Almost a decade after vertebroplasty for osteoporotic fractures was removed from the MBS amid questions about its benefits, it is set to be returned for a select group of patients.
The Medicare Services Advisory Committee (MSAC) has recommended the controversial procedure be funded for severely painful thoracolumbar osteoporotic fractures of three weeks’ duration or less, according to the recently released summary of its April meeting.
The decision was welcomed by the Interventional Radiology Society of Australasia (IRSA), which lodged the application for MSAC to fund the procedure in 2017.
The MSAC meeting recommended the procedure – which involves injecting polymethylmethacrylate (PMMA) into the fractured vertebral body – be funded in cases where:
- pain is severe (≥ 7/10)
- symptoms are poorly controlled by analgesic therapy, namely opiates
- fracture duration is ≤3 weeks; and
- there is MRI (or SPECT-CT if MRI unavailable) evidence of acute vertebral fracture.
“I’m relieved,” said IRSA past-president Dr William Clark, Director of Interventional Radiology at St George Private Hospital, who spearheaded the fight for the procedure to be publicly funded. “For me personally, it has taken 10 years of my life.”
While IRSA initially applied for the procedure to be funded for patients with fractures of less than six weeks’ duration, it later came to a consensus with MSAC for the application to consider the procedure in patients with fractures of duration of three weeks and less, as they comprised the majority of participants in the supporting VAPOUR trial.
Dr Clark said the recommended MBS rules would cover most patients who could benefit from vertebroplasty, but who currently had to pay around $2000 for private procedures.
“I have seen that for well-selected patients who really battle to get out of bed it [vertebroplasty] is really effective, so I thought it was worth fighting for,” he told the limbic.
I’m happy with the way it’s worked out.”
However, Dr Clark said it was expected to take another 12 months before vertebroplasty was actually put back on the MBS, as the logistics of the funding rules are worked out.
The MSAC decision may bring a close to the long-running debate about vertebroplasty, which was first listed on the MBS in 2005 before being removed in 2011 in response to two randomised controlled trials that revealed it was no more effective than placebo in reducing pain.
Dr Clark, who was a member of the expert panel behind the 2011 MSAC decision but dissented from its final decision, then led a new randomised controlled trial of the procedure known as VAPOUR.
The VAPOUR study, published in The Lancet in 2016, was the first such trial to include hospitalised patients, and found vertebroplasty was superior to placebo for pain reduction in patients with acute spinal fracture of less than six weeks’ duration.
Those findings formed the basis of the IRSA’s 2017 application to MSAC, with subgroup analyses of all patients with fractures of ≤3 weeks duration, and of those with thoracolumbar fractures of ≤ 3 weeks’ duration, subsequently provided to support the application.
MSAC said the findings showed a statistically significant advantage for vertebroplasty over placebo at all time points (3 days, 14 days, 1, 3 and 6 months) apart from for the disability score at one month which wasn’t statistically significant.
Dr Clark said the largest benefit over placebo was shown in those with thoracolumbar fractures of ≤3 weeks, so the final MSAC recommendation to restrict treatment to that group of patients was “a good outcome”.
New registry for procedures
MSAC said it “accepted that vertebroplasty has a benefit in a small population of patients by helping them to regain their mobility sooner and reducing pain in the short term.”
While it noted that the cost-effectiveness of funding the procedure was uncertain, it said the financial impact would be small because of the small population involved.
However, it recommended a registry be developed to monitor MBS-funded procedures. It will report on the centre/state where the procedure is performed, whether the patient is hospitalised when the decision is made to perform the procedure, their length of hospital stay and any associated adverse events.
Dr Clark questioned the value of the registry, saying it was about ensuring compliance with the MBS rules, rather than proving the efficacy of the procedure.
However, Australian osteoporosis expert, Professor Peter Ebeling, welcomed the recommendation for a registry.
“That is a very positive thing as we might get real-world evidence about how effective the procedure is in these patients,” he said.
Professor Ebeling, Head of the Department of Medicine at Monash Health, led an American Society for Bone and Mineral Research (ASBMR) Task Force investigation into vertebroplasty, which last year reported findings that the procedure provided no clearly significant benefits in pain control over placebo procedures.
He said the ASBMR report was aimed at drawing attention to the fact that vertebroplasty should not be the “standard of care” for all osteoporotic fractures, as it was in some Asian countries and to some extent in the US.
The MSAC recommendation appeared to be based largely on evidence from VAPOUR study, he said.
“If anything, that suggests that if vertebroplasty is used, it is most effective in that situation [fractures ≤ three weeks’ duration],” he said.
Professor Ebeling agreed a small number of patients could benefit from the procedure, estimating that there were about three patients per year seen at his large osteoporosis centre that would be assessed as clinically suitable for vertebroplasty.