NEW YORK (GenomeWeb) – Starting April 1, the UK's National Health Service will begin offering Genomic Health's Oncotype DX breast cancer recurrence test to patients who meet certain eligibility criteria.
The National Institute for Health and Care Excellence in September 2013 issued a final guidance for Oncotype DX, recommending it as a tool that doctors can use to gain a more definitive assessment of a woman's risk of breast cancer recurrence after she is found to be at intermediate risk (those with a Nottingham Prognostic Index score above 3.4) for distant disease recurrence using standard assessment tools. The woman should also have early-stage, invasive breast cancer that involves hormone receptors but doesn't have HER2 over-expression and hasn't spread to the lymph nodes.
The NICE recommendation specifies the use of Oncotype DX for intermediate risk patients for whom doctors are unclear whether to prescribe chemotherapy. With the Oncotype DX score they can hope to garner additional guidance as to whether a patient is likely to benefit from the addition of chemotherapy with tamoxifen.
Genomic Health cited research that found that fewer than 10 percent of early-stage breast cancer patients benefit from chemotherapy and that one-third of physicians' treatment recommendations change based on Oncotype DX test results.
"The NHS decision brings us an important step closer to achieving our goal of improving the quality of treatment decisions for cancer patients worldwide," Genomic Health CFO Brad Cole said in a statement. The firm estimates that 3,500 women in the UK have been tested with Oncotype DX.
NICE calculates the cost effectiveness of healthcare interventions and advises NHS whether it should pay for them. The agency considers a drug, test, or strategy to be cost effective when it falls within the range of £20,000 to £30,000 per QALY gained. Based on an initial appraisal, where NICE considered a broader indication for Oncotype DX, the test didn't meet its cost-effectiveness threshold.
After that, Genomic Health proposed a "revised price" to NICE, making Oncotype DX available to NHS at an undisclosed amount for women deemed to be at intermediate risk of recurrence based on standard methods.