Favorable coverage decision for molecular gene profile analysis (Oncotype DX) in Norway

Molecular gene profile analysis (Oncotype DX) to predict the benefit of chemotherapy in estrogen receptor-positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) early-stage invasive breast cancer was evaluated within the "New Methods" framework starting from 2021. In October 2023, the method assessment phase was completed, and the National Institute of Public Health (NIPH) HTA report was published. 

On August 26, 2024, the Decision Forum made the following recommendations:

• Molecular gene profile analysis (Oncotype DX) is introduced as part of the decision-making process for predicting the benefit of chemotherapy in patients with ER+, HER2- early-stage invasive breast cancer, who are postmenopausal and lymph node-positive. In this category of patients, Oncotype DX can fill an unmet need;
• Oncotype DX is not introduced for ER+, HER2- lymph node-negative early-stage invasive breast cancer. There is a test already available for the same purpose (Prosigna), and there is no documented added value for Oncotype DX. The same cost was assumed for this decision.

See the full details here.

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