Medicare funding for transcatheter aortic valve implantation (TAVI) will further expand from July, with a new MBS item set to be introduced for patients in the low surgical risk cohort.
The minimally-invasive procedure is already on the MBS for patients with severe native calcific aortic stenosis at high-risk of complications for open surgical aortic replacement, while an item for intermediate risk patients was added two months ago.
But the new item 38522 will expand eligibility to any patient with the condition, regardless of their surgical risk.
Details around its rebate and descriptor are yet to be released.
However, with rebates of $1,117.70, both existing TAVI items require the procedure to be performed via transfemoral delivery, unless transfemoral delivery is contraindicated or not feasible.
They can be claimed a maximum of once every five years per patient.
A new MBS item for transcatheter insertion of a dual-filter Cerebral Embolic Protection (CEP) will also be introduced for when a patient is undergoing the insertion of a TAVI implant.
This new item may be used for patients in all risk categories for primary TAVI procedures, CSANZ has said.
It comes just a year after the Medical Services Advisory Committee (MSAC) knocked back an application by device-maker Edwards Lifesciences to fund TAVI using a balloon-expandable valve (BEV) system for low surgical risk patients.
At the time, the committee stressed it was “largely accepted” that TAVI-BEV was safe, effective and cost-effective compared with surgical aortic valve replacement (SAVR).
Nevertheless, it said there were concerns about valve durability over the longer term, given that the low surgical risk population was younger, had longer life expectancy and generally had good long-term outcomes with SAVR.
In addition, MSAC noted that there was “limited evidence on reintervention with TAVI (valve-in-valve procedures) and whether this procedure performs as well as an initial TAVI procedure”.
But two months later, the committee changed its advice, endorsing a separate application by Medtronic Australasia that did not specify the type of TAVI device used.
It noted TAVI “had a different safety profile compared with SAVR”, with patients undergoing the less invasive procedure more likely to have paravalvular leakage, left bundle branch block and need a new permanent pacemaker implanted.
In making its recommendation, the committee added there were economic benefits to TAVI, particularly given the fact that it was still in its relative infancy and would likely become more cost-effective over time.
Separately, CSANZ announced two new MBS items would be introduced from November covering remote options for cardiac implanted loop recorders (ILRs) to encourage providers to offer the treatment in regional and rural locations.
Some eight MBS items would be amended at that time for CT surgery to incentivise advanced practice and rectify minor unintended consequences of the MBS Taskforce Review recommendations, it said.
As of last year, there were six TAVI devices listed on the Australian Register of Therapeutic Goods: three for patients at all risk levels and three restricted to patients at high surgical risk.