Sweden

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.

On August 26, 2022, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning within the Orderly introduction framework for products that promote the transition to so-called “Close care” (Nära vård). Products of interest should enable diagnosis, treatment, and follow-up outside a healthcare facility, for example, remote monitoring. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until September 28, 2022.

In June 2022, the National Board of Health and Welfare published the report "Towards a more coordinated cancer screening", which outlined measures taken to improve coordination in the area of cancer screening, and proposals for developing screening programs for early detection of cancer.

On May 31, 2022, Regional Cancer Centers collaboration (RCC) updated the national care program for breast cancer. New and updated recommendations concerned genetic testing, molecular diagnostic, de-escalation of surgical treatment for certain patient groups, radiotherapy regimens, and pharmacotherapy. A new chapter was added on breast cancer in men.

On April 11, 2022, the Swedish Medical Technologies Product (MTP) Council released recommendations on devices for diagnosing atrial fibrillation via self-recording of electrocardiogram evaluated within the Orderly Introduction framework since 2020. MTP Council outlined that Coala Heart Monitor and Zenicor ECG could be used in certain types of patients only, whereas KardiaMobile, CardioMem CM 100 XT, and PhysioMem should be refrained from use.

On March 16, 2022, the Swedish Medical Technologies Product (MTP) Council released recommendations for SpaceOAR Hydrogel and Barrigel used to reduce the side effects of radiotherapy in prostate cancer. MTP Council recommended the regions wait with the use of technologies until more knowledge is available or use them only within the clinical trials.

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.