A controversial procedure used for osteoporotic spinal fractures is about to make its first major step towards relisting on the MBS.
The Interventional Radiology Society of Australasia (IRSA) has made an application to the Medicare Services Advisory Committee (MSAC) to secure MBS funding for “vertebroplasty for severely painful osteoporotic vertebral fractures of less than 6 weeks duration”.
A spokeswoman for the Federal Department of Health told the limbic that the new application would be considered by the PICO Advisory Sub-Committee (PASC) on April 12.
She said the committee would determine if the application should progress through to the next stage of the MSAC process.
“MSAC is a three step process,” she said.
“It is a comprehensive process of evaluation of clinical evidence to ensure that public funding supports services that are safe, cost-effective and clinically effective.”
Based on current timing and straightforward progression through each step of the process, a final decision by MSAC (step 3) could be in late 2017, the spokeswoman said.
“These elements ensure that the service, should it be recommended by MSAC and implemented by Government, is an appropriate, accurate, effective, safe and targeted service that is of benefit to Australians at an appropriate price,” she said.
“If MSAC recommends public funding for the service, the actual MBS listing date is a matter for Government, subject to financial and legislative approval.”
Vertebroplasty is no stranger to the MBS
The procedure, which involves the injection of polymethylmethacrylate (PMMA) into the fractured vertebral body on the premise that fracture stabilisation can provide pain relief, is already no stranger to the MBS.
It was first listed 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.
However the MSAC application, signed by IRSA President Dr John Vrazas, claims the controversial decision to remove vertebroplasty from the MBS in 2011 was entirely based on “two negative placebo controlled trials of vertebroplasty.”
“This was a controversial decision causing a split in the MSAC expert advisory panel, with both IRSA representatives Dr Murali Guduguntia and Dr William Clark (a strong proponent of the procedure), as well as the College of Surgery representative, Dr Graeme Brazenor, opposing it,” Dr Vrazas wrote.
“Their main argument was that the main group of patients likely to benefit from vertebroplasty, elderly patients with fractures less than six weeks’ duration and severe pain, were largely missed by these two placebo trials.”
The two papers were both published in the New England Journal of Medicine in 2009 (see here and here), and the procedure was also listed as a ‘do-not-do’ treatment in the Grattan Report in 2015.
Issues with VAPOUR
In response to the MSAC decision, Dr Clark, a Sydney-based interventional radiologist and a team of researchers moved to conduct a placebo controlled trial of vertebroplasty, which would become known as the VAPOUR trial.
Results published in The Lancet late last year supported the use of vertebroplasty for fractures of less than six weeks.
At the time Dr Clark told the limbic that the VAPOUR trial filled 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.
He also said the trial results “provided a strong case to have the procedure relisted on the MBS”.
The news that the procedure is being reconsidered for an MBS relisting coincides with the release of a commentary in BMJ Evidence Based Medicine that has raised concerns about the VAPOUR trial used by the IRSA to support its application.
According to the commentary co-authored by rheumatologist Professor Rachelle Buchbinder, an NHMRC Senior Principal Research Fellow, and Director of the Monash-Cabrini Institute Department of Clinical Epidemiology, the benefits of vertebroplasty might have been overestimated because of a number of issues, including the differential blinding of participants.
“Patients undergoing vertebroplasty recall the cement odour and the tapping of vertebra. Clark et al used odourless cement and only injected local anaesthetic into the subcutaneous tissues.
“Problems with blinding may have led to a significant difference in the proportion of participants who correctly guessed their treatment allocation at 14 days (80% in the vertebroplasty group vs 54% in the placebo group),” they wrote.
“The placebo may not have been credible as a placebo, and the very different proportion of people who correctly guessed their treatment group suggests that this might be the case,” Professor Buchbinder explained in an interview with the limbic.
There were also concerns about the lack of clinically important between-group differences for most secondary outcomes such as mean pain.
“These results do not support the finding from the primary outcome and casts doubt on the validity of the interpretation of the results,” she said.
“At the very least, it would be important to see a plot of mean improvement in pain and understand why these results differed.”
The authors said in their commentary that “Discounting overestimation of treatment benefit in unsuccessfully blinded trials vertebroplasty might be appropriate for a small subset of patients with acute fractures (≤3 weeks) at the thoracolumbar region”, but that this should be “carefully weighed against potential harm and the known favourable natural history.”
Professor Buchbinder – lead investigator on one of the original placebo-controlled trials of vertebroplasty – explained that even at best, this trial only found a benefit for a very small subset of patients, which may not be biologically plausible.
Further clarity is likely to be forthcoming upon publication of VERTOS IV, a completed placebo-controlled trial that included a patient population similar to VAPOUR, she added.