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

25

Nov 2019

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.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

The latest related news

24

Mar 2022

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 2472 of February 10, 2022, Tuscany Regional Healthcare has published assessments of five medical devices of various therapeutic areas, such as cardiovascular and peripheral vascular areas.

Read more

23

Mar 2022

In late January 2022, Swedish Medical Technologies Product (MTP) Council issued an updated version of recommendations regarding gene expression analysis for decision-making on the adjuvant breast cancer treatment, initially published in November 2021. The recommendation to the regions remains the same. The changes were only concerned with the clarification of some facts.

Read more

18

Mar 2022

On February 22, 2022, a repository of innovative acts outside the nomenclature of biology and anatomopathology (RIHN) and a Supplementary list of IVD tests were published. Minor changes were introduced in the 2022 RIHN list.

Read more

16

Mar 2022

In February 2022, Swedish Medical Technologies Product (MTP) Council issued an updated recommendation on FreeStyle Libre for continuous glucose monitoring in type 2 diabetes (T2D). The initial recommendations were published by NT Council in 2018 and updated by MTP Council in 2020 to include FreeStyle Libre 2. In the 2022 update, MTP Council decreased the Hba1c limit from 70 to 60 mmol/mol and added a statement on lifestyle changes and treatment optimization with non-insulin antidiabetic drugs.

Read more

15

Mar 2022

The Belgian Health Care Knowledge Center (KCE) initiated a study aimed at defining a clear and transparent procedure for the evaluation of digital health technologies in Belgium.

Read more