
Dr Clark told the limbic that the results proved there was a clear case for the procedure to be relisted on the MBS. He said an application to the Medical Services Advisory Committee (MSAC) was expected to be lodged within a matter of weeks.
“There is an MSAC application being planned,” he said.
He said the procedure was ideally suited to patients over the age of 60 who are in severe pain with osteoporotic spinal fractures that are less than six weeks old.
“Technically the earlier it is the easier it is to treat and we achieve the best outcome,” he said.
Dr Clark said the VAPOUR trial results provided a strong case to have the procedure relisted on the MBS.
“It would be difficult for MSAC not to list it on the MBS,” he said.
While he conceded there were still likely to be vocal opponents to the application, he said the tide of opinion was turning in favour of vertebroplasty as an effective treatment.
“I expect there will be opposition to it, but I expect there will also be strong support for it,” he said.
“I’d certainly be disappointed if they (MSAC) didn’t find in favour of it.”
Leading Melbourne endocrinologist and medical director of Osteoporosis Australia’s Medical and Scientific Committee, Professor Peter Ebeling, who has previously co-authored research that claims vertebroplasty to be ineffective, said the new research was compelling.
“I think it does demand a rethink,” he told the limbic.
However he said any moves to have it relisted on the MBS should come with strict conditions on who would be eligible for it.
“I would support it if the indication was limited to 2-6 weeks of vertebral fracture for low thoracic or high lumbar fractures with relatively severe pain (pain score ≥7), as these are the patients who benefited most from the procedure in the recent study,” he said.
Professor Mark Cooper, Head of the Discipline of Medicine at Concord Hospital, Head of the Adrenal Steroid Lab at the ANZAC Research Institute and a member of Osteoporosis Australia’s Medical and Scientific Committee, described the paper as “exciting”.
He said he believed it would reopen the debate about the role of vertebroplasty but noted that additional information is usually required such as a health economic/quality of life analysis as part of any application to MSAC for MBS listing.
“Hopefully this will follow on from the recent paper using their data,” he told the limbic.
Vertebroplasty involves the injection of polymethylmethacrylate (PMMA) into the fractured vertebral body; on the premise that fracture stabilisation can provide pain relief.
The procedure was first listed on the MBS in 2005, costing taxpayers up to $1500 per treatment. On November 1, 2011, it was removed following a systematic literature review by MSAC that found there was substantial evidence of lack of efficacy for vertebroplasty.
It was also listed as a ‘do-not-do’ treatment in the Grattan Report in 2015.
However according to Dr Clark the VAPOUR trial fills an evidence gap in what is known about vertebroplasty’s efficacy in the treatment of acute, painful, osteoporotic vertebral fractures, most notably for those in the thoracolumbar region.
Dr Clark said it was important to understand that not every patient would be a suitable candidate for the procedure.
“There’s enough evidence in those two trials (the ones in 2009) that it’s not effective in older fractures,” he said.
“We’re gradually weaning out the group who’s going to benefit most from it.”
The VAPOUR trial received a funding education grant from CareFusion Corporation, a medical equipment supplier.