Assessments of monitoring and diagnostics of atrial fibrillation products released in Sweden

On February 07, 2022, the Dental and Pharmaceutical Benefits Agency (TLV) accomplished its work on health economic assessments of the following products for monitoring and diagnostics of atrial fibrillation:

• PhysioMem PM 100 by GETEMED Medizin- und Informationstechnik AG
  • The assessment was not conducted as the company refrained from participating in the evaluation;
• CardioMem CM 100 XT and PhysioGate App by Acertys
  • Due to the absence of published clinical studies on CardioMem CM 100 XT showing clinical efficacy/patient benefit, the health economic assessment was not performed;
• Zenicor ECG by Zenicor Medical Systems AB
  • The main study that compared Zenicor ECG with 24-hour Holter ECG is relatively small; it shows uncertainty about its effectiveness;
  • The analysis shows that the use of Zenicor ECG compared to Holter ECG 24-hours leads to 0.0037 won quality-adjusted life years (QALY) on average with a cost saving of 384 SEK. The TLV's health economic assessment indicates that the use of Zenicor ECG provides greater benefit and lower cost than its alternative;
• Coala Heart Monitor Pro by Coala Life SE
  • The TLV outlines that included study is relatively small and describes the uncertainty about the device’s effectiveness;
  • The analysis shows that the use of Coala Heart Monitor Pro in comparison with the Holter ECG 24-hours leads to between 0 and 0.0024 won quality-adjusted life years (QALY) with a cost saving of approximately 606 to 929 SEK. The TLV's health economic assessment indicates that the use of Zenicor ECG provides greater benefit and lower cost than its alternative;
• KardiaMobile by AliveCor
  • The scientific knowledge is based on small studies with different patient groups and alternatives; there is uncertainty about the results transferability to patients in atrial fibrillation and the comparison alternative based on Swedish conditions;
  • TLV estimates the proportion of the avoided strokes is 0 to 0.67 percent; cost savings are from 293 to 10,128 SEK compared to the Holter ECG 24-hours. The TLV's analysis indicates that the use of KardiaMobile can provide greater benefit and lower cost compared to its alternative. When no stroke is detected, the investigation with KardiaMobile is considered cost-saving compared to the Holter ECG 24-hours.

For the conducted assessments, it was outlined that the portable devices provide more limited information than standard ECG measurements; therefore, it was mainly estimated for atrial fibrillation.

The full details in Swedish can be found here.

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