Decision to Issue a Recommendation
Products proposed by the MTP council's evaluation group are presented to the MTP council, which decides whether a national recommendation should be drawn up for the products. The MTP Council's assessment is based on set priority criteria. If there are several similar products, a recommendation can also cover a product group.
Basis for Recommendations
The type of documentation needed for the MTP Council to be able to make a recommendation can vary depending on the type of product. The following is usually the basis for a recommendation:
- Health economic evaluation.
- Legal analysis regarding IT security and personal data management.
- Purchasing strategy, analysis of commercial conditions.
- Dialogue with clinical experts.
Temporary Recommendation to Wait
When deciding if a recommendation should be drawn up, the MTP Council can recommend the regions to delay the introduction of the medical device while waiting for the MTP Council's evaluation and recommendation.
Health Economic Evaluation
A health economic evaluation is a tool for assessing costs and effects in connection with resource use in healthcare. The purpose of the evaluation is to facilitate the prioritisation of available resources to get the most health possible. The most common method is to calculate the cost-effectiveness of a medical device, i.e. the relationship between the benefit and cost of use compared to a relevant comparison alternative. The health economic assessment is carried out by the Dental and Pharmaceutical Benefits Agency, TLV, at the request of the MTP council. In the health economic evaluation of a medical device, the company behind the product must provide scientific data that shows the costs and benefits that arise for society when using the product compared to the most relevant comparison option.