In June of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the MicraTM Transcatheter Pacing System (Micra TPS) - a leadless pacemaker produced by Medtronic to reduce the rate of complications following pacemaker implantations through design and novel technology. The objective of the assessment was to investigate the clinical efficacy, safety and cost effectiveness of Micra TPS in patients indicated for single chamber ventricular pacemaker implantation.
Two alternative patient groups that may benefit from a pacemaker which can demonstrate a lower frequency of complications were defined:
- All patients recommended for single-chamber ventricular pacing;
- Patients recommended for single-chamber ventricular pacing, but who are at high risk for complications following pacemaker implantation.
The key conclusions from the report are provided below:
- Main clinical outcomes:
- The electrical parameters are within the reference values;
- There are four device or procedure related deaths in a cohort of 1521 patients;
- The major complication rate for the Micra device is 4% (95%CI 2.7-6.1%) six months after implantation;
- The major complication rate for conventional pacemakers, as represented in a historical control, is 7.4% (95%CI 6.4-8.4%) six months after implantation;
- Economical outcomes:
- For the indicated patient population:
- An estimated total added cost of NOK 26,653,195 in year five based on a patient population of 650 patients;
- The calculated incremental cost-effectiveness ratio (ICER) was over NOK 1,770,495 per quality-adjusted life years (QALY) gained;
- For patients with high risk of complications:
- An estimated total added cost of NOK 4,652,759 in year five based on a patient population of 10-30% of the total indicated patient population;
- ICER was estimated to be NOK 1,077,363 per QALY gained;
- For the indicated patient population:
- Overall conclusion:
- The current evidence is not sufficient to prove that the Micra TPS gives less complications than standard pacemakers;
- The device is leadless and hence avoids all complications related to lead and pocket, which is previously reported to be in the range of 2.5-5.5% in the indicated patient group;
- Published device or system related deaths were four in 1.575 implanted patients;
- The analysis of the budget impact of introducing Micra to all patients indicated for single chamber ventricular pacing shown a total added cost of NOK 27,386,992 in year five. The ICER for this group rises well above the level that have been considered cost-effective in Norway;
- Offering the Micra device to only patients particularly susceptible to complications or have a defined high risk of complications, may be an alternative model. Although there was no clinical evidence that the Micra may be beneficial to any specific subgroup of patients, the cost-effectiveness for offering the Micra device to patients with high risk of complications, and more specific, with high risk of infections was analyzed. This group was estimated to be 10-30% of the total indicated patients. The analysis show that the total added cost will be about NOK 4,652,759 in year five, by introducing Micra to this group in a Norwegian setting. After adjusting the model to account for important shortcomings in the submitted analysis, related to clinical effect input data, the ICER is considered not to be cost-effective for this sub-group
See the main results of the assessments in Norwegian and English here.
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