A recent MJA article puts vertebroplasty back in the spotlight, ahead of next year’s MSAC decision on whether the controversial procedure for osteoporotic spinal fractures should be granted limited Medicare subsidies.
The procedure –which involves injecting polymethylmethacrylate (PMMA) into the fractured vertebral body– was removed from the MBS in 2011 after a systematic literature review by Medicare Services Advisory Committee (MSAC) found substantial evidence of lack of efficacy.
That decision was controversial, according to vertebroplasty proponents who claim the decision was entirely based on the results of two masked trials (here) and (here) published in the New England Journal of Medicine in 2009 which found vertebroplasty no more effective than placebo in reducing pain.
As previously reported by the limbic, the proponents from the Interventional Radiology Society of Australasia (IRSA) argue the trials largely miss the group of patients that can benefit from the treatment – patients over the age of 60 with osteoporotic spinal fractures less than six weeks old in severe pain – and have applied to MSAC to consider an MBS item.
To support their application they point to the results of a randomised, double-blind placebo-controlled trial of 120 people published in The Lancet in 2016 which supports efficacy of vertebroplasty for acute vertebral fracture of less than six weeks.
One of the study’s co-authors is Sydney-based rheumatologist Associate Professor Paul Bird, who in an article published in the MJA this week note that in their own practice patients “seemed to benefit from the procedure, often dramatically” from the procedure and argue there are three key reasons why the results of the 2009 trials differ so radically from that of the VAPOUR trial.
One reason is the 2009 trials enrolled patients who experienced back pain for up to 12 months, with only a small proportion less than six weeks, Associate Professor Bird, from the St George and Sutherland Clinical School and his co-authors wrote.
The interventions in both trials used “low” mean volume of PMMA– 2.6 mL and 2.8 mL compared to the VAPOUR trial’s 7.5 mL.
Lastly, the two studies did not include inpatients (excluded in one trial and not reported in the other).
“Although the trials were rigorously conducted, they did not reflect the patient group that we were treating, nor the technical approach that we were using,” they wrote.
Professor Bird and his colleagues conclude that vertebroplasty “emerges from the VAPOUR trial as an effective treatment for acute vertebral fracture — with the caveat that the procedure should be performed within 6 weeks (and preferably within 3 weeks) of symptom onset, using a vertebral fill technique.
“When there is disconnect between trial outcomes and clinical experience, we should examine the situation closely to determine the reason, or risk losing a valuable intervention.”
Rheumatologist and clinical epidemiologist Professor Rachelle Buchbinder is co-author one of the 2009 NEJM trials, and also co-authored an individual patient meta-analysis combining both trials which found vertebroplasty no more effective than placebo in a sub-group of patients with fractures of less than 6 weeks’ duration.
Professor Buchbinder, president of the Australian Rheumatology Association and a member of MSAC, has previously voiced multiple concerns over the VAPOUR trial.
These centre on the credibility of the placebo, success of blinding of participants, lack of benefit in important secondary outcomes and selective reporting.
There was a large difference in the proportion of people who correctly guessed their treatment at 14 days, while a self-confessed strong proponent of the treatment performed most procedures, she told the limbic last year.
“Furthermore our two year radiologic outcomes (not discussed in the VAPOUR trial) and other observational data suggest that there might be an increased risk of further vertebral fractures, something that this short term trial was unable to address.”
“Injecting cement into broken bones might seem like an appealing idea; but it clearly does not fix the problem. One month after the vertebroplasty, three quarters of the patients still needed to take painkillers and even by six months over half still required painkillers,” she said.
People on both sides of the fence will no doubt keenly await the outcome of the Medicare application for severely painful osteoporotic vertebral fractures of less than six weeks’ duration, which has passed the first hurdle and is now scheduled for consideration by the evaluation subcommittee of the Medical Services Advisory Committee (MSAC) in February 2018, the second in a three-stage process.
A spokesperson for the department of health said: “Based on current timing and straightforward progression through each step of the process, MSAC should consider the application in 2018.”