Swedish Medical Technology Product Council updates recommendations on FreeStyle Libre

14

Sep 2020

On August 18, 2020, Swedish Medical Technology Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in type 2 diabetes, which now includes FreeStyle Libre 2.

Until March 2020, New Therapy (NT) Council was making recommendations for the use of medical technologies. In 2020 a pilot project for national orderly Introduction of medical technologies became permanent, and the new MTP Council is now responsible for decisions and recommendations within this framework.

The following recommendations were provided for FreeStyle Libre 2:

  • FreeStyle Libre 2 can be used if the need cannot be covered with FreeStyle Libre 1. This applies to both type 1 and certain patients with type 2 diabetes, according to the previous recommendation published by the NT Council in 2018
  • The MTP Council has not made any assessment regarding the handling of any personal data or for the cloud-based service Libre View that can be connected to the device. Each region must decide for itself

Measurements ​​from FreeStyle Libre 2 can be uploaded to the smartphone via a CE-marked app connected to a cloud-based system for diabetes management (Libre View), which cost is included in the product’s price. It is outlined that there are no significant differences in performance or price between FreeStyle Libre 1 and 2 and no new health economic assessment done. However, due to price adjustments since the NT recommendation was published, the cost-effectiveness of FreeStyle Libre improved from 389,000 SEK to 294,000 SEK / QALY.

The conditions for use FreeStyle Libre in type 2 diabetes patients remain the same - patients must be treated with basal insulin in combination with mealtime insulin and have Hba1c > 70 mmol/mol or recurrent severe hypoglycemia despite efforts to adjust insulin doses.

See the full document in Swedish here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

The latest related news

23

Mar 2022

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.

Read more

16

Mar 2022

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.

Read more

11

Mar 2022

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.

Read more

08

Mar 2022

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.

Read more

10

Feb 2022

In January 2022, the Scottish Health Technology Group released a recommendation of the closed-loop systems and the artificial pancreas for type one diabetes mellitus. The limited use of closed-loop systems in routine clinical care makes it difficult to estimate device-related adverse event rates. No evidence was identified for artificial pancreas systems (multi-hormone closed-loop systems) available on the UK market.

Read more