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White Paper: Clinical evidence requirements for the “Orderly Introduction of Medical Technologies” process in Sweden
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Automated Insulin Delivery (AID) systems will be covered in Sweden for adults with type 1 diabetes
Automated Insulin Delivery (AID) systems have been evaluated within Sweden’s national Orderly Introduction framework for medical technologies. This staged process includes horizon scanning, a health economic evaluation by the Dental and Pharmaceutical Benefits Agency (TLV), and, based on the TLV report, recommendations from the Medical Technologies Product (MTP) Council to the regions.
In September 2024, the MTP Council commissioned TLV to conduct a health economic evaluation of AID systems. The TLV report, published in December 2025, concluded that AID systems result in greater reductions in HbA1c and diabetes-related complications over a lifetime compared with insulin pens used with glucose meters, particularly in patients with higher baseline HbA1c levels. The report also found that AID systems can reduce healthcare costs, improve quality of life, and lead to slightly longer survival.
On June 16, 2026, the MTP Council made the following recommendation to regions regarding the introduction of AID systems for adults with type 1 diabetes:
- AID systems should be offered to patients with HbA1c >70 mmol/mol, or to patients assessed as having a high risk of hypoglycemia, regardless of HbA1c level;
- AID systems may be offered to patients with HbA1c of 64–70 mmol/mol, or to patients assessed as requiring significant effort to manage blood glucose, regardless of HbA1c level;
- Patients already treated with AID systems who benefit from them should continue treatment.
The recommendation is contingent on the regions being able to achieve cost-effective pricing.
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