Sweden

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.

In December 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) finished the theme survey in the obstructive pulmonary diseases field, which was conducted as a part of the Orderly Introduction for Medical Technologies framework. Identified technologies could potentially be included in the Orderly Introduction of Medical Technologies framework, which aims to facilitate the introduction of novel technologies on the national level.

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) systematically evaluates healthcare technologies and practices from medical, economic, ethical, and social standpoints. The following assessments were initiated in the third quarter of 2021: ultrasound-guided arterial catheters insertion in adults, the basis for national guidelines for heart disease. The final reports will be published on the SBU website upon completion

On November 18, 2021, Swedish Medical Technologies Product (MTP) Council recommended the use of gene expression analysis (Prosigna and OncotypeDX) for decision-making on the adjuvant breast cancer treatment. The technologies have been under evaluation within the Orderly introduction framework since 2020.

In November 2021, the National Board of Health and Welfare released an annual update of the Swedish procedure coding classification (Classification of Health Care Measures, KVÅ) that will come into force in January 2022. KVÅ includes two parts – medical procedures (KMÅ) and surgical procedures (KKÅ) divided into chapters based on anatomical principles. In 2022, six new surgical procedure codes will be introduced. Furthermore, structural changes will be made in Chapter V "Operations on the aorta, peripheral vessels, and lymphatic system," introducing two new sub-chapters with 318 new codes. A total of 53 new medical procedure codes (KMÅ) will be added.

In October 2021, the National Board of Health and Welfare released the Swedish version of the 2022 NordDRG. Six new DRGs were added, and they concern the cardiovascular area, vaccination, cochlear implants, and visits in primary care. Also, several changes in DRG content and logic were made.

On September 20, 2021, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning for medical technology products used in obstructive lung diseases within the Orderly introduction framework. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until October 15, 2021.

On August 19, 2021, the Dental and Pharmaceutical Benefits Agency has announced the withdrawal of the assessments of the MammaPrint and EndoPredict tests for various reasons.

At the end of August 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has initiated a theme survey on digital image diagnostics to identify new and innovative technology that may become important in Swedish healthcare. This could lead to potential inclusion of the technology in the Orderly introduction of medical technologies framework. The suggestions could be submitted no later than September 24, 2021.

In July 2021, the Dental and Pharmaceutical Benefits Agency released two completed health economic evaluations on the cost-effectiveness of the Oncotype DX and ProSigna tests. The evaluation was performed at the request of the Medical Technology Product (MTP) Council. The cost per quality-adjusted life-years for ProSigna is estimated to be 207,000 SEK compared to the stand-alone clinical pathology assessment. The analysis indicates that the use of Oncotype DX provides greater benefit than the alternative, also at a lower cost.