Swedish recommendations for FoundationOne CDx genomic test by the New Therapies Council

In Sweden, there is a group of experts that supports the Swedish county councils on questions concerning new drug therapies, with the aim of enabling equal drug treatment for patients throughout the country, which is called the New Therapies (NT) Council.

The NT Council is commissioned to make recommendations to the county councils on the use of new drug therapies. The county councils have appointed one representative with medical or pharmaceutical expertise per health care region to the council. In addition, the council includes members with expertise in, for instance, ethics, health economy, oncology, horizon scanning, and patient engagement.

The NT Council provides the comments on medical technology products and methods that are evaluated within the framework of the Dental and Pharmaceutical Benefits Agency (Tandvårds Läkemedelförmånsverketthe, TLV) medical technology assignment. The recommendations are given on the same basis as for medicines and in dialogue with national program councils and care program groups.

In October 2019, the NT Council released the following recommendations regarding FoundationOne CDx - comprehensive genomic profiling test for all solid tumors that incorporates multiple companion diagnostics:

• Do not use FoundationOne CDx in routine healthcare for treatment control without the established diagnostic methods
• FoundationOne CDx or similar methods for comprehensive genomic profiling may be considered in specific cases (e.g., when necessary molecular pathological analyses are not available) when the choice of treatment should be linked to indications and guidelines approved in national care programs
• Use comprehensive genomic profiling as support for the drug treatment choice in the context of clinical studies as there is a great need for knowledge and validation.

See the full details in Swedish here.

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