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Breast Cancer Molecular Tests Included in Recommendations by UK's NICE

NEW YORK (GenomeWeb) – The UK's National Institute for Health and Care Excellence (NICE) has included three molecular diagnostics — Myriad Genetics' EndoPredict, NanoString's Prosigna, and Genomic Health's Oncotype DX — in recommendations for tests guiding chemotherapy decisions for early-stage breast cancer patients.

An earlier review by NICE, which evaluates whether interventions improve patient outcomes, calculates their cost effectiveness, and advises whether the UK's National Health Service should pay for them, had resulted in draft recommendations where the organization had said that none of the tests offer a significant enough impact on health outcomes compared to current practice to make them cost effective. Sponsors like Myriad, Genomic Health, and others had objected and reached out to NICE with additional data. 

The latest, final guidance from NICE suggests the group was somewhat swayed by these efforts. It recommended EndoPredict, Oncotype DX, and Prosigna as options for guiding adjuvant chemotherapy decisions for early-stage breast cancer patients with estrogen receptor-positive, HER2-negative tumors that haven't spread to the lymph nodes, if they meet certain criteria.

After reviewing the data, however, NICE still felt there were uncertainties in the economic modeling around the tests' ability to guide pre- and post-test chemotherapy decisions and the effect of adjuvant chemotherapy on distant recurrence. The organization also noted the lack of data comparing tumor profiling tests with validated breast cancer risk assessment tools, such as Predict.

As such, NICE recommended EndoPredict, Prosigna, and OncotypeDx for patients who are at intermediate risk for distant recurrence using a validated tool such as Predict or the Nottingham Prognostic Index, adding that the information from these tests should help patient choose, with their doctors, whether or not to have chemotherapy.

"The companies provide the tests to the NHS with the discounts agreed in the access proposals," NICE noted. Additionally, NICE has asked clinicians and companies to make "timely, complete, and linkable record-level test data available to the National Cancer Registration and Analysis Service."

Meanwhile, NICE did not recommend Agendia's MammaPrint for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2‑negative, and lymph node-negative early breast cancer, deciding it is not cost effective. Also, NICE did not recommend IHC4+C for this purpose "because the analytical validity of the test is uncertain."