Sweden

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.

On April 09, 2021, the Swedish Medical Technologies Product (MTP) Council decided to add more technologies to the ongoing evaluation for self-monitoring of atrial fibrillation within the Orderly introduction framework, initiated in December 2020. MTP Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health-economic evaluation of five products (Coala, KardiaMobile, CardioMem CM 100 XT, PhysioMem PM 100, Zenicor). MTP Council will then make recommendations to the regions on whether to adopt these technologies or not.

In the middle of February 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched the assessment on the following prognostic platforms for gene diagnostics in breast cancer: Oncotype DX, MammaPrint, ProSigna. The evaluation is planned for the spring of 2021.

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. Currently, the SBU is working on assessments of treatment methods of gastrointestinal conditions, musculoskeletal disorders, pain treatment, medical aids, e-health technologies, and other topics.