Sweden

In December 2020, Swedish Medical Technologies Product (MTP) Council decided to evaluate new technologies for self-monitoring of atrial fibrillation within the Orderly introduction framework. MTP Council commissioned the Swedish Dental and Pharmaceutical Benefits Agency (TLV) to perform a health-economic evaluation of Coala Heart Monitor Pro and KardiaMobile; however, other products may also be considered later.

In early December 2020, the Swedish National Board of Health and Welfare announced significant changes in the Swedish Classification of Health Care Measures (KVÅ) structure related to vascular surgery procedure codes. New Chapter V, “Operations on the aorta, peripheral vessels and lymphatic system,” will be introduced from January 2021, gathering all vascular surgical procedures previously located in several subchapters.

In November 2020, Stockholm Region issued a preliminary version of the prospective report for the management of health care up to 2040. The report raised the need for new ways of organizing health care in the Stockholm Region and outlined the increase of standardization and alignment trend, emerge of collaborative governance models, the increase of care structure complexity, etc.

On December 03, 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) published a report on its activities in health economic evaluations of medical technologies in 2020. The significant change is that since 2020 TLV has a permanent assignment to carry out horizon scanning and health economic evaluations of medical technology products as a part of the national orderly introduction framework.

The ultimate step in establishing reimbursement is achieved by making reimbursement applications to authorities. MTRC provides support with the development of reimbursement applications for a novel procedure code, change of diagnosis-related groups (DRGs) and establishing other payment mechanisms in the Nordic region and Russia.

In November 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched a theme survey for medical technology products in stroke, focusing on products for diagnostic/assessment in case of suspected stroke. The submissions in relation to this survey will be closed on December 16, 2020

In late October 2020, the Swedish prospective cost-weights for NordDRG 2021 were released by the National Board of Health and Welfare (Socialstyrelsen).

In late September 2020, the Swedish version of NordDRG for 2021 was issued by the National Board of Health and Welfare (Socialstyrelsen). Four (4) new DRGs were added, and few minor changes in DRG names and logic were made.

In September 2020, Swedish Medical Technologies Product (MTP) Council decided to evaluate gene diagnostics for breast cancer within the Orderly introduction framework. Swedish Dental and Pharmaceutical Benefits Agency (TLV) will perform health economic assessments of these tests, including MammaPrint, Oncotype DX, ProSigna, and EndoPredict

On August 18, 2020, Swedish Medical Technology Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in diabetes, which now includes FreeStyle Libre 2. The previous recommendation was published by New Therapy (NT) Council in 2018.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is currently performing a theme survey for medical technology products for ischemic heart disease and heart failure. The submissions in relation to this survey will be closed on August 21, 2020

In the middle of May 2020, Västra Götaland HTA-Centre published an HTA on magnetic resonance image-guided radiotherapy in patients with cancer aiming to assess whether the studied method improves treatment results compared to current methods. It was concluded that the new technique might be associated with a higher proportion of treatment sessions reaching target coverage goals and a lower number of treatment sessions with violations of organs at risk constraints. However, the extent of improvement varied substantially between studies, and the certainty of the evidence is low.