NEW YORK – The UK National Institute for Health and Care Excellence (NICE) on Thursday recommended three prognostic gene expression tests as tools for guiding adjuvant chemotherapy treatment decisions in an expanded population of early breast cancer patients.
In a final guidance, NICE said Myriad Genetics' EndoPredict (which is being sold to Eurobio), Veracyte's Prosigna, and Exact Sciences' Oncotype DX can be used within the National Health Service (NHS) to guide adjuvant treatment for postmenopausal women or men with estrogen receptor-positive, HER2-negative early breast cancer and one to three positive lymph nodes. Previously, the institute had recommended these tumor profiling tests to guide treatment for lymph node-negative patients only.
The final guidance applies to NHS patients treated in England and Wales.
NICE did not recommend MammaPrint, Agendia's breast cancer risk assessment test. "MammaPrint is likely to be less clinically effective and costs more than standard care," the committee wrote in the final guidance.
NICE's independent diagnostic advisory committee made the recommendation based on evidence behind the three tumor profiling tests, which it found supports their use in deciding whether patients would benefit from post-surgery chemotherapy. The companies that market these tests have agreed to sell them to the NHS at an undisclosed discounted price.
"Our committee has recommended three tests, which they believe are clinically and cost-effective, reenforcing our commitment to get NHS patients the best innovative care based on evidence while at the same time ensuring value for money for the taxpayer," Mark Chapman, the interim director of NICE's Health Technologies Program, said in a statement.