Regionernas samverkansmodell för läkemedel och medicintekniska produkter.

Health economic evaluation

All medical devices that are subject to nationally managed introduction must undergo a health economic evaluation. Then the cost-effectiveness of the use is assessed, i.e. the relationship between the benefit of the use in relation to the cost compared with a standard intervention. The evaluation is usually made by TLV, but other actors (such as SBU, regional HTA and international HTA bodies) may also be relevant.

The medical device company must provide a health economic documentation that shows the costs and benefits that arise for society when using the product in comparison with the most relevant intervention alternative when the product is used. The Swedish Dental and Pharmaceutical Benefits Agency, TLV, then carries out the health economic assessment.

What information must be submitted

The following elements can, for example, be included in the documentation:

  • Background description of the clinical problem and description of the patient population.
  • Product description.
  • Description of relevant comparison options.
  • A comparison of the cost of the product during normal use as opposed to the cost of the comparison alternative.
  • Documentation describing the benefit (including side effects) the patient receives from the product, set against the benefit provided by the comparative alternative.

For more information, see

The basics of health economics

A health economic evaluation is important in the assessment of a new medical device. Here you can see a film that gives a brief update of the health economic principles.

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