Recent news and posts
Swedish MTP Council recommendations on devices for atrial fibrillation diagnosing
On April 11, 2022, the Swedish Medical Technologies Product (MTP) Council released recommendations regarding devices for diagnosing atrial fibrillation (AF) via self-recording of electrocardiogram (ECG) by patients, which were evaluated within the Orderly Introduction framework since 2020. This framework aimed to manage the national introduction of novel technologies as a staged process, including horizon scanning, selection of the method for evaluation, the decision on national collaboration, health economic evaluation by the Dental and Pharmaceutical Benefits Agency (TLV), and recommendations by the MTP Council to regions.
In February 2022, TLV completed a health economic evaluation of five products: Coala Heart Monitor Pro (by Coala Life), Zenicor ECG (by Zenicor), KardiaMobile 1L (by AliveCor), CardioMem CM 100 XT (by Getemed), and PhysioMem PM 100 (by Getemed). Based on the TLV assessment, MTP Council made the following recommendations to regions:
- Coala Heart Monitor and Zenicor ECG can be used for symptomatic patients without known cardiac arrhythmia suspected to have an AF. The introduction of these products should take place in close collaboration between primary care and specialist care (cardiology or clinical physiology) with clear selection criteria for patients;
- To refrain from using KardiaMobile 1L for examination of patients because MTP Council identified high deficiencies in the processing and protection of personal data when using KardiaMobile with associated services. The recommendation can be reconsidered if the manufacturer brings the protection of personal data in accordance with current legislation in Sweden and the EU;
- To refrain from using CardioMem CM 100 XT (due to the lack of evidence) and PhysioMem (as the manufacturer declined to participate in TLV health-economic assessment).
See the full details here.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).