FoundationOne CDx comprehensive genomic profiling test for all solid tumors assessed in Sweden

The Dental and Pharmaceutical Benefits Agency (Tandvårds Läkemedelförmånsverketthe, TLV) is a central government agency with the mission to decide whether pharmaceutical products, some types of medical devices, disposable medical devices, and dental care products/procedures shall be subsidized by the state and included in the national benefits scheme for such products and procedures. For this purpose, TLV conducts a number of health economic evaluations of medical devices.

However, there are no decisions neither regarding the purchase of the products by county councils or municipalities, nor the inclusion of medical devices into the high-cost protection scheme provided in these assessments. Thus, the economic evaluations do not have a direct impact on reimbursement, although they influence decision-making in the County Councils regarding the use of the evaluated medical technologies and could influence changes in the reimbursement system of medical devices in Sweden.

In June 2019, the TLV has published a completed health economic evaluation regarding the cost-effectiveness of comprehensive genomic profiling test for all solid tumors FoundationOne CDx in six types of cancers: non-small cell lung cancer, breast cancer, carcinoma of unknown primary, melanoma, colon and rectal cancer and ovarian cancer.

The following conclusions were provided:

• TLV believes that in most cases, the use of FoundationOne CDx is more expensive in comparison to current treatment methods. However, the current method has greater sensitivity and accuracy in the diagnostics
• There are high uncertainties in cost calculation, which relate to tests that could be considered as standard and cost associated with them. TLV has collected data from six healthcare regions and noted that tests and costs might differ

Current health economic evaluation will form the basis of a national recommendation for new treatment methods with further genetic analysis offer with the use of FoundationOne CDx.

See the full details in Swedish here.

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