April exclusion of several consumable medical devices from the list of pharmaceutical benefits by Dental and Pharmaceutical Benefit Agency

In late January 2022, Swedish Medical Technologies Product (MTP) Council issued an updated version of recommendations regarding gene expression analysis for decision-making on the adjuvant breast cancer treatment, initially published in November 2021. The recommendation to the regions remains the same. The changes were only concerned with the clarification of some facts.

In February 2022, Swedish Medical Technologies Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in type 2 diabetes (T2D). The initial recommendations were published by NT Council in 2018 and updated by MTP Council in 2020 to include FreeStyle Libre 2. In the 2022 update, MTP Council decreased the Hba1c limit from 70 to 60 mmol/mol and added a statement on lifestyle changes and treatment optimization with non-insulin antidiabetic drugs.

On February 07, 2022, the Dental and Pharmaceutical Benefits Agency has announced the withdrawal of the assessments of the PhysioMem PM 100 and CardioMem CM 100 XT and the finalization of the assessments of the Zenicor ECG, Coala Heart Monitor Pro, and KardiaMobile. 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.

At the end of February 2022, the Dental and Pharmaceutical Benefits Agency (TLV) has launched a theme survey on products for monitoring and diagnostics of sepsis to identify products that may be relevant for health economic assessments at TLV. The suggestions for the products of interest, ongoing clinical studies, or innovation projects could be received until 23 March 2022.

On February 08, 2022, the Reimbursement Commission of the Social Security Institution released an updated version of the Healthcare Implementation Communique. The main changes relate to the increase in reimbursement fees of services and medical devices by approximately 35-75%.