Swedish TLV report on its activities in health economic evaluations of medical technologies in 2020

On December 03, 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) published a report on its activities in health economic evaluations of medical technologies in 2020. The significant change is that since 2020 TLV has a permanent assignment to carry out horizon scanning and health economic evaluations of medical technology products as a part of the national orderly introduction framework.

During the 2020 year, TLV played an important role in horizon scanning, aiming to identify new and innovative medical technology products that may become important in Swedish healthcare. Based on horizon scanning MTP Council decides whether to launch a national orderly introduction process and orders TLV theme surveys and/or health economic assessments. TLV considers three types of horizon scanning:

• International surveillance -  TLV regularly monitors what the corresponding authorities in some selected countries publish, focusing on publications from British National Institute for Health and Care Excellence (NICE), Canadian Canadian Agency for Drugs and Technologies in Health (CADTH), and American Food and Drug Administration (FDA)
• Input from companies with information about their product - TLV has a questionnaire that companies can fill in on the website. In 2020, about ten submissions from companies have been received. The number of inputs will likely increase as the general knowledge of the orderly introduction process is rising.
• Thematic surveys – a particular focus on medical devices in a specific area of ​​therapy and for the particular purpose of use, announced by TLV during a certain period. The evaluation group selects the areas of use in consultation with groups within the national knowledge management system. TLV uses different communication channels to actively encourage relevant actors - provides information through publicly available channels and directs information specifically to stakeholders such as industry organizations, patient associations, professional associations, other authorities, and universities.

Two thematic surveys were initiated in 2020. The first one was conducted during the summer related to ischemic heart disease and heart failure. Submissions for products and development projects were received from 15 stakeholders, including industry organizations, companies, patient associations, etc.

In November, TLV began a second thematic survey focused on medical technology products for diagnosis/medical assessment in case of suspected stroke that leads to faster treatment decisions.

MTP Council can also order a survey from TLV before a decision on national collaboration. The survey aims to provide information about, for example, alternative products market and/or health economic evaluations carried out in other countries.

• In 2020, TLV delivered a survey of genetic testing platforms for breast cancer. This survey emerged that the products Oncotype DX, Mammaprint, EndoPredict, and Prosigna are mentioned in the Swedish care program for breast cancer and several international clinical guidelines. TLV reported the survey for the MTP Council in August.

If MTP Council positively decided on national collaboration, it initiates a health economic evaluation and typically commissions it to TLV. A health economic assessment from TLV always refers to a specific medical technology product. TLV requests the basis (documents) for a health economic assessment from the company. From the time the documentation has been received to TLV, the processing time shall not exceed six months.

• In September 2020, TLV began the first health economic evaluation commissioned by the MTP Council. The order included four similar products within the breast cancer area: Oncotype DX, Mammaprint, Prosigna, and EndoPredict.TLV is currently waiting for information from the companies. The companies providing Oncotype DX, Mammaprint, and Prosigna were positive to the request and are working to develop the documentation requested by TLV. The company producing EndoPredict refused participation.

See more information in Swedish here.

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