The Australian Medicare Services Advisory Committee (MSAC) has recommended restoring Medicare funding for vertebroplasty in patients with severely painful thoracolumbar fractures of less than three-weeks duration.
The MSAC is an independent, non-statutory committee established by the Australian Government Minister for Health in 1998. The body appraises new medical services proposed for public funding, and provides advice to government on whether a new medical service should be publicly funded (and, if so, under what circumstances) on an assessment of its comparative safety, clinical effectiveness, cost-effectiveness, and total cost, using the best available evidence. Interventional News has been informed by an Australian interventional radiologist that, following the MSAC recommendation, “It is now a formality that parliament will approve a Medicare item number for vertebroplasty”.
The MSAC recommendation comes after the Interventional Radiology Society of Australasia (IRSA) submitted an application to the Department of Health requesting the reinstatement of Medicare Benefits Schedule listing for vertebroplasty for severely painful osteoporotic thoracolumbar vertebral fractures of three-weeks duration or less in Australia, which was discussed at the 78th MSAC Meeting, on 3 April 2020.
MSAC’s advice to the Minister reads: “After considering the strength of the available evidence in relation to its safety, clinical effectiveness and cost-effectiveness, MSAC supported public funding for vertebroplasty for severely painful thoracolumbar osteoporotic fracture of three-weeks duration or less, as suggested during the MSAC Stakeholder Meeting on Vertebroplasty held on 7 June 2019. MSAC also advised that a prospective registry be developed to monitor this listing.”
Lead author of the VAPOUR trial (Vertebroplasty for Acute Painful Osteoporotic fractURes) William Clark (St George Private Hospital, Sydney, Australia) explains how the VAPOUR trial identified a subset of patients who benefit from the minimally invasive procedure, expanding on these ideas in a commentary for this newspaper how the VAPOUR trial results ultimately led to the reinstatement of Medicare funding in Australia.
Vertebroplasty is defined in the MSAC recommendation document as “A procedure in which acrylic cement is injected into a bone of the spine to treat a break (fracture) where the bone was already weakened due to osteoporosis, and where the break has resulted in pain and limited mobility affecting quality of life.”
“MSAC accepted that vertebroplasty has a benefit in a small population of patients by helping them regain their mobility sooner and reducing pain in the short term,” states the consumer summary. “However, MSAC noted that the cost-effectiveness of vertebroplasty is uncertain. MSAC also considered that the procedure might be used in patients for whom there is no evidence of any benefit. Therefore, MSAC advised that the use of vertebroplasty be limited to those patients with recent and severely painful fractures of a certain type and location. The Committee also suggested that this use is monitored through a registry for at least two years, so that information can be collected about who is receiving the treatment and the costs associated with that treatment. This will provide data that MSAC can review in the future to ensure that the procedure is being used appropriately according to these specified criteria.”
Vertebroplasty previously stripped of eligibility for Medicare funding: A timeline of events
Vertebroplasty was previously listed on the Medicare Benefits Schedule from 2005 to 2011 based on recommendation in the 2005 MSAC report. The interim item number was to be reassessed by 2010.
MSAC completed its second review in April 2011 and did not recommend continued public funding based on two randomised controlled trials, published together in the New England Journal of Medicine in 2009, that did not appear to support vertebroplasty.
An application for relisting vertebroplasty for severely painful osteoporotic vertebral fractures of less than six-weeks duration on the Medicare Benefits Schedule was submitted to MSAC after the results of the VAPOUR randomised controlled trial were published in The Lancet in 2016. The six-week limit for facture duration was later modified by consensus between MSAC and IRSA to three-weeks.
MSAC considered this application for relisting vertebroplasty in a November 2018 meeting, but did not support pubic funding for vertebroplasty due to the committee being “uncertain of its clinical significance”. They did, however, acknowledge that there may be “a small clinical benefit” from vertebroplasty.
In March 2019, MSAC again considered the application, but deferred its advice until a stakeholder meeting could be held, as the body believed this would “provide a broader clinical perspective and patient input, [and] could inform the uncertainties in the application”.
The June 2019 stakeholder meeting represented a turning-point for vertebroplasty advocates. In the publicly-available minutes of this meeting, it is noted: “One clinician commented that there is respect among his colleagues for the MSAC process. They feel it is fair and rigorous and prevents adoption of low value practice and wastage of health funding. However, there is some concern that the process is quite arduous, and the difficulty of obtaining the evidence required may discourage people from submitting applications for services that may be beneficial.
“The clinician suggested that MSAC needs to have procedural consistency in dealing with differences of opinion between professional groups. They commented that vertebroplasty is an established technique, and related that clinicians were achieving good results with it when it was previously funded. Clinicians were surprised when the 2009 randomised trials showed no benefit. The clinician commented that the VAPOUR trial compensated for problems in the early trials, and showed that with strict patient selection criteria, results can be positive. They expressed their disappointment that so far results of the VAPOUR trial had been combined with, and effectively ‘drowned out’ by, the other trials. Other clinicians agreed that there is no rationale for combining data from the VAPOUR trial for patients in the acute phase with data from other trials in patients with chronic fractures.”
Following the discussion at the stakeholder meeting, MSAC gave their funding recommendation.