New MBS item approved for leadless bradycardia pacemaker

Medicare funding is a step closer for transcatheter insertion and removal of leadless permanent pacemakers for the treatment of bradyarrhythmia after items were recommended by MSAC to the Federal Government.

However, the proposed price of the devices themselves would first need to come down to meet the government’s cost-effectiveness thresholds, according to the Medical Services Advisory Committee.

The items endorsed by the committee would each have a rebate of $580, covering percutaneous insertion, retrieval and replacement of pacemakers for the treatment of bradyarrhythmia that requires single-chamber ventricular pacing.

A fourth item, with a rebate of $2400, has been suggested for explantation of the same.

In its official advice (link here), the committee said there was unmet clinical need for those patients for whom a transvenous pacemaker (TVPM) is inappropriate due to inaccessible upper extremity venous system, increased risk of infection or history of venous thrombosis.

The extent of this patient group would need to be defined in the item descriptor, it said.

It follows an application by pacemaker manufacturer Medtronic, which said it was also planning to apply for its Micra™ Ventricular Transcatheter Pacing System device to be listed on the Prostheses List.

The committee stressed Medicare funding would be contingent on that listing, which would require Medtronic to drop its unit prices for the devices.

MSAC noted there were “limitations in the clinical evidence”, but accepted the devices were superior for long-term safety and noninferior for effectiveness compared with TVPM.

Currently the only such device available in Australia, the pacemakers are inserted via the femoral vein and implanted directly into the right ventricular myocardium, negating the need for transvenous wires.

MSAC said this would lead to potential advantages including the elimination of lead and pocket complications, as well as possibly improving patient satisfaction due to the absence of a scar and subcutaneous device location.

On the other hand, given the pacemakers had an average lifespan of 12 years, it was likely they would need to be replaced over time, particularly in younger patients, the committee said.

As a result, MSAC questioned whether there should be maximum number of leadless permanent pacemakers implanted per lifetime, but said this question would be left open pending consultation with CSANZ.

Extraction once encapsulated, required an invasive approach and was difficult, so few clinicians would want to perform the procedure and instead would opt to leave the pacemaker in situ, the committee wrote.

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