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Health economic evaluation of KardiaMobile in atrial fibrillation

TLV has performed a health economic evaluation of the medical device KardiaMobile on the request by the Swedish Regions. KardiaMobile together with KardiaApp is intended for self-registration of ECGs by patients. With the help of KardiaPro, healthcare professionals can access patients' registered ECGs with associated data.

On the request by the regions' Medical Technology Council, the MTP Council, TLV has carried out a health economic evaluation of KardiaMobile. TLV's health economic evaluation will be part of the decision basis for the MTP Council's forthcoming national recommendation for the use and procurement of KardiaMobile in clinical praxis.

Atrial fibrillation is the most common arrhythmia in adults. About three percent of Sweden's population over the age of 20 and ten percent over the age of 80 are estimated to have atrial fibrillation. Atrial fibrillation carries an increased risk of blood clots, which can cause ischemic stroke (cerebral infarction caused by decreased blood flow). Therefore, it is important to diagnose atrial fibrillation early and, if necessary, treat with, for example, oral anticoagulants to reduce the risk of stroke. Atrial fibrillation diagnosis is made by electrocardiogram (ECG). A 12-lead ECG is routinely used to diagnose atrial fibrillation during a health care visit. If necessary, the examination can be performed with ECG equipment that measures continuously over a longer period, for example Holter ECG.

KardiaMobile is a medical device that is intended to be used to periodically record, store, and transmit single-channel ECGs. KardiaMobile is used together with the KardiaApp application for patients and the KardiaPro software for healthcare professionals.

According to TLV's clinical experts, hand-held ECG devices can be used to diagnose atrial fibrillation. However, they provide more limited information than conventional ECG measurements. TLV therefore estimates that hand-held ECG devices will mainly be used for the investigation of suspected atrial fibrillation.

The patient population that TLV has considered as relevant based on the MTP Council's request regarding diagnosis are patients who seek primary care with some form of symptoms that may be atrial fibrillation-related, and for whom no atrial fibrillation diagnosis can be made at the first primary care visit.

The patient populations that TLV has considered relevant based on the MTP Council's request regarding monitoring are patients who have undergone some form of surgery, such as ablation, as well as patients who are on frequency-regulating drug treatment for atrial fibrillation.

The scientific support for KardiaMobile is based on small and heterogeneous studies regarding patient population and comparators. TLV finds that there is uncertainty about transferability of data to the intended patient population and the comparator based on Swedish conditions.

There are major uncertainties in the health economic analysis. However, these have been addressed through scenario analyzes as well as sensitivity analyzes and the impact on the result is not considered to affect the conclusion about the product's cost-effectiveness.

TLV estimates the proportion of avoided first strokes at between 0 percent and 0.67 percent and cost savings at between SEK 293 and SEK 10,128 per patient in comparison with the Holter ECG 24-hours. The scenario analyzes in the health economic evaluation thus indicate that the use of KardiaMobile can provide greater benefit at a lower cost than the comparator. Even if no stroke is avoided, an investigation with KardiaMobile is cost-saving in comparison with the Holter ECG 24-hours.

Publicerad 07 februari 2022

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