Introduction of national collaboration regarding medical devices in Sweden
29 Jan 2020

The new national medical device council (MTP-council) in Sweden has come in to force as of January 2020. It is based on the previous done by the NT-council for new drugs. Prior to establishing the MTP-council, a few medical devices have been evaluated by the NT-council, see below summaries of the outcomes:

  • Freestyle libre continuous glucose monitoring 2018-02-05
    • Product: Free style Libre
    • Indication: Type two diabetes treated with meal and basal insulin and have problems with recurrent hyper- or hypoglycemia and with an HbA1c above 70 mmol/mol.
    • Recommendation:
      • To use for patients in the above indication
      • Not to use outside indication.
      • That the agreements with the company should follow the national price adjustment valid from 2018-03-01.
    • Follow up:
      • The use of the product should be monitored in the national diabetes registry where the type of diabetes, HbA1c-values and the name of the producer should be monitored.
  • Optune 2018-06-28
    • Product: Optune, based on Tumour Treating Fields
    • Indication: Glioblastoma (more details in report)
    • Recommendation:
      • To use the rental model that has been agreed with the company and the regions
    • Follow up: None defined
  • Hybrid insulin pumps for diabetes 2018-11-15
    • Product: Minimed 670G, hybrid closed loop insulin pump
    • Indication: Type 1 diabetes
    • Recommendation:
      • Patients who previously used other pump and require a replacement
      • patients with type 1 diabetes follow the guidelines from the ministry of health regarding the use of sensor augmented pump
    • Follow up: To monitor the use of the product in the national diabetes registry.
  • FoundationOne CDx 2019-11-06
    • Product: FoundationOne CDx, extraction and Next Generation Sequencing
    • Indication: Solid tumors
    • Recommendation:
      • It should not be used in routine health care.
      • It may be used in extraordinary cases.
      • It has a particular role within clinical trials in the evaluation of drug treatments, where this is a significant demand for knowledge and validation.
    • Follow up: None defined

The new MTP council

The new MTP-council has the following responsibilities based on the preliminary definition:

  • Support all the regions regarding the use of medical devices to ensure equal care for all patients in the country.
  • Provide recommendations regarding the use of the medical devices, based on the same foundation as the ethical platform for the NT council and when appropriate TLV’s board for pharmaceutical benefits, considering the specific nature of medical devices.
    • A recommendation should be a significant guidance for how the products are used in the regions.
  • The task of the council is to:
    • Make decision if a product should be introduced according to a national managed entry program, the method of introduction and follow up.
    • Co-ordinate the request of formal health-economic evaluations, HTA reports, evaluations and monitoring towards affected organizations within the system for knowledge management.
    • Provide a recommendation for all products included in the managed entry program.
    • When providing recommendations, establish the necessary advisory groups to support the process.
    • Communicate the results from the monitoring activities and determine if the introduction can be considered completed and if necessary, give additional recommendations.
    • Support the purchasing organizations regarding the understanding of willingness to pay and ethical considerations.