Recommendations

The MTP Council has the regions' mandate to provide recommendations on the use of medical devices and medical devices for in vitro diagnostics within the framework of a nationally managed introduction. The purpose is to achieve an equal, cost-effective and appropriate use of a selection of new medical devices. This applies especially to areas where the risk of unequal care and high costs are considered high and which can pose a challenge for the regions.

There are four different types of recommendations:

• refrain from introduction
• can introduce (used when there are different options to choose from)
• should be introduced (used when different regional decisions regarding implementation may jeopardize good and equal care)
• wait to introduce (used when awaiting decision on introduction).

Prioritisation

The MTP Council's statements are recommendations to the regions. The recommendations are based on the assessment of the value of one or more products and are based on the ethical platform for prioritisation in the healthcare sector (Bill 1996/97: 60) adopted by the Swedish parliament. The ethical platform has three principles in hierarchical order, but must be handled as a whole:

• The human value principle - care must respect the equal value of all people.
• The principle of need and solidarity - more of the healthcare sector’s resources should be distributed to those who have the greatest needs, the most difficult diseases and the worst quality of life.
• The cost-effectiveness principle - means that a reasonable relationship between costs and benefits, measured in improved health and increased quality of life, must be sought.

This means that the MTP Council sometimes needs to say no to a product, for example if the price is high per product or the benefit of introducing the product is low or uncertain.

Balanced assessment

In its assessment, the MTP Council weighs the severity of the condition, the effect the size of the intervention, the uncertainty of the health economic assessment and the prevalence of the condition. These factors are set in relation to the benefit calculated in the health economic evaluation, where the value of the product/products/method is compared with the best current intervention or aids for improved function and ability. The MTP Council and the NT Council also have a policy for assessing society's willingness to pay, which is based on the ethical platform.

In cases where the introduction of new medical technology entails major legal problems, organizational problems or an increased need for key competencies, which would lead to the displacement of other equally important care, it can also be considered in deciding on a recommendation. This may mean that the Council does not recommend introduction even if the product, based on other factors, meets the requirements for prioritization.

Communication

The MTP Council's recommendations are published on the website for nationally managed introduction and are communicated directly to the regions and to the companies concerned.

Period of validity

The MTP Council makes a new assessment of an issued recommendation no later than after two years. If the recommendation is still deemed to fulfill a function to ensure equal use, it remains for a further maximum of two years. If the medical device is considered to be implemented in accordance with the issued recommendation, the national managed introduction will be completed and the regions will be informed of this.

If the recommendation becomes obsolete, for example if a similar product is about to be introduced or will be introduced later, or if the product has been used outside the intended indication, the recommendation will be revised.