Sweden

On August 30, 2023, the National Board of Health and Welfare introduced national screening for spinal muscular atrophy (SMA) in newborns. The screening test will identify children with homozygous deletion in the SMN1 gene and 1–3 copies of the SMN2 gene. As a result, those affected by the most severe forms of SMA can receive treatment before the onset of symptoms.

On June 13, 2023, the Swedish Medical Technologies Product (MTP) Council recommended that all regions delay the introduction of robotic systems for knee, hip, and spine surgery until they have been evaluated as part of the Orderly introduction framework. For now, MTP Council recommends robotic systems in these indications only to be used in the context of research.

In April 2023, Swedish Medical Technologies Product (MTP) Council recommended that Magtrace and Sentimag be used for locating sentinel lymph nodes in breast cancer. The products were evaluated within the Orderly introduction framework, in which all Swedish regions collaborate to manage the national introduction of innovative medical technologies.

The Dental and Pharmaceutical Benefits Agency is currently conducting several health economic assessments of products for electrical spinal cord stimulation. The assessments were commissioned by the Medical Technology Product Council as the first step of the national Orderly Introduction process for new medical devices. The evaluations are planned to be accomplished during 2023.

In February 2023, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning within the Orderly introduction framework for medical technologies to be used in benign prostatic hyperplasia. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until March 31, 2023.

On January 24, 2023, the Swedish National Board of Health and Welfare recommended introducing a national screening program for spinal muscular atrophy (SMA) in newborns. It will identify children with a homozygous deletion in the SMN1 gene and 1–3 copies of the SMN2 gene. SMA testing must be included in the existing newborn screening (so-called PKU test). The launch of the new screening program is expected in the summer of 2023.

In November 2022, the National Board of Health and Welfare released the Swedish version of the NordDRG system to come into force in January 2023, including the list of DRG codes, names, and cost-weights. A total of 77 new DRGs will be implemented. Key new DRGs were introduced in cardiovascular, gastrointestinal, and endoscopy fields, also for breast reconstruction and bone-anchored hearing implants.

In November 2022, Swedish Medical Technologies Product (MTP) Council issued a policy of proven experience for medical technology, which complies profession's assessment of how appropriate medical technology is in specific conditions. The policy provides some examples of how the MTP Council acquires knowledge of proven experience and its impact on the MTP Council's recommendations.

In November 2022, an annual update of the Swedish procedure coding system (Classification of Health Care Measures, KVÅ) was released to come into force from January 2023. A total of 119 new surgical procedure codes and 98 new medical procedure codes will be introduced concerning cardiovascular, diagnostic imaging, eHealth, endocrinology, endoscopy, ENT, gastrointestinal, IVD, nephrology and urology, peripheral vascular, and others.

On October 31, 2022, the Dental and Pharmaceutical Benefits Agency (TLV) initiated conducting a theme survey for technologies used for the diagnosis or treatment of lung or colorectal cancer. Manufacturers of medical devices have an opportunity to notify TLV about a new product related to the theme of the survey. The notification form is available on the TLV website and should be submitted no later than November 22, 2022.

Swedish Medical Technologies Product (MTP) Council is currently evaluating devices for spinal cord stimulation (SCS) as part of the Orderly introduction framework, a staged process aimed at managing the national introduction of novel technologies. On September 23, 2022, MTP Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of five SCS devices. Based on the TLV assessment, MTP Council will make recommendations to regions regarding the introduction of SCS devices and the criteria for use.

The Dental and Pharmaceutical Benefits Agency (TLV) has planned a theme survey on products for the diagnosis or treatment of lung cancer and colorectal cancer to identify products that may be relevant for health economic assessments at TLV. The survey is planned to be carried out in September – October 2022. No further information has been provided yet.